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ASCO CEO Meets ASCO CMO: Retiring ASCO Chief Medical Officer Dr. Richard L. Schilsky Gives Far-Reaching Interview on this AiA Podcast Dec 21, 2020

Retiring ASCO Chief Medical Officer Dr. Richard L Schilsky gives a far-reaching interview with ASCO in Action podcast host ASCO CEO Dr. Clifford A. Hudis, who examines Dr. Schilsky’s trailblazing medical career, his leadership in ASCO and indelible mark on its research enterprise, and what he sees for the future of oncology. ASCO’s first-ever Chief Medical Officer even offers some friendly advice for Dr Julie Gralow, who starts as ASCO’s next CMO on February 15, 2021. In a touching tribute, Dr. Hudis also shares what Dr. Schilsky’s friendship and mentorship has meant to him personally, and suggests that Rich will still be supporting ASCO on critical priorities moving forward. Don’t miss this exchange with one of oncology’s greats!

Transcript

DISCLAIMER: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

CLIFFORD HUDIS: Welcome to this ASCO in Action podcast brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insights into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org.

The ASCO in Action podcast is a series where we explore the policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for-- people with cancer. My name is Dr. Clifford Hudis. And I'm the CEO of ASCO and the host of the ASCO in Action podcast series.

For today's podcast, I am especially pleased to have as my guest my friend, colleague, and mentor Dr. Richard Schilsky, ASCO's chief medical officer. Now, I am sure that many of our listeners have already heard that Dr. Schilsky will be leaving ASCO in February of 2021, retiring.

However, I want to reassure everybody that even in retirement, he will continue to make contributions and provide leadership to all of us. And his illustrious and path-blazing career in oncology spanning more than four decades is not quite over thankfully.

Rich is ASCO's first chief medical officer. And as such, he has made a truly indelible mark on all of us. He started with a proverbial blank piece of paper. The position had no precedent. It had no budget. It had no staff.

But now after just eight years in the role, he has helped make the CMO a critically important position at the society. And I have to say that success is more than anything due to Rich's vision and his leadership. And that's some of what we'll be talking about today.

So Rich, thank you very much for joining me today for what I hope is going to be a great casual but informative conversation about your amazing career, your unique role at ASCO, and maybe most importantly in the end what you see for the future of oncology not just in the United States, but around the world. Thanks for coming on, Rich.

RICHARD SCHILSKY: Thanks, Cliff. It's great to be here today.

CLIFFORD HUDIS: So with that, let's just dive right in and start at the very beginning. Rich, tell everybody why you decided to become an oncologist and maybe share a little bit about what those early days looked like for you and, in that context, what it was like to have cancer at the beginning of your career.

RICHARD SCHILSKY: Well, I knew from an early age that I wanted to be a doctor. And in fact, I had written a little essay when I was in sixth grade as a homework assignment called My Ambition. And my mother had tucked that away in a scrapbook. And I found it a number of years ago. And on rereading it, it was quite amazing to me to see what I was thinking about even then.

Because I said not only did I want to be a doctor, but I didn't think that was enough, that I wanted to be a medical researcher because I wanted to discover new information that would help people heal from whatever their diseases might be.

And so it was never really any doubt in my mind that I would be a physician. I went to medical school at the University of Chicago. But I was living in New York City at the time having grown up in Manhattan. And the only year we had off in medical school, the only time we had off in medical school, was the summer between the end of the first year and the beginning of the second year.

So during that time, I went back to Manhattan. And I was able to get a fellowship from the American College of Radiology that allowed me to essentially hang out in the radiation therapy department at New York University Medical Center, which was within walking distance of where I grew up. And so I would go over there every day. And I was taken under the wing of a young radiation oncologist.

And of course, I wasn't really qualified to do anything at that point except to follow him around, talk and listen to the patients. But that turned out to be a really formative experience for me because we saw the whole gamut of cancer. We saw head and neck cancers. We saw lung cancer. We saw patients with breast cancer and prostate cancer.

And in those years-- this is the early 1970s-- many of these patients have fairly locally far advanced disease and were quite debilitated by it. But listening to their stories, hearing about their hopes and their struggles, really demonstrated to me the human side of cancer.

So I went back to school and thought about this in the context of my own personal experience, which dated back to when I was in college when my mother's mother, my maternal grandmother, was diagnosed with breast cancer. This was 1968. And as you well know, there were very few therapies available for breast cancer in the late 1960s, mostly hormone therapies.

And my grandmother had the treatment that was considered standard of care at that time, which was extended radical mastectomy followed by chest wall radiation. And some years after that first mastectomy, she had a breast cancer that developed in the opposite breast and had a second extended radical mastectomy and chest wall radiation. And these were very traumatic and disfiguring procedures for her to go through.

Anyway, long story short is after another few years, she developed bone metastases and then brain metastases. And there was really very little that could be done for her other than hormone therapies. And having observed her go through that illness and realizing how limited our treatment options were and then having the experience after my first year in medical school pretty well cemented for me that I wanted to be an oncologist.

I thought actually about being a radiation oncologist. But then I did my internal medicine rotation in medical school, fell in love with internal medicine. And that sort of put me on the path to be a medical oncologist.

The clinical challenge of caring for cancer patients, the emotional attachment to those patients, and, of course, even then, the unfolding biology of cancer was so intellectually captivating that I actually applied for oncology fellowship when I was a senior medical student. So even before going off to do my medical residency, I had already been accepted as a clinical associate at the National Cancer Institute to start two years hence. And that's how I became an oncologist.

CLIFFORD HUDIS: So it's so interesting. Because, of course, the story I'm sure for many people interested not just in oncology, but even medical education, there are little things that don't happen nowadays that happened with you like that last little vignette about the early acceptance into an advanced training program before your fellowship among other things.

Can you remind us about the timeline? Because I think one of the things that many of our listeners often can lose sight of is just how new oncology really is as a specialty. ASCO itself founded in 1964. And the first medical oncology boards were mid-'70s, right? So you were in med school just before that second landmark, right?

RICHARD SCHILSKY: That's right. I graduated from medical school in 1975. I started my oncology fellowship in 1977. And I got board-certified in medical oncology and joined ASCO in 1980. And so that was the time frame at that point.

CLIFFORD HUDIS: So the internal medicine was actually, if I heard you right, just two years, not the now traditional four.

RICHARD SCHILSKY: Yeah. I was a short tracker. I did only two years of internal medicine training rather than three. I did my training at Parkland Hospital and University of Texas Southwestern in Dallas with at that time a legendary chair of medicine, Don Seldin, who I had to get permission from him to leave the program prior to completing the third year of residency because I had already been accepted into fellowship at NCI.

And he, Seldin, who was a brilliant chairman and a brilliant nephrologist, was not at all interested in cancer. And it took a bit of-- I was going to say arm twisting, but it really took bleeding on my part to get him to agree to allow me to leave the residency program to go to the NCI. But he eventually agreed.

And in those years, the first-year clinical fellowship at the NCI was like being an intern all over again. There were about 15 of us. We were on call overnight in the clinical center once every two weeks. We cared for all of our inpatients as well as had a cadre of outpatients.

We did all of our own procedures. We had no intensive care unit. So patients who were sick enough to require ventilator support, we cared on the floor in the inpatient service on our own with guidance from senior oncologists. It was a bit different from the way it is now. But, of course, it was fantastic on-the-job training because we just learned a ton and had to learn it very quickly.

CLIFFORD HUDIS: So that's actually a great segue to the advances because there was a lot to learn then. But, wow, there's a lot more to learn, I think, now. And I have real sympathy for trainees and younger oncologists for the breadth of what they need to learn. Again, just testing your memory, but platinum came along pretty much in the mid-'70s as well, right? That was a pivotal expansion of the armamentarium for us.

So what do you see-- when you summarize progress in cancer research and care over these decades, what do you think are the most pivotal or revolutionary milestones that you identify over the span of your career?

RICHARD SCHILSKY: Yeah. It's really interesting to think about it historically. There were the early years of discovery in oncology from the 1950s to the 1970s when we really had the introduction of the first chemotherapy drugs and the miraculous observation that people with advanced cancer could actually obtain a remission and, in some cases, a complete remission with chemotherapy and combination chemotherapy in particular.

And so that was the formative years of oncology as a medical specialty and really proof of concept that cancer could be controlled with drugs. When we got into the 1980s, the 1980s in many respects were the doldrums of progress in clinical oncology. There really was not a lot of innovation in the clinic.

But what was happening and what was invisible to many of us, of course, was that was the decade of discovery of the fundamental biology of cancer. That's when oncogenes were discovered, when tumor suppressor genes were discovered, when it became clear that cancer was really a genetic disease. And that is what transformed the field and put us on the path to targeted therapy and precision medicine as we think of it today.

So I think that clearly understanding the biology of cancer as we do now and all that it took to lead us to that point, which was a combination of understanding biology, developing appropriate technology that would, for example, enable the sequencing of the human genome and then the cancer genome.

And the other formative technology in my opinion that really changed the way we care for cancer patients was the introduction of CT scanning. When I was still a fellow at the NCI, we did not have a CT scanner. If we needed to get detailed imaging of a patient, we did tomography. And if you remember what tomograms looked like, they were really blurry images that you could get some depth perception about what was going on in the patient's chest or abdomen. But they really weren't very precise.

When CT scanning came along, it really revolutionized our ability to evaluate patients, assess the extent of disease, stage them in a much more precise way, which then allowed for better patient selection for curative surgery, better radiation therapy planning. So we don't often point to imaging advances as some of the transformative things that paved the way in oncology, but I think imaging is really overlooked to some extent.

So I think the technology advances, the biological advances, are the things that really allowed the field to move forward very quickly. And by the time we got into the mid-1990s, we were beginning to see the introduction of the targeted therapies that have now become commonplace today.

And then it was around 2000, I think, that we saw the introduction of Gleevec. And I'm reminded always about an editorial written by Dan Longo in The New England Journal a few years ago. And Dan and I were fellows together. We worked side by side on the wards at the clinical center and became very good friends.

And Dan in his role as a deputy editor of The New England Journal wrote an editorial a few years ago that was titled "Gleevec Changed Everything." And Gleevec did change everything. It changed our entire perception of what were the drivers of cancer and how we might be able to control cancer very effectively and potentially put it into long-term remission.

Now, of course, we know now that the whole Gleevec story is more of an exception than a rule in targeted therapy. And, of course, we know that tumors become resistant to targeted therapies. But we couldn't have known any of this back in the early years of oncology because we had no real insight into what caused cancer to grow or progress. And the notion of drug resistance, while we realized that it occurred, we had no idea what the mechanisms were. So it's such a different landscape now than what it used to be. It's quite remarkable.

CLIFFORD HUDIS: So as you tell the story, there's, of course, a lot of focus on technology, whether it's biology and understanding the key features of malignancy or imaging or more. But what I also note in your story and I want to come back to is the people. And I can't help but reflect on where we are in this moment of the COVID-19 pandemic. Yes, we've moved to telemedicine. Everything can be accomplished via technology. And, yet, the human touch is so important.

When we think about being in the room with people, when we think about face to face from the context of career development and your own career, you touched on Dr. Seldin, I think, already from the perspective of internal medicine training. But are there are other mentors or important shapers of your career that you think we should know about?

RICHARD SCHILSKY: Well, probably, the most influential person early in my career in medical school was John Altman. John, you may know, was the inaugural director of the University of Chicago's NCI-designated Cancer Center, which was one of the very first NCI-designated cancer centers in 1973 after the National Cancer Act of 1971 created the cancer centers program.

And John, who was a leading oncologist studying Hodgkin and non-Hodgkin's lymphoma, was a faculty member there. He was the director of our cancer center as I said. He took me under his wing even when I was in medical school and served as a real role model and mentor to me.

When I was in my internal medicine training as I mentioned earlier, Don Seldin, the chair of medicine, was never particularly interested in oncology. So, to some extent, I didn't have-- I had great internal medicine training. But I did not have good mentorship in oncology. When I got to the NCI, then my whole world really opened up.

And the two pivotal people there in my career were Bob Young, who was chief of the medicine branch and was my clinical mentor and remains a mentor and friend to this day, and then, of course, Bruce Chabner, who was the chief of the clinical pharmacology branch.

And in my second year of fellowship when we all went into the laboratory, I went into Bruce's lab. And that's where I really got interested in the mechanism of action of anti-cancer drugs and ultimately in drug development and early phase clinical trials. And both Bob and Bruce remain very close to me even today.

CLIFFORD HUDIS: So I'm concerned about time on our call today on our discussion. Because we could obviously fill lots of hours on all of these remarkable experiences and amazing people you worked with. But I'm going to ask that we fast forward a little bit.

You and I share, I think, passion and love for ASCO. So I think that it's reasonable for us to focus a little bit on that for the time we have left here. You didn't start out obviously as chief medical officer at ASCO. But you were a really active ASCO volunteer and leader. Maybe tell us a little bit about some of the ASCO volunteer roles that you engaged in and what that meant to you at the time and how that led to this role.

RICHARD SCHILSKY: Well, I'll be brief. I joined ASCO in 1980 at the first moment that I was eligible to join ASCO. I had attended my first ASCO meeting the year before, 1979, when I was still in my fellowship training. And it was clear to me even then when the whole annual meeting was about 2,500 people in two ballrooms in a hotel in New Orleans that that was a community of scholars and physicians that I wanted to be a part of.

And so, over the years, I did what people do even today. I volunteered to participate in whatever ASCO activity I could get involved with. Over the years-- I think I counted it up not too long ago-- I think I served or chaired 10 different ASCO committees, more often serving as a member, but in a number of those committees also serving as the chair over many years.

And as I became more deeply involved in ASCO and saw other opportunities to engage, I had the opportunity to run for election to the board and was-- after a couple of tries was elected to serve on the board and then eventually elected to serve as ASCO president in 2008-2009.

But the attraction of ASCO in many ways was a community of diverse but, in many ways, like-minded people, people who had similar passion and drive and focus. But I think what you get at ASCO in many ways is the wonderful diversity of our field. If you work in a single institution for much of your career as I did and as you did, you get to know that institution pretty well. You get to know its perspectives and its biases and its strengths and its weaknesses.

But there's a whole world of oncology out there. And you can get exposed to that at ASCO because you meet and work with colleagues from every clinical setting, every research setting, people who have remarkable skills and interests and passions. And it's just a wonderful environment to help develop your career. So I consider myself to be extremely fortunate to have had the journey in ASCO that I've had culminating, of course, with ultimately my coming on the staff as ASCO's first chief medical officer.

CLIFFORD HUDIS: We often joke about that blank sheet of paper. But in retrospect, it's very obvious that you had built up that collection of LEGO blocks, and then you assembled them all into the ASCO Research Enterprise, a name you gave it.

And it really, in retrospect, builds, I think, very cleanly upon all of your prior experience, but also the vision that you developed based on that experience for how research should be conducted. Can you maybe share with everybody the scope and vision for the ASCO Research Enterprise, what the intent was, and where you see it going, and what it includes today?

RICHARD SCHILSKY: Sure. I won't claim that I came to ASCO with the whole thing fully developed in my mind. As you said, when I came, I literally did have a blank slate. Allen Lichter, who hired me, said, come on board and help me make ASCO better. And so I, in a sense, reverted to what I knew best how to do, which was clinical research.

And having in my career been a cancer center director, a hem-onc division chief, a cooperative group chair, I had a lot of experience to draw on. And it was obvious to me that ASCO was fundamentally an organization that took in information from various sources, evaluated it, vetted it, collated it, and then disseminated it through our various channels, most notably our meetings and our journals.

But ASCO itself did not contribute to the research enterprise. And that seemed to me to be a lost opportunity. We knew that ASCO had lots of data assets that could be of interest to our members and to the broader cancer community. But they were scattered all around the organization and not particularly well annotated or organized. So we began to collate those. And they are now available to ASCO members on the ASCO data library.

I recognized that we did not have an organized unit in ASCO to support or facilitate or conduct research. So, in 2017, we formed the Center for Research and Analytics and brought together staff who were already working at ASCO but scattered in different departments but all people who had an interest in clinical research or research policy and brought them into this new unit, which has really become the focal point for research work at ASCO.

We recognized that ASCO members for many years were interested in surveying their colleagues, surveying other ASCO members, to help advance research questions. But ASCO actually had a policy that prohibited that.

So that never really made good sense to me. It seemed like a lost opportunity. And we were able to create a program and have the ASCO board approve it whereby any ASCO member could opt in to participate in what we now call the Research Survey Pool.

And in doing so, they are essentially agreeing to participate in research surveys conducted by their colleagues. So that program is now up and running. There are, I think, eight surveys that have been completed or are currently in the field. And this is now a service that ASCO provides through CENTRA to its members to enable them to survey their colleagues for research purposes.

Most importantly, I think we saw an opportunity back in 2014 or 2015 to begin to learn from what our colleagues were doing in clinical practice as they began to deploy precision medicine. And there was a lot of genomic profiling that was going on at that time. It was revealing actionable alterations in roughly 30% or so of the tumors that were profiled.

But there was a lot of difficulty in doctors and patients obtaining the drugs that were thought to be appropriate to treat the cancer at that particular time because most of those drugs would have to be prescribed off label. And there was not a sufficient evidence base to get them reimbursed. And, moreover, even if they could be reimbursed, there was no organized way to collect the patient outcomes and learn from their experiences.

So that led to us developing ASCO's first prospective clinical trial, TAPUR, which really solves both of those problems. Through the participation of the eight pharmaceutical companies that are engaged with us in the study, we are providing-- at one point, it was up to 19 different treatments free of charge to patients.

These are all marketed drugs but used outside of their FDA-approved indications. And we were collecting data on the patients, the genomic profile of cancer, the treatment they received, and their outcomes in a highly organized way.

And so now this is a study that we launched in 2016. We're now almost to 2021. We have more than 3,000 patients who have been registered on the study, meaning consented to participate, more than 2,000 who have been treated on the study. And we are churning out results as quickly as we can about which drugs are used or not useful in the off-label setting for patients whose tumors have a specific genomic profile.

So we built all this infrastructure. And having this in place has also then allowed us to respond rapidly to unmet needs. So when the COVID-19 pandemic overwhelmed all of us, and when our members were looking for information about what was the impact of COVID-19 on their patients, one of the things we were able to do because we had CENTRA, because we had a skilled staff and an infrastructure, was to very quickly stand up the ASCO COVID-19 registry, which we launched in April of this year.

And there are now about 1,000 patients who've enrolled in the registry from around 60 practices that are participating. And we will follow these patients now longitudinally and learn from their experiences what has been the impact of the COVID-19 illness on them and their outcomes, how has it disrupted their cancer care, and ultimately how that impacts their overall cancer treatment outcomes.

So as I now contemplate leaving ASCO after eight years having started with a blank slate, I'm very proud of the fact that I think I'm leaving us with a remarkable infrastructure. We now have a clinical trials network of 124 sites around the country participating in TAPUR that we never had before. We have through the work of CancerLinQ a real-world evidence data generator that is beginning to churn out valuable insights.

We have a capacity to survey ASCO members for research purposes. We have an ability to stand up prospective observational registries to gather information longitudinally about patients and their outcomes. We have a core facility in CENTRA with highly skilled data analysts and statisticians that can support these various research activities.

So ASCO is now primed, I think, to really contribute in a very meaningful way to the gaps in knowledge that will forever exist in oncology just because of the complexity of all the diseases we call cancer. And that's what I mean by the ASCO Research Enterprise. It is in fact remarkable and, I think, powerful enterprise if we continue to use it effectively.

CLIFFORD HUDIS: Well, that's an interesting segue to my next thought, which is really about what comes next. I'll talk about you. But let's start with ASCO first. Your successor, Dr. Julie Gralow, obviously has been announced publicly. She's an accomplished clinician and researcher. She has a known recognized passion for patients, patient advocacy, clinical research through her leadership at SWOG but also health care equity and global oncology.

So from your perspective, having created all of these assets and resources, what advice would you give Dr. Gralow publicly on how to make the position hers, what to take us to next? And I do want to acknowledge for everybody listening that the hints I've been making up until now are that Rich has agreed that he will continue to contribute as a leader to TAPUR for the short term, at least, at least the next year helping Julie get fully oriented to this program and others. So what will your advice be to Julie?

RICHARD SCHILSKY: That's a great question. She's a great selection. And congratulations on hiring her. I think there are two key issues, I think, maybe three. One is to have a broad scope and cast a wide net. Oncology care and cancer research and cancer biology are incredibly complicated and nuanced and broad in scope.

And although Julie is an accomplished breast cancer clinician and researcher, in this role at ASCO, you have to be very broad. You have to understand all of cancer care, all of cancer research, all of policy and advocacy not as an expert in necessarily in any one aspect of ASCO's work, but you have to understand the impact of all of those things on cancer care providers and on cancer patients.

And it's important to always be looking to the future. The future is going to be here before you know it. And we as a professional society have to prepare our members for that future. So that leads me to the second point, which is listen to the members.

The members are the people on the front lines who are delivering care to patients every day. And, fundamentally, ASCO's job is to be sure that our members have all the tools and knowledge and resources that they need to deliver the highest quality care to patients every day. So listening to what they need, what their struggles are, what their burdens are, is extremely important.

And then the third thing I would recommend to her is that she get to know the staff and colleagues that she'll be working with. ASCO has a remarkably accomplished, skilled, motivated, passionate staff, many of whom have been with the organization for years, if not decades, who understand what ASCO can and cannot do and who understand what our members need. And she will be well advised to spend a good portion of her first few months on the job just listening and learning from her colleagues.

CLIFFORD HUDIS: That's always good advice for anybody making a big career move. But, of course, the wisdom you bring to it is palpable and much appreciated. And I'm sure Julie will be taking your advice. And, by the way, so will I continue to do that even after you make your move. So speaking of your retirement, can you share with us a little bit about what it's actually going to look like for you? Is it about family? Or are you still going to have some professional engagement? Again, I suggest that there might be some already, but maybe you could expand on it.

RICHARD SCHILSKY: Yeah. I'm still fully focused on my work at ASCO. And, of course, as you know, when I wake up on February 15, I will no longer be ASCO's chief medical officer. And it's going to be a bit of a rude awakening. Fortunately, I will be able to continue my engagement with ASCO through the TAPUR study as you mentioned. I will, of course, forever be at ASCO member and a donor to Conquer Cancer and be willing to serve the society in any way.

I have a number of activities that I've been involved with even throughout my time at ASCO. Not-for-profit boards, for example-- I'm on the board of directors of Friends of Cancer Research. I'm on the board of directors for the Reagan-Udall Foundation for FDA.

I plan to continue with those activities as long as they'll have me. I've been serving the last few years on the board also of the EORTC, the large European cooperative clinical research group. And I expect to continue in that role.

Beyond that, I will see what opportunities come my way. I think one of the things about retirement if you will that I'm looking forward to is the opportunity to pick and choose what to work on based on what interests me without having the burdens of having a full-time job.

On the personal front, of course, we're all looking forward to crawling out from the pandemic. I've basically been locked in my home outside Chicago since March. And I'm looking forward to getting back out to a little bit of a social life. As you know, I have two grown daughters and now three grandchildren, two of whom are in Atlanta, one of whom is near by us in the Chicago area. So looking forward to spending time with them as well.

So it will be a change for me to be sure after working as hard as-- I feel like I've worked for really now 45 years since I graduated from medical school. But I also feel like I'm not quite done yet and that I still have ways in which I can contribute. I just feel like at this point, maybe it's time for me to choose how I want to make those contributions and spend a little bit more time doing some other things.

CLIFFORD HUDIS: Well, both you and my predecessor, Allen Lichter, are modeling something, have modeled something, that I think is not often discussed but can be very important. For people and for institutions, change is not a bad thing. And setting the expectation that you will pour your heart and soul into something but not necessarily do it alone or forever and not prevent others from taking that role at some point, that's a really-- I think it's a selfless kind of sacrifice in a way.

Because, of course, you could stay and do what you're doing for longer. But as you and I have discussed, there is a value for all of us collectively in having fresh eyes and new people take organizations in a new direction. That's how I ended up here frankly. And I think that's the kind of opportunity you're creating right now, something that should be celebrated in my opinion.

RICHARD SCHILSKY: Well, thanks. And I couldn't agree more. When I look back at the arc of my career and having all the different kinds of leadership roles that I've had, I basically have made a job change every 8 to 10 years. I was the director of our cancer center for nearly 10 years. I was associate dean for clinical research at the University of Chicago for eight years, another position that I created from a blank slate at that institution.

The exception was serving 15 years as a CALGB group chair. But that was a position I really loved and enjoyed and felt like at the end of the first 10 I hadn't quite accomplished everything I wanted to accomplish.

But the point is that I think it is both necessary for organizations to have regular leadership change. And it's also refreshing for us as individuals. There gets to a point where you feel like you can do your job in your sleep. And I actually think that's a good time to make a change.

Because if that's the way you feel, you're not being sufficiently challenged. And you're probably not being sufficiently creative. And so it's a good time to move on and refresh your own activities and give your organization a chance to bring in someone to hopefully build on whatever you've created and bring it to the next level.

CLIFFORD HUDIS: Well, I agree with all that, although I think your comment there about doing the job in your sleep would not apply because I'm pretty confident that the environment and opportunities have continued to evolve in a way that has made it interesting from beginning to end. But you don't have to rebut me on that. I just want to thank you very, very much, Rich.

As we set up this podcast, I expected that we would have a really fun and enlightening conversation. And, of course, you did not disappoint. We could talk for much, much longer if we only had the time.

On a personal note to you and for the benefit of our listeners, I want to share that Rich has been for me a remarkable friend and mentor and colleague. I first met Rich at the very beginning of my career when my mentor, Larry Norton, pushed me out from Memorial into the larger world. And he did that first and primarily through ASCO and the Cancer and Leukemia Group. Those are really the two places where I was exposed to the world.

And through the CALGB, Rich really began to offer me and others, many others, opportunities that shaped careers plural, mine and others. So when I got to ASCO as CEO, Rich was there. And I knew I could always depend on you to be clearheaded, intellectually precise, constructive, visionary. And the thing about you, Rich, is that you never would say yes to anything unless you knew for sure you could do it and indeed, I think, how you could do it.

I always share this story which your staff at CENTRA pointed out to me. And I have to admit that I hadn't picked it up myself. But in all the years of now working down the hall from Rich, probably hundreds and hundreds of hours of meetings, he never has taken a note in front of me. And, yet, everything we talk about, every action item we conclude to pursue, they all get done.

So I don't know, Rich. You have a remarkable way of organizing your thoughts and your plans, keeping it together, and getting things done. And I'm going to miss that tremendously in the years ahead.

So, Rich, I want to say congratulations. Congratulations on reaching this really important milestone in your life. Thank you on behalf of ASCO and the broader oncology community and the patients we care for and their families for making the world a better place. And just as a small thing, thank you for joining me today for this ASCO in Action podcast.

RICHARD SCHILSKY: Thank you, Cliff. It's been great.

CLIFFORD HUDIS: And, for all of you, if you enjoyed what you heard today, don't forget to give us a rating or a review on Apple Podcasts or wherever you listen. And, while you're there, be sure to subscribe so you never miss an episode. The ASCO in Action podcast is just one of ASCO's many podcasts. You can find all of the shows at podcast.asco.org. Until next time, thank you for listening to this ASCO in Action podcast.

Sneak Preview: ASCO to Hold First-ever Virtual Congressional Advocacy Summit and Week of Action in 2020 Sep 02, 2020

In the latest ASCO in Action podcast, ASCO CEO Dr. Clifford A. Hudis shares a quick preview of what's to come for the 2020 ASCO Advocacy Summit and Week of Action, which will take place September 14-18.

Typically, ASCO volunteers from across the country gather in Washington, D.C. to advocate for policies that will improve access to high-quality, equitable care for people with cancer and ensure robust funding for cancer research through in-person meetings with their Members of Congress. Due to the COVID-19 pandemic, the 2020 ASCO Advocacy Summit will be a virtual event, but participants can expect the same important advocacy and education opportunities that the event provides every year. All ASCO members are encouraged to participate in the Congressional Week of Action by signing up with the ACT Network (through the Advocacy Center on ASCO.org).

Subscribe to the ASCO in Action podcast through iTunes and Google Play.

Transcript

Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Dr. Clifford Hudis: Welcome to the ASCO in Action Podcast, brought to you by the ASCO Podcast Network, a collection of 9 programs covering a range of educational and scientific content and offering enriching insight into the world of cancer care. You can find all of the shows, including this one, at “Podcast dot ASCO dot org” (podcast.asco.org)

The ASCO in Action Podcast is ASCO’s podcast series that explores the policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for—people with cancer.

I’m Dr. Clifford Hudis, CEO of ASCO and the host of the ASCO in Action podcast series. For this podcast, I wanted to share with listeners a preview of the 2020 ASCO Advocacy Summit and Week of Action taking place September 14-18.

Typically, ASCO gathers volunteer advocates in Washington, D.C., in September for education sessions and in-person meetings with their Members of Congress.

Due to the COVID-19 pandemic—like so many events scheduled to take place this year—the 2020 ASCO Advocacy Summit will be a virtual event, but that said, participants can expect the same advocacy and education opportunities that the event provides every year.

ASCO volunteers will meet with Members of Congress and their staff by phone or video to advocate for policies that will improve access to high-quality, equitable care for people with cancer and ensure robust funding for cancer research.

Advocacy Summit attendees will also attend webinars to receive education and training on lobbying Congress and the current political landscape.

What is different this year is our online Week of Action, which will give all ASCO members an opportunity to advocate on critical issues of great importance to the cancer care delivery system in the United States.

Participants in the Week of Action will amplify the Advocacy Summit’s messages through email and social media messages to Members of Congress using ASCO’s ACT Network. And, it’s easy to get involved and make your voice heard. You just need to click on the link to the ACT Network in the Advocacy Center on ASCO.org and sign up to receive ASCO ACT Network emails. Then, you’ll get all the information on the fastest and easiest ways to contact lawmakers delivered directly to your inbox. We hope you will participate as much as you can—the effort will take just minutes. Even one message a day by every ASCO member to your representatives in Congress will have a tremendous impact.

During the virtual Advocacy Summit, which will be held in the middle of the Week of Action on September 16, ASCO volunteer advocates will have their virtual meetings with Members of Congress and their staff. The three issues or “legislative asks” that they will be discussing will be the same asks that ASCO members will contact their Members of Congress about during the Week of Action.

One, we will ask Congress to support legislation—The CLINICAL TREATMENT Act, which will give all Medicaid beneficiaries coverage of routine costs when enrolled in clinical trials—coverage Medicare and private insurance plans already provide. The importance of improving health equity has become even more apparent during the COVID-19 pandemic, and this legislation takes us one step closer to that goal.

Two, ASCO volunteer advocates will request lawmakers to co-sponsor the Safe Step Act, which will help protect patients from harmful step therapy protocols, which ASCO believes is never appropriate in the treatment of cancer.

And three, we’ll address the impact COVID-19 has had on cancer practices and research. Specifically, advocates will ask Congress to endorse maintaining reimbursement flexibilities for telehealth, as many oncology practices have rapidly transitioned to telehealth to ensure patients continued receiving treatment during the pandemic. We’ll also be asking Congress to provide emergency funding to the National Institutes of Health to mitigate disruptions caused to labs and clinical trials by COVID-19, and to restart research across the county.

These are the same issues that participants in the Week of Action will be advocating for all week long in their outreach to Congress.

The goals of the Advocacy Summit and Week of Action are to advance priority legislation, amplify the collective voice of the cancer care community on Capitol Hill, and to get ASCO members involved in advocacy initiatives.

Members of Congress and their staff have grown accustomed to virtual constituent meetings, and personal stories continue to be the most effective form of advocacy, so the Advocacy Summit and Week of Action—even virtually—remain critical to ASCO’s larger advocacy efforts.

In addition to the meetings and messages between advocates and lawmakers, the ASCO Advocate of the Year and the Congressional Champion for Cancer Care will be named during the Advocacy Summit.

In closing today, I encourage everyone listening today to follow the Advocacy Summit through social media by way of the hashtag ASCO Advocacy Summit (#ASCOAdvocacySummit) on Twitter AND to participate in the Week of Action through the ACT Network.

A link to the ACT Network and all the information you’ll need to participate in the Week of Action is available at ASCO dot org slash ASCO Action (www.asco.org/ascoaction).

Until next time, thank you for listening to this ASCO in Action podcast and if you enjoyed what you heard today, don’t forget to give us a rating or review on Apple Podcasts or wherever you listen and while you are there, be sure to subscribe so you never miss an episode.

The ASCO in Action Podcast is just one of ASCO’s many podcasts; you can find all of the shows at “Podcast dot ASCO dot org” (podcast.asco.org).

Get to Know Dr. Lori J. Pierce and Her Plans to Improve Equity in Cancer Care During Her ASCO Presidential Year Jul 31, 2020

ASCO President Lori J. Pierce, MD, FASTRO, FASCO, joins ASCO CEO Dr. Clifford A. Hudis in the latest ASCO in Action podcast to discuss how her childhood inspired her to become an oncologist and how the theme of her presidential year, “Equity: Every Patient. Every Day. Everywhere.” is more important than ever as the country responds to a healthcare pandemic that is disproportionately impacting people of color.

“Every patient, no matter who they are, deserves high-quality care and every patient has the right to equitable care,” says Dr. Pierce. “We have to get to the root causes to understand the barriers that patients face if we’re going to really make a difference, so it’s important to me that equity be front and center of everything that we do."

Subscribe to the ASCO in Action podcast through iTunes and Google Play.

Transcript

Dr. Clifford Hudis: Welcome to this ASCO in Action podcast, brought to you by the ASCO Podcast Network. This is a collection of nine programs covering a range of educational and scientific content and offering enriching insights into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org.

The ASCO in Action Podcast is ASCO's series where we explore policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for--people with cancer. My name is Dr. Clifford Hudis. And I'm the CEO of ASCO, as well as the host of the ASCO in Action Podcast series.

Today I'm really pleased to be joined by Dr. Lori J. Pierce, ASCO's president for the 2020-2021 academic year. Dr. Pierce is a practicing radiation oncologist. She is a professor and vice provost for academic and faculty affairs at the University of Michigan. And she is the director of the Michigan Radiation Oncology Quality Consortium.

Dr. Pierce, thank you so much for joining me for this podcast. My hope today is that our conversation will give our listeners a better idea of who you are, what and who has had important impact and influence over your life, and what your professional career and path as a radiation oncologist has looked like. I also hope to highlight what you hope to accomplish during your presidential year.

Dr. Lori Pierce: Thank you, Dr. Hudis. I'm glad to join you today. Before we get started, I just want to note that I have no relevant financial relationships to disclose.

Dr. Clifford Hudis: Now before we start to discuss the details of your presidential theme and your current role at ASCO, I think our listeners will be really interested to learn how your childhood inspired you to become a radiation oncologist. And I hasten to add ASCO staff were really excited by the stories that you shared when you gave an all staff presentation a few weeks back. So, can you talk a little bit about your childhood summers in North Carolina, how they were informative for you, and how they inspired your career?

Dr. Lori Pierce: Sure. I'm happy to. So first of all, I'm originally from Washington D.C. But my father's family, which is quite large, is from a small town in North Carolina called Ahoskie. And that's in the north eastern part of the state, maybe about 30 minutes just beyond Virginia. And I have tons of relatives. I used to love to go visit them every summer because I would get spoiled.

But that was in the south in the '60s. And in retrospect there was significant segregation there. And I again would have a great time going to visit my family. But I noticed--and it was something you noticed and you put in the back of your head--that when there were health care issues, there was one doc that my family could use. And he was great. Doc Weaver, he did it all.

He was the one who would come to the homes, deliver babies, take care of all the medical issues--he did at all. And so, people just revered him because he always seemed to help people. And that stuck in my mind. That was actually when the first times that I thought about possibly becoming a physician because he always seemed to make people better.

But then also the experience as I got older made me acutely aware that there was indeed segregation in Ahoskie and that there was inequity in care. Even Doc Weaver seemed to be a great doctor for someone--I was 5 or 6 at the time. And to my eyes, he was great. Clearly there weren't choices in terms of care. And that was my first exposure to inequity in terms of health care.

Dr. Clifford Hudis: Well that's interesting, of course. And obviously we're going to circle back to this. But before we get to that, one of the things that I always point out to Nancy Daly--who's the CEO of Conquer Cancer--is that all roads lead through Philadelphia in medicine. You proved that true, right?

Dr. Lori Pierce: Yes. So, I went to the University of Pennsylvania. I got my degree in engineering. I should say at that time I clearly was planning to go into medicine. But I was going to go into radiology. And so biomedical engineering was a great area to pursue. I majored in biomedical engineering and minored in chemical engineering from the University of Pennsylvania.

And so, then I applied to Duke for medical school. I was accepted. But I decided to defer my admission. And so, I worked for a while before going into medicine.

Dr. Clifford Hudis: Well that's interesting. And when you deferred your admission, was this because you had something you wanted to do, or you needed to essentially to save money in order to go to medical school? What did you do in that break?

Dr. Lori Pierce: Yeah. So, it was very much the latter. My parents were absolutely wonderful people. And they focused very much on education from my sister and me--for us to go to the best possible colleges. My parents never had an opportunity to go to college. And so, they very much wanted the best colleges for my sister, Karen, and I.

But we had a ground rule in our family. And that was that if my sister or I decided to go and pursue education beyond undergraduate degree that we would need to pay for that. And so, I knew that. And even though I was very fortunate to get quite a bit of scholarship from Duke, there was still going to be a lot that I was going to have to pay.

And so, I made a decision, instead of taking out a lot of loans, that I was actually going to work. At that time--probably now as well--being an engineer brought a very good salary. And so, I elected to defer my admission for medical school and take the offer that gave me the most money.

And that ended up being a job in Round Rock, Texas, which is just outside of Austin. And I have to tell you this was back in 1980. And it's not at all what Round Rock is like now. I hear Round Rock--since industry is there now--is really just a suburb of Austin. But at that time, Round Rock was a sleepy town I-35 from Austin. So, I can live in Austin and work in Round Rock.

And it was a very interesting experience. I worked for McNeil Consumer Products. I was the second shift supervisor. And it was an interesting time because here I was fresh out of undergrad, green behind the ears, and an African-American woman, as a supervisor to people who were generally in their 40s through 60s, most of whom had never been out of the state of Texas, and you look at that and you say, oh my gosh. How did I get here? Why am I here? Why did I decide to do this?

And you think about how different people are. But when you start to work with people, you realize that there are common threads. And you find those common denominators. And you learn that even though we may look different on the outside, there are a lot of things that are similar in the inside.

And I think the lessons that I learned as that second shift supervisor have served me well in medicine because you can always find a common denominator with patients, even when apparently at first look, it looks like you're very, very different. So, they were very good lessons I think that I learned that I wouldn't have done had I not chosen that path.

Dr. Clifford Hudis: So, I think that some of what you learned will no doubt pop up as we talk in greater detail now about your presidential theme. Let me just start by saying for me personally, this is one of the highlights of the year for me each year, when our president comes on board in a sense and begins to present their vision for their theme and what they hope to see us achieve over the year they serve as president.

And it's amazing because of course the wide range of background experiences as well as aspirations that different people bring. And you certainly I think came into this with a very clear vision of equity for every patient every day everywhere. Can you expand I think--I wouldn't say speak on this because you've already begun to touch on it--but can you expand on what you were hoping to see accomplished through this theme and what motivated you to focus on it specifically in your role as ASCO president?

Dr. Lori Pierce: A multitude of things. It's hard to really pick out one. But certainly, I think we all are acutely aware of the different outcomes for people of color. In terms of almost any industry you look at, the outcomes are less favorable, significantly so for people of color. And you look at those numbers and you know that there are reasons to explain this.

And it's not just biology, which is what a lot of people propose. And quite often it's not biology at all, that clearly these patients are lower socioeconomic status. The majority of these patients are poor. Late diagnoses, inability to receive treatment, transportation issues--there's a whole myriad of reasons why the outcomes are different. And you look at that, and you say, every patient no matter who they are, deserves high quality care. And every patient has the right to equitable care.

And we have to get to the root causes to understand the barriers that patients face if we're going to really make a difference. And so, it's important to me that equity be front and center in everything we do. And ASCO again has done so much. That's at the heart of ASCO, of making sure the message is there that every patient deserves high quality care.

But I wanted to actually make equity our theme. Equity has actually never been the theme at ASCO. So, I want to actually call it out and make it our theme for the year.

Dr. Clifford Hudis: Well the timing of course in many ways is really quite remarkable. I know a lot of people would use the word fortuitous. And the truth is that just means in a sense coincidental. But that's what it was.

In early 2020 certainly nobody could have anticipated that we would be facing, nationally and globally, a pandemic that would so disproportionately impact people of color or that there would be a tipping point through yet another brutal crime against a black American and that this would so completely capture the nation's attention. And I have to say broad support. Can you speak a little bit more therefore about the timing of these events and your theme and why this is so important for us to act at this point?

Dr. Lori Pierce: I think you summed it up actually very nicely. Again, the theme was chosen before the pandemic. It was just the theme that I felt was the appropriate theme at this point in ASCO. And then the pandemic happened. And we saw how it disproportionately affected those who had comorbidities, those who were the essential workers, so those people who didn't have the luxury to work from home. Often the people who had a lot of comorbidities and the ones who were most at risk for contracting the virus and subsequently dying from the virus.

And I actually take a little bit of pride in that I'm from the state of Michigan. And Michigan was actually one of the first states that started reporting the COVID data by race and ethnicity. So, it was actually one of the first states that made the observation that there were cohorts of patients that had a significantly worse outcome. And so, the country--the world learned that people of color did more poorly with COVID.

It's not enough to say, OK, these people do poorly with this. We then have to dissect the reasons why and provide explanations, so we get to the root of the problem. So that's COVID. And then we saw that more of the senseless deaths that we've seen in the past, but we've seen even more of as of late.

And maybe that's because we now have cell phones. And we see things a lot more--things that have probably been going on for quite a while. We know that these have been going on, but maybe not to the degree that we know now. And we have to acknowledge there's structural racism. And so, once we acknowledge that, then the next thing is we have to initiate steps that eradicate it. And we have to initiate mandatory steps to eradicate it.

So, then you come back to the theme--equity, every patient, every day, everywhere. And I should have said in everything that we do. We see these horrors playing out. And we can look at that and say--maybe not the pandemic, but the senseless murders--we've been here before. We've been here with the protests. We've seen all that before. And nothing has changed.

I am cautiously optimistic that this time is different, that the world is in a different place. And this is no longer acceptable. And people are not going to look away, that they are going to stare this down. And they are going to create change.

And so, I am I'm optimistic that this will not just be another set of deaths of poor people at the hands of police, that the world is awake now, and change will come. And so, the theme of equity is perhaps more impactful now than it ever would have been in the past.

Dr. Clifford Hudis: I'm going to just switch gears here a little bit, and speaking from personal experience, both warn you and challenge you that the year as ASCO president goes really quickly. And given that and given the lofty ambition, is there any way that you would be able to commit to what you actually want to see get done? What box can we actually check off during this term?

Dr. Lori Pierce: I like the way you phrased that. I think back--there was an interview that I did when I was President-elect--and someone said what do I want my legacy to be? And I pushed back on that because you can't create a legacy in a year. It goes by very, very quickly. And so, I think the question is, what do you think you can realistically accomplish in a year?

And the answer that I gave to them is going to be similar to the answer that I give to you. And that is you want to use your time and take a great organization like ASCO and perhaps make it even greater. And I think that is a very real goal here because again, I am building on a strong foundation of a lot of what ASCO already has in place.

Equity is at the heart of everything ASCO does. You know this. You're the CEO. You know this. And so ASCO has stood up so many programs in their various divisions that relate and are based on equity of care. But ASCO by being large and being complicated can have some of these programs in silos. And if I can help to connect the dots, if you will, and make it almost a seamless presentation of equity, that will be a major strength.

For example, one of the things that I want to do--and people have told me I will not be successful--others have tried and were not successful--and that was to embed equity in our annual meeting. As you know what we've typically done is have sessions that are dedicated for equity, which is great. And they've been fabulous sessions and wonderful speakers.

The problem is a lot of our members have not taken advantage of those opportunities. And it's not because people don't want to know about equity. I'm sure it's just they're trying to fit so much in a short amount of time because there's so much going on at the same time at ASCO, trying to learn all the latest therapies. And they just don't have time for the equity sessions.

So, I get that. So, a strategy would be to embed equity in the sessions. And again, I've been told that this has been tried before and has failed. That doesn't deter me. That doesn't dissuade me from moving forward with this and being optimistic that it will succeed this time, again, because we're in a different time now. I think the world has awakened. And equity is very important. So, it is very high up on people's checklist when they go to ASCO.

And then second, I'm the president of ASCO. So, I hope to use both of those to gently push this idea so that we really can capture more of equity in all of the sessions, or the appropriate sessions at the annual meeting.

Dr. Clifford Hudis: Well I've got to say--speaking of connecting the dots, which was the image you used--there is one I think area of progress that's already taking shape. And that's this exciting new collaboration between ASCO and the Association of Community Cancer Centers, or ACCC. This is focusing on increasing participation of both racial and ethnic minority populations in cancer research, which to your point, is something that we have been focusing on for years. But we really need somebody to move the needle. Can you talk a little bit about this initiative and what you hope to see formed and accomplished through this?

Dr. Lori Pierce: Sure. So, I am very happy--actually, largely thanks to you for putting Randy Oyer, who is the president of ACCC, and I in contact with one another--to set up this collaboration. So, we all know that if you look at people of color--let's say African Americans and Hispanics--and look at their participation in clinical trials, it is much lower than their representation as cancer patients. If you look at most the numbers, maybe it's around 3% to 5% of patients in the clinical trials are Hispanic or African American, whereas those two groups make up about roughly 15% of patients with cancer. So, there's clearly a disconnect in the representation of those ethnicities and races in our clinical trials.

And so many have tried to come up with strategies to improve the enrollment. And we are working together--ACCC and ASCO--we're putting together a very robust steering committee of individuals who have thought long and hard about accrual of minorities under clinical trials. And we are sending out an RFI to request ideas from people in ASCO and ACCC who also have been thinking long and hard about this issue for their strategies--their suggestions for strategies for how we can improve accrual.

And then the steering committee will review what we take in as well as our own thoughts and then try one or two of these strategies within TAPUR. As you know TAPUR is the trial with an ASCO. TAPUR is completely run by ASCO. So, we have the flexibility to be able to try out new things. It's almost like a laboratory, if you will, for new ideas.

And if we see that there are one or two strategies that do seem to be successful in terms of increasing the uptake of minorities, these will be strategies that we can suggest to some of the cooperative groups to employ in their trial. So, it's an exciting time to use TAPUR as a laboratory to try out new strategies. And I am very grateful for the opportunity to be able to work with Randy and all of the infrastructure that ASCO has to make this a reality. So, we're working on that.

Dr. Clifford Hudis: Well that's great. This is not to put you on the spot. And there may not be any more. But is there anything else that you want to make sure ASCO members hear or take away from this conversation? What's the one message that you think that they should receive from our conversation?

Dr. Lori Pierce: I guess we're all in this together. The beauty of ASCO is from member engagement. We just have fabulous members in terms of their motivation to make lives better for our patients. And so, I guess I would ask if there are any additional ideas that our members have that will help us move the needle even more and even more quickly, please reach out to me.

I would love to hear people's thoughts. We're always open for new concepts. And it takes a village. And I just would hope people would feel comfortable providing ideas for us to go forward.

Dr. Clifford Hudis: Well that's great. Thank you, Dr. Pierce, for taking the time to speak with me today. I'm really grateful to you for this. And I'm excited as well for the year ahead, both for you and for all of us at ASCO.

Dr. Lori Pierce: Thank you so much.

Dr. Clifford Hudis: I want to remind listeners that you can visit asco.org to learn more about the ASCO ACCC initiative. And even better that's where you can submit ideas that will help address the issues related to longstanding barriers to diversity in cancer clinical trials. We want to hear from you.

Until next time, thank you for listening to this ASCO in Action podcast. And if you enjoyed what you heard today, please don't forget to give us a rating or review on Apple Podcasts or wherever you listen. And while you're there, be sure to subscribe so you never miss an episode.

The ASCO in Action podcast is just one of ASCO's many podcasts. You can find all of the shows at podcast.asco.org.

ASCO Special Report: Resuming Cancer Care Delivery During COVID-19 Pandemic Jul 06, 2020

American Society of Clinical Oncology (ASCO) CEO Dr. Clifford A. Hudis is joined by Dr. Piyush Srivastava, the past chair of ASCO’s Clinical Practice Committee, in the newest ASCO in Action Podcast to discuss the recently released ASCO Special Report: A Guide to Cancer Care Delivery During the COVID-19 Pandemic. Dr. Srivastava was instrumental in developing the report, which provides detailed guidance to oncology practices on the immediate and short-term steps that should be taken to protect the safety of patients and healthcare staff before resuming more routine care operations during the COVID-19 public health crisis.

Subscribe to the ASCO in Action podcast through iTunes and Google Play.

Transcript

Dr. Clifford Hudis: Welcome to this ASCO in Action podcast brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insights into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org.

This ASCO in Action podcast is ASCO's series where we explore the policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for, people with cancer.

I'm Dr. Clifford Hudis, CEO of ASCO. And I'm the host of the ASCO in Action podcast series. I'm really pleased to be joined today by Dr. Piyush Srivastava, the past chair of ASCO's Clinical Practice Committee. Dr. Srivastava is also a practicing gastrointestinal oncologist, the regional medical director of the End of Life Options program, and the director of Outpatient Palliative Care at Kaiser Permanente Walnut Creek Medical Center in California.

Today, we're going to talk about the recently released ASCO Special Report: A Guide to Cancer Care Delivery During The COVID-19 Pandemic.

Dr. Srivastava was instrumental in developing the report. And we'll speak today about the guidance that the report provides for oncology practices as they return to more routine care delivery. Piyush, thank you so much for joining me today.

Dr. Piyush Srivastava: Thank you, Dr. Hudis for taking the time to speak with me. Just before we start, I just want to say that I do not have any relationships to disclose. So, thank you.

Dr. Clifford Hudis: Thank you very much for joining us today. Now, just to provide some context, today as we speak, we're approaching month five of the COVID-19 public health crisis in the United States. We've had more than 2.15 million confirmed cases of the virus and well over 100,000 deaths.

In fact, as we record this today, several of the largest population states in the United States-- California, Texas, and Florida-- are just reporting their largest single-day increases in cases and the health care systems in some of their big cities are approaching the kind of near breaking point that we saw earlier in New York. So, the problem is still very much with us.

When the outbreak began, oncology practices nationwide immediately began making operational changes designed to protect the safety of patients and the safety of staff. This meant adjusting to resource shortages that were unfolding and complying with national and state restrictions on elective procedures, among many other things.

Today, communities across the country are in varying states of recovery. And as I just described, some of them actually are probably pausing their recovery right now. Either way, they are facing a real transition in terms of oncology practice. And some are returning to something more like routine care while continuing to be acutely attuned to protecting the health and safety of both patients and staff.

So, Dr. Srivastava, could you start us off and tell our listeners just a little bit about what's happening in your own practice and how you have been adapting to the changing circumstances?

Dr. Piyush Srivastava: Of course. I would be very honored to share my experiences at Kaiser Permanente in Northern California. So, at the start of the pandemic, we were very fortunate to be nicely set up to provide care remotely. We've had a very strong existing telehealth structure. So, we were quickly able to adapt to the pandemic situation.

Initially, we nearly went 100% remote, with doing all of our new consults and chemo checks via video visits and telephone visits. If a patient needed some more attention, to be seen by a care practitioner, many times that we would coordinate with the on-call physician on site, who would see the patient on the chemotherapy infusion chair.

We also looked as an institution which services we could provide remotely and take off site and so that we didn't need to bring the patients into the cancer center. For example, we activated our home health nursing team to be able to provide port flushes in the home setting.

We also made a very conscientious effort to see what treatments and what procedures that we could postpone or actually decrease the frequency or increase the timing in between events. For example, bisphosphonate administration and port flushes, which we increased to do every three months.

What was extremely eye opening and inspiring to me is a large organization such as Kaiser Permanente was extremely nimble and flexible and was able to respond to the outside pressures. I believe, when I speak to my colleagues across the country, that many people experienced the same things with their institutions. And their institutions responded very flexibly to the ongoing pandemic.

Dr. Clifford Hudis: Thanks very much. It's really interesting, I think for me, and I'm sure for many of our listeners, to hear how you adapted but also to compare that with their own experiences. It sounds to me like some of the key features were clear eye on the safety of patients and staff but also having a structure that respected the needs of the clinicians from the beginning. And then, of course, understood that the flexibility overall was a key attribute. And I just think that's something that many people will be reflecting on.

As we hit it from that one in a sense, forgive me, but anecdote, which is how one center, one operation adapted, I wonder if you could talk a little bit about ASCO's role in providing the more general guidance that you helped to develop. Why did this society feel it was necessary to provide guidance at that level?

Dr. Piyush Srivastava: Yes. So, as we are all extremely aware, many individual health care professionals, institutions, and health systems look to ASCO for mentorship when it comes to oncology care. So, this current pandemic was no different. I believe ASCO felt a strong duty and a responsibility to partner with the oncology world to ensure the highest quality and efficiency of cancer care and delivery through this pandemic.

Also, the beginning of the pandemic, there was a lack of really clear guidance from federal and state agencies. So, cancer care providers and administrators looked to ASCO to help develop their plans of providing care during the pandemic. Now, also opening and ramping up as well, they're looking to us.

Dr. Clifford Hudis: I see. So, as we think about staff at ASCO headquarters, it's really pretty straightforward on a daily basis. Our decisions to open headquarters, for example, or not are predicated, number one, on the safety of our staff. So, when you look at the Special Report, what would you say was the one or the several overarching goals that drove the development of the Special Report?

Dr. Piyush Srivastava: So, when constructing the report, we did very much realize that there are so many varied practices across the country, really around the world, right? For example, we have small rural practices. We have medium-sized private practices. We have academic centers, and we have hospital systems. And all these organizations look to ASCO for cancer guidance and guidance to cancer care delivery.

By no way were we going to be able to solve individual operational care delivery issues for each practice. So, the Special Report is made to serve, if you will, as a starting point or a launching pad for individual institutions to develop their own policies and operational adjustments.

So, what I would like to do now is maybe just dive a little bit deeper into some of the specific policies and practices that were outlined in the report. And as I look at it, it was really broken down into stages of patient care.

So, for example, before a patient even arrives on site, many practices are in a sense pre-screening them or triaging them. What are some of the methods that you have seen put into place and that have been effective that we should recommend to practices just getting open?

So, the Special Report lists out very clearly sequential steps to consider in safely bringing patients into cancer centers. And I'll highlight a few of them, which I feel is extremely important. The first step is to actually reach out to the patient well before their scheduled visit to the cancer center. So, if we can call these patients and family members well before their visit, we can educate them as to the process that they'll experience when they come into the cancer center.

Allow them to ask questions and to give the reasoning behind or the why to we are doing this. I think that will go a long way. So transparent communication, I think, will reduce anxiety and fear.

I also believe an effective second step was to do a quick check in, anywhere from 12 to 48, 72 hours prior to the actual visit, depending on what your operations would allow, just to check in to make sure that you're screening for the COVID symptoms and the patient doesn't test positive to any of those symptoms.

I may just add also in the first step, when you reach out to the patient well before their appointment, that's also a good time to screen for COVID questions. And then a third implementation can be as a single point of entry.

So, when a patient comes into the cancer center, there's one point of entry so that way a temperature could be checked, a patient could be screened again for those COVID symptom questions. And so that when that patient arrives inside the cancer center, there's been essentially three checks and balances of checking for COVID-19 symptoms.

So, this provides obviously the safety to minimize the risk of bringing COVID into the cancer center. But I also think an extremely important added benefit is that the staff and providers will feel confident and safe that the institution has done these many different steps to ensure their safety as well and to minimize their risk of exposure to COVID.

Dr. Clifford Hudis: I see. So that's one part of this. Now, the implication in all of this is the volume coming through the clinics is likely to be lower. And one of the ways in which it is controlled, of course, is through the reduction of less critical face-to-face encounters and arguably an increase in telemedicine. What are some of the considerations that you think oncology practices should factor into their use of telemedicine in care delivery?

Dr. Piyush Srivastava: Yeah. That's actually a fantastic question, because telemedicine has really-- well, telemedicine was forced upon most institutions. And the institutions had to really find an effective way to provide care remotely. So, it's a very interesting and important topic. For example, I think one thing that I personally struggled with, and I think my institution struggled with is, who is the right patient for telemedicine?

So, the report talks about specific patient categories that you can think of that would be easier to provide patient care remotely. So, for example, those that are not requiring in-person physical exam, those who may not actually actively be getting chemo treatment, those that don't need any in-office diagnostics. So, don't necessarily need lab work tied to that appointment or you don't necessarily need imaging exams at that moment.

Other visits that the report recommends to think about is follow up. So, follow up could be done through telemedicine. Or those that are on oral oncolytic treatments. And so, it's a quick check in just to make sure that they're taking the medication and the adherence is high could be done by video or by phone.

A couple of things to consider with telemedicine, obviously, is the audio and visual capabilities. And so even in the Bay Area in California, we do have spots that don't have the best reception. And so that can become problematic. So that's something to also think about.

The other sort of counterbalance or countermeasure to this is just to make sure that patients feel that they're being taken care of and they feel satisfied. So in my own practice, I've now adopted that when we finish a video visit or we finish a telephone visit, I let the patient know that I have felt comfortable with the interaction and that I felt that I was able to accomplish the care plan and execute the care plan as needed by the video and phone. But then I ask them, do they feel comfortable and are they OK proceeding this way or do they prefer face-to-face visit.

Dr. Clifford Hudis: Yeah. I think that's an interesting observation about telemedicine. I think everybody is feeling their way right now and learning. And we want to be careful not to go too far away from the direct physical encounter since so much can be lost without those subtle cues from body language and classic physical findings as well. Now, coming back once more to the workforce, the report addresses how we maintain a healthy workforce.

And it specifically, I think, gets into questions of testing and scheduling and even dealing with stress. Can you walk through that a little more about antibody testing or saliva or nasal swabs and the frequency and exactly what facilities and practices should be thinking about for their staff?

Dr. Piyush Srivastava: Sure. And this is an extremely hot topic, and the interesting thing about this topic is it can vary widely just depending on what's available at that moment in your location, what the county is ordaining and what the state is ordaining as well. So, there's a bit of variability.

But what the Special Report does very nicely, it lays out considerations for institutions to think about when they are caring for the workforce, both physically and emotionally. So, this Special Report lays out some PPE guidelines, and really, it's based on what the CDC is recommending.

And as we know, as one of the largest sort of scientific research-based organizations, it's important that we bring the CDC's sentiment forward when we talk about PPE, especially with PPE stewardship as this goes on for some time, we may have some issues with the supply chain.

The other thing the Special Report calls out is to really have institutions make sure that they are putting their health care practitioners in the forefront. So, checking in with health care practitioners to make sure that they are not ill, that they're feeling OK, that they haven't been exposed to anybody outside of the medical system. And I think what's really, really special about this report is that it really talks to the practitioner's well-being. I think this is scary for any provider in the front line.

We are also worried about our own health and what we can bring back to our loved ones outside of the medical center. But also, I think all of us as oncology providers are feeling a little disillusioned and a little saddened, because we are not able to provide oncology care like we normally have been.

And so that's a huge adjustment for the oncology provider. And of course, that comes with some moral distress. So, the report also calls out for institutions to check in with their health care providers to make sure that their emotional well-being is good and to also make sure that they feel that their family and loved ones are safe at home. So, I think that was a really added benefit.

Dr. Clifford Hudis: Yes. Really important to acknowledge the importance of all of that to the individuals. And it is not just about narrowly the safety of the surfaces and workspaces they're in, but really in a sense their holistic experience in life. I want to turn to the broad public approach to cancer care and focus on the corners that we cut, if you will, in going into this crisis, the compromises with old ways of doing things that we very quickly adopted.

The report focuses on some of those immediate short-term steps that we took. And I think looking at the effectiveness of that, I can tell you that I asked the ASCO leadership on the staff side and on the volunteer side why those adaptations couldn't just be our new permanent normal.

That is to say, if it was safe enough to do telehealth in April of 2020, why isn't it safe enough to do it forever? So that was the nidus of our Road to Recovery Task Force. And I know you sit on the group focused on care delivery. What do you think we can expect from that effort?

Dr. Piyush Srivastava: Yeah. And this is fantastic. I am honored to be sitting on the Road to Recovery Task Force, because I think this is an issue that's facing every oncology care provider in the country and, frankly, around the globe. And the task force is composed of a group of really active and very intelligent oncology providers who are putting their minds together collaboratively to see how we can continue to provide cancer care in an efficient and in a high-quality manner moving forward beyond the pandemic.

And as you said very nicely, Dr. Hudis, we have gained several insights through our care over the last few months, and can we harness those insights and continue to practice oncology in a very efficient and high-quality manner?

So, the task force is extremely comprehensive. The group is addressing several buckets, if you will, that are very pertinent to oncology care and delivery. So, they're looking at health equity. They're looking at resetting clinic and patient appointments.

They're looking at practice operations, telemedicine, home infusion. I know that's something that we've all been grappling with. Financial assistance to practices, which is extremely important when we look at the economy around us.

Quality reporting and measurements. So, we want to make sure-- we want to challenge ourselves to make sure that we are practicing the highest-quality cancer care that we can. Utilization management. So that's also extremely important as we are looking at the economy around us.

Psychosocial impact on patients. So, this has been obviously extremely traumatic for patients in their very vulnerable state. The task force also is looking at provider well-being, which once again, I can't reinforce how important that is as we go back into somewhat normal operations, whatever that normal may be, but looking at the sort of stress that the providers are feeling in that.

And then ongoing preparedness I think, which is extremely essential, because we just don't know what the virus will do over the next year and what might also come in the future. So, the task force is extremely collaborative, extremely thorough. And it is a group of very active individuals on oncology care that are bringing their brilliant minds together to come up with some guidance.

Dr. Clifford Hudis: Well, I think that's really great. As we wrap up now, I wonder if at the highest level if there's a single or several major takeaways that you want listeners and our entire community to take away from these recommendations?

Dr. Piyush Srivastava: Yeah. You know, I've actually had some time to reflect. It's been a very privileged experience for me to be a part of this and to be a listener and to be a learner from all these brilliant minds around me who are putting their heads together to accomplish this. I find that recommendations in the Special Report to be very thoughtful and very comprehensive.

I do hope practices remember that these are actually guidelines to help them develop and change policies at individual institutions. I also hope that oncology practitioners and administrators remember that we're all in this together. And so, there is going to be an ever-changing environment.

So, I hope that this report is just a start of a collaboration that can be ongoing with ASCO and with oncology providers around the world. I am fully confident that ASCO is a tremendous and a large resource for us in the oncology world to be able to accomplish collaboration and to actually uplift and maintain cancer care during and after the pandemic.

Dr. Clifford Hudis: Well, that's really, I think, is nice and as great and complete a summary as one could hope to hear. So I want to thank you, Dr. Srivastava, for speaking with me today. I'm really grateful to you for your time on this whole initiative and the effort that you've put to it as well as, of course, for the time today.

Dr. Piyush Srivastava: I appreciate it. It has been a great honor. And so, thank you very much to you, Dr. Hudis, and thank you very much to the ASCO staff, who do a tremendous job on a daily basis to make sure that we are doing the best we can.

Dr. Clifford Hudis: So, the Special Report, and later, ASCO's Road to Recovery, are all part of ASCO's larger commitment to providing information, guidance, and resources that will support clinicians, the cancer care delivery team, and patients with cancer, both during the COVID-19 pandemic and then well beyond it.

We invite listeners to participate in the ASCO survey on COVID-19 in Oncology Registry or ASCO registry. This is a project where we are collecting and then sharing insights on how the virus impacts cancer care and cancer-patient outcomes during the COVID-19 pandemic.

We encourage all oncology practices to participate so that we will have the largest possible data set and represent the full diversity of patients and practices across the United States.

I'll remind you that you can find all of our COVID-19 resources and much more at asco.org. And until next time, I want to thank everyone for listening to this ASCO in Action podcast.

If you enjoyed what you heard today, please don't forget to give us a rating or a review on Apple Podcasts or wherever you listen. And while you're there, be sure to subscribe so you never miss an episode. The ASCO in Action podcast is just one of ASCO's many podcasts. And you can find all of the shows at podcast.asco.org.

Listen Now: Ethical Considerations on Allocating Scarce Resources During a Pandemic Jun 09, 2020

In the latest ASCO in Action Podcast, American Society of Clinical Oncology (ASCO) CEO Dr. Clifford A. Hudis is joined by Dr. Jonathan Marron, incoming Chair of ASCO’s Ethics Committee and a lead author of the new Ethics and Resource Scarcity: ASCO Recommendations for the Oncology Community During the COVID-19 Pandemic.

In this episode they discuss ASCO’s recommendations, why ASCO developed this guidance, and what patients, families, and the entire medical community need to know about allocating limited resources during the COVID-19 Pandemic.

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Transcript

Dr. Clifford Hudis: Welcome to this ASCO in Action podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content that offers enriching insights into the world of cancer care. You can find all of our shows, including this one, at podcast.asco.org. The ASCO in Action podcast is ASCO's podcast series, where we explore the policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for, people with cancer.

My name is Dr. Clifford Hudis, and I'm the CEO of ASCO. And I'm proud to serve as the host of the ASCO in Action podcast series. Today, I'm very pleased to be joined by Dr. Jonathan Marron, incoming chair of ASCO's Ethics Committee and a lead author of ASCO's recent recommendations for the oncology community on ethically managing scarce resources during the COVID-19 pandemic.

Dr. Marron is also a bioethicist at Boston Children's Hospital, a pediatric oncologist at Dana Farber Cancer Institute, and he is on the Center for Bioethics teaching faculty at Harvard Medical School. Today, we're going to talk about those recommendations. And I'll note that they were published just recently as a special article just in early April in the Journal of Clinical Oncology. We'll focus specifically on the reasons that ASCO took this step and what it is that oncologists, patients, families, and the entire cancer care community need to know about this issue. Dr. Marron, thank you so much for joining me today.

Dr. Jonathan Marron: Thank you so much, Dr. Hudis. It's really a pleasure to be speaking with you, and an honor as well. Before we get started, I do want to just point out that I have no conflicts of interest to disclose.

Dr. Clifford Hudis: Well, that's great. Now, just to provide some context as we start this discussion, it's the middle of May as we're recording this. In the United States, the COVID-19 public health crisis bubbled up to awareness a little bit in January, became seemingly near threat in February, and seemed in the public's eye, I think, to breach our shores at the beginning to middle of March. So, we're about four months, more or less, into this public health crisis.

The US has had now about a million and a half-confirmed cases of the virus. And I think this week, we crossed the 90,000 number in terms of deaths from the virus. From the very early days, there was-- and we all remember this-- an extraordinarily emotional and widespread concern that medical resources, and especially ventilators, but also medications, as well as space, critical and intensive care beds-- those three things, that they would be stretched, that some communities would be especially hard hit, and that, as a consequence, access to those resources might be limited.

And when that arose as a concern, what followed, especially for people who work in this field, and bioethicists in general, as well as everyday clinicians, was the very real possibility that they would be forced to make some painful and difficult choices. And I'll say some of our members wrote about these experiences as well in ASCO Connection and elsewhere. So, can you now maybe help our listeners understand why ASCO in particular thought that this situation needed to be addressed and why we decided to provide the very specific guidance that you took part in creating in the form of these recommendations?

Dr. Jonathan Marron: Absolutely. So you really highlighted a couple of the main questions and concerns that we had that we wanted to do our best to address, in the sense that at the outset of the pandemic, it was really difficult to tell what direction things were going to go and just how bad everything was going to get. Seeing the experience in China and seeing the experience in Italy, there was significant concern that, as you mentioned, our health care system would not be able to support the critical care needs that we would have. There is a long history of people thinking about how to utilize and best utilize resources like this in the setting of scarcity.

One of the concerns that comes up whenever you have to make these difficult or realistically impossible choices is how you're going to do so. And so really, that's where we came, as oncologists and as the ASCO community, to try to figure out how we could best represent the oncology community and to ensure that cancer unto itself was not going to keep a given patient from having a fair chance to access these potentially lifesaving resources, even in the setting of a public health crisis like this, even in the setting of scarce resources.

Dr. Clifford Hudis: So, I remember as this was being developed having conversations with, I think, you and other members of the panel. I'm going to push a little bit on at least one of the areas that I think is really a concern but can be misunderstood. And that is this high-level statement you just made that people with-- if I understood correctly-- that people with cancer might find themselves discriminated against in these moments of triage, fundamentally. There's one ventilator. There are three patients at need. And God forbid we're ever in this situation-- how do you decide who gets it.

On the one hand, of course, there's a fairness doctrine. But on the other, there is a medical reality. And cancer is not one thing. So, could you just talk a little bit about what we mean when we say protecting the cancer patients? And let me be clear. We're not saying that cancer as a diagnosis, stage, prognosis should be ignored exactly, right?

Dr. Jonathan Marron: Absolutely. And I think what you said there really is one of the most, if not the most, important aspects here, that there are a couple of different ways that you can go about trying to take, as the example that you had of the three patients, and decide which of those three will get the ventilator. If not the perhaps fairest way would be simply to make a choice at random and say each of those three individuals has an equal chance at it, and we'll flip a coin or do some other random way of deciding who will get it. That's certainly fair.

But some people would say, you know what? They may not be equal in all ways. And if we're trying to maximize our resources and maximize the potential outcome benefits of these scarce resources, we want to do something more than just do something-- choose randomly. And we've actually learned in the past from work with community groups that people don't love the idea of randomly choosing things like this, in a public health emergency or otherwise.

And so then-- the question, then, is OK, so how are you going to make that choice. If we're trying to maximize health care outcomes, and which you usually think about that being survival, we want to use medical information. But then the question is, what is the information that should be used.

So, one of the concerns is that there could be certain disease processes, cancer or otherwise, that would be seen as exclusion criteria. That's to say, OK, we have these three patients. We have one ventilator. Patient one has cancer, so therefore we're going to not even give them a chance at that ventilator. And that's really where this comes in. That's not the way to do this. Cancer absolutely should come into the consideration. But that patient's specific cancer-- their diagnosis, their prognosis, the medical information-- the best medical information that we have, the best evidence-based medical information that we have about their specific disease so that we can make an informed decision, or at least a maximally informed decision about who is the most likely to survive if they are given access to the ventilator or ICU bed or whatever it might be.

Dr. Clifford Hudis: Yeah, I think this was one of the areas that you had to read somewhat carefully and be patient to understand the context, because if I understand correctly-- and with no disrespect to our colleagues outside of oncology-- one concern is that in the ER, a patient who once had cancer might just be, in a blanket way, discriminated against. But look, I was a breast cancer doc for 30 years. Most of my patients were, frankly, cured. And the fact that they had breast cancer in 1996 is of essentially no meaningful relevance to any medical decision, almost. I'm oversimplifying it here, rather.

But our concern, I think, was that in the front lines, under duress and pressure, that mistaken judgments might be made, and we wanted to advocate for that. Is that-- I may not have said that so elegantly. But is that-- that was one of the concerns in the other direction, right?

Dr. Jonathan Marron: Absolutely, yeah. And it's certainly conceivable that somebody, in a very well-intentioned way, would think that OK, this patient currently has cancer or at some point in the past had cancer. And as wonderful as the electronic record is, sometimes it can be difficult to tell if something is a current medical problem or a past one. But either way, simply the diagnosis of cancer is not the be-all, end-all. And there needs to be a thoughtful and ethically rigorous process by which these decisions are made. And that's what we hoped to inform with the paper and with the recommendations.

You know, it's interesting. And if I may just think of the sweep of time, I always put things in the ASCO context. So, the society was founded in '64. The medical oncology boards were in the mid-70s for the first time. The curative systemic therapies for testes cancer, for the lymphomas were a little before that, obviously, and in that general era. It is quite a testimony, when you think about it, to the advances in oncology that we're now worried that people will, in a sense, make too much in the negative direction about prognosis of a cancer diagnosis.

Dr. Clifford Hudis: And I'm thinking of the last few years, where suddenly there are tranches of survivors of melanoma and non-small-cell lung cancer and other diseases that historically had a very poor prognosis, and now they may still have, on average, a bad prognosis. But there are survivors and long-term survivors with formerly incurable diseases. They need to be protected, in a sense, from this one-size-fits-all judgment, right?

Dr. Jonathan Marron: Absolutely, yeah. And as a pediatric oncologist, I run into that every day that people assume that, oh, my gosh, children who are diagnosed with cancer, that they're dying left and right. And people are generally quite surprised to hear that we have an 85% survival rate in children with cancer. So that certainly would be a concern in that population as well, that if there were the setting of resource scarcity that a child could come in and say, OK, well, they have cancer, even if it's active cancer, but they, in many cases, would be expected to have a very good chance of survival.

Dr. Clifford Hudis: It's interesting you bring that up, because I will say in a distantly related aside, certainly one of the more interesting and repetitively surprising conversations many of us have is the one that involves pediatric oncology with friends and neighbors or whatever who aren't that familiar. They're always surprised at the high success rate in that field. And it just makes the point that we can't let a diagnosis stand as the only interpretable fact. So, look, these recommendations establish an important principle. A cancer diagnosis alone should not keep a patient from a fair chance to access potentially life-threatening-- or rather lifesaving, sorry, resources, even during a public health crisis.

But let's go a step further. One of the other recommendations in there were that decisions regarding allocation of scarce resources should be separated from bedside decision-making. This one, I struggled with as a reader as well. And I wonder if you could explain to our listeners what the intent or thinking behind this recommendation would be. As I ask that question, in my mind's eye, I picture I'm called to the ER. The ER doc is looking at my patient's dropping O2 sat and is turning to me for advice and guidance and understanding of the disease specificity or the specific disease circumstances in this patient so they can make the triage decision. And I'm struggling to understand what we actually mean by decisions regarding allocation of scarce resources should be separated from the bedside.

Dr. Jonathan Marron: So ultimately, that piece comes down to the fact that we as humans and decision-makers are imperfect. And it would be unreasonable and probably impossible to expect that any one of us, as a clinician or just as a person, could reasonably weigh all of these different things simultaneously, because there is ultimately a huge conflict of interest in saying that I am the clinician taking care of this patient in front of me, but simultaneously, my job is to steward the resources for my institution or, even more broadly, the resources for the entirety of the country or whatever I might consider to be my patient population. And so what we are trying to-- the message we were trying to send with that piece is not only that it shouldn't be the oncologist who's making that resource allocation decision, but it's actually not the emergency room clinician who should be either, because it's just completely unreasonable to expect someone at the bedside to be weighing those two things at the same time and to be making an unbiased decision.

Dr. Clifford Hudis: Well, apart from the pandemic and the specific kinds of acute resource shortages that the paper addresses, the truth of the matter is, we've been talking about finite healthcare resources and hard choices for years. And these questions often are raised in the context of oncology. So I want in that way to just ask you about something that you mentioned at the very beginning, but I'm going to push you to a more precise answer, the recommendation that says allocation of scarce resources in a pandemic should be based on maximizing health benefits. And you alluded to that a little bit.

So, can you just expand a little bit on what it is you mean? You've said overall survival is often taken as one. But of course, there are trade-offs. There's quality-of-life issues. There are a number of people who might benefit modestly, more people, fewer people, benefiting more deeply, whatever it is. So, I won't hold you to this exactly, although it's being recorded. But what do you think should be the goal when we talk about maximizing health benefits? What exactly does that mean?

Dr. Jonathan Marron: So, this is really where we get into the weeds with this, as you were sort of alluding to. So certainly, we want to save the most lives. I think there is general agreement from most people out there that that's a reasonable and a fair way to look at this. One of the questions that's been debated most over these past couple of months as we've been thinking about these things, perhaps more than we ever have before, is whether we want to somehow integrate the idea of saving the most life years.

So, what do I mean there? So, the idea that a person who is expected to live five years, do we think about that life differently than a person who's expected to live another 45 years? Intuitively, I think many people would say, oh, well, if we have to make that choice, that awful, impossible, choice, we should save the person who is going to live 45 years over the one who's going to live five years.

That's getting at this question of saving the most life years, number of total years of life. And so with that, I'll ask you, is there anything else you think ASCO members or the cancer care community or health care institutions should understand about this work in this moment? Is there anything their families and patients you would want to-- is there anything else you'd want them to know about this that we haven't touched on?

I mean, I think one really important but really challenging piece about all this is the role of communication, in every sense of the word, that these are absolutely unprecedented times. And these types of decisions, if and when they have to be made, are luckily things that-- the kind of decisions that we don't typically ever have to make. And so if they have to be made, ensuring that oncologists who have the long-standing relationship with patients and families take on a role of communicating with patients and with their families as much as they can to explain why these decisions are being made, and why they have to be made, to ensure that everybody is on the same page I think is really important.

What makes this even more difficult is the fact that most hospitals now have visitor policies such that families and caregivers often, if not most times, are not able to be at the bedside of patients, which makes this only that much harder, but makes communication that much more important.

I would want to highlight something you just said, because it resonates, at least for me, and I think for many in our in our community. And that is communication. At root, of all of this is dependent and made easier and smoother by high-quality communications.

Dr. Clifford Hudis: And I would actually extend what you said by pointing out that it also includes discussions about intentions and desires on the part of patients. And this is something we who take care of cancer patients, I think, do try to spend a lot of time on. This discussion is much easier if a patient who does know about a life-limiting prognosis is clear about what they want. Certainly, for the whole team, some of the ethical dilemmas might be minimized that way, right?

Dr. Jonathan Marron: Yeah, I couldn't say that better. That's one thing we try to highlight in the guidelines as well, that we consider advance-care planning and having goals-of-care discussions to be really at the core of clinical oncology practice. And that continues in the setting of this pandemic. And if anything, it's only more important.

Dr. Clifford Hudis: Well, I think this is really great. I hope that listeners find this discussion intriguing and go and take a more in-depth look at the actual publication. I want to point out that the recommendations that we've been discussing are just one part of ASCO's longstanding commitment to provide information, guidance, and resources that will support clinicians, the cancer care delivery team, and patients with cancer throughout their journeys, and also during this COVID-19 pandemic. That is, what we're doing here is not unique to this pandemic moment, even if the acuity of the need is heightened.

There are some other resources that you should be aware of, including patient care guidance for oncologists who treat patients with cancer during the COVID-19 pandemic. There are guidances available for practices on how to adjust our policies in response to the virus and, just recently, on how to begin to return to more normal styles of work. There are also updates on federal activities that have been aimed at responding to this crisis. And everybody knows that this has been a very fast-paced time of change.

We recently launched the ASCO survey on COVID-19 in Oncology Registry or ASCO Registry. And our goal is to collect data and share insights on how the virus has impacted cancer care, but also cancer patient outcomes throughout the COVID-19 pandemic. And we encourage all oncology practices to participate so that we can gain the largest data set possible, and therefore represent the diverse population of patients and practices around the United States.

I want to remind listeners you can find all of these resources and a whole lot more at ASCO.org. There is also patient-focused information available at Cancer.net. And with that, until next time, I want to thank everyone for listening to this ASCO in Action podcast. I want to remind you that if you enjoyed what you heard today, you should take the time to give us a rating or review on Apple Podcasts or wherever you might listen. And while you're there, be sure to subscribe so that you never, ever miss an episode. I want to thank Dr. Marron for joining us today.

Dr. Jonathan Marron: Thank you, Dr. Hudis. It was an absolute pleasure to join you.

Dr. Clifford Hudis: And lastly, I want to remind you that the ASCO in Action podcast is just one of ASCO's many podcasts. You can find all of the shows at Podcast.ASCO.org.

Drug Repository Programs Address High Costs, Access and Waste Issues for Patients with Cancer May 13, 2020

In the latest ASCO in Action Podcast, American Society of Clinical Oncology (ASCO) CEO Dr. Clifford A. Hudis is joined by Dr. Ray Page, Past Chair of ASCO’s Clinical Practice Committee and President of the Center for Cancer and Blood Disorders, to discuss the benefit of drug repository programs solely for oral medications that are maintained within a closed system.

These programs can play an important role in helping patients afford their treatment and can reduce the financial toll on the cancer care delivery system, provided that important guardrails are implemented to keep these programs safe.

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Transcript

Dr. Clifford Hudis: Welcome to this ASCO in Action podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content, and offering enriching insights into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org. The ASCO in Action podcast is an ASCO series where we explore the policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for-- people with cancer.

My name is Clifford Hudis, and I'm the CEO of ASCO, as well as the host of the ASCO in Action podcast series. For today's podcast, I am really pleased to join once again Dr. Ray Page. Dr. Page is a past chair of the American Society of Clinical Oncology's Clinical Practice Committee, he is the President of the Center for Cancer and Blood Disorders where he also serves as a medical oncologist and hematologist, and he's a great and good friend of ASCO's.

Earlier this year, ASCO released a position statement on state drug repository programs outlining the society's support for such programs solely for oral medications and provided that they are maintained within a closed system. ASCO's statement also makes recommendations to help ensure that these programs are implemented appropriately with sufficient patient protections in place.

Today, Dr. Page and I will discuss the important role that these programs can play in helping our patients afford their treatment while reducing the financial toll on the cancer care delivery system as a whole. We will discuss the important guardrails that are needed to keep these programs safe. And with that, I want to welcome you, Dr. Page, and thank you for joining me today.

Dr. Ray Page: Thank you very much, Cliff, for having me for this conversation today. And I just want to let you know that I have no disclosures for this conversation.

Dr. Clifford Hudis: Thanks again for joining us today, it's a real pleasure to talk with you once more. And I want to get to today's subject. First and foremost, what are state drug repository programs? How do they work and what's the purpose?

Dr. Ray Page: In its simplest definition, a drug repository program is basically a legal process that allows unused drugs that have been prescribed to patients to be able to be donated and reused rather than thrown away or set aside if it's no longer needed. Its purpose is to offer a practical way to increase access of prescription drugs for patients. And often, this process can offer more timely access to drugs with a negligible financial impact for the patients. And this was a program that has managed at the state level, and it's subject to individual state laws and State Department of Pharmacy rules and procedures.

And these kind of programs are of exceptional importance to cancer patients who are constantly challenged today with getting affordable access to vital drug treatments for their disease, and these issues are described very well in ASCO's 2017 position statement on the affordability of cancer drugs. And this has all been on the radar of ASCO's State Affiliates Council in recent years where our state society presidents and their executive directors have shared model state legislation to advance these kinds of drug donation programs in their individual states.

Dr. Clifford Hudis: So, Ray, before we go any further, can you tell me, what does this actually mechanically in practical terms look like at the level of a practice or from the perspective of a patient or a pharmacy? What actually happens physically with product in the context of a repository?

Dr. Ray Page: It really varies from practice to practice and state to state, but Cliff, I can tell you that I see this in my own practice absolutely every day in my doctor-patient interaction. And this is really what's gotten me personally intensely interested in pursuing and establishing laws in Texas to allow for pill donation. Because ideally, we would like to have that transaction between the doctor and the patient of being able to get unused drug for those patients where the drug's not used anymore

And so there's many reasons why in the office, these people don't need the drug anymore. They could have progression of disease that requires new drug, or alternatively, they could have completed their treatment regimens that may have resulted in a cure. But oftentimes there can be interval dosage adjustments due to side effects and toxicities where they just need a new prescription.

And lastly, I just have to mention a little bit about the negative impacts of the pharmacy benefit managers in this world, and I'll refer our listeners to our previous podcast that we did together a few months ago just understanding the global concerns of the PBMs, but however, I'll just say that their drug distribution process oftentimes contributes to the tremendous cancer drug wastage that we have in the United States.

Dr. Clifford Hudis: Well, I mean, picking up on that, if readers take a look at ASCO's position statement, they'll see that we identify there the fact that appropriately-implemented drug repository programs can help address some of the cancer drug waste, And if I remember correctly, this was quantified by researchers in New York at Memorial Sloan Kettering Cancer Center. I think they found an estimate of about $3 billion annually.

The question is, exactly what causes this waste? And you alluded to the fact that you see this in your practice as well, but I just want to be really clear and in a practical sense, this waste is that a patient is dispensed-- I'll say, for argument's sake, 60 pills, and has progression of disease or a toxicity-based dosage adjustment and comes back for a routine office visit and still has, for argument's sake, 20 of the pills leftover. And the goal here is to essentially recycle those pills back into the supply, is that right?

Dr. Ray Page: That is correct. And so that's the basic mechanism. And as practicing physicians we see this issue all the time, where for the reasons that I explained, there's always unused pills that we don't need anymore. And if there is a mechanism by which we can safely transfer that drug to somebody that can actually use it and need it, there can be substantial positive impact with that for our patients.

Dr. Clifford Hudis: And is it only a financial benefit, Ray? Or are there non-financial benefits as well that this repository programs can somewhat mitigate?

Dr. Ray Page: Yeah. Well the financial impact of this is huge. The Americans are paying over $61 billion a year in out-of-pocket expenditures for drugs, and drug abandonment can have serious effects on a patient's health leading to hospitalizations, extensive health care cost, and even death. And the British Medical Journal reported an estimated $3 billion in leftover cancer drugs are discarded in the United States every year, and that's truly a tragic impact on our society.

But also, outside of financial, in 2015 the Environmental Protection Agency estimated that about 740 tons of drugs are wasted just by nursing homes every year, and obviously this can't be good for our environment, and we've all heard reports about many of these discarded drugs ending up in our water systems. So redistribution and enabling access to these unused drugs can help alleviate some of these problems that go outside the finances.

Dr. Clifford Hudis: Well thank you for that. I mean, high out-of-pocket expenses have been for a long time a serious concern for us at ASCO, and you've I think touched on how this can help reduce them. My question is, are there any pushbacks from patients or providers with regard to these programs? I mean, I can imagine that there might be some bureaucratic overhead that might represent a challenge for small practices or maybe there's some risk associated with it, but I'm just guessing. Is there any clear objection to these that we should be thinking about and possibly working to mitigate?

Dr. Ray Page: In general, in my interactions with my patients, most everyone has negligible concern about getting a donated drug for immediate use. There should be informed consent and disclosure, obviously, but the patients generally trust their physicians recommendations and are truly interested in just getting the opportunity to get access to the drugs. From a patient's perspective, I generally think that their greatest concern are just getting quick access to the oral drugs so they can get started on their cancer therapy as soon as possible, often to alleviate active symptoms that they're having, and to alleviate some of the fear of just not getting access to beneficial drugs.

And the physicians I think share that same sentiment of the patients, but in addition, physicians have concern and desires and assurances that these donated drugs are indeed safe for re-distribution.

Dr. Clifford Hudis: And Ray, is that what the informed consent would allude to? I was sort of wondering when you said informed consent. In a sense, is there anything different in the informed consent versus what would but with any other cytotoxic prescription, for example? I mean, is there really a way to describe the potential risk or the changes in the risk that there might be some loss of purity in a substance or substitutes? Or-- I'm just trying to figure out what the consent really ultimately conveys.

Dr. Ray Page: At least through some of the mechanisms that I'm familiar with that we've developed in Texas is basically there's just a disclosure form that the drug that was in possession of the patient, that they just sign a disclosure that they haven't tampered with it, messed with it, they're stored properly, those kind of things to create those assurances. And then the patient's just given a basically informed consent that they're aware that this transaction has been through a patient and outside the pharmacy.

Dr. Clifford Hudis: I see. OK. I mean-- so it sounds to me like we're just, in a sense at a societal level, trying to basically make it clear that there's a theoretical risk of some loss of control, but it's, from a practical point of view, not particularly high, right?

Dr. Ray Page: Yes. And I think many oncologists across the United States have just had those experiences with patients in the office that maybe don't have the financial resources, they're looking just for access to drugs. And if there's drug that's available that's been donated, a lot of patients seem to have no problem accepting the drug. And again, I mentioned that a lot of the patients generally trust their physicians' recommendations in that transaction.

Dr. Clifford Hudis: Well, I just have to say, I'm as you're talking, I'm reflecting on my own practice experience over the decades. And even for old and inexpensive drugs, it always bothered a lot of my patients that they couldn't simply give their inexpensive tamoxifen, for example, or aromatase inhibitors-- generic drugs, for that matter-- to somebody else in need when they no longer could use it. I think they just were offended by the waste. And even apart from the financial aspects that you've so clearly described, there is, I think, a real altruistic desire to use these drugs and not discard them wastefully, and it's nice to see that there may be the opportunity for patients to satisfy that need.

Dr. Ray Page: I agree with you, Cliff. I think there is a strong sense of altruism with our patients. Without a doubt, I think patients have extreme difficulty taking a drug that they know that they-- that the cost of that-- monthly cost of that drug was, say, $12,000 or $16,000, and that they're forced to discard it or flush it in the toilet or turn it in without it being potentially used by somebody else that may be in need, because they've certainly been in those shoes and experienced that themselves.

Dr. Clifford Hudis: As you know, ASCO strongly supports repository programs, but we're very focused on oral medications, and we make the assumption that they will be maintained within a closed system. For our listeners, can you describe the difference between a closed system and open system and why we would be favoring a closed system? What makes it safer?

Dr. Ray Page: So, Cliff, to define a closed system versus an open system, a closed system is a way to have the spirit of having an overabundance of precaution to assure patient safety. And basically, that allows for drugs that are prescribed to a patient and they bring back in that they have appropriate disclosure and supervision, and those drugs are reviewed by a pharmacist and assured that they're safe and able to be recycled according to state laws and pharmacy board rules.

And that's as opposed to an open system where, say, you have a patient that comes into the office and they got a bottle of pills that are unused and they give them to the physician, and then the physician turns around and redistributes those drugs to the next patient who's in need.

Dr. Clifford Hudis: I think for many listeners, and probably for even more of our patients nowadays, when they think of cancer treatment, many people are used to thinking about perennial therapies, infusions and the like. But this is really focused obviously on oral medications. What are some of the oral treatments that have been made available? You indirectly alluded to some in terms of price, but what are some of the specific ones that have been successfully made available to patients through drug repository programs so far?

Dr. Ray Page: Great question, Cliff. I'll just emphasize it today. Over 40% of cancer therapies that oncologists prescribed are oral drugs, and we have several hundred experimental oral cancer drug that are in clinical trials. So it's anticipated that as time goes on in the future, we're going to be prescribing more and more oral cancer therapies rather than patients spending all day in a chemo chair getting IV infusions. And that's a great thing for our patients.

But currently, I estimate that there's probably over 100 oral anti-cancer drugs and supportive care drugs that are being prescribed to our patients, and these encompass a wide range of treatments, including your classic cytotoxic chemotherapy pills, hormonal agents, molecularly-targeted drugs, and symptom management drugs. And so each state has a drug repository program, has its own pharmacy rules for that redistribution. And in general, most of these drugs, in order to be available, must be in untampered and in secure packaging such as blister packs.

And so most states require inspection by a pharmacist, and therefore, there's a number of great drugs that may not be readily available for redistribution based on state laws and pharmacy rules that are designed to protect patient safety.

Dr. Clifford Hudis: Are there other safeguards or any other provisions you think that state drug repository programs could take advantage of to improve their ability to serve patients? Is there anything else we should be doing, you think, as we gain experience with these programs?

Dr. Ray Page: You know, Cliff, I'm very pleased that ASCO came out with this position statement in support of the drug depository program that are being developed by each state. And ASCO has provided a few guiding principles for states to consider in their programs, and I think the ASCO recommendations for redistribution in a closed system is in the spirit of an abundance of precaution to assure patient safety.

However, like I said, this can potentially reduce the availability, but ASCO has made some recommendations to the states to where they want to assure that if they're not in a closed system, that the state and federal legislative address the concerns of drug related redistribution that are not in a closed system, that the surplus medications are administered in a safe, effective, and private manner in accordance with the prescribing clinician's guidance.

And the state should have a liability protection in accordance with their state health regulatory authority, and that includes such things as the informed consent and disclosures that we talked about. And then ASCO and other professional medical organizations should continue to make efforts to educate physicians about the existence and the value of these programs, and then ASCO also suggests that this drug repository program should be implemented and no additional cost, or at least as a negligible cost to the patient.

Dr. Clifford Hudis: Ray, I think that's great, and I actually, personally and on behalf of the membership and our whole community, applaud you for your activism in this area. Is there anything else that you haven't said that you would want our listeners to know about or have we pretty much covered it all?

Dr. Ray Page: Yeah, Cliff, I think there is just a couple of closing thoughts that I want to convey to you. So first, most states allow the redistribution of pills and blister packs, but not pills that are partially used in bottles as we've discussed. But during the last couple of years and again today, I want to implore to the pharmaceutical manufacturers to package their new, often very expensive anticancer drugs in blister packs.

So studies have shown that packaging in this way usually results in improved patient safety and compliance with taking their pills, but most importantly, if for whatever reason those pills are not needed anymore by the patient, the patient or the prescribing institution can donate those pills for redistribution to a fellow patient with a similar cancer. So it's the right thing to do.

And lastly, most states have some form of drug repository program already in their laws; however, unfortunately, most states do not have the program properly turned on. A few states, such as Iowa and Wyoming and Oklahoma, have successful programs working for the patients, but some states have rudimentary programs that need expansion. And then many states need to update their laws and get their programs working again, and this is not an easy process by any means.

I've been working for many years to get a meaningful Texas law passed, which although not perfect, we got a law passed in 2017. And in Texas in the last couple of years, we have been working on the rules and the forms and the processes, and I'm proud to say that my cancer center in Fort Worth is the first registered provider in the state of Texas, and we are currently working with the University of North Texas Health Science Center School of Pharmacy on this, and we've been collecting donated drugs, and we hope that very soon we'll be the first provider in Texas to re-distribute cancer drugs in the state of Texas.

So again, this is not an easy process, but I encourage all states to dust off and modernize their laws to allow cancer patients the ability to get affordable access to drugs through such opportunities as the drug repository program.

Dr. Clifford Hudis: Ray, again, I just have to emphasize how deeply grateful I am and I'm so happy to see that you've taken this on and with so much passion. It is hard to understand an argument against this, and that doesn't make it easy, but it's good to be right and it's good to see the effort that you've put into this and to start to see this success. It really does matter to patients as we have been discussing.

So for those of you who want to read more about this, I encourage you to open up ASCO's position statement on drug repository programs. Also there you can find breaking cancer policy news and more, all of that at ASCO in Action. That's on the website at asco.org/ascoaction, remembering that ascoaction is written here as one word.

And until next time, I want to thank everyone for listening to this ASCO in Action podcast. I want to remind you that if you enjoyed what you heard today, we'd love it if you'd give us a rating or a review on Apple Podcasts or wherever you listen. And while you're there, be sure to subscribe so you never miss another episode. The ASCO in Action podcast is just one of ASCO's as many podcasts. You can find all of the programs at podcast.asco.org.

Listen Now: New Registry Helps Cancer Community Learn About COVID-19’s Impacts on Cancer Care Apr 28, 2020

In the latest ASCO in Action Podcast, ASCO CEO Dr. Clifford A. Hudis provides an update on a new initiative, the ASCO Survey on COVID-19 in Oncology Registry (ASCO Registry), which aims to help the cancer community learn more about the pattern of symptoms and severity of COVID-19 among patients with cancer, as well as how the virus is impacting the delivery of cancer care and patient outcomes.

“We have an urgent need to learn more about how COVID-19 is directly and indirectly affecting the people with cancer who we serve. In times of crisis, it’s especially important that we learn from every patient so that we can refine our approaches and continue to provide the highest quality care,” said Dr. Hudis.

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Transcript

I’m Dr. Clifford Hudis, CEO of ASCO and the host of the ASCO in Action podcast series. For this podcast, I wanted to provide a quick update about one of ASCO’s newest initiatives, the ASCO Survey on COVID-19 in Oncology Registry, which we’ve launched in response to the COVID-19 pandemic.

It’s clear that the COVID-19 pandemic poses a threat to people all across the globe.

Since the worldwide outbreak of the coronavirus, we’ve learned that certain populations – including individuals with cancer – are more likely to be vulnerable to the worst outcomes from COVID-19.

However, there’s still so much that we do not understand. We have an urgent need to learn more about how COVID-19 is directly and indirectly affecting the people with cancer who we serve.

In response, ASCO recently announced the new ASCO Survey on COVID-19 in Oncology Registry or ASCO Registry for short. This exciting new initiative was developed under the leadership and vision of ASCO’s Chief Medical Office Dr. Richard Schilsky, with support from a dedicated team of professional staff who work for our Center for Research & Analytics (CENTRA).

The ASCO Registry was established so that we can learn more about the pattern of symptoms and severity of COVID-19 among patients with cancer, as well as how the virus is impacting the delivery of cancer care and patient outcomes.

We’re not just looking at point-in-time data on patients with cancer. The ASCO Registry will capture longitudinal data on how the virus impacts patient care and outcomes throughout the COVID-19 pandemic and into 2021. We hope that longer-term look will tell us if the virus resulted in specific complications for patients, delayed patients’ ability to get a specific type of treatment, or if certain approaches resulted in better outcomes for patients.

Once we have sufficient data in the Registry, we plan to release periodic reports to the cancer community and the broader public on key learnings. These reports might include details like the characteristics of patients with cancer most impacted by COVID-19, estimates of the severity of disease among patients with cancer, changes or delays to treatments, and the implementation of telehealth in a cancer care setting.

We also hope to be able to report on the clinical outcomes among patients with cancer during the pandemic. And, we might even learn that certain unconventional approaches might allow us to deliver care more efficiently or safely without jeopardizing patient outcomes.

The ASCO Registry is open to all U.S. oncology practices. That includes physician-owned, academic, hospital or health system-owned practices, and hospitals themselves.

Participating practices will be asked to complete a baseline data capture form on each patient with cancer who has a confirmed diagnosis of COVID-19.

Later, practices will be asked to provide follow-up information on each patient’s status, treatment, and outcomes.

Data will also be collected on practice-level changes, such as new screening procedures, implementation of telehealth in the practice, and changes to clinical trial enrollment procedures.

The ASCO Registry will securely collect limited patient identifying data – such as zip code, date of birth, gender, race, ethnicity, type of cancer, and comorbidities. By collecting this type of data, it will be possible for us to conduct longitudinal analysis.

Data from practices participating in the registry will be collected and securely stored on the CancerLinQ® platform.

We’re not alone in our work to better understand the impact of COVID-19 on the cancer care system and the patients we serve. Other registries, including the COVID-19 and Cancer Consortium (CCC19) and the American Society of Hematology (ASH) Research Collaborative COVID-19 Registry for Hematologic Malignancy have already been launched, and other multi-site registries are in development.

We are encouraging all oncology practices to participate in one or more registries based on their specific needs and to reflect the patients they serve. Each of these registries has a different focus and timeline, so participating in multiple registries will not compromise our efforts or prevent all organizations from working together. We are actively looking for opportunities to collaborate with our colleagues on these initiatives.

The ASCO Registry is part of our ongoing efforts to provide the most current information and resources the virus to our members and the larger oncology community.

We’ve developed a wide variety of COVID-19 resources to support clinicians, the cancer care delivery team, and patients with cancer.

Some of those resources include patient care guidance for oncologists treating patients with cancer during the COVID-19 pandemic; guidance for practices on how to adjust their policies in response to the virus; and updates on federal activities to respond to this crisis.

We’re also co-hosting a weekly webinar series with the Oncology Nursing Society on COVID-19. Each webinar examines a range of issues to help clinicians care for people with cancer during the COVID-19 pandemic.

You can find all of these resources and more at asco.org. Patient-focused information is also available at cancer.net.

We invite all of our listeners to learn more about the ASCO Registry on asco.org.

In times of crisis, it’s especially important that we learn from every patient so that we can refine our approaches and continue to provide the highest quality care.

The ASCO in Action Podcast is just one of ASCO’s many podcasts; you can find all of the shows at podcast.asco.org.

The Science Behind the Science Fiction: CAR T-Cell Therapy Mar 03, 2020

In the latest ASCO in Action Podcast, ASCO CEO Dr. Clifford A. Hudis is joined by Dr. Jason Westin, member of the Government Relations Committee of the Association of Clinical Oncology, to discuss CAR T-cell therapy, a groundbreaking and lifesaving cancer treatment that comes with significant side effects, a jaw-dropping price tag, and limited locations where treatment is currently available.

“This is potentially home run therapy for patients who have decades of life left to go,” says Dr. Westin. While he stresses that CAR T is a major step forward in ridding the world of cancer, Dr. Westin worries about the high cost of the treatment, which “is an incredible amount put upon the system.”

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Transcript

Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience and conclusions. The mention of any product, service, organization, activity or therapy should not be construed as an ASCO endorsement.

Dr. Clifford Hudis: Welcome to the ASCO in Action podcast brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insights into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org.

The ASCO in Action podcast is ASCO's podcast series where we explore the policy and practice issues that impact oncologists, the entire cancer-care deliver team and the individuals we care for--people with cancer. My name is Clifford Hudis, and I'm the CEO of ASCO as well as the host of the ASCO in Action podcast series.

For this podcast I am really pleased to have Dr. Jason Westin as my guest. Dr. Westin is a member of the Association for Clinical Oncology's Government Relations Committee. And he is the director of lymphoma clinical research in the Department of Lymphoma Melanoma within the Division of Cancer Medicine at the University of Texas MD Anderson Cancer Center.

Today Dr. Westin and I will discuss chimeric antigen receptor, or CAR T-cell therapy. Two years ago, ASCO named CAR T-cell therapy as our advance of the year in our annual Clinical Cancer Advances Report. CAR T is a groundbreaking and life-saving treatment for children and young adults with acute lymphoblastic leukemia, and also for adults with diffuse large B cell lymphoma.

But it comes with serious side effects, an extraordinary price tag and a limited number of places--at least in the United States--where the treatment is currently available. Today Dr. Westin and I will discuss the current state of the science on CAR T-cell therapy, as well as access issues that are facing those patients who are seeking treatment with this new modality. Welcome, Dr. Westin, and thank you for joining me today.

Dr. Jason Westin: Thank you for having me. Before we begin, I'd like to disclose that I have clinical trial funding disclosures that are listed on the ASCO conflict of interest website. Those that I view to be specifically relevant for today's discussion include advisory work as well as clinical trial research funding for CAR T-cell companies including Kite/Gilead, Novartis and Juno. I also do clinical trial work with Celgene, Genentech, AB V, Amgen, MorphoSys, Curis, and 47 Inc.

Dr. Clifford Hudis: Thank you very much for that. We appreciate that. Let's get into the real focus of our conversation today. And let's start, of course, with CAR T-cell therapy. What is it, for those who might not be familiar? How would you describe it? And further, what makes it so potentially transformative in oncology?

Dr. Jason Westin: CAR T-cell therapy is an incredible breakthrough for our patients fighting cancer. The word car--c a r--stands for chimeric antigen receptor. What a CAR T-cell is taking a T-cell that's functional and in the body to fight infections, infusing a new receptor on the outside, often a receptor that has an antibody fragment fused to parts of a T-cell receptor that now allow this car T-cell to recognize the wolf in sheep's clothing that's the cancer.

CAR T-cells are usually modified genetically using a virus to introduce new DNA into the patient's T-cell. And these are prepared in the lab, modified in a way that these can now recognize a surface marker, and then these cells are re-infused into the patient, where they can now grow. They can now find the cancer, and they can destroy it

This has been potentially transformative because it is something that has completely different resistance mechanisms than standard chemotherapy. CAR T-cells have shown incredible promise in clinical trials and now in early days standard of care. And the sky is the limit for how this could be used in the future, targeting other markers on other types of cancer and really opening up a whole new field of how we treat cancer, much in the way that immunotherapy with checkpoint antibodies has done over the past decade or so.

Dr. Clifford Hudis: Well, that's exciting. But you just hinted at what I think is the obvious next question. Breakthrough though this may be, clearly this has, at least for some patients, fairly significant side effects. And some of them, I understand, are somewhat different from what an earlier generation of oncologists might have been trained to recognize and to treat. Can you talk a little bit about what some of those side effects are, typically at least? And how we hope to limit that in the future?

Dr. Jason Westin: CAR T-cell side effects are certainly unique and not overlapping in the way that we think of oncology therapies side effects. The CAR T-cell therapy side effects in the short term are broken down into two main camps. The first is something called cytokine release syndrome, sometimes abbreviated CRS. Cytokine release syndrome is effectively almost like sepsis, in that it's an overwhelming immune response where the T-cells that have been manufactured and infused into the patient release an avalanche of cytokines to effectively recruit other immune cells to come help fight the cancer.

And in doing so, induces sepsis-like phenomenon of organ dysfunction, fever, and sometimes hypertension, which can be severe. The other acute short-term side effect that we can see from CAR T-cell therapy is a significant neurologic toxicity. And this is a new diagnosis, a new syndrome that's recently been classified by a consensus group as immune effector cell associated neurologic syndrome, or ICANS, for short.

This can range from mild slowing of speech or mild slowing of cognition all the way to status epilepticus and anything in between. The most common troubles folks have are mild slowing, but aphasias and/or seizures can certainly occur and can be quite distressing to the patient and to the family.

Thankfully it seems that both cytokine release syndrome and ICANS, the neurologic toxicity, appear to be fully reversible in the nearly all patients, in the vast majority of patients. The late side effects of CAR T-cells are also unique and different from what we've seen from prior chemotherapy-type induced side effects. These include, depending upon what target you're going after, an effective lack of the target expression long term.

And for CD 19 focusing therapies, this effectively means a B cell aplasia that can sometimes be for a year or longer after the one infusion of car T-cells are administered. We know from other immune therapies that depleting certain parts of the immune system is not usually overwhelming infections or other obvious toxicities, but can result in chronic infections, inflammation and need for replacement of things like intravenous immunoglobulin to replace immunoglobulin deficiency.

So, CAR T-cell side effects are not what we typically think of in terms of chemotherapy, of cytopenias, nausea and fatigue, or immune therapies of inflammatory responses off target from the projected cancer. These are more specific toxicities related to the extreme expansion and cytokine release of these Car T-cells during the battle against cancer as well as lingering effects from these T-cells remaining active for many months and maybe even years after the infusion.

Dr. Clifford Hudis: There are a number of barriers right now. You've highlighted some of them. First of all, we don't have applicability yet established for a large number of diseases. That's an area for research. There are special toxicities. And it sounds like, realistically, anybody starting to do this needs to be trained and needs support staff and teams, just like you described. So there's a geographic limitation.

But beyond all of that, there's also a more conventional limitation, which is just outright cost. And as I understand it, the cost, or at least the list price for available agents, can range from $373,000 to treat an adult with an advanced lymphoma up to 475 to treat a pediatric indication.

And further, I think these prices do not include the additional costs of hospitalization or managing side effects, and maybe other adverse events. I'm curious, do these prices matter day to day in your practice? Do your patients need assistance navigating this? Or what's the real-world experience, given this price point?

Dr. Jason Westin: This is a major concern for us for the future of CAR T-cell therapy. The accessibility not just based on physically being able to get it but financially being able to get these therapies, as you mentioned. The cost of the actual product itself, the one-time infusion of these T-cells that are manufactured specifically for each given patient, it's a major cost.

But in addition to that, the actual hospitalization, which is usually a significant amount of time. For most patients that receive CAR T-cell, they're hospitalized between a week to 10 days. This is not a trivial admission for observation overnight in the hospital.

These are huge costs. Now payers, including commercial and private payers, and now government payers, are supporting this. However, as the number of patients grow, this is going to be something that's going to increasingly strain the ability of the system to support an incredibly expensive therapy.

This is potentially home-run therapy for patients that may, in some cases, have decades of life left to go. So, the cost is not trivial for the benefit received. But it is an incredible amount that's put upon the system, put upon the payers. Right now, through payers, it's doable. But I worry about the future of this as the number of patients who can benefit from this goes up.

Dr. Clifford Hudis: Well, I guess if it's as transformative as you're describing, it is at least plausible that it's front-loading costs, but net actually might not be particularly more expensive than traditional, long-standing, less-effective therapies. I assume those kinds of economic models and reports are being developed. Is there anything you can say about that at this point? Or is it just too soon to make those estimates?

Dr. Jason Westin: It's still very early days. But there are absolutely analyses being done at looking at the number of quality life years gained from these kinds of treatments. And depending upon the effectiveness of the treatment, it can absolutely be a net long-term positive of somebody getting back to health and not requiring chronic therapies, or not dying at a premature age.

So, there is no doubt that the cost of this is high, but the benefit is also very high. But if this continues long term to scale up for more and more patients, even net long-term success and long-term neutrality of a cost, if you're paying more now and getting less costs later, it can still strain the system, if the upfront cost is substantial.

So, I think this is something that's going to have to be looked at in terms of, what is the true cost of making CAR T-cells? And potentially bringing those costs down as we try to scale up for more patients over time.

Dr. Clifford Hudis: So, you spoke about getting approval, and it sounded like you were talking about conventional commercial payers. Last year, the Centers for Medicare and Medicaid Services, or CMS, announced that Medicare would cover CAR T nationwide and we at ASCO were really delighted with that.

But we recognize that, while the drugs are being reimbursed, that reimbursement remains at a level well below the actual acquisition costs. So, I think this is another version of the same question, but how is that shortfall impacting patients? And how is it addressed? Or is that just something that the institutions have to eat?

Dr. Jason Westin: It's different from different institutions, depending upon their status with CMS and if they're grandfathered into older systems, or if they're not protected in that way, it is certainly a problem. And it's something that the approval for this to be funded by CMS was absolutely great for our patients. However, the reimbursement, as you mentioned, that's proposed for that approval is quite low.

It's not close to the price for the product as well as for the inpatient stay. And so many hospitals are treating commercial patients with the idea that they are reimbursed at a higher level to cover patients who are treated and covered by government payer systems. The government payer systems also have temporary funding that's associated with the new technology, the end-tap mechanism, where there's an initial bump in the reimbursement that's not permanent.

This is--these add-on payments are helping hospitals who are at risk of having a net loss financially for doing CAR T-cells. But these are only usually two years in length, meaning that this is not going to be a cost assistance for those hospitals for the long future of CAR T-cells. This is short term.

So, this is something that is new to government payers. This took quite a while after approval for CMS to make a determination on where this would be supported or not. It's all brand new. And it takes time to figure out the potential benefit, the potential long-term reimbursement levels.

But the current reimbursement levels are not going to be sustainable from government payers to hospitals, as a modality to keep this viable therapy for patients. We've already seen some hospitals that are not able or willing to treat patients who are on a government health-care system, actually sending them to larger systems that are treating many commercial patients to try and subsidize this net loss for a patient on Medicare or Medicaid.

This is something that is a big problem that's in addition to the cost of it. The substandard reimbursement is going to be a strain on the system in the long run.

Dr. Clifford Hudis: Well, that's interesting. I mean before the CMS coverage announcement came out, we at ASCO actually submitted comments to the agency, and this included our perspective on both appropriate coverage and reimbursement for CAR T as well as an overarching description of ASCO's principles on approval coverage and getting the right treatment to the right patients at the right time. That's really the underlying principle that we try to rely on.

I mention that because I know you have some familiarity with policy making in government, and then you've been--we've been--lucky, I think, that you're serving on the government relations committee right now. From the perspective of that, GRC, I wonder if you care to just expand a little bit on the importance of ASCO coming out and taking a stand on an issue like this?

Dr. Jason Westin: I think it's essential for organizations like ASCO to advocate on behalf of our patients to try and educate policymakers and lawmakers about exciting new breakthroughs and why this matters for our country, as well as for our future. This technology is so new and so innovative. So different than what we've done before in terms of treating diseases with medications or with antibodies, that it is sometimes a shock to the system about what exactly is this CAR T-cell. What exactly does that mean?

And having lawmakers and policymakers learn from organizations of experts like ASCO. And having policy statements and comments made on potential proposed recommendations. If we don't speak up for our patients, then our patients are going to suffer. And so, I applaud ASCO and the team at ASCO that works on these recommendations and policy statements.

Because this really is essential for us to speak up and to be seated at the table in a way that we can advocate for our patients. It's sometimes difficult for lawmakers or for policymakers to know what to prioritize. Or if this is something that's real, or if this sounds too good to be true, and therefore we shouldn't learn much about it or pay attention to it.

As mentioned earlier on this podcast, this is the beginning of a new era of therapy for fighting cancer. And we need to make sure that our policymakers and our lawmakers are aware this is coming, and aware that this is something that's going to be potentially transformative. And therefore, legislating and making policy in a way to allow patients dealing with cancer to have access to these incredible new treatments.

Dr. Clifford Hudis: So, on the question, again, of access, maybe going in a slightly different direction. We've talked a good bit just now about the science. We've talked a little bit about the toxicities. And we've spoken about the geographic limitations as well as payment. But addressing the geography issue.

Obviously with scale and familiarity, it's at least conceivable that more centers could offer this, and they might offer it on an entirely outpatient basis. What do you think about that as a near-term potential? And what do you think we have to maybe accomplish? What advances might be needed in order to facilitate that? Or you could say, I guess, not going to happen. So, what do you think is coming in that regard?

Dr. Jason Westin: I think that the CAR T-cell delivery has such a special need for both monitoring as well as anticipation of management of troubles, that this is not something that I see the current generation of CAR T-cells being administered widely in settings that don't have experience with this, or settings that don't have experience with prior transplant-type treatments.

This is treatment which has potential danger to go sideways in a hurry. And if you've never done this before, you may not anticipate that, and not be able to help your patients. So, there are current geographic limitations, and centers that do this and centers that don't. And I think that's probably for good reasons at this point and should not be something that we try and break down those walls and have this available at every oncology clinic until we work out ways to make this safer and less dangerous.

So, it's been a significant challenge to try to transition the current generation of CAR T-cells from an inpatient setting to outpatient setting. We are working on that, as others are. And there are some CAR T-cell products that may lend themselves to easier use as an outpatient, either because of less toxicities or less severe toxicities projected.

So, this is not something that's going to be a forever problem. But to the current generation of the FDA-approved products, the vast majority are administered inpatient, which is a strain on the hospital systems as well as on patients who prefer not to be cooped up in the hospital for a week to 10 days, if they don't need to be. So, I think this will change as we get better technology, as we get systems in place to monitor patients through telemedicine system as an outpatient. And hospitals have more direct lines from the hotel to the inpatient service, if you have a toxicity. That's coming, but it's been a challenge.

Dr. Clifford Hudis: I think that's a great place for us to start to wrap this up. I have to ask though, reflecting on what we've covered, is there any area of CAR T science or clinical use that we've neglected to surface in this conversation? Or anything else you want to convey to the listeners?

Dr. Jason Westin: I think the CAR T-cell story is an incredible advance. When I describe it to my patients, I describe it as almost a science fiction-like therapy where we're able to take your immune system, modify it in a way that it can now see the wolf in sheep's clothing, and get back and re-infuse these cells back in your body. And get them to work to effectively eliminate the cancer that they've not been able to do thus far.

This is a therapy that works incredibly well for relatively rare cancers at this point. And so I think, as we're smarter and as we learn how to better manipulate the immune system in therapeutic ways, the sky is the limit for how we can both treat cancers and hopefully, even as we get further afield, maybe even prevent cancers from ever developing.

If we know somebody has a genetic risk that is a high probability of developing a cancer, teaching their immune system new tricks, so that we can have the sky be the limit and really work to try to end cancer, to try and conquer cancer. This is something that is obviously a goal for many researchers and many people who focus on cancer. But this new advance of cell therapy, of CAR T-cell therapy, is a major step forward in our efforts to try and rid the world of cancer.

Dr. Clifford Hudis: Well, I mean that's just a great way to wrap this up, I think. And I want to again thank you, Dr. Westin for taking the time to speak with me today and for providing so much clear and understandable information. I'm sure this will be useful for a lot of people. Really appreciate it.

Dr. Jason Westin: Thank you very much for having me.

Dr. Clifford Hudis: And I do hope that all of our listeners have enjoyed this conversation on CAR T-cell therapy, an exciting and developing area of cancer care. I hope you also see, woven through this, the way in which we are able to take evidence-based advocacy to policymakers to support the kinds of cutting-edge, scientific advances that are members and all of our listeners contributed to through their research and their study.

And I think that this is something that highlights the connected nature, again, of all of our work and the importance of our engagement. For those of you who want to learn more about CAR T and also breaking cancer policy news, we have that for you at ASCO in action on our website.

And again, as a reminder, that's ASCO.org/ASCOaction. And in this case, ASCO action is all one word. Until next time, I want to thank everyone for listening to this ASCO in Action podcast. If you enjoyed what you heard today, please don't forget to give us a rating or a review on Apple podcasts or wherever you listen.

And while you're there, please make sure you subscribe, so you never miss an episode. The ASCO in Action podcast is just one of ASCO's many podcasts. You can find all of our shows at podcast.asco.org.

Listen Now: New Podcast Highlights Cancer Advance of the Year Mar 02, 2020

In the latest ASCO in Action Podcast, American Society of Clinical Oncology (ASCO) CEO Dr. Clifford A. Hudis is joined by ASCO Chief Medical Officer Dr. Richard Schilsky to discuss the recently released 2020 Clinical Cancer Advances report, which named the refinement of surgical treatments for cancer as the Advance of the Year.

“A lot of the advances we’re seeing in surgical approaches now are driven by better systemic therapies for cancer. These systemic treatments have improved survival outcomes and quality of life for our patients, and have now begun to transform the role of surgery in cancer management by reducing the amount of surgery in some cases, eliminating the need for it in others, or, conversely, increasing the number of patients who could undergo surgery when it’s needed for treatment of their cancer,” says Dr. Schilsky.

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Transcript

Dr. Clifford Hudis: Welcome to this ASCO in Action podcast brought to you by the ASCO Podcast Network. This is a collection of nine programs covering a wide range of educational and scientific content and offering enriching insights into the world of cancer care. You can find all of ASCO's podcasts, including this one, at podcast.asco.org. The ASCO in Action podcast is ASCO's podcast series that explores policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for--people with cancer.

My name is Clifford Hudis, and I'm the CEO of ASCO, as well as the host of this series, and I'm delighted today to have as my guest the Society's Chief Medical Officer and Executive Vice President, Dr. Richard Schilsky. He's also an executive editor for the recently released 2020 Clinical Cancer Advances Report. In this report, ASCO identifies the most important clinical research advances of the past year across the full trajectory of the disease, from prevention and screening, to treatment and survivorship. The report also announces ASCO's Advance of the Year and updates our list of research priorities that have great potential to accelerate progress against cancer. Rich, welcome, and thank you for joining me today.

Dr. Richard Schilsky: Thanks a lot, Cliff.

Dr. Clifford Hudis: Now, starting at the beginning, this year ASCO has recognized refinement of surgical treatment of cancer as the Advance of the Year, and this is an area of clinical cancer research that has demonstrated the most significant progress in a year's time. I have to say, before we get into that, it seems almost poetic to me that this has happened this year because, one, we lost a leading surgical investigator in our field, Bernie Fisher, this year, and two, as I think about it, it came as a little bit of a surprise to me only because the mid 19th century was really the beginning of the century of surgery, and surgery for cancer dates back to Roman and Greek times, actually. So, can you tell us, in light of all of that, what was it that brought this back to the fore this year?

Dr. Richard Schilsky: Over the years, we've seen a great deal of progress in developing the new systemic therapies for cancer, and this really, I think, illustrates the prescient work of Bernie Fisher in his seminal research on adjuvant therapy for breast cancer, because a lot of the advances that we're seeing in surgical approaches now are driven by better systemic therapies for cancer. These treatments have improved survival outcomes and quality of life for our patients, and they've now begun to transform the role of surgery in cancer management by reducing the amounts of surgery in some cases, and even eliminating the need for it in others. Or conversely, increasing the number of patients who can undergo surgery when, in fact, it is needed to help in the treatment of their cancer.

Dr. Clifford Hudis: That's great to hear, because I was wondering at first if it was simply the fact that we just had a president who was a surgeon, and it's clearly about much more than that. What are some are the specific advances that you actually would cite as supporting this call out of surgery this year?

Dr. Richard Schilsky: Yeah, I think there some really interesting reports that are summarized in this year's Clinical Cancer Advances that really speak to this issue. In melanoma, for example, there are two studies that examine the efficacy and safety of neoadjuvant treatments for patients with locally advanced disease. Australian researchers examined the combination of two molecularly targeted drugs, dabrafenib and trametinib, given before surgery in patients with stage 3c melanoma that has BRAF V600 mutation. Not only did 86% of patients on the trial respond by the time of resection, but almost half had a complete response, either obviating the need for or simplifying the surgical treatment.

In another study, patients with stage three melanoma that was still treatable with surgery received ipilimumab and nivolumab for two cycles prior to surgery, resulting in a pathologic response rate of 77%. These studies are already changing practice, helping patients with locally advanced melanoma avoid surgery in many cases, or making surgery possible in patients with locally advanced disease who might not otherwise have been candidates for surgical resection. So this really is the year, I think, where we're seeing highly effective systemic therapies making surgery more possible where surgery can contribute to achieving better cure rates, or obviating the need for surgery where surgery is actually no longer necessary given the effectiveness of systemic treatment.

Dr. Clifford Hudis: From your point of view, as you look at both our Clinical Cancer Advances for this year and also the totality of public health data, what role would you ascribe to federal funding in generating these advances?

Dr. Richard Schilsky: Well, I think it's pretty clear that essentially every cancer advance begins in the basic science laboratory. It begins with new discovery, new understanding of biology, new description of mechanism of cancer progression, and the identification of novel cancer targets, and all of that basic research that's funded by NCI and NIH more broadly is the foundation for all the progress that we've made in development of new therapies, as well as prevention strategies and early detection strategies and so on. So, the federal funding is critical.

This year's Clinical Cancer Advances Report highlights 10 studies that were supported, directly or in part, by funding from the NIH, so that highlights another important role for the federal funding. Not only is there the discovery work, but there is also the work through NCI-funded cooperative group studies and other clinical trials that actually is helping to translate those basic science discoveries into clinical trials, and more importantly, helping to design clinical trials that are not likely to be pursued by commercial interests, but that answer important clinical questions that directly impact the way patients are treated by their physicians.

Dr. Clifford Hudis: This is the second year that ASCO has included with its Clinical Cancer Advances Report a specific set of research priorities. Can you tell us a little bit about the motivation for creating this so-called research agenda for the country, and then the criteria that are used to select these specific priorities?

Dr. Richard Schilsky: Well, as you said, as much progress as we're making, there still is substantial unmet need, and so we need to continue to accelerate progress in many areas and focus our resources, so we launched ASCO's list of research priorities to accelerate progress against cancer by sparking momentum in those areas of research where the opportunity is really ripe to spur new advances. The goal in doing this is to provide the cancer community with direction, or at least insight as to where to focus their investments and resources. The research priorities represent areas that have the potential to significantly improve the knowledge base for clinical decision-making and help us address vital needs in cancer care that remain unfulfilled.

Dr. Clifford Hudis: Now, these priorities are nominated by ASCO volunteers and clinical experts who've worked on the Clinical Cancer Advances Report and have identified not only what the big advances are for the year, but what the unmet needs are, where the opportunities still lie to continue to accelerate our research momentum. So, they were then discussed and distilled and evaluated by various groups of ASCO experts, and what's now in the report represents our best current thinking about where we have opportunities to really have a big impact.

And I think, if I'm not mistaken, one of the hopes for results of this is to recognize that there are areas that get a lot of research. We know there are literally more than 100 I-O drugs theoretically in development right now around the world. Our goal here, I think, is to highlight some of the areas that may not be supported directly by industry necessarily, but in fact, may be dismissed as people think about high-impact targets. There are some places where we need to make progress in order to offer the most patients the greatest benefit.

Dr. Richard Schilsky: I think the research priorities are not necessarily what might be thought of as underrepresented areas of research, but they are areas where ASCO feels that there is opportunity to have a big impact, because there's already sort of a glimmer of progress being made in these areas, and we believe that with further investment and prioritization, we can really much more rapidly accelerate progress in these areas. And the research priorities are by intention fairly broadly stated, because we're talking in the research priorities not necessarily about a specific disease or a specific target, but really a specific approach or an area where we believe we can have broad impact by focusing on a specific population or a way in which we can use therapy more effectively or with less toxicity.

Dr. Clifford Hudis: So as an example, and just making it up, but a difficult to treat disease where there is not, again, meaningful scientific advance actually wouldn't make the list because there's not really an opportunity right now in our minds, right?

Dr. Richard Schilsky: Absolutely. And in fact, when you look at the list, you'll see that there are no specific cancers that are called out in the list. The list is really about specific populations, specific approaches, ways in which we can better utilize available therapies or limit the toxicities of available therapies so that overall, the impact of treatment is greater for the particular patient population.

So then why don't we just dive right in and talk about what are some of the research priorities that made the list this year.

There are eight priorities this year. They really fall into three major thematic areas. The first of those is getting treatments to the patients who can benefit from them the most and sparing the toxicities and costs of treatment for the patients who would benefit the least. So, two priorities in that area are identifying strategies that predict response and resistance to immunotherapies.

So these are therapies that we already know can have an enduring impact on a small proportion of patients across a variety of different diseases, and the real question is, who are the patients who are likely to receive that long-term benefit, and who are the patients who are unlikely to benefit and understand why, but also if the patients are not going to benefit from those therapies to then turn to alternative treatments with fewer toxicities. Another priority in this area that sort of echoes of the advance of the year is to further understand how to limit the expensive surgery by optimizing systemic therapy, and this really gets back to the whole concept of adjuvant therapy in many ways, where we know that many patients who receive adjuvant therapy either don't need it or don't benefit from it. And what we want to be able to do is to tailor adjuvant therapy in such a way that it has the greatest impact on the population that needs it the most.

Now, the priorities are also focusing on improving treatment and care of special populations, emphasizing the importance of improving representation of these populations with clinical trials so that we actually have reliable data to better inform treatment approaches. A few priorities in this thematic area include increasing precision medicine research and treatment approaches in pediatric and other rare cancers, optimizing care for older adults with cancer, increasing equitable access to cancer clinical trials so that more patients can benefit from those studies, and importantly, reducing the adverse consequences of cancer treatment, particularly in long-term survivors who, in a sense, have to live with the consequences of their cancer and its treatment for the rest of their lives.

Finally, but not least, the research priorities focus on reducing the risk of cancer and on detecting it early. So, there is a priority on reducing obesity's impact on cancer incidence and outcomes, I know that's been of particular interest of yours for many years, and then on better identifying premalignant lesions and predicting when treatment is needed. We know from the natural history of many premalignant cancers that they never will evolve to invasive cancer, and so there's a risk of over-treating people based on a diagnosis of a pretty invasive cancer. We want to better understand the biology and natural history of those circumstances so that the patients who need treatment will get it and the patients who can safely forgo it can skip it.

Dr. Clifford Hudis: Yeah, and one can imagine in the years ahead that that will actually, if you will, leap into even low-grade, but invasive cancers and start to help us know who actually needs therapy and you can just have a cancer--

Dr. Richard Schilsky: Yeah, I'm sure you could do many hours of podcasting about DCIS and the controversy surrounding that type of cancer. Of course, the same is true in prostate cancer and other cancers that have a diverse natural history. There are clearly circumstances where patients who have early stage, but biologically indolent cancer may not need treatment or may not need aggressive treatment. We just have to be able to identify who those patients are.

Dr. Clifford Hudis: Right. So, for people who are intrigued by this, and I hope you are, I encourage you to take a look at the full and detailed list of the research agenda by visiting asco.org/cca. That's asco.org/cca, and there, you can take a deeper dive into all of these items. Now, Rich, if we were to succeed and direct the right resources to these priority areas, how would you see this actually transforming patient care in the next few years?

Dr. Richard Schilsky: Well, at a high level, I think it's-- we hope it'll dramatically change the care of cancer patients and allow more patients to get the right treatment at the right time, and of course, enabling them to live longer, fuller, better lives. It's really all about understanding the biology of each person's cancer, its likely natural history, its vulnerabilities, and then developing a treatment plan that is optimized for the care of that particular individual.

Dr. Clifford Hudis: Now, we recognize-- and we touched on this already-- that we can't do all of this within ASCO, and we don't have the ability to specifically direct research programs. So, what is it that would satisfy us that the cancer community is responding to this goading, if you will, and is trying to make progress? What would be the indicators that you would find?

Dr. Richard Schilsky: Well, as you said earlier, I mean, we continue to vigorously advocate for increasing federal funding for cancer research, which is the foundation of all the basic science breakthroughs that enable everything that flows from that in terms of development of new molecular diagnostics and treatments, so we want to continue to be aggressive in advocating for that improved funding. We clearly still need better prevention and screening approaches. We saw very little in the way-- other than vaccination, as we discussed earlier, and a few drugs, like some of the drugs that are approved to treat or reduce the risk of breast cancer in high-risk individuals, we saw very few effective prevention strategies. We need a lot more research on how to identify what those strategies might be and how to bring them to fruition.

We have a lot of opportunity that can really only be supported through federal funding to do what's often referred to as comparative effectiveness research. The pharmaceutical company's job is to bring new drugs to market, not to necessarily show which drug among many is the best drug for an individual person. And yet, we know that patients and doctors are confronted with these decisions all the time, particularly when there are several approved drugs in a given indication. Which is the best one to use, which is the least toxic, which is the one that's likely to produce the best outcomes for my particular patient? Those are questions that can be answered through comparative effectiveness studies that can be funded by federal funds.

And then finally. Breakthroughs on rare cancers. Rare cancers are not necessarily a focus for commercial drug development because they represent small markets. Now, we are beginning to see with the FDA approval of some histology agnostic drug approvals that even drugs that target very rare molecular alterations can potentially be attractive to the pharmaceutical industry. Because in the histology agnostic approval, it opens up a much broader market. But rare cancers otherwise are likely to not get the attention of commercial developers, and we need federal funding to support research in those areas, to be sure.

Dr. Clifford Hudis: So really, our hope with these priorities is that we stimulate the entirety of the research and treatment ecosystem to think about these studies, to support them, design them, and enroll patients on them given the opportunity, right?

Dr. Richard Schilsky: Well, that's exactly right. And the whole ecosystem has a role to play in bringing drugs from the discovery phase, through development, through ultimate commercialization, and then the effectiveness research then follows on after the commercialization so we really actually understand how the drugs perform in real-world populations, many of whom never get the opportunity to participate in the pivotal clinical trials.

So fundamentally, this can all be understood as advocacy. And in that regard, I guess it's reasonable, or at least our listeners may wonder what steps they and ASCO members in general can take to urge Congress to support these policies and support the critical cancer research that we're highlighting.

The easiest thing for ASCO members is to contact their members of Congress through ASCO's ACT, A-C-T, Network, which they can access at asco.org/actnetwork, and there, they can easily generate a letter advocating for federal support for cancer research to their congressmen and their senators. And I can't stress enough how important it is that all members get involved in this advocacy work. There are also opportunities for people to come to Washington to participate in ASCO's Hill days and to get involved in ASCO's other activities through the Government Relations Committee and other work that their society is doing on their behalf.

Dr. Clifford Hudis: Well, this is great. In just about a half an hour here, we've covered a large amount of material and a lot of progress. Maybe at the risk of some redundancy, what do you think, in summary, is the takeaway that you hope that listeners and everyone reading the Clinical Cancer Advances Report takes away?

Dr. Richard Schilsky: It's a bit hard for me to sort of grapple with this from time to time, but I've now been an oncologist for 40 years, and over the 40 years of my career, when you look at it through that broad span of time, I really feel like I've seen remarkable progress that we have made together in understanding cancer biology, developing far more effective and less toxic therapies, developing much better supportive care strategies, and we're now really beginning to see that at the population level with this substantial fall in cancer mortality rates that you alluded to earlier that's been occurring now year over year over year for at least the last two decades. And this year, as you suggested, it's being attributed, at least in part, to far more effective treatments for cancer than we've ever had in the past, particularly for lung cancer, which is still the nation's biggest cancer killer, but for which we have far better therapies than we've ever had before. All of this comes only from a sustained commitment to research, from having an ecosystem, as you suggested earlier, that's committed to making progress in every cancer type for every cancer patient. And I am remarkably optimistic as we now head into a new decade that the pace of progress is going to continue to accelerate in a very unprecedented way.

Dr. Clifford Hudis: Yeah, I agree. I mean, it's been interesting to watch the advances I think one of the places where we have to acknowledge frustration on the part of our members and community and the patients we serve is that the advances are often very pointed because of scientific breakthroughs, and they are profound, and meaningful, and they transform disease, but the totality of the burden of cancer remains substantial. For some reasons outside the scope of this discussion, it will even continue to grow on a global level. So, we have a challenge here to celebrate real advances while respecting the fact that we have a lot of progress ahead, right?

Dr. Richard Schilsky: Our work's not done, but it's gotten a lot easier, and in many ways, a lot more fulfilling.

Dr. Clifford Hudis: Well, Rich, I want to thank you again, both for leading the production of this report, and for joining me today on this ASCO in Action podcast to talk about it. I encourage our listeners, again, to read the full report by visiting asco.org/cca.

Dr. Richard Schilsky: Thanks, Cliff. This is really a fun project for me to work on every year with wonderful ASCO volunteers, and I hope our members will enjoy reviewing all the advances summarized in the report this year.

Dr. Clifford Hudis: For those of you listening, if you enjoyed what you heard today, please don't forget to give us a rating or a review on Apple Podcast or wherever you listen. And while you're there, be sure to subscribe so you never miss an episode. The ASCO in Action podcast is just one of ASCO's many podcasts. You can find all of the shows at podcast.asco.org. Until next time, thank you for listening to this ASCO in Action podcast.

Disclosure: Dr. Schilsky reports serving on the board of directors for the Reagan-Udall Foundation for FDA and research grants to ASCO in support of a clinical trial from the following companies: AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Meyers Squibb. Genentech, Lilly, Merck, and Pfizer.

ASCO Patient-Centered Oncology Payment Model: Clearest Way to Move from Fee-for-Service to Value-based Care Jan 07, 2020

In the latest ASCO in Action Podcast, ASCO CEO Dr. Clifford A. Hudis is joined by Dr. Jeffrey Ward, a leading contributor to the society’s updated Patient-Centered Oncology Payment (PCOP) model, to discuss how PCOP can improve patient care and lower costs.

“If we don’t find a way to bend the cost curve, we’re not going to be able to fulfil the mission to take care of our patients,” said Jeffrey Ward, MD, FASCO. Currently the clearest way to move from fee-for-service to value-based care, notes Dr. Ward, PCOP “will invigorate our specialty and our practices” and “improve the way we give care.”

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Transcript

Dr. Clifford Hudis: Welcome to this ASCO in Action podcast, brought to you by the ASCO Podcast Network. This is a collection of nine programs covering a wide range of educational and scientific content and offering enriching insights into the world of cancer care. You can find all of ASCO's podcasts, including this one, at podcast.asco.org.

The ASCO in Action podcast series explores policy and practice issues that impact oncologists, the entire cancer care delivery team, and most importantly, those individuals we care for-- people with cancer. My name is Clifford Hudis, and I'm the CEO of ASCO, as well as the host of the ASCO in Action podcast series.

For today's podcast, I'm delighted to have as a returning guest Dr. Jeffery Ward, past chair of ASCO's Government Relations Committee. He's here today to talk with us about ASCO's newly updated Patient-Centered Oncology Payment model, or PCOP. This is an alternative payment model which he had a major role in authoring and developing. Dr. Ward, who in many respects could be considered a Founding Father of ASCO's payment reform initiative, is going to tell us more about the significant updates in this model, its goals, and how it could work to improve care for patients with cancer. Welcome, Dr. Ward.

Dr. Jeffery Ward: Thank you. Good to be here.

Dr. Clifford Hudis: Jeff, I'm going to dive right in. I've called you a Founding Father because you played such a critical role in shaping ASCO's more than five yearlong effort to develop a viable alternative to the current pay-for-service reimbursement system. Before we get into the updated model, can you tell our listeners a little bit about how we got here today? Why are you a Founding Father?

Dr. Jeffery Ward: Well, my recollection is that it actually began about eight years ago, but it took three years to get a work product. Through an intermediary, the Brookings Institute, they asked ASCO if we had any ideas or offerings that the Congressional Budget Office could score as savings without driving oncology out of business.

At the time, I was a brand-new CPC chair, and waiting with Rocky Morton from Iowa. We pulled together-- the CPC steering committee-- about 15 doctors, mostly from community practices, and had some fairly heated meetings focused on what has proven, over time, to be a very tall peak to climb-- alternatives to buy-and-bill chemotherapy.

At the end of the day, we told the supercommittee that we had nothing for them but promised to stay engaged. That wasn't a good feeling. It wasn't a good day. And we decided that that wouldn't happen again. So, we put together a payment reform workgroup consisting of community, hospital, and academic-based oncologists, pulled in a lot of ASCO support staff, and hired a consultant-- or mediator-- to try and keep us focused. The only prerequisite to be on this group was that you had to be reform-minded, and our task was to forget everything that existed and propose a novel reimbursement model.

Dr. Clifford Hudis: Well, that brings us right to the current day and we recently put out the update of this. The official name is the ASCO Patient-Centered Oncology Payment, which is a community-based medical home model-- or PCOP for short. But at a very high level, can you tell us, what does this updated PCOP do? What makes it unique as an alternative payment model?

Dr. Jeffrey Ward: I think at a high level, it makes the oncologists responsible for being a good steward of our cancer care delivery system-- I think, arguably, the best cancer care delivery system in the world-- without making us responsible at the same time for what the market will bear-- drug prices that are both ridiculous and entirely out of our control. So, I think it aligns what we aspire to and how we get aid into one cohesive model.

Dr. Clifford Hudis: What are the specific approaches that our PCOP uses to make sure that patients have access to high-quality care, and practices have the resources they need to provide that care? And you alluded to the tension already, but I'll clarify, maybe, even more. There are those critics who will say that doctors should be focused solely on quality of care and outcomes for individual patients. And there are many others in our community who make very clear arguments for our responsibility to society to balance benefits against costs. So how do we thread that needle?

Dr. Jeffrey Ward: Well, I don't think that that's a dichotomy. I think what you have to do is, you have to say, those two goals can and should be married into a cohesive model of both delivery of care and reimbursement. PCOP actually has two reimbursement models. It has a starter track. It'll be familiar to followers of Medicare's oncology care model demo. It takes a performance-based reimbursement system and puts it on the backbone of traditional fee-for-service. But there's one big difference, in that it doesn't hold practices responsible for drug list prices.

Then there's an advanced track that's really closer to the original payment model we first published in 2014. It transitions fee-for-service oncology to monthly bundled payments and replaces the margin on drugs with a suitable pharmaceutical management fee. Critically, both tracks then marry the reimbursement model with an oncology medical home model of care and value-based clinical pathways in an effort to hold us responsible for care management and appropriate utilization of oncologics that, I believe, broadly applied, would put downward pressure on pharmaceutical drug prices without putting practices in the middle anymore.

Dr. Clifford Hudis: I want to drill down a little bit on this oncology medical home framework. What would it actually take for a practice to engage in this, and how would a patient perceive benefit?

Dr. Jeffrey Ward: For a practice to be able to say, “we're going to do this”, they would start, probably, with the simpler track and work their way up. In the advanced track, the PCOP payment methodology actually involves three components. There are monthly payments, there is residual fee-for-service reimbursement, and then there's performance incentive payments. Practices are held accountable for providing high value, evidence-based care under three different performance categories. These three scores of equal weight then contribute to a score that, done well, improves your reimbursement. Done poorly, it lowers your reimbursement. And though it's contrary to business as usual, I think it's hard to argue that it shouldn't, particularly when you as a practice had a role in creating the parameters themselves.

Dr. Clifford Hudis: What happens-- just for people who might either be interested in this, but haven't participated, or for people that are approaching this slightly more academically, you're going about your business and you're in a practice. What triggers you to start doing this? Another is, why don't you just put your head down and keep doing things the way you have?

Dr. Jeffrey Ward: I think for several reasons. One reason is that we have a system that isn't going to be able to continue the way it is. There's no doubt that prices are accelerating in such a way that, if we don't find a way to bend the cost curve, we're not going to be able to fulfill the mission we have to take care of patients.

The second reason is that this is a pathway that actually is going to improve the way we give care. The struggle we have with fee-for-service medicine in general is that it rewards the provider for doing more. This effect is amplified dramatically when you apply it to the cost of drugs. On the other hand, value-based pathways-- what we've built into this-- that look at efficacy first, toxicity second, and cost as a tiebreaker, can reward me for using the right drug in the right patient at the right time. And a well-constructed pathway will avoid both over and under-utilization of therapies. And that helps make PCOP, I think, uniquely different from payer-mandated pathways because it's a prospective pathway agreed upon by the providers and the payers in a transparent and collaborative way. So, there's several things, I think, that we've done to try and combine both reimbursement and care into one cohesive model, instead of two separate tracks that incentivize different things.

One other aspect of this-- beyond the internal control that you have with pathways-- is, of course, that nobody practices in a vacuum. And I understand a major element of the PCOP design is its emphasis on implementation in communities that include multidisciplinary providers and practices. It also includes, at least theoretically, multiple kinds of payers-- federal and state on the one hand, and then private on the other, the latter including employers. And finally, it can include patients with some mobility and span regional health networks.

Dr. Clifford Hudis: I guess I have two questions. One, what is the benefit of this broader approach to the PCOP model? And the second is, what are some of the challenges that that brought?

Dr. Jeffrey Ward: I think one thing that's really unique in the update in the model-- it's certainly not something that we had envisioned initially, and it's why evolution, I think, of the model is important-- is the recognition that quality improvement happens slowly if you're in a silo. And so PCOP is really designed to bring together geographic communities of providers, payers, policymakers, and then it yokes them together to the patient's benefit. It allows for efficient sharing of best practices. One of the things that being involved, I think, in both the Washington State Medical Oncology Society here in my state and in ASCO at the same time has taught me that being collaborative helps our patients a whole lot more than being competitors.

Dr. Clifford Hudis: I asked this question a little bit before, but now, even thinking about networks and collaboration, I'm going to ask it again and maybe push, even, a little harder. But in practice, how do you implement PCOP? How does a practice go from, it's Tuesday morning and we're running along the way we have since 2003, and it's Wednesday and now I'm in PCOP? What actually do you do to engage?

Dr. Jeffrey Ward: Yeah, I do think that there is a bit of a hurdle there. But there are also, I believe, some natural places that this could happen and get a foothold, and that once people see how this model worked and how effective it was, that it would certainly gain in popularity. I think Medicare Advantage plans, Medicaid HMOs, some accountable care organizations in particular have really struggled with, how do we manage oncology? And one way to do it is to partner with the providers and be able to manage together, and PCOP would be a godsend for some of those payors.

Dr. Clifford Hudis: Well, I think-- not to get too inside the beltway about this-- we know for sure that the bandwidth and resources within CMS right now-- in CMMI, rather-- are limited enough that it is unlikely that they will wholesale adopt our model. And that leaves two possibilities. One is, they may take pieces of it as they upgrade the existing model. The other is that we might go it alone-- that is, outside of the Medicare system. But I think, in either case, we're really hitting on something which I wanted to get out there. It feels to me like it isn't ultimately-- narrowly-- up to the practice to adopt this. It's up to the payers to press practices in this or another direction. This is a response to pressure from payors. Do I have that right, or am I off base on that?

Dr. Jeffrey Ward: I think different communities feel pressures differently. In Washington state, I think we've been a little bit slow for our payers to step in and begin pressing us for alternative payment models. It's been more common in other places. But I do think that practices should consider this their counterproposal to some of the draconian efforts that we're seeing payers develop in other parts of the country. It's going to be a whole lot easier, I think, long-term if we're working together than if we are at odds.

And as-- this really raises two questions, a narrow one about the ideal practice setting for this, and the other is about the resources necessary to make this step. So, I guess my question is, do you think that this is targeted specifically at small community practices, or is it applicable to other types of practices? And related to that, can you talk about how ASCO itself is able to provide additional support for people that might want to do this?

I know that the concepts in PCOP can improve patient care and they can lower costs. I think it would ultimately invigorate our specialty and our practices if we were to move in this kind of direction. We know our current system is unsustainable, and ultimately won't be good for us or our patients. This represents a real opportunity that, as they say, you're either at the table or on the table.

Dr. Clifford Hudis: Well, ultimately, for this to succeed, it has to fill a need, or it has to help with something. We know that the majority of practices are dealing with a variety of meaningful, serious pain points. Our most recent ASCO Practice Census found that almost 60% of practices found payer pressures-- or cited payer pressures as their top concern. How would the PCOP reduce that pain for those practices?

Dr. Jeffrey Ward: Well, somebody's going to listen to this and they're going to think I'm a complete Pollyanna. But I really think the biggest reason for the enmity between the providers and payers is that we're playing with two different sets of rules. And PCOP allows for setting the rules for both of us. So if our focus is on the patient-- and I really do think that most payers want a patient focus of care-- I think we can find common ground around PCOP once we get together and start talking to each other instead of talking at each other.

Dr. Clifford Hudis: Do you think that this is-- or how big of a part do you think this is in the ongoing transformation from fee-to-service to fee-for-value-- in other words, the conversion to value-based care? Is this ultimately how we get there, or do you think there'll be other routes that practices can follow?

Dr. Jeffrey Ward: I'm certainly not going to say there's only one way to do anything. But I think-- I could certainly get in trouble in some circles for saying this out loud, but I think that the demise of fee-for-service medicine and buy-and-bill chemotherapy is coming. I think ASCO should take the lead in implementing the change. I think oncology as a community should take that lead and then improve on it. So, I don't think this is the end-all. I think there could be other ways to do it. But right now, I think this is the clearest way to get there.

Dr. Clifford Hudis: If you talk to policymakers and you listen to candidates on the campaign trail, health care costs in general-- drug prices specifically-- are clearly at the top of the agenda and get a whole lot of rhetoric these days. So, if PCOP were to be implemented, how do you see it actually changing the cost of care? Where would the cost savings come from? And I think, alluding back to the comment you made before regarding fee-for-service, how confident are you in the ability of the health care system to distribute high-quality providers and access to care the way we need it, to be sustained? Because that obviously is sustained in part by the fact that people can make a living doing this.

Dr. Jeffrey Ward: Yeah. Data and experience tells us that the savings available through triage pathways, proactive patient-reported outcomes, efficient use of hospital facilities to limit ER visits and hospitalizations can produce real savings. The savings that occurred in the United Healthcare demo all came out of those kinds of savings, not from changing drug prescribing habits, or at least drug costs. I think there's also sufficient evidence to believe that value-based clinical pathways do bring savings. And I think there's a lot of improvement yet to be done in that arena.

Dr. Clifford Hudis: ASCO has estimated that PCOP could bend the total cost curve for cancer care by 8%. That's huge. It doesn't try to measure the impact that widespread use of value-based pathways may have on drug prices. In my opinion, if everybody was on a value-based pathway, the only way to move up on the pathway if you're a drug company may be to lower your price, and we may see competition on list prices. That's something that's never happened in brand-name drugs today. I think that there's an opportunity, if this caught on and large numbers of practice were doing it, to actually bend the cost curve on drugs beyond just the 8% that ASCO has estimated so far.

And-- I'm just curious. You alluded already to the fact that the Center for Medicare and Medicaid Services model-- the pilot program, which was the first oncology alternative payment model, called the OCM-- that it's actually about to sunset. And you talked already about that pressure of time-- and I'm thinking about cost control, which is really their issue-- how does PCOP build on what we've learned from OCM? There must be some lessons that we can then implement in round two here, no?

Dr. Jeffrey Ward: Yeah, I think there is. And we've answered some of this in our discussion already. The amount of data that the practices have access to has really allowed them to fine-tune their practices and lead the practice transformation. Unfortunately, we've had to hire actuaries to figure it out, but that may be the price of success. We've tried to take the good-- we have OCM incorporated into our new proffered PCOP-- and leave the bad.

As we've mentioned, I really believe the Achilles heel of our OCM is that it puts drug list prices front and center and makes providers responsible for them. I know that CMMI has doubled down on this, and they believe that they can win their way into limited risk. But it still makes winners and losers based on luck of the draw-- based on who walks in your door. So, I really hope that CMMI will take a hard look at PCOP-- test as it is, or tear it apart piecemeal and use its best parts to improve OCM. It would be a shame if OCM was thrown out as a failed experiment just because it hasn't reached a point where people are ready or capable of taking two-sided risk.

Dr. Clifford Hudis: We've covered a lot, and yet we've, I think, just begun to scratch the surface. So, if a practice listening to this-- a payer, if an employer or any other stakeholder has their interest piqued by our discussion and wants to implement PCOP, or just wants to learn more, what should they do? Who should they contact?

Dr. Jeffrey Ward: Well, I think that first they can head to the ASCO website at asco.org. They can also reach out to Clinical Affairs Department at clinicalaffairs@asco.org.

I think that-- for those of you that didn't get a chance to write it down, I would just urge you, clinical affairs as written as one word. So clinicalaffairs@asco.org. That's an attended email box. And frankly, by coincidence, I happened to be looking for the PCOP article this morning. And if you just Google PCOP and ASCO, one of your first few hits will be the 64-page PDF with a nice introduction from our current president, Skip Burris.

Dr. Clifford Hudis: I do encourage people to follow Jeff's lead and dig into this, and start to familiarize yourself both with the specifics, but also with the concepts. I think this is likely to be a long-standing conversation and a gradual evolution for our community. So, with that, Jeff, is there anything else you want to add? Do you think we've missed any important topics as we are closing out this conversation today?

Dr. Jeffrey Ward: I'm sure we have. I can't think of them.

Dr. Clifford Hudis: Well, I do want to thank you for joining me for this particular ASCO in Action podcast. It's always nice to have you back. And we look forward to hearing about the progress of PCOP and hearing even from CMMI what their review of it is in the months ahead.

Dr. Jeffrey Ward: It's exciting times. Thanks.

Dr. Clifford Hudis: And for those of you listening today, if you've enjoyed what you heard, don't forget to give us a rating or review on Apple Podcasts or wherever you listen. And while you're there, be sure to subscribe so you never miss an upcoming episode. The ASCO in Action podcast is just one of ASCO's many podcasts. You can find all of the shows at podcast.asco.org. For now, and until next time, thank you for listening to this ASCO in Action podcast.

Survey Promotion: If you like what you hear from the ASCO podcast, please let us know. Take our listener survey and help shape the future of the ASCO Podcast Network. Visit podcast.asco.org click on the Survey link. Once again, that's podcast.asco.org. The survey will just take a few minutes to complete and will help us get to know you better. Thank you so much for listening.

How Will Your Practice be Affected by the 2020 Medicare Physician Fee Schedule? Dec 10, 2019

In the latest ASCO in Action Podcast, ASCO CEO Dr. Clifford A. Hudis, discusses updates that will affect oncologists in the 2020 Medicare Physician Fee Schedule final rule, which outlines changes to Part B reimbursement policies and the Quality Payment Program.

ASCO’s goal will always be “to ensure that oncologists can provide the right treatment, at the right time,” says Dr. Hudis, “and we aim to help CMS implement policies that advance that goal.”

Take the ASCO Podcast Survey and help ASCO improve its podcast program: https://www.surveymonkey.com/r/ascopodcasts

Transcript

I’m Dr. Clifford Hudis, CEO of ASCO and the host of the ASCO in Action podcast series. For this podcast, I wanted to provide a quick update on an important announcement from the Centers for Medicare & Medicaid Services, which of course we refer to as CMS on this podcast.

In early November, the agency released its final rule for the 2020 Medicare Physician Fee Schedule—commonly referred as the “physician fee schedule”—and other changes to Medicare Part B reimbursement policies, including proposed updates to the Quality Payment Program.

Just to review, the physician fee schedule is a complete listing of fees that Medicare uses to pay doctors or other providers and suppliers. It is also a comprehensive listing of maximum fees that is updated each year and used to reimburse providers on a fee-for-service basis.

At ASCO, we always review this rule closely and assess its likely impact our members and, most importantly, our patients.

The top takeaway from the rule is that CMS estimates a zero percent overall impact for the hematology/oncology and radiation oncology specialties in 2020.

Though it’s important to note that the actual impact on individual physician practices will depend on the mix of services the practice provides, and practices in certain states may see a change due to the elimination of the 1.0 threshold previously applied to the geographic practice cost indices.

CMS also finalized provisions to align Evaluation & Management (or E&M) coding with changes laid out by the CPT Editorial Panel for office/outpatient E&M visits.

This is a welcomed update that comes after ASCO and other stakeholders expressed concerns that earlier CMS proposals to consolidate E&M codes would have diminished the resources available to care for Medicare beneficiaries with cancer.

We appreciate the fact that CMS listened to our perspective and revised its plans to better serve people with cancer.

The physician fee schedule rule also finalizes updates to the Quality Payment Program for 2020 and beyond.

A key update to the Merit-Based Incentive Payment System (or MIPS)—one of the Quality Payment Program’s two tracks—is that all four MIPS performance categories will remain at their 2019 weights in 2020, but the performance threshold, which is the minimum total MIPS score needed to avoid a negative payment adjustment will increase to 45 points in 2020 (up from 30 points in 2019).

CMS also finalized its plan to establish “MIPS Value Pathways” (or MVPs) beginning in 2021.

CMS has described MVPs as a way to reduce the burden of participating in MIPS and for CMS to collect more meaningful performance data.

The MVP framework would connect activities and measures from the four MIPS performance categories that are relevant to a patient population, a medical specialty, or a specific medical condition such as cancer.

For years, ASCO has encouraged the use of high-quality oncology clinical pathways to help ensure patient access to high-quality, high-value cancer care. We are hopeful that this provision in the CMS final rule is a move in the right direction.

We have also appreciated CMS’ recent efforts to reduce administrative burden for providers. MVPs, if implemented appropriately, may help improve the quality and accessibility of cancer care. We will continue to work closely with CMS as it implements this new provision.

I hope this summary of the updates to the physician fee schedule for 2020 was helpful to our listeners.

Our ultimate goal is always to ensure that oncologists can provide the right treatment, at the right time, and we aim to help CMS implement policies that advance that goal.

To that end we will submit detailed comments on the final rule during the open comment period, to ensure CMS understands the needs of the oncology community, and the full impact this rule is likely to have.

If you’d like more information on Medicare physician reimbursement in 2020, please visit the ASCO in Action website at asco.org/ascoaction.

The ASCO in Action Podcast is just one of ASCO’s many podcasts; you can find all of the shows at podcast.asco.org.

mCODE Could Vastly Improve Cancer Care by Standardizing Patient Records in Electronic Health Records Nov 26, 2019

CancerLinQ Medical Director Dr. Robert Miller discusses how ASCO’s new initative, mCODE (Minimal Common Oncology Data Elements), will help take the oncology community one step further to achieving interoperability in electronic health record systems.

In the latest AiA podcast with host ASCO CEO Dr. Clifford Hudis, Dr. Miller says that doctors are expected by their patients to have all their relevant medical information to ensure they receive the highest quality cancer care. mCODE is working to encourage vendors to adopt a consistent set of data elements in their EHR platforms to achieve that goal.

Transcript

Survey Promotion: If you like what you hear from the ASCO podcast, please let us know. Take our listener survey and help shape the future of the ASCO Podcast Network. Visit podcast.asco.org and click on the survey link. Once again, that's podcast.asco.org. The survey will just take a few minutes to complete and will help us get to know you better. Thank you so much for listening.

Dr. Clifford Hudis: Welcome to this ASCO in Action Podcast, brought to you by the ASCO Podcast Network. This is a collection of nine programs covering a wide range of educational and scientific content and offering enriching insights into the world of cancer care. You can find all of ASCO podcasts, including this one, at podcast.asco.org. The ASCO in Action Podcast is ASCO's podcast series that explores policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for-- people with cancer.

My name is Clifford Hudis, and I am the CEO of ASCO, as well as the host of the ASCO in Action Podcast series. For today's podcast, I am delighted to have as my guest Dr. Robert Miller. Dr. Miller is the medical director of ASCO's CancerLinQ initiative. And as many of our listeners know, CancerLinQ is a big data technology initiative that collects and analyzes real world cancer care data from multiple health care IT systems seeking to deliver insights to physicians, improve quality of patient care, and support new research.

What our listeners may be less familiar with is that, earlier this year, ASCO and CancerLinQ announced a very exciting collaboration that has the potential of bringing the oncology community one step closer to our goal of achieving interoperability amongst electronic health record systems. The project is called mCODE. That's a lowercase m and then capital C-O-D-E. It stands for Minimal Common Oncology Data Elements, or mCODE.

Dr. Miller is going to tell us a whole lot more about this important initiative. And I welcome you. Thanks for joining us, Dr. Miller.

Dr. Robert Miller: Thanks for having me.

Dr. Clifford Hudis: So, we've all heard about the inability of electronic health record systems to share information with each other. And I always, at the beginning of this, used to talk about my favorite proverbial story. A patient is discharged from a big-city emergency room after a month in the hospital. That hospital uses a single electronic record system, all the details are there. The person is on their way home and developed chest pain, ends up in a neighboring emergency room a mile away. And in most cases, how much of their record from the hospital where they spent a month, to the hospital where they're finding themselves in the emergency room, is transmittable at that moment?

Dr. Robert Miller: Yeah, I think that's an important question. And that's an example that I think we all have had experience with ourselves personally in health care, or their families. And it's easy to say, well, that's because the systems don't talk to each other. To answer your question specifically, it's probably a small percentage, a minority. There are certain laboratory values and other things that may make it across, but a lot of the important information is missing. And it's just not easy to get.

Dr. Clifford Hudis: Well, if they're in different health care systems, and even sometimes if they have the same health record system installed, sometimes there's essentially no real transmission possible. And I mention that only because I think outside of medicine, people who are less familiar with this expect this to work like banking or airline reservations. They expect transmittal of the entire package of relevant information at that moment's notice. And unfortunately, sadly, in modern medicine, and indeed in oncology, we don't yet have this. And I'll just close this little editorial soliloquy by pointing out that Congress thought they were supporting the development of this when they passed HARP legislation more than a decade ago. But in fact, the reality isn't that. And that is the setup for what we're really going to talk about now, isn't it? Which is how mCODE can help fix this problem.

Dr. Robert Miller: Exactly.

Dr. Clifford Hudis: So, tell us a little more now that we've set up the problem. How is mCODE able to begin to address this issue?

Dr. Robert Miller: So, I think it's important to realize that while all medical care is complex, there's a certain level of complexity in oncology given the explosive growth in knowledge and a lot of the new therapies even in the last five to 10 years. But I think what is really underlying the source of the problem is the fact that so many of the important parts of the cancer patient journey are just not entered into electronic records in a way that they can be easily retrieved.

So what I mean by that is things like measuring the cancer stage, or the basic biomarkers, or in the pathology report, or in the blood, and certainly more abstract concepts like, is the cancer growing or not, is the patient getting worse, or are they getting better, and so forth. The outcomes, the adverse events, are put in the electronic record in a variety of incompatible ways.

And that's not really through, necessarily, anyone's fault or the way things were designed. It's because the electronic record today looks very much like the paper record of yore. And largely, this type of information is captured in what we call an unstructured note, or a document, so that the clinician either dictates, or types, or just puts in text that tells a story. And that's important to tell the story, but it's not easy for a computer to retrieve that information.

Dr. Clifford Hudis: And the real point is, at scale, you can't take 1,000 patients and consolidate some of the basics into a single file that you could then interpret, right?

Dr. Robert Miller: That's right. The problem is that you can try. You can take human beings--we call this abstraction, or curation--and you can pull out the data elements from the notes and from the stories, but that doesn't scale. It's incredibly expensive, and it's also very inaccurate.

Obviously, there's a very big problem here. Tell us a little bit about how this actually came to be.

The mCODE project started last year in 2018, and there was the alignment of a number of individual work streams. So, let me just say that, as background, ASCO had already been active in the area of data standards going back a number of years. They worked with the standards organization called HL7.

If you look at the QOPI program, that's a quality registry that has to capture data, at least in certain fields. And one of the volunteer work groups at ASCO, the Informatics Task Force, was looking at the idea of a minimal data element. And of course, CancerLinQ--which you mentioned earlier--is a big data initiative that has to bring in cancer data in a certain way.

I think this really didn't align until the middle of 2018, and that was--I will give credit to the leadership of Dr. Monica Bertagnolli, who was ASCO President at the time. She also continues to hold the position of Chair of the Alliance for Clinical Trials. And her theme at the ASCO annual meeting, as we all remember, was caring for every patient, learning from every patient.

So that really, in a way, is a data problem. It basically says that if you really want to learn from every patient, from their information, from the data that's in the electronic record, you have to be able to retrieve it. ASCO, under Dr. Bertagnolli's leadership, together with the organization MITRE-- MITRE is a not-for-profit. It's what's called an FFRDC, or a Federally Funded Research and Development Center.

They were already working on something they called the Standard Health Record, or SHR, and they were trying to use modern data standards to improve the quality and the capture of electronic data. They weren't necessarily focusing on cancer, but there was this alignment in 2018. This was all built on a standard called FHIR, which is an acronym for F-H-I-R, which stands for Fast Health Interoperability Resources, or FHIR.

ASCO convened a group of experts in the summer of 2018 to try to create a minimal data standard to provide structured oncology data for electronic health records. So, this was ASCO volunteers and all the clinical oncology specialties, it was other scientists. It involved experts in standards, and quality, and policy, and so forth. The group met over a series of face-to-face meetings, and phone calls, and WebExes. We brought in experts from industry, as well, from electronic health records for their advice.

And the group created a data standard, or a data specification, saying these were the important data elements. They were open to public comments in January of 2019, and ultimately were approved by the mCODE executive committee, and announced publicly on June 1, 2019.

Dr. Clifford Hudis: So, when you describe mCODE right now, it's clearly centering on some core set of data, not all data elements. Can you talk a little bit about which elements are actually being captured with mCODE? And maybe for listeners, describe in a very practical way how a clinician experiences mCODE. How does it get into their workflow, for example?

Dr. Robert Miller: Sure. So, the mCODE data specification is designed around six different domains that describe the cancer patient journey. The first is the patient, which is the demographic and other clinical characteristics--the disease, which are our specific details around the cancer.

The third is genomics, because we knew that molecular characteristics of the cancer are so important for determining certain types of therapy. And largely, this is an area of real need.

The fourth was the labs and the vital signs, the fifth was the treatment. And that could be surgery, radiation, and other drug treatments--chemotherapy, immunotherapy, and so forth.

And finally, the outcomes. Again, this would be the cancer status of the patient--is the cancer better, worse, in remission or not--and ultimately, what the patient's survival is.

The way the user experiences mCODE, if you will, is it's really within their normal workflow of capturing the patient record in the EHR. So, we're not totally there yet, but the anticipation is that the electronic systems of today, the EHRs that are being used, will embed these data elements within their core systems that are exposed to oncologists. And basically, the oncologists will--they may have to enter some information manually at the time of the visit, but our hope is, really, that that's minimal, because I think that there are plenty of things that are already in other electronic systems like pathology and laboratory that simply don't need to be repeated by a human being.

Dr. Clifford Hudis: How specifically will mCODE get that patient's age, or that patient's stage, or the biomarkers, or the disease status, into the more structured format that you describe?

Dr. Robert Miller: So, I think there's going to be a few ways that we're going to see this. And I'll be honest and say some of this is still being worked out. Some of these details, we're working with the HR vendors to understand exactly where the needs are.

I will say that, of the various companies that we've talked to, most of them already have somewhere in their systems all of the data that we need--those six data elements and those domains that I described. That already exists, it's just not organized very well.

So, I think it's going to be a combination of these elements that are going to be carried forth from somewhere else in the system that may be entered, like an age, that you don't need to enter a birth date more than once. In fact, a human being probably doesn't need to enter a birth date. That's already captured some way. And then that populates the clinician note, but then the clinician is probably going to have to enter certain key things.

For example, the current disease status--is the patient alive with disease, do they have no evidence of disease, and so forth. There's going to be some, if you will, burden of entry on the doctor, but that's the part we're trying to minimize so that it, at the end of the day, doesn't add to the workload at the time of the visit.

Dr. Clifford Hudis: I remember Dr. Bertagnolli demonstrating at some point what looked to me, as an outsider, like macros. They were essentially dropdowns, where if you put a certain phrase in, you would get the right terminology inserted, maybe with hashtags so that then it could be picked out and structured. Is that a key part of this or is that unrelated?

Dr. Robert Miller: No, that actually-- that's correct. That is part of what we anticipate some of the implementations will be for mCODE, depending on the EHR type.

One of the things that our colleagues at MITRE-- one of things they're testing is that type of capability. And it is actually a hashtag symbol that you just have to, if you will, know the code. And you enter that into your note, and then the computer finds that. And at the back end, there is going to be a dictionary, or what we might call a lookup table, that pulls that into the mCODE data structure.

The other thing that I want to emphasize is that while it's certainly not revolutionary to think that you need to capture a patient age or a basic biomarker status of their cancer, one thing that mCODE is bringing to the table is the fact that we are strictly defining and requiring specific vocabularies and terminologies. So the computer can only understand things if it's coded in a certain way.

So, within mCODE, and really within the entire electronic record, if we constrain the use of certain lists of variables in defined terminologies, that's going to make the computers able to talk to each other. And that really goes back to your initial scenario of the one-month hospitalization and only being able to find a certain amount. If you used a terminology that one computer could understand from another, then you're not going to have that problem.

Dr. Clifford Hudis: I got it. So we've come, in a way, full circle from talking about the big problem qualitatively--talking about what we need, which is structured data--and then describing a specific pathway to make it easy for clinicians to record data in a way that a computer can then read, in a sense, and restructure.

Dr. Robert Miller: Yes.

Dr. Clifford Hudis: And then that delivers both interoperability on the one hand, but that has critical downstream consequences for our community. It means, ultimately, that quality measures might be more easily fired, and tested, and reported. And it might, of course, mean that that research of various types is much more easy to assemble. Is that right?

Dr. Robert Miller: That's exactly right, and I think that that was one of the main motivations of trying to do this in the first place, was to be able to reuse the data in other ways. So, if you think about it, the electronic record is primarily a transactional tool. It's what treating clinicians used to document their care. Of course, it's used for billing purposes, and for compliance documentation, and so forth, but it could be used for so much more, right.

It could be used to aggregate. The data could be aggregated, and then those data could be used to run queries on large populations. You can't do this unless you know you're looking at--you're comparing apples to apples, basically. And that's why this basic data standard--again, as simplistic as the opening gambit is--I think, will make a big difference for secondary research, for quality improvement, public health reporting, all those things. Yes.

Dr. Clifford Hudis: Yeah, I have to say when electronic record systems first rolled out in my career, one of the promises was it would automate the billing, because after all, over or under coding are issues that concern clinicians. And one would think that an accurate medical record system would essentially be able to automate the generation of a bill that was accurate because it reflected what was in the chart. So that seems, to me, to be at least eventually one of the deliverables in all of this.

Dr. Robert Miller: And I don't think it's that hard to do. It really isn't rocket science, that part of it. But I think we're focusing now on the clinical and quality improvement aspects. I think that's going to come with it, and that'll be a big advance.

So, lots of people have lots of great ideas for things we should do in medicine, but I think the critical step for all of us is converting these ideas and even these theoretical advances into practical ones. And to do that, we have to begin to pilot and to test them.

Dr. Clifford Hudis: I understand--I know Monica Bertagnolli has spoken a good bit about this--that there are clinical trials within, I think, the Alliance and beyond, and practices that are piloting mCODE. Can you tell us a little bit about the status of those pilots, where we are?

Dr. Robert Miller: Yes. There are two main programs that are piloting mCODE right now. The first one that Dr. Bertagnolli is, in part, running and participating in is something called the ICAREdata study. This is through the Alliance for Clinical Trials, and the first part of this is actually already complete.

This was some work done at the Dana-Farber Cancer Institute, a few other centers. I believe it was St. Joseph's in Michigan, ThedaCare in Wisconsin, a few others. And they looked at, specifically, two breast cancer trials. They basically looked to see if you could capture critical data elements from the EHR that you needed as part of that trial. That was basically the proof of principle.

The more interesting part with ICAREdata is opening soon. Again, it's some of those same institutions, and they're looking to see if mCODE could look for two very specific questions. The first is, what is the patient's current cancer disease status? Now again, that sounds very obvious, but it's not an element that is typically captured in discrete fashion in the EHR. It's sort of put into clinical notes with a lot of flowery prose and so forth. So, the question is, if you define it in mCODE using a specific terminology, can you pull it out of the EHR and make it work in a clinical trial setting?

The second is another very important thing. Again, I'm sure you'll recognize that it doesn't always get written down right--is what is the reason for a change in the cancer treatment? The idea of testing in the ICAREdata study is to look to see if you can answer that question using mCODE. That's the first program.

The second is something that ASCO has been quite involved with--Intermountain Healthcare. This is an institution that participates in the CancerLinQ initiative. They have been great collaborators, and they're actually piloting mCODE, looking at building something called a SMART on FHIR application. So that is something that our colleagues at MITRE have built.

And basically, all that really is a small piece of software that gets plugged into the electronic health record at Intermountain. And really, this could be done anywhere once the prototype's fully done. And it basically queries the Intermountain electronic health record for a specific set of patient characteristics.

And then we've actually built an application programming interface with CancerLinQ, so you can go back to the CancerLinQ database and pull out a cohort of de-identified patients to find something that's called Patient Like This, or Cohort Builder. But this is the Compass app, and this is undergoing beta testing at Intermountain right now. The beta part is actually done, and we're looking for the next steps.

Dr. Clifford Hudis: So that's a start. And that means that--I wouldn't say if mCODE's quite in the wild yet, but maybe it's near release, right?

Dr. Robert Miller: Yes.

Dr. Clifford Hudis: And so, what do you think happens next? Can anybody decide they want to participate in mCODE, support its development, and contribute to it? Is it ultimately envisioned as a free add-on for any electronic record system, or would you have to pay to use it? What's going to happen here?

Dr. Robert Miller: So right now, the mCODE data specification is freely available on the mCODE website--which I'll say this a few times, but it's www.mcodeinitiative--one word--.org. This can be downloaded. There is no cost for mCODE. All of the terminologies and all the components of mCODE are non-proprietary. It's released in what's called a Creative Commons Zero license, and it really is open to all. ASCO, MITRE, and others are looking to build a coalition of cancer centers, of interested electronic health record vendor companies, and other technology companies, frankly, to support this.

We're kind of in the coalition building phase right now, in the sense that we recognize we also have to bring the oncology clinical community, and ultimately the research community, around to say that this is important, to say that we can't continue our current use of the electronic records and documentation tools. We have to standardize it more. There will be a part for treating clinicians to play. There will be a bigger part, I believe, for vendors to play.

Dr. Clifford Hudis: And speaking of vendors, I have to say there are a lot of vendors in the US. In fact, some people think that's part of the problem that we're facing. They have different platforms. They capture, I guess, largely overlapping data, but not always identically coded. And you and I will remember--I can't remember precisely the number--but two plus years ago, we found that there were more than 60 different ways that the term white blood cell was recorded, right?

Dr. Robert Miller: Right, right. Or smoking status, white blood cell--many ways to say it.

Dr. Clifford Hudis: It seems very obvious, I think, to the outside world, that recording data in a single standard way would lower the cost of interoperability and potentially improve quality of care. So that leads to the question, what do you think is the prospect of the vendors adopting these standards, and what can we do in ASCO to encourage that adoption?

Dr. Robert Miller: So, the electronic health record vendor community has been very supportive of this initiative. They have been part of some of our early conversations. As I mentioned, they were part of some of our early discussions when we built the specification. Most of them provided very robust comments. The MITRE organization had a cancer data summit which was held in the DC area last month.

So bottom line is they are interested in this. They have told us in our one-on-one conversations they want to contribute, they want to see this specification used. They seem willing to set aside competitive interests to do this because they recognize that this is the right thing to do. Fingers crossed; I think we may be at a moment in time where there will be some alignment around this standard. But again, I'm actually pretty optimistic that the EHR vendors are going to come along with this.

Dr. Clifford Hudis: Well, I think that's really great. It's nice to hear. To the outsider, it reminds me a little bit of what I understand to be the way that other standards in IT have evolved, like USB sticks. You can stick a USB thumb drive into any computer. It doesn't matter in the operating system at this point, or hardware. It will be read. And the reason, of course, is that the manufacturers came together and agreed upon universal standards. Is this analogous, do you think?

Dr. Robert Miller: I think to some extent. I guess one of the things that was most eye-opening for me when I first started in informatics about 10, 12 years ago, was that a lot of these standards are voluntary. It's not like the government says, for things like health IT, that you have to use certain things.

Dr. Clifford Hudis: Now let me just clarify, that is perhaps changing with some recent regulations from CMS. But I think when it comes to electronic health records, these standards are voluntary. That's why voluntary organizations like HL7 exist.

Dr. Robert Miller: So yes, they're voluntary, but that also gives you flexibility for a group of vendors under, hopefully, the pressure in the leadership of ASCO and the rest of the mCODE group to agree to adopt these standards.

Dr. Clifford Hudis: So, I have a couple questions that I think will build very nicely on the last point that you made. First is about the data set. How do you envision it evolving over time? Obviously, we're not suggesting that we'll just launch this and that's it--it's one-and-done. Quite the opposite, right? So, is there a system to expand it, a formal way to decide where to put our priorities going forward?

Dr. Robert Miller: Yes, so that is built into the mCODE governance structure. First of all, the priorities can come from anywhere. There is an advisory council that we are forming of interested parties across the ecosystem. There is a technical group that's part of the mCODE governance that's called the TRG--or Technical Review Group--that will receive these proposed use cases from the community. And we fully expect that we will be building out extensions or supplements to the primary mCODE specification as it exists today.

Right now, mCODE is the six domains that I mentioned earlier. It's a total of 73 data elements, but that's going to grow. Now whether we add data elements to the core or whether there are always supplements remains to be seen, but we recognize that the minimal core set is not going to support the complete nuance and complexities of multidisciplinary cancer care. S,o it has to grow, but the governance has built that in. And we are actively looking for input from the community for that.

Dr. Clifford Hudis: So, thinking about where we are today, we're about two years really into this project. And admitting that others and ASCO have tried to establish informatics standards in the past, what do you think at this juncture not just makes mCODE different, but makes it more likely than prior efforts at standardization to succeed?

Dr. Robert Miller: So, I think there's several things. Let me just go through those quickly. I think in the past, exchange standards were purposefully left very flexible so that each vendor could--they would have to follow a very high-level broad standard, but they could customize any way that they wanted. And that led to some of the Tower of Babel that we have today, OK.

So, mCODE really is--we're specifically trying to standardize the health data itself. It's not just about how the two systems talk to each other--to the earlier example--it's that these are the ways to describe the patient journey, the genomics, the labs, and so forth. So that's different.

I think the other thing that's different, I mentioned earlier, is the use of the standard called FHIR, that this is probably the most important data standard in the world today in health care. It's very flexible. It's built on the modern structure of the world wide web, and it can be complemented with what are called APIs--Application Programming Interfaces. So, in a way, exchanging data may be as simple as the way it works when you go to a website now, and that's different than the way it was done maybe 10 years ago.

The two other things quickly: one is that--we've already kind of alluded to this--there's a lot of stakeholders involved. We have the vendor community involved early. This isn't just an ASCO initiative, it's not just a project of a professional medical society. We have MITRE as an FFRDC and others on board. And I think that's different.

And finally--and this may be the most important, I'll just say--is that we're actually bringing this mCODE standard through the HL7 formal recognition process--something called balloting. So the mCODE standard has now been tentatively approved by HL7 as what's called an STU--Standard for Trial Use--which means that it just gives it a little more gravity in terms of the EHR vendors, that it's not something that's not going to be supported going forward. We've built this out, and then others can use it. So, I think that's an enormous difference from what we did previously.

Dr. Clifford Hudis: I have to say, it's been really interesting to me to watch this bubble up from the volunteer leadership of ASCO, because Dr. Bertagnolli had a clear vision for this. She brought it to ASCO, she leveraged in a very productive way, I think, the inherent skills and talents of the group that you're leading, and the rest of CancerLinQ for that matter. And I think it's a fascinating--and, I would say, beyond clearly needed--it's desperately needed. And I think it's critically important for all of us that this succeed.

Dr. Robert Miller: I'm very, very proud that ASCO has been able to play such a critical role in developing this, in supporting Dr. Bertagnolli's vision, which I think was absolutely critical to this being launched. I want to thank you for all--not just for this great interview and clarifying all this for our listeners, but also for the long hours you've put into this project already, leading this from internally. And I think it's going to be exciting to see where it goes.

Dr. Clifford Hudis: I think you said this before, there's a special website. But if listeners want to learn more, what is that address again?

Dr. Robert Miller: It's www.mcodeinitiative.org. You can download the data specification there. There's some background material and links to other things.

Dr. Clifford Hudis: And just at the risk of opening up another thread in this conversation, is there anything that we should have mentioned that I've neglected to ask about here?

Dr. Robert Miller: I think the only thing I'd say is that this isn't just a dry topic of data standards, and computers, and EHRs, etc. This is really about what our patients expect from us. They--when we go in to see the physician, certainly when someone is in the stress of an oncology visit--they expect their doctor to have all the information. They expect their physician to be able to query what was in the EHR from across the street, or even what the last 10 cases like them would be. And it's not something that is over and above. This is fundamental to what medicine is.

And the other thing we've seen, certainly, is that our patients are--and many of them are altruistically motivated to share their own data. And this gives them another way to do this. If we can define their cancer journey in a standard way so that we can group like with like, then there are new insights that can be gained that we just can't do right now. And I think the mCODE initiative will help enable this.

Dr. Clifford Hudis: And Bob, I really want to thank you, again, both for all the work on this, and for joining me for today for this ASCO in Action Podcast. We look forward to continuing to hear more and more about the progress of mCODE as it’s refined and deployed more broadly.

For everybody listening, I want to remind you that if you enjoyed what you've heard here today, don't forget to give us a rating or a review on Apple Podcasts or wherever you listen. And while you're there, be sure to subscribe so you never miss an episode.

The ASCO in Action Podcast is just one of ASCO's many podcasts, and you can find all of the shows at podcast.asco.org. Until next time, thank you very much for listening to this ASCO in Action Podcast.

Listen to Coverage of ASCO’s 2019 Advocacy Summit on Capitol Hill Sep 30, 2019

On September 25-26, ASCO held its 2019 Advocacy Summit, during which oncology care providers from across the United States came to Capitol Hill to urge Members of Congress to support policies that will improve access to high-quality, high-value care for people living with cancer. Listen to coverage in this new ASCO in Action podcast.

Transcript

My name is Clifford Hudis, and I'm the CEO of ASCO, as well as the host of the ASCO in Action podcast series, which explores policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for: people with cancer.

Recently, ASCO held its 2019 Advocacy Summit. More than 130 oncology care providers from across the United States came here to Washington DC to meet with members of Congress and to urge support for policies that improve access to high-quality, high-value care for people living with cancer.

This is one of the highest impact events that ASCO holds every year. There's nothing like seeing ASCO advocates hit the halls of Congress with such passion and dedication, with the collective goal of ensuring that lawmakers focus on policy changes that will improve the lives of people with cancer and the care they receive.

ASCO president Dr. Howard, or "Skip", Burris kicked off the activities at the Advocacy Summit and spoke about why it's so important for us to be on Capitol Hill.

Dr. Howard “Skip” Burris: ASCO's on Capitol Hill today so that our members actually get to meet with their representatives and congressmen and their staff so they understand how important cancer care is to this country, and to make sure that they understand the issues that are facing our patients that we care for who are experiencing cancer.

The decisions that Congress makes, with regard to health care and cancer care in particular, is so important and powerful to cancer patients. Access to therapy, timely access to getting treatments initiated, making sure that there's appropriate coverage of new therapies, all those things are critical for us to implement the great scientific and clinical advances that we've made into the care and outcomes for our patients.

Dr. Clifford Hudis: ASCO advocates asked lawmakers for their support for legislation that will make a big difference in the lives of individuals with cancer. One of those pieces of legislation is HR 913, the CLINICAL TREATMENT Act, which would guarantee coverage of the routine care costs associated with clinical trial participation for Medicaid enrollees with life-threatening conditions, including cancer. Medicaid is the only major payer, including Medicare, that is not required to cover these care costs today, and we hope to address this.

Dr. Karen Winkfield, chair of ASCO's Diversity Inclusion Task Force, says that changing this policy is critical to improving the validity of clinical research data and to improving patient outcomes. Dr. Karen Winkfield joined other ASCO advocates in urging members of Congress to support this bill.

Dr. Karen Winkfield: So the Clinical Treatment Act is really vitally important because it will allow all patients equal opportunity to access clinical trials that would be beneficial to not only them, but also other individuals who may come from the same backgrounds, including racial and ethnically diverse populations, but also those of lower socioeconomic status. We want our clinical trial to be representative of every single individual in this country.

Dr. Clifford Hudis: The Advocacy Summit was packed with meetings with congressional lawmakers and their staff. Dr. Jason Westin, a member of ASCO's Government Relations Committee, participated in the summit and he spoke about why these direct meetings are so important.

Dr. Jason Westin: I think advocacy is very important for cancer doctors and cancer professionals to be an advocate for our patients. I think that there are so many opportunities for us to help our patients in the clinic, in the research arena. But if we're not involved in advocacy, then others are advocating in other directions that may not benefit our patients in the way that we would like.

Many doctors view that as somebody else's job, or they view that as something that's not important for them to be involved in. I think if we don't step up, if we're not sitting at the table, then we may be on the menu.

Dr. Clifford Hudis: Many ASCO members are concerned with payer-imposed strategies that are designed to contain costs, but often unnecessarily, and sometimes dangerously, delay care for patients with cancer. Dr. Melissa Dillmon, chair of ASCO's Government Relations Committee, explained why these utilization management practices can be particularly harmful in cancer care, and also spoke about legislation that will help address these concerns.

Dr. Melissa Dillmon: So, utilization management strategies, like step therapy and prior authorization, hurt our patients because they cause delays in care and cause patients to take drugs that are less effective. So, we are asking for support on two critical bills.

One is Improving Seniors' Timely Access to Care Act, which really looks at prior authorization and simplifying the process, making sure that it's a timely approval of medications that are critical to getting them on treatment and getting them healthy again.

The other act that we're asking for support on is the Safe Step Act, which really looks at step therapy and making sure that if step therapy is in place in an insurance program, that it does not prevent patients, especially oncology patients, from getting the best drug at the right time.

So, as oncologists we're really fortunate in that drugs are being developed in a rapid manner, and we have many new drugs to help us fight their cancers. And so, we don't have the ability to use the cheapest drug always, because the best drug is sometimes the newest drug. And it may not be the one that's first approved on that step therapy utilization management strategy.

Dr. Clifford Hudis: One of the highlights of the Advocacy Summit is presenting ASCO's Congressional Champion of the Year award to lawmakers whose leadership on behalf of patients with cancer deserves special recognition. This year, we recognize Congressman Ben Luján from New Mexico and Congressman Gus Bilirakis from Florida for their work. Congressman Luján addressed the attendees at the reception.

Rep. Ben Luján: Your work and the difference you make every day saves people's lives. And it's certainly why I'm hopeful that more of my colleagues that have not had the chance to learn from you take a moment to meet with you, to spend time with you, to understand the magnitude of a difference that you're delivering for the constituencies that we all represent.

Dr. Clifford Hudis: We also recognized ASCO volunteers whose advocacy efforts made a significant impact in 2018. Dr. Alexandra Thomas, a participant in ASCO's Leadership Development Program, was named ASCO's Advocate of the Year.

Dr. Alexandra Thomas: Receiving this honor only makes me embrace the exciting work ahead even more. And I hope that will include extending our network so even more voices can join in this chorus, so Dr. Burris's picture of the ASCO Advocacy Summit will get bigger each year.

But perhaps even more importantly, the virtual picture will get bigger as more and more of us join in and advocate and tell our patients' stories and realize robust and continuous government support to improve the lives of our patients with cancer.

Dr. Clifford Hudis: The ASCO Advocacy Summit is a unique opportunity to educate members of Congress and their staff about the current realities of the cancer care delivery system and how their decisions impact real people who have cancer. The support of lawmakers is critical to ensuring that our patients have access to high-quality, affordable cancer care.

This is why we feel it is so important that our collective voice be heard on Capitol Hill. A big thank you to all of ASCO members who participated in the summit, as well as those who participated virtually, by sending messages to their members of Congress through social media or ASCO's ACT Network.

I encourage all of our listeners to participate in ASCO's advocacy efforts. Visit asco.org/actnetwork to learn more about how you can get involved. To stay up to date on all of ASCO's advocacy work, visit asco.org/ascoaction.

Until next time, thank you for listening to this ASCO in Action podcast. If you enjoyed what you heard today, don't forget to give us a rating or review on Apple Podcasts or wherever you listen. And while you're there, be sure to subscribe so you never miss an episode.

Until next time, thank you for listening to this ASCO in Action podcast.

Get to Know Dr. Howard A. “Skip” Burris and What He Hopes to Accomplish as ASCO President Sep 17, 2019

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In this interview, ASCO President Dr. Howard A. “Skip” Burris discusses why he became an oncologist, the importance of mentors in his career, the most significant changes he’s witnessed in cancer care during the past three decades, and his vision for the coming year as he serves in this top volunteer position. Dr. Burris stresses that we can’t “divide and conquer, to conquer cancer,” a message underscored by his ASCO presidential theme, “Unite and Conquer: Accelerating Progress Together.”

Find all of ASCO's podcasts at podcast.asco.org

Shannon McKernin: Hi. My name is Shannon McKernin, and I'm the host of the ASCO Guidelines Podcast series. When a new ASCO guideline publishes, we release a podcast episode featuring an interview with one or more expert panel members. Each episode highlights the key recommendations and the implications for patients and providers. You can find the ASCO Guidelines Podcast series on Apple Podcasts or wherever you're listening to this show, and you can find all nine of ASCO's podcasts, which cover a wide range of educational and scientific content and offer enriching insight into the world of cancer care at podcast.asco.org.

Clifford Hudis: Welcome to this ASCO in Action podcast brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content offering enriching insights into the world of cancer care. You can find all of ASCO's podcasts including this one at podcast.asco.org.

This ASCO in Action podcast is part of our series exploring policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals who care for people with cancer. My name is Clifford Hudis, and I am the CEO of ASCO as well as a host of the ASCO in Action podcast series.

For today's podcast, I am delighted to be joined by Dr. Howard, or "Skip", Burris. He's ASCO's president for the 2020 term, and if we're lucky today, we'll find out why he's called Skip. In the meantime, Dr. Burris is joining me to share his vision for his presidential year. That is what he hopes to accomplish by this top ASCO volunteer leadership position is an opportunity to leave a lasting mark on our organization and indeed the larger oncology community. Skip, welcome and thank you for joining me today.

Howard “Skip” Burris: Thank you for having me. Looking forward to the conversation.

Clifford Hudis: So, Skip, every one of us comes to oncology for individual reasons and personal motivations, and I know that's true for you as well. So before we get into the details of your current role at ASCO, I think our listeners will be interested in learning why you became a medical oncologist when there are so many places to go in medicine, so many exciting specialties, what was it that drove you to choose taking care of patients with cancer for your career?

Howard “Skip” Burris: Interesting question and story. I was driven to medicine really thinking that I wanted to do something that was meaningful, something that helped others. And I was influenced by actually a number of friends whose fathers were physicians when I was in high school. And as I initially went into the medical field, I thought surgery was so exciting, and I actually spent many of my electives doing surgical sub-specialties and in particular thoracic surgery. And it was an exciting time in the '80s with heart transplantation and bypass surgeries.

And yet I also was dissatisfied with the fact that it seemed transactional. While important, and certainly lifesaving for those patients, these were surgeries and then, quote unquote, were done taking care of that patient. And then I had a seminal moment after rounds one day when we were in the intensive care unit. And I was talking to a patient, and the team moved on. And my attending yelled at me, “hey, Burris, what are you doing?” I looked at him and he said, “Come on. He's fixed. Let's go.”

And I half smiled and I thought, well, this guy's got such an interesting story and he was terribly appreciative of the care he'd receive, but he looked at that attending as somebody had truly had saved his life. And so fast forward to fumbling through internship and trying to figure out really what type of specialty I might want to go into. And two groups of folks that I ran into contact with shaped my career.

One were the oncology patients. Rounding on the oncology patients, doing that elective early in my internship, they were grateful. They were so appreciative. It was a great program in San Antonio. It was folks participating in clinical trials. And these were patients who not only wanted to help themselves but understood that what they were doing might help others. But really every person was so unique and had such a powerful story.

And then secondly, the attendings that were taking care of those patients, the oncologists truly seemed to love what they were doing. And it was really those two groups, I thought these are the kind of patients I'd like to take care of, and these are the types of physicians that I'd like to practice with. And I began shifting as many rotations as I could as a resident into oncology, and I've enjoyed being an oncologist now for almost 30 years.

Clifford Hudis: And so it was the patients, and it was the physicians really that in the end drove you into this specialty it sounds like, right?

Howard “Skip” Burris: Yes. I had been taught early on, and I tell some of our younger folks today, working with people that you like and working with people that you respect is such an important part of the job. And then the service that you're providing knowing that folks are appreciative and there's a teamwork in that both the doctors and the patients in the field of oncology are so special.

Clifford Hudis: So you just touched on a big part of what I think motivates or at least supports so many of our members throughout their careers and that is collaboration, working with others. And I can't help but imagine that your experience in terms of your education at West Point and your service with distinction in the Army has a relationship to that camaraderie, that connection, and that collaboration. How do you see that experience as preparing you for medicine, or maybe you think it didn't?

Howard “Skip” Burris: Actually it did, and I appreciate the question, the opportunity to comment on that. Going to the US Military Academy, going to West Point for undergrad was a decision made because I wanted to go to a great school. It was a great scholarship package, the way they handled it. And I knew I'd get a great education and was attracted, one of these kids in high school who gravitated toward leadership positions, and going to an institution that would teach leadership was attractive.

And then you realize as soon as you get to West Point, you're part of this big team. Everything you do during your years there is all about your group of individuals, your team, your squad, your company, surviving together, thriving together, and being successful. And, in fact, the motto that they teach is strength is one. And it was clear that you were at school with a talented group of folks who all wanted to be leaders, and everybody had to learn how to fit in, pick their place to lead, pick their place to be humble, pick their place to take charge.

And those sorts of teachings and the mentors and the colonels and generals that were my teachers on that led the program, they were simple things but they were things that stuck with me forever, and I think they've served me well as a physician. One was around the simple concept of you know if no one's following, you might not actually be leading. And you got to stop and take a look behind you and see if while you're heading in whatever direction you might be going, if no one's following, you got to check yourself.

I think a second thing that has stuck with me is better to be decisive than to be sure you're right. Very rarely are you sure you're right, and I think that teams even in medicine and maybe particularly in medicine really like a decisive leader. And I think that's something that is a great characteristic for physicians, gathering the appropriate data and making the decision and moving forward. But looking around and trying to emulate some of those folks who became leaders of the country was inspirational and then also gave you the opportunity to take away some of those teachings and try to embed them in terms how you carry yourself.

One thing about the army it's very hierarchical, but the generals, you know, know that those privates are what's going to make them successful. So the chain of command and that respect for each other, respect for the position, and respect for their role on the team is very similar to the role of doctor to nurse to the support staff and the like. So it actually ended up being a great foundation for my career.

Clifford Hudis: So it's interesting throughout medicine and especially in the last few decades, we have increased our emphasis on the role of mentoring. And I have I guess two questions which would be, one: how did you find mentors in your post military career given the strength of the leadership that you saw displayed there? And the other question is how did you translate that into your own service as a mentor?

Howard “Skip” Burris: Yeah, so I think important-- I think picking the right mentor-- maybe picking the mentor where you resonate with that person and think that somebody who you'd like to model and picking that mentor who can teach you something and really has your best interests at heart I think are key. Picking the wrong mentor is something that could really set somebody off on the wrong track if they're not careful.

I was very lucky. As I went into internship and residency, my chief of medicine was a fabulous mentor. He was one of those individuals who kept the patient first, was kind but firm, and just the thing I learned from him was what now we talked to as emotional intelligence, this fact that he was optimistic. He was very self-aware, and he was in control of his emotions.

And no matter what we'd done or not done and however the result went, he was the steady hand, and I always looked up and thought, I want to be that person. I want to be the person who's calm in the storm, and I want to be the person that people look to and say he's not panicking, and he's got the situation where we're going to get through this together. So that was a great mentor in my chief of medicine.

And then my other mentor during my oncology fellowship was a famous oncologist, still in the field today, in Arizona, Dr. Dan Von Hoff. I mentioned Dr. Von Hoff's name, he's been a Karnofsky Award lecturer. And Dr. Von Hoff was the one who got me interested in drug development and phase 1 clinical trials.

And I would say that Dr. Von was a great mentor for a few specific reasons. One is he always pushed us in front of him. He didn't need to take the credit. He pushed us to be presenters, pushed us to be first authors, pushed us to be the person that was in front of the clinical trial. And that was something that really was important for somebody early in their career.

And then secondly he really taught that perspective that it was a great responsibility both for the patient on the clinical trial and for overseeing that clinical trial and that while your title might be principal investigator, you might be the leader of the program that you really were beholden to those researchers that brought the drug forward and to those patients who were volunteering to participate in the study. And Dr. Von Hoff has always been a great person in that regard, and his Karnofsky Lecture was actually a highlight to and a tribute to all those patients who had participated in phase one trials through the years. So those were two mentors that really stood out and have impacted me throughout my career.

Clifford Hudis: Do you see yourself I guess echoing those styles of mentorship or expanding on them? Do you see anything in your own role as a mentor that hearkens back to what you saw in West Point and in those mentors in medicine for you personally?

Howard “Skip” Burris: I do think I've had embodied in me the patient centric, patient first approach. I am one of those physicians who has always wanted to get to know his patients, have always taken the social history as an important part. It's funny, a number of my longtime patients are comfortable calling me Skip on occasion. I actually know their stories and know who their family is, and I know what they're wanting to fight for in terms of grandchildren and trips and the like. So that I'd be really being grateful on having a relationship with the patient I think is something that has carried forward.

I will say to my chief of medicine mentor I still aspire to that. I wish I was always as calm as he was. I wish I was always as optimistic as he was and had that sort of strength, but it is still something that's front of mind for me and something that I at least strive to be as much as I can.

Clifford Hudis: So, reflecting on your career just for a little bit, I have a couple of questions. One is a general one and one more specific. But thinking generally first, you've been in medicine a long time. I guess you're around 30 years if I'm not mistaken. From your point of view, what do you see as the most significant change in the field that -- can be good or bad or whatever -- but that we have to think about and maybe help our trainees and younger members adapt to?

Howard “Skip” Burris: Well, the flow of information, the speed at which we're making discoveries and just the educational challenges there are immense. And so, I think that is something where the speed of drug development and approvals just to throw one statistic out, eight new drugs approved in 1998, 48 new drugs are indications approved in 2018, so what a change over the past 20 years.

I think the most significant change, though, is we knew early on in our careers-- you and I always knew that no two patients were alike. They might be in ERP or positive breast cancer that they really were not the same patient. They might be a adenocarcinoma, but they were really different.

And now with the advances in pathology -- advances in molecular profiling, understanding biomarkers, we do know that no patients are alike. And we know that everybody has to be approached individually. The tendency has always been to want to lump patients into groups to make broad treatment recommendations.

And that is part of the challenge with the education and information flowing forward. It is as simple as continuing to look at some of the prognostic indices that we have for some tumors, the next generation sequencing for others, whatever that test might be to really determine what's the best therapy for that patient. So those advances have really helped us in terms of looking at tumor biology and knowing whether we're thinking about an immunological approach to a patient or chemotherapy approach to a patient or whether it might be one of the new oral biologics. But that has been such a significant change.

And only a few years ago, it seems like we were giving immunotherapy in the form of drugs like interleukin 2, and now we have these fabulous new checkpoint inhibitors that are in front of us. Thinking back to really something like tamoxifen being truly a targeted therapy now thinking about the dozens of drugs that are out there now that are targeting other biomarkers on patients. That really has been an amazing advance.

Clifford Hudis: Well, I mean, I have to agree that this is certainly an exhilarating and challenging time in oncology, so maybe we can pivot to think about that and talk about your presidential year. What do you think are specifically the biggest challenges facing us? And let's call those challenges promising opportunities. Where do you think we have to focus right now?

Howard “Skip” Burris: I think one very top of mind is the oncology workforce. Physicians, leveraging up the physicians, having enough nurses and enough nurses interested in oncology, attracting young physician talent into wanting to be an oncologist, and then the other ancillary health care providers, nurse practitioners and the like, we need a bigger and more robust workforce to take advantage of the opportunity given to us with the survivors. It's incredible when we think about the advances and the number of cancer survivors in this country, individuals either under treatment or surviving with the disease where we're talking in numbers approaching 20 million over the next two years so really very amazing in that regard.

I think education, it is tough. We still have a lot of physicians particularly in the United States that are seeing multiple different tumor types during the day, and with the advances in information, it's just important that we as ASCO do our part in trying to educate and provide the information.

And then with all these new advances, it becomes the challenge of clinical trial accrual. While many of these therapies have made important differences in patients' lives, we're still not curing enough patients. And so, there is room and certainly the need for better therapies. And so, in this busy workforce and in the challenges of having everyone aware of the opportunities, how do we improve clinical trial accrual?

And then lastly, I'll just mention, of course, cost of care. That goes a little bit with patients living longer or taking therapy for a longer period of time sometimes in a chronic setting and then the cost of some of these new therapies. So those were certainly factors we're going to have to deal with. So, some big challenges for the field of oncology.

Clifford Hudis: Well, hearing you run to that list-- workforce, research, cost, patients, and survivorship, all of that-- it sounds like it builds right up to your presidential theme of unite and conquer, celebrating progress together. That sounds like a lofty and aspirational statement, but I also see immediately connections back to again all those points you just made. Do I have that right? Can you unpack the meaning of that for us at least, as you see it?

Howard “Skip” Burris: Yes, it's an interesting theme, unite and conquer, celebrating progress together. I specifically resonated with that. I have long taught my young attendings and my colleagues at Sarah Cannon that the challenge is too big and the needs too great for us to actually go with the divide and conquer mentality. We've actually got to be together as a team to get this accomplished and have the best care provided.

So I have talked about uniting and conquering for many years here at Sarah Cannon, and I think it fits nicely when we think about the oncology workforce and the members of ASCO. And then accelerating progress together, there is a great need to step things up a bit. I think that can come in a few different fashions. I am excited about the emerging opportunities and real world evidence. I do think some of the clinical trials are getting smaller and more narrow to fit specific groups of patients.

And then I think we're beginning to leverage up some of our physicians with technology, with advanced practice providers, nurse practitioners, physicians assistants, all those pieces coming together. And then I'll admit also having conquer in the phrase was important to me. The Conquer Cancer Foundation, ASCO's foundation, I think is so important. When you come back to some of these topics we just talked about, it's really one of our best ways to invest in and inspire young investigators. Some of the awards provided by Conquer Cancer and the mission it provides I think are really going to be key to ASCO's success.

Clifford Hudis: I think that's a great vision, and it's certainly one that does resonate, not just with you but I think with many in the audience. You touched in that description on that diverse expertise that we all believe we need to make faster progress. And for me, of course, this reminds us of our upcoming meeting in Bangkok, which is looking at speakers from some of the unconventional fields. How do you see that diversity coming together to drive innovation in cancer research and care?

Howard “Skip” Burris: It's an interesting opportunity for us, and I'll digress for a brief minute and then go to the Nashville Analogies. So, Sarah Cannon, based here in Nashville, and some of the things we've talked about really revolves around what it takes to put on a musical performance. So only one person might have the microphone at the time, but you've got the band and you've got the engineers and you've got the people that have setup the stage, sold the tickets. Every aspect of that's key to having that concert pulled off.

And I think Breakthrough is a meeting and when you think about the oncology ecosystem not too different. We need and have invested in information technology. I mean some of those IT individuals are so key to doing a variety of things, getting data to us, sorting and analyzing data, we were seeing telemedicine coming at us, artificial intelligence and natural language processing, all those pieces, which then moves quickly into where the engineers or participating.

Engineers and medicine, I think, are going to help make some of the greatest advances. I think certainly engineers in terms of how we're looking at robotics and surgery, how we're thinking about different techniques for radiation therapy, and even engineers getting involved in some of the drug discovery process.

And then bioinformatics and we've talked about big data and the excitement behind that. I commented on real world evidence, but this whole idea of being able to have decision support through bioinformatics and the understanding that those experts bring to the table. Those are some of the things that'll be highlighted at the Breakthrough Meeting. I think those are individuals who are going to need to be core pieces to the cancer solution and to cancer centers. And it's just an exciting time, and I think this meeting will be a great place to highlight how those groups can come together and have a conversation.

Clifford Hudis: So, we are now a few months into your presidency year. I have to ask: has there been anything that has surprised you about the experience, something that you did not expect as you entered into this leadership role?

Howard “Skip” Burris: I think the one surprise is how many individuals want you to lend an ear with email and text, that's a little bit easier. But folks that want to stop and grab you and give you a suggestion. I say surprised by that because I think these members, our colleagues, folks that are participating in the oncology care field really have ideas, thoughts, and passions.

The individuals that speak to me really want you to take their ideas seriously, think about it, and bring it forward. And I'm appreciative of that. I'm surprised that they wouldn't see me taking this role in this title as being an opportunity for them to have that conversation and want to push their idea of forward. But that's been both a surprise and yet a pleasant experience, and I've enjoyed the conversations.

I will also comment and throw some kudos out. I knew the ASCO staff was smart. I knew the ASCO staff was very hard working. But as you become ASCO President and you're seeing and signing and reading and participating in their communications that they put out in a variety of fashions, just this sheer legislative communication they have back and forth with congressional staff and answering various health care initiatives. One, it's a high volume, two, ASCO's voice and input on this is really needed and appreciated and respected, and, three, we really have a very talented ASCO staff sitting with our organization, and I think that's something that it would be great for all 40-plus 1,000 of our members to really appreciate.

Clifford Hudis: Well, you know I agree. Now I have to ask, in addition to your long history of volunteer leadership within ASCO and your current role, especially as president, you also have a busy day job. You're currently chief medical officer and president of clinical operations as well as executive director of drug development all at the Sarah Cannon Research Institute, which is a leading cancer center for clinical research in the country. You're also an associate of Tennessee oncology. Now I was once ASCO president myself, and I know how busy the role keeps you. How do you do it all, Skip?

Howard “Skip” Burris: Well, you certainly did it, and I don't mind saying I looked at folks like yourself to understand how better manage my life. I do think I've become better at scheduling. Through the years, I've learned that if I don't schedule myself in, I don't schedule a family in, and schedule a little downtime, that can be hard. So, I have become more disciplined with that through the years.

I think secondly, I've been blessed to have constant and consistent team. Same nurse practitioner for more than 15 years, same pharmacologist for more than 20 years, nurse, staff, et cetera, so that has helped and enabled me to delegate and empower them and others. And recruiting in great talent has been important.

The work energizes me, and I have really enjoyed working with really smart people. And then lastly some credit to my wife, Karen. Surely after being elected president, Karen put me on a diet, and I think that's provided a little bit of extra energy for me as well.

Clifford Hudis: And how's that working out?

Howard “Skip” Burris: Yeah, it's going pretty well. She's been a great encourager for me, and we've been able to drop a few pounds. And we can button the jacket, and so that will help me out with the pictures and being onstage.

Clifford Hudis: So that leads me to maybe a piece of low hanging fruit here, but at the end of this year when you look back on your year as ASCO president, what's the one thing you hope you've accomplished? And don't tell me it's dropping 20.

Howard “Skip” Burris: No, I won't 'cause Karen would tell you dropping 30, but I'm open for dropping 20. I hope that when we look back on my presidential year that it will be seen as a year where we bridge some gaps and connected people to begin to have some conversations to really push some advances. I think this idea of connecting people and bridging the various stakeholders is important to me, that will come in a variety of ways.

I think my educational chair Dr. Prowell, Tatiana, coming from the FDA and from Johns Hopkins and Dr. Melissa Johnson, the two of them bring a very unique perspective in. So how the committees are formed and who's engaged in planning the annual meetings and how we have various participants and speakers, I think we're hoping to engage more of the oncology workforce and care force in terms of participating in the meeting.

I also hope that we'll begin to push this idea of why all should be a member of ASCO. I think there's nothing more important than being together as an association. There has been articles out of late touting why doctors should organize, so I'm also hoping during this year we see an increase in membership for years going forward. Maybe we can set some of that platform up.

And then also really continue to energize and push the Conquer Cancer Foundation. I think it should be something that all of our members will be proud of to say that they've contributed to Conquer Cancer and that they'd invested in the future of oncology. So those are a few of the things I hope to get started. It's a fast year. I know it'll go by quickly, but I'm hoping some of those initiatives can get rolling and we can have that carry forward in years. And when we look back we'll think that I had a small part in getting some of those programs moving along.

Clifford Hudis: Well, that's great. I want to thank you again, Skip, for joining me today. It's been a great conversation. I've appreciated especially hearing more about your vision and your hopes for the coming year as well as the impact you want to leave. I have to say at the opening I teased a little bit about how you came to be called skip, and you haven't shared that. So, this is your chance if you want to let the membership know why we call you Skip. That'd be great.

Howard “Skip” Burris: Well thanks, Cliff. Howard A Burris, III and, of course, Howard, Sr lived down the street and Howard, Jr was in the same house with me. So, when I first came home from the hospital, my mom called me Skip. I have had that nickname since I was born. And I always talked about switching back to Howard when I went to college or after medical school or when I turned 40.

And for whatever reason, personality, friends, I've always stayed a Skip. There is no middle name, Howard A Burris. A is just the initial. So, there's been no middle initial to fall back to. So, I think Skip's what it's going to be and that seems to be what's sticking with me through the years. So that's the story.

Clifford Hudis: That's great. Well, I want to thank you again and want to remind our listeners until next time. We appreciate your taking the time to join us for this ASCO in Action podcast. If you enjoyed what you heard today, don't forget to give us a rating or a review on Apple podcast or wherever you listen. And while you're there, be sure to subscribe so you never miss an episode.

The ASCO in Action podcast, remember, is just one of ASCO's many podcasts. You can find all of the shows at podcast.asco.org.

Removing Barriers to Clinical Trial Access for Patients with Medicaid Sep 03, 2019

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Dr. Melissa Dillmon, the Chair of ASCO's Government Relations Committee, joins ASCO CEO Clifford A. Hudis to discuss improving access to clinical trials for patients with Medicaid. Medicaid covers 20% of Americans, however unlike Medicare or private insurers, Medicaid is not federally required to cover the routine care costs associated with clinical trials.

Find all of ASCO's podcasts at podcast.asco.org

Transcription Shannon McKernin: Hi. My name is Shannon McKernin, and I am the host of the ASCO Guidelines Podcast series. When a new ASCO guideline publishes, we release a podcast episode featuring an interview with one or more expert panel members. Each episode highlights the key recommendations and the implications for patients and providers.

You can find the ASCO Guidelines Podcast series on Apple Podcasts or wherever you're listening to this show, and you can find all nine of ASCO's podcasts, which cover a wide range of educational and scientific content and offer enriching insight into the world of cancer care, at podcast.asco.org.

Clifford Hudis: Welcome to this ASCO in Action podcast. This is ASCO's monthly podcast series where we explore policy and practice issues that impact oncologists, the entire cancer care delivery team, and most importantly, the individuals who care for-- people with cancer. My name is Clifford Hudis, and I'm the CEO of ASCO, as well as the host of this ASCO in Action podcast series.

For today's podcast, I am really delighted to be joined by Dr. Melissa Dillmon-- Missy-- the chair of ASCO's Government Relations Committee, and a longtime dedicated ASCO volunteer.

Now, regular ASCO in Action podcast listeners may remember that just a few months ago, I spoke with one of our colleagues, Dr. Beverly Moy, the issue of financial barriers to clinical trial participation, and we focused on ASCO's work to address those barriers to try to make it easier for patients to enroll in clinical research studies.

Today, we're going to follow up on that. Dr. Dillmon is going to join me as we drill down deeper into one of the barriers that we've touched on previously-- in this case, the lack of coverage of routine care costs that are associated with clinical trials, but very specifically, the challenges that are faced by patients who have Medicaid.

Dr. Dillmon, welcome, and thank you for joining us today.

Melissa Dillmon: Thank you, Cliff, for having me and discussing what I think is a very timely and important issue.

Clifford Hudis: Since it's something I know you care deeply about, maybe you could start off at a high level and give us a little bit of background. What is it exactly that we're talking about here, when we talk about clinical research and coverage for patients with Medicaid?

Melissa Dillmon: So Cliff, you know that in many cases, clinical trials provide the best or sometimes the only treatment option for our patients with cancer. And we live in a time when there is an incredibly rapid pace of development, with new investigational treatments that are dramatically altering the course of cancer for the better. Patients with Medicaid have a unique barrier to accessing clinical trials because Medicaid is the only payer that is not federally required to cover the routine cost of clinical trial participation.

So Medicare and major commercial payers are required to have coverage for routine costs of clinical trial participation. Medicare provided this coverage beginning in the year 2000 after the Medicare National Coverage Determination Act protected their beneficiaries. The Affordable Care Act also requires insurers to cover routine patient care costs for trials participation. But Medicaid was not specifically called out or included in this requirement.

So today, commercial payers and Medicare are paying for the routine cost of clinical trial participation, but Medicaid is not required in any of the states by the federal government to cover these costs. And we know that these patients have financial barriers to accessing basic medical care and preventative services anyway. So this lack of mandated coverage makes it even harder for some Medicaid patients to participate in potentially life-saving treatment trials.

Clifford Hudis: I remember from, obviously in my days of doing clinical studies, there was often a lot of discussion about what was a routine cost of clinical care and what was a research cost. Can you expand a little bit on which parts of this are covered, or are they all covered, by these requirements?

Melissa Dillmon: So routine care costs are the regular doctor's appointment or E&M charge, radiology exams, drugs to manage side effects, supportive care medications, laboratory tests. It is not the cost of the drug or anything specifically related to that, it's just the routine care costs that go along with cancer treatment care, whether that patient was on a trial or on a regular, on-label drug.

Clifford Hudis: And in an ideal world, when this is working efficiently, this dovetails neatly with the fact that the non-routine care costs-- those things that are being required only because the participants involved in a very specific research study-- those costs are generally borne by a sponsor, right?

Melissa Dillmon: Correct. So perhaps if there is a genomic sequencing that was required, or a special laboratory test to assess a response in a marker that was not a routine care cost, that's usually covered by the sponsor of the clinical trial.

Clifford Hudis: And so just to make sure every listener is following, the irony here is without this requirement, in a sense, a person with good commercial insurance historically could find themselves not covered for the exact same costs that normally would have been covered solely because they're getting some treatment that is part of a clinical trial. And that seems like a perverse incentive in the wrong direction for all of us across all of society, right?

Melissa Dillmon: Exactly, especially at a time when it's challenging to get enough people on clinical trial, and we're trying to get more people on clinical trials. We're trying to remove those barriers.

Clifford Hudis: Right, and I would go even a step further and say it's a little bit of a paradox because it doesn't actually cost the insurer any more money for a person to be on a clinical trial and be covered for routine care. It's not as if they're getting an increased charge back because the patient's on a clinical trial. The research study is typically covering the non-standard research components of care anyway, right?

Melissa Dillmon: Correct. And then oftentimes, if there's an investigational drug, they're taking the cost of the drug out of the picture. So in some ways, you're actually saving the insurer that money.

Clifford Hudis: So it's funny, as well, a little paradox that Medicaid is the only major payer not federally required to cover their costs. Yet at the state level, I think-- and I just heard about another one today, I'll tell you-- some states have taken half steps or full steps to require Medicaid to cover the costs of clinical trial participation for patients, right?

Melissa Dillmon: That's correct. About a dozen states have taken action, through written statutes, or regulations, or policies, to require their Medicaid plan to cover these costs. But that's only a dozen states. That leaves about 42 million Medicaid patients who do not have guaranteed ability to participate in clinical trials.

Clifford Hudis: You know, I think some listeners may be surprised that you get that big number-- 42 million. And of course, that raises some basic questions about the reach, and scale, and extent of Medicaid. I think we should talk about that for a moment. So who has Medicaid as their primary insurance? That is, who is covered by Medicaid-- what kinds of patient populations and so forth?

Melissa Dillmon: So Medicaid covers about 20% of Americans. Patients on Medicaid are often lower income. It's usually children, older adults, patients with disabilities, and some patients in rural areas are more likely to have Medicaid. So depending on where those dozen states are that have those statutes, those may be states that don't have as large rural populations or lower income patients.

So racial and ethnic minorities are also overrepresented in Medicaid. For example, African-Americans represent about 12% to 13% of Americans, but 21% of patients receiving Medicaid are African-American. Hispanics represent 18% of the American census population, but 25% of patients on Medicaid are Hispanic.

Clifford Hudis: So this is the same old issue, where certain racial features, as it were, are surrogates for lower socioeconomic status, and that's what you're describing, unfortunately. Right?

Melissa Dillmon: Correct.

Clifford Hudis: OK. And so we take this group of patients that are, in general, a little bit disadvantaged-- lower socioeconomic status as an average, perhaps more rural, which itself represents a barrier to care-- and then you add on the limitation in terms of clinical trial participation coverage. So how does this translate into an increased burden for this special population, as opposed to everybody else?

Melissa Dillmon: Well, we already know that cost is a major barrier to participation in clinical trials. Patients who have larger income are more likely to participate in clinical trials, or be offered a clinical trial, or live in an area where there is a clinical trial available for them. Patients who have a lower income-- less than $20,000 per year-- have a much lower participation rate in clinical trials, and we are therefore missing a lot of patients who could be benefiting from those clinical trials and who could be contributing to the science.

And these patients don't have the financial resources to pay for their routine cost of care. They cannot afford to pay the E&M visit, or for a chest x-ray, or a CAT scan on their own. So that would pose a huge barrier for them to even consider participating in a clinical trial.

And one of the things that frequently is stated is, of course, this means that if you can't participate in a clinical trial, that they might be missing out on life-extending or life-saving therapy. And we have to admit that that, of course, is uncommon, but not impossible. But there are also more subtle ways that clinical trial participation can benefit the individual.

Clifford Hudis: They may enjoy a higher quality of life with some experimental therapies sometimes. And the other thing, of course, is that we all, as a society, benefit it clinical research studies are concluded more quickly. We get an answer faster and we can move on to the next big thing or build upon what we've learned. So it isn't as if the cost of this is limited solely to people with Medicaid. It's something, I guess, we all pay, right?

Melissa Dillmon: As a society, I think we suffer when patients are not able to participate in these studies.

ACS CAN President Lisa Lacasse Discusses Advocacy Priorities, Partnership with ASCO Aug 06, 2019

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Lisa Lacasse, president of the American Cancer Society Cancer Advocacy Network, speaks passionately about the critical importance of advocacy and ACS CAN’s partnership with ASCO in reducing the cancer burden, in latest AiA podcast with host ASCO CEO Dr. Clifford Hudis.

Find all of ASCO's podcasts at podcast.asco.org

TRANSCRIPT

Ad: Hi. My name is Shannon McKernin. And I am the host of the ASCO Guidelines Podcast Series. When a new ASCO guideline publishes, we release a podcast episode featuring an interview with one or more expert panel members. Each episode highlights the key recommendations and the implications for patients and providers. You can find the ASCO Guidelines Podcast Series on Apple Podcasts or wherever you're listening to this show. And you can find all nine of ASCO's podcasts, which cover a wide range of educational and scientific content, and offer enriching insight into the world of cancer care at podcast.asco.org.

Clifford Hudis: Welcome to this ASCO in Action Podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insights into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org. This ASCO in Action Podcast is ASCO's podcast series where we explore policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for-- people with cancer. My name is Clifford Hudis. And I'm the CEO of ASCO, as well as the host of the ASCO in Action Podcast series. For today's podcast, I am really pleased to have Lisa Lacasse, president of the American Cancer Society Cancer Action Network, or ACS CAN, as my guest. Welcome, Lisa.

Lisa Lacasse: Thanks so much, Cliff. It's really great to be with you today. I appreciate the invitation.

CH: Well, I'm really delighted that you could join me today for this discussion. And I think there are probably hundreds of topics that you and I could discuss. But I want to start with the big picture first. The American Cancer Society, of course, is a very well-known, nationwide organization with a mission of saving lives and leading the fight for a world without cancer. Can you tell our guests about the American Cancer Society Cancer Action Network, ACS CAN? What's the relationship with ACS itself? And what exactly does ACS CAN do?

LL: So thanks. That's a great question, Cliff. So many are very familiar with the American Cancer Society, which is a large, old organization that attacks cancer from every angle. The Society works to advance breakthroughs in research, treatment for patients, providing direction and information to help people manage their cancer care, and also mobilizes volunteers at the community level to really support patients in their fight against cancer. But we know that the fight to end cancer doesn't just happen in a doctor's office or a scientific lab. It really requires the government and all elected officials to join us to impact the disease. And so that effort to engage government requires advocacy. And that's where the American Cancer Society Cancer Action Network, ACS CAN, steps in. And we are the advocacy affiliate of the American Cancer Society. So ACS CAN simply urges lawmakers and rallies all of our community partners to lead in the fight against cancer. And together-- the American Cancer Society and the American Cancer Society Cancer Action Network-- although we're two independent organizations, we're working towards the same mission. However, ACS CAN uses different but complementary set of tools. So we obviously resemble ACS in a lot of important ways. We're both nonprofits. We are both absolutely, obviously evidence-based. And we're both supported by a vast army of volunteers. And we all focus on the ultimate goal of eliminating cancer as a major health problem. But ACS CAN advances this mission using tools that aren't fully available to ACS. One, an electoral program called Cancer Votes, which is really an effort to educate voters on important issues to cancer. And we also do a significant amount of lobbying. And that's not just in Washington DC, but in all 50 state capitals and many, many localities. And because of the breadth of that direct lobbying, that's often beyond what's allowable for a charity. So back in 2001, which is-- we're coming up on our 20th anniversary, which is very exciting-- the American Cancer Society Board really recognized that if we were going to achieve our goal to reduce the cancer mission, we had to do that by improving public policy. And so they decided to create ACS CAN. And my job as president is really to empower this huge network of grassroots advocates across the country. And with their staff partners-- we have about 200 people that work for ACS CAN-- every single day, they're imploring their elected officials, working with administrative officials to impact the cancer burden.

CH: Well, I mean, that's a remarkable portfolio. And I would say, obviously that ACS CAN has been a key ally and a natural partner for us here at ASCO in our own mission to conquer cancer through research, education, and the promotion of the highest quality patient care. I know that ASCO shares many advocacy priorities with your organization, including our strong support for robust federal funding for cancer research, improving patient access to clinical trials, and addressing, among other things, the alarming rise in youth tobacco use-- something listeners will recall, we discussed in detail with Scott Gottlieb last year. So it's really a privilege to be able to talk to you about all of this. One of the efforts I think that many of our listeners would want to hear more about would be the Medicare Part D, six protected classes issue. I think earlier this year, ACS CAN mounted a very public outcry and a very visible advertising campaign against a proposal that would have potentially impeded or limited access to lifesaving drugs within the Medicare Part D program, specifically in the six protected classes. And we were proud to join your campaign. We at ASCO couldn't have been more pleased than we were with the impact. Can you explain why this effort was so necessary and talk to our listeners a little bit about how it turned out?

LL: Absolutely. And I do want to say thank you to ASCO's partnership on this issue. It was really important. So this is a regulatory issue. As you mentioned, it's colloquially referenced as the "six protected classes." But that's policy that was established more than a decade ago to make sure that Medicare beneficiaries had access to innovative therapies. So really, the concept's fairly simple. If you're a health insurer and you provide a Medicare Part D plan to a Medicare beneficiary-- so you sell a Part D plan, which is a prescription drug plan-- you are, by definition, required to cover virtually all drug therapies that treat cancer, epilepsy, HIV/AIDS, mental illness, and organ transplant. And unfortunately, late last year, the Department of Health and Human Services proposed to alter that rule. And if the rule that they had put forth had been finalized, we believe it would have dramatically impacted access and affordability to critical medications for cancer patients who are part of the Medicare Part D program. So the proposal, although it was put forth as an effort to save Medicare money-- programmatically to save Medicare money-- we were really concerned that that approach would potentially have the exact opposite effect. We were worried that it would result in raising costs in other parts of the Medicare program and absolutely shifting costs to patients. So that certainly would have happened, because the proposed changes included, for example, excluding drugs from formularies or increasing the use of utilization management tools, such as step therapy. And we know that for a disease like cancer, specific drugs are very important for specific cancers. So if beneficiaries were unable to access their prescription drug that was most medically appropriate for them, they certainly would incur higher costs because it wouldn't be a covered medication. But we also were worried that they wouldn't get physician services, or they would need additional physician services because they weren't getting the right medication, and/or they would end up in the emergency room, which is all things that we know happen if you're not on the right drug regime for your cancer diagnosis. So had these proposed changes gone into effect, it really could have been devastating for cancer patients and survivors. And because of that, once we analyzed the proposed rule, we launched a multi-pronged campaign. It's one of the things that we take a lot of pride in, and we're able to address these issues in many different ways. But one of the most powerful is working in coalition. So ACS CAN and ASCO were joined by nearly 60 other patient and provider organizations. And we ran an advertising campaign-- a very visible advertising campaign. We did a Twitter Day of Action, where all of our volunteer advocates from all of our organizations directed their concern to HHS Secretary Alex Azar. We know that he heard from us. We got confirmation of that. And additionally, ACS CAN and ASCO were among more than 23 patient provider organizations actually went to the Hill for a day, did a lobby day on the hill-- again, making sure that our legislators, congressional members really understood the patient perspective of this proposed policy change. And then finally, ACS CAN did something that we actually don't do that often, which is we shot and ran some television spots. We really wanted to make sure that we were coming at this issue from many different directions because we felt it was so critical to our cancer patients and their need to have access to innovative drugs. So once we went through all of that, we were really proud and, more importantly, thrilled for our cancer patients. The final rule did not include all the proposed changes to the six protected classes that were put forth. These plans are not allowed to impose additional utilization management techniques such as prior authorization and step therapy if a cancer patient already has an established Medicaid regimen. And we really think-- we know, actually-- that HHS and the White House, hearing from doctors and patients and survivors in such an incredible coalition made the agency realize that this could be a very problematic rule. And so I want to, again, Cliff, say thank you to ASCO providing such a critical perspective from your physicians, your oncologists. They know firsthand what these barriers and delays can mean. And the partnership really, really worked. And we're proud of the outcome of that campaign.

CH: Well, again, we want to applaud ACS CAN for your bold leadership on the issue and the wonderful success. It does show the tremendous impact that we can have with a unified, collective voice on behalf of people with cancer. So another issue that I guess, in a way, relates at least tangentially to this-- and I know is near and dear to your heart-- is federal funding, in this case for cancer research and for clinical trials. But before you started ACS CAN, which I think is more than a decade ago, as I understand correctly, you were the CFO of the NIH's Cancer Research Center. So how did that experience shape your understanding of the federal research infrastructure and the need for increased funding for cancer research at the federal level?

LL: So it's a great question. And it is true. I was at NIH for nearly a decade, a decade ago. I have been at ACS CAN for just a little over 10 years now. And NIH is really a fascinating place to work. And I learned so much when I was on the NIH campus just up the road in Bethesda. And I would say most importantly and what has been most impactful is really through that time understanding that the pathways to discovery, particularly in cancer, are very long, and they're very complex, and they are extremely resource-intensive. And all parts of that journey-- every single step has to work well together from the very early scientific discoveries at the bench to ultimately bringing those discoveries to the bedside of patients. And the government has a critical role to play in that journey. Because a lot of that initial science, as you know, is risky, you really have to take a long view. And the very, very early clinical trials, which is what the clinical center focused on-- really phase 0 and phase 1, a few phase 2 trials, natural history trials-- those can only be done in certain types of facilities that have a lot of resources like the NIH Clinical Research Center. And then the other thing that I think about often as I'm doing my work is the many, many patients that I met while I was there at the Clinical Center. We had a 200-bed hospital, a huge outpatient center. And they really are the true heroes. I really think a lot about the many patients who knew that they were enrolling on trials that may or may not benefit them, but would potentially move us forward in the fight against cancer. And so I'm very passionate about the resources that are needed for NIH and NCI. And a lot of that is driven because of this, what I consider, a really transformative experience for me while I was at NIH.

CH: Well, many listeners will remember that I occasionally talk about when I was president of ASCO back in 2013 and '14. And that was the end of an era-- about a decade-long era-- where we had flat funding in dollars. And that, of course, with inflation meant a relative loss of purchasing power and missed opportunities. And this really rallied our broad community. And this is a bit of a little detour, but one of the things that ultimately helped, I think, increase the enthusiasm of many of our members for political engagement and reduce some of our cynicism is that the last few years, we've seen, instead, a steady rise and consistent support for federal funding. And it's crossed party lines. It's clearly been bipartisan. I wonder-- I mean, we like to take some credit for it-- but, of course, I was one of thousands of people knocking on doors and one of many thousands of people repeating the message. But why do you think that we currently are enjoying a period of such steady and reliable bipartisan support? And as you answer that, I would ask you to think about the future. Do you think that support can continue?

LL: Yeah. Look, I think it's a really important question. And I do think that one of the important things that we collectively lend to this discussion is a bipartisan lens. I mean, cancer does not discriminate. It is not political. We ran a big campaign, as you might remember, a few years ago that we dubbed the "One Degree Campaign," because if you are not your own cancer story, you are certainly not more than one degree away from a cancer story. I think there are a couple reasons why we've been able to rally support from a bipartisan standpoint. One is, I do think that people can clearly understand the important role government has in the fight against cancer. But also, just that our patients are very compelling storytellers. They are there, talking to their lawmakers on both sides of the aisle in Washington DC when they're in district about their experiences-- their own, personal experiences about their fight or their engagement with someone else in the fight against cancer, and how critically important federal investment is in what their experience has been. And I do think that when members hear those stories from people who've been directly impacted, or maybe they've experienced it themselves or seen it themselves, it's compelling. I think collectively, as a community, we're getting better at continuing to show the incredible impact that NIH has. And the statistics sort of bear this out, right. There has been incredible progress in diagnosing cancer, treating cancer, caring for people who have cancer. And in the last 50 years, every major medical breakthrough in cancer can be traced back to NIH and the NCI. So I think when we tell those stories, we remind so many people that people that they love are alive today because they have helped fuel that discovery. And they do that by appropriating money for NCI. And so to that end, we would like to call it an evergreen issue. Getting appropriations every year from Congress is something that we can never let up on. It is a sustained effort. And we must continue to really coordinate well among partners-- so between ACS CAN and ASCO and many, many of our cancer partners-- so that we're sure to be bringing a concerted, collective voice to this issue. And we certainly know, because we see it every day in our political lives, that Congress definitely has a habit of reacting to the latest crisis. And so we want to make sure that we don't want cancer to continue to be such a huge crisis. We want continued forward movement. And that's why it's so critical that we bring the patient voice to this issue. We are good partners, again, united with ASCO, ACS CAN, and others in One Voice Against Cancer, which we fondly call "OVAC," which is our coalition that continues to make the case on a regular basis to lawmakers and their staff. But I'm really seeing-- and, Cliff, I know you probably have through your career, as well-- but if we get the patient voice to an elected official, it's not hard for them to support our cause and to understand why these funds to NIH are so critically important to changing the face of this disease.

CH: Well, one of the ways-- I mean, one of the most tangible, obvious ways that we do that and the patients see it, of course, is through clinical trials. Those advances you describe at the NIH have to lead to clinical trials before they can actually change a standard of care. And this is another policy area where we've been working together, in particular advocating for the passage of the Clinical Trial Act. This is legislation that would federally require Medicaid to cover those routine care costs that come with participating in clinical trials, which would bring Medicaid into line with every other major payer, including Medicare, for example. Can you talk a little bit about what impact this bill would have on patients with cancer? And I ask that, reminding everybody that we will shortly post another podcast where we discuss this in detail with Melissa Dillmon, who is the current chair of our Government Relations Committee and on the front lines.

LL: And a shout-out to Dr. Dillmon, because she actually worked with us on a congressional briefing around the six protected classes. And she is a fabulous leader. So congratulations for getting her to work with you. Because her voice needs to be heard in these fights, as well. And I want to do a shout-out to ASCO for your leadership in this particular piece of legislation. So specifically with Medicaid-- I mean, Medicaid by definition obviously serves people facing financial challenges. So right now, it is, as you mentioned, the only major category of insurance where routine costs in cancer clinical trials aren't covered. And so just to be clear, there's the experimental part of a cancer trial, but there are also maybe just regular standard of care that a patient would be getting even if they weren't enrolled in the trial. And those are the costs that you're talking about in this piece of legislation, and that when we talk about the financial challenges of enrolling on a clinical trial, it's not the experimental part of the trial itself. It's really the care around that. So currently, only 12 states and the District of Columbia have state requirements that Medicaid cover these routine trial costs. So that means 38 other states, if a patient wants to enroll in a trial, they're responsible for 100% of that routine costs out of pocket, which we know very few Americans could afford, much less those on a limited incomes. So to us, we see this as essentially a ban on participation by Medicaid patients, which really doesn't make any sense since, by definition, those routine costs would certainly be covered if they were seeing a doctor just on a regular visit. And we also don't want to exclude this whole cohort of millions of patients that we want to have participate in these clinical trials, since that is a critical success factor, as you noted, getting discovery out there that can impact a cancer diagnosis.

CH: Well, while we're on the topic of Medicaid-- and here we were focusing on coverage of its beneficiaries' participation in clinical research-- but can you talk a little bit about your Medicaid Covers Us campaign? How does that relate to this, if it does at all? Or what direction does that take us in?

LL: So Medicaid Covers Us-- I really hope that people that are listening to the podcast can take a minute and go to our URL, which is medicaidcoversus.org. And this is a campaign that we launched last year. And although ACS CAN has a very long history of advocating for Medicaid, Medicaid is just an insurance coverage, right. It just happens to cover a lower level of income for patients. But really, the focus of that program is to improve access to screening, diagnosis, treatment, which happens if you have insurance coverage. So when the Affordable Care Act was passed, there was an opportunity to expand Medicaid, although it is optional for a state. ACS CAN has worked hard with many partners to actively advocate for expanding and really educating the public on how important Medicaid is in the insurance landscape. And so part of that-- what we realized is that we really wanted to make sure that people understood what Medicaid truly is. And one of the ways we are doing that is through this campaign. And this is a public education campaign that's really trying to create a dialogue for everyone who touches health care, which is really an entire community, to understand the importance. If you want to achieve a healthy community, healthy economy, health care is a really important part of that. And Medicaid plays an important role in health care. So we decided to pursue kind of this larger educational effort, and it's really been an exciting project. We have gotten a lot of opportunity to have many members of a community have this conversation. And we're excited about the role that we're able to play in continuing to make sure that people understand that quality cancer care needs access to insurance. And access to insurance for many, many people means access to Medicaid.

CH: So really, in the last few moments we've talked about Medicaid from two perspectives. One is coverage for a substantial bloc of Americans at about 42 million, if memory serves me correctly. And the second is specific coverage of a vulnerable subset that is those beneficiaries who need access to clinical research for advanced cancer or cancer at all. Is that a fair summary of the two prongs of this effort?

LL: 100%, 100%. And I think that we want comprehensive coverage. And Medicaid provides, again, a lifeline for so many patients. And we really want to work to address a couple of big challenges right now in Medicaid. One is that there still 15 states that have not fully expanded their Medicaid program. So that means that there are low-income parents, adults that are not able to access affordable health insurance. And we've seen through a significant amount of research that we've done on our end that there are a lot of cancer patients in the Medicaid program. So that program itself is very, very important to our mission. And then another issue that we're paying a lot of attention to and trying to make sure through ACS CAN that we're having influence on, our policy changes that are creating some barriers if you actually are in Medicaid-- things like what are known as 1115 waivers that are introducing things like work requirements, or maybe some other types of barriers like a lockout period that really create a significant barrier in a pathway for patients to make sure they continue to be able to seek care. So we want to make sure that for all Medicaid enrollees with serious conditions like cancer, that they're able, one, to continue to work-- if they are unable to work, though, that they don't lose their coverage. So we are continuing to work on many, many components of Medicaid, so both the public education and awareness, but also a lot of these very direct lobbying issues.

CH: You know what's interesting, I was thinking as you described all that, the ability to understand the system and then help to constructively shape it is, in fact, the reason-- personally, I can tell you-- that I was so interested in making the career change to go from breast cancer doctor to ASCO CEO. You've been at ACS CAN in total, as we heard already, for just about a dozen years. But recently you stepped into the role of president for the organization. So thinking about all of this, I wonder, has your view of the organization and its role and potential changed over these years? And what are the things that you want to focus on, going forward with this tool that you now have at your disposal?

LL: Yeah. So that's a great question. I'm almost at my six-month mark, so that's very exciting. And it's certainly interesting and always very, very different to work in an organization from a different vantage point. But as president, the first thing I'll say as I continue to be unbelievably impressed with our partnerships and our staff and our incredible volunteers nationwide and their ability to impact policy through very deliberate approaches that we have trained people on-- and when we're clear about the impact that we can have and we talk to our legislators about that impact, we've found a lot of champions. I continue to be very proud, but also convinced that the role of advocacy is critically important to the future of cancer and changing that future for more and more people to have more opportunities to successfully fight their diagnosis. And for organizational goals, I think we obviously want to continue to grow ACS CAN. The bigger our organization is, both from a network of volunteers to resources, the more influence I know that we can have. And then finally, a personal passion of mine is to make sure that our organization is relevant to the entire cancer ecosystem, but particularly everyone who is going to face a cancer burden. And we know that cancer burden is unequal in many, many segments of our population. So I feel a great responsibility and drive to work with my many colleagues, including you, Cliff, and ASCO, to do everything we can to very deliberately reduce the disparity of cancer.

CH: Well, that's an inspiring way, I think, to wrap up this conversation. I can't thank you enough for joining me today for this ASCO in Action Podcast. ASCO and ACS CAN share so many common goals, as I'm sure everybody will hear through this conversation. And we are both dedicated to helping people whose lives have been affected by cancer. And when patients, survivors, families, cancer care providers work together the way we do, and so many others, it's clear that the results can be tremendous in terms of impact and change. So thanks again for leading this charge with us.

LL: Well, Cliff, it really was my pleasure to do this today with you. And I look forward to many years of productive partnership between ASCO and ACS CAN. Thanks for having me today.

CH: Sure. And for all of you listening, if you want to keep up with ASCO's advocacy efforts, I encourage you to visit our website. This is ascoaction, written as one word, .asco.org. And there's more information about ACS CAN and Medicaid Covers Us available at fightcancer-- that's written as one word-- .org. And, Lisa, I think you previously told us that there's a special website for Medicaid Covers Us. What's that URL again?

LL: Medicaidcoversus.org.

CH: I don't know how I forgot it. So until next time, thank you for listening to this ASCO in Action Podcast. If you enjoyed what you heard here today, don't forget to give us a rating or review on Apple Podcasts or wherever you listen. And while you're there, be sure to subscribe so you never miss an upcoming episode. The ASCO in Action Podcast is just one of ASCO's many podcasts. And you can find all of them at podcast.asco.org.

Policy Program Helps Oncologists Advocate for Their Patients, Fellows Say Jul 09, 2019

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Dr. Joanna Yang and Dr. Robert Daly join ASCO CEO Dr. Clifford A. Hudis to discuss the Health Policy Leadership Development Program (HP-LDP). As former fellows, Drs. Yang and Daly provide insight as to how the program has made them better advocates for their patients.

TRANSCRIPT

Clifford Hudis: Welcome to this ASCO in Action podcast. This is ASCO's monthly podcast series, where we explore policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for, people with cancer. My name is Clifford Hudis. And I'm the CEO of ASCO as well as the host of the ASCO in Action podcast series. For today's podcast, I am delighted to be joined by not one, but two of ASCO's rising leaders, Dr. Robert Daly and Dr. Joanna Yang. Both Dr. Daly and Dr. Yang are recent participants in ASCO's Health Policy Leadership Development Program, formerly known as the Health Policy Fellowship Program. This is a professional development program designed to build health policy and advocacy leadership expertise among our members. It's a one-year program where fellows get practical experience working with our policy and advocacy staff and council to craft policy positions and statements, along with other educational sessions on communication, leadership, and advocacy. Starting this year, participants will be able to participate as well in ASCO's Leadership Development Program, which offers mid-career oncologists the opportunity to improve their leadership skills and gain valuable training to set them up to be future leaders in oncology. Dr. Daly and Dr. Yang, welcome, and thank you for joining me today.

Joanna Yang: Thank you so much for the opportunity.

Robert Daly: Yes, thank you so much for having us.

CH: So Dr. Yang, I'm going to start with you. You were an ASCO Health Policy Fellow in 2017-2018. And I want to kick off our discussion by talking about what brought you to the program. Why were you interested in developing special expertise in policy work?

JY: Sure. So I've always been interested in health policy. And I had the opportunity to study health policy and health economics during undergrad. But of course, studying health policy is very different than creating or influencing health policy. When I started residency, I saw many ways in which health policy on a national level or even state level affected the patients I was caring for. And I felt compelled to do more. But the issue is that there is never any clear way for me to get involved or even to learn how I could learn how to shape health policy. And that's why the ASCO program is so great. I feel like it came at exactly the right time. I was looking for a way to learn more to develop the skills I needed to influence health policy. And ASCO came out with this structured and immersive experience where I could take the things that I had studied in school, and also the things that I'd seen in practice, and use them to actually have an impact on the patients I take care of.

CH: So Dr. Daly, you as well were one of our inaugural Fellows. What prompted your interest in applying for the program, especially given I think you were the first year?

RD: Yes.

CH: Right, so you took a leap off of the ledge there and said, I'll go first.

RD: Yeah, I'm similar to Dr. Yang. I had a real interest in cancer care delivery research during my fellowship at the University of Chicago. And I was lucky enough to be mentored by Funmi Olopade and Dr. Blase Polite. And Dr. Polite was really fundamental and helped developing the ASCO Health Policy Fellowship. And so I really saw this as an opportunity to augment that training but really gain skills in leadership, advocacy, and health policy, areas that I hadn't had exposure to in the past. So this seemed like the perfect program for me at that point in my career.

CH: I have to say parenthetically that I'm jealous of both of you, because while I was personally drawn, especially in later years in my career to the policy and advocacy aspects of work with ASCO-- and it truly is the reason that I moved from my traditional academic career to this role as CEO at ASCO-- I never, of course, had the opportunity to be trained and to learn how to do this professionally as you two have. So I am in awe of your accomplishments, as well as the opportunities that are going to continue to unfold in front of you because of this. So given that, and given that this is really the beginning, we hope, of a career with impact, we should talk a little bit about what you actually did. The program, as I mentioned earlier, lasts for a year. And during that time, Fellows worked very closely with our policy staff on a mentor project. So I'll start again with Dr. Yang. Can you talk about the project you worked, what it entailed, what you learned, and where this is going?

JY: Sure. So I worked on a two-part project with Alex Chen, who was my co-fellow during the past year. And as you hinted at, the work is actually still ongoing. So the first part was we looked at whether a bundled payment model could work in oncology. And this really culminated in a white paper for us. But the second part of the project, which built on the first part, was really the most fascinating. In the second part, it was really asking, if not bundled payments, then what? And we actually built on some of the work that Dr. Daly did that he'll probably describe in a little bit. But we actually worked on designing a pathway-based alternative payment model. And of course, going into this, I had no experience designing alternative payment models at all. But the beauty of the program is that from the very beginning, Deb Kamin, said, we will not be having you do any work that is not necessary. So all the work that you do is important to ASCO, is important to our patients. And that was really true for our project. So we were able to work with the ASCO staff, and our mentors, Ray Page, and Linda Bosserman, and a whole team of experts to create an alternative payment model that we thought would allow oncologists to prescribe the right drug at the right time, without being penalized by the high drug costs.

CH: So I guess, based on that, we really should have started with you, Dr. Daly. But your mentor project was centered around clinical pathways. And I understand that ends up being the foundation for the alternative payment model that Dr. Yang just described. So can you talk a little bit about that process, what you did as an inaugural fellow in this and what you learned as you went through the work? RD: Absolutely. So I was lucky enough to be able to serve on the ASCO Task Force on Pathways. So that was an incredible experience for me because I really got to interact with leaders on this issue, including Robin Zon and Ray Page, who are very active in cancer care policy, both at the state level in Indiana and Texas, but also on a national level. So to be able to gain their mentorship that early on in the fellowship was really a great asset for me. And we were looking at, how do we write the criteria for what constitutes a high-quality pathway? So I really got to see, from soup to nuts, how do you write a policy statement? How do you solicit input from those important stakeholders? So the stakeholders in this case were fundamentally the patients, but also providers, ASCO's Government Relations Committee and State Affiliate Counsel, ASCO's board, the vendors-- get all of their input together to create a policy statement that can really influence change. And then lastly, I played the part of representing ASCO and in discussions with the pathway vendors about these criteria for high-quality pathways. So I learned about the important role ASCO can have on influencing the development of products and services that impact patient care, but also the impact ASCO can have on legislation. So in California, Connecticut, and other states, they started to look at policy around pathways, policies around implementing the criteria that ASCO had developed, so that those pathways that were being used in their state were high quality. So it really showed me the reach of ASCO and the impact of ASCO on patients and providers. CH: That is amazing because it really is a reminder-- and I'm going to come back to this idea-- about how much impact one person and one project can ultimately have. And I think that in these sometimes cynical times, people forget that. I alluded to this before about my own engagement with ASCO was accelerated by my experience as an advocate on Capitol Hill-- again, an amateur to your professionalism. So I wonder if you would reflect on your experience during the fellowship program. I understand you were both frequently called on to join in advocacy meetings on Capitol Hill. And this is with federal agencies, as well as, I assume, with representatives, senators, and their staff. Did either of you have any experience doing this before ASCO took it to Capitol Hill? RD: I had never had any experience doing advocacy meetings. So it was really-- the fellowship really helped me learn how to do that and how to do that effectively. CH: What was the first meeting like? RD: My first meeting was here in Manhattan. It was at the office of Senator Gillibrand. And I was accompanied by Heather Hilton, who is an ASCO advocate and someone who's served on the Government Relations Committee. And I was really nervous. I didn't know what to expect. But we met with one of her health policy staffers and really had an engaging discussion about an ASCO advocacy issue where we really felt heard. We were able to share patients' stories and also deliver data that ASCO had collected to help support our view. So it was really an exciting experience for me. And then I got to replicate that experience on Capitol Hill, meeting with congressional representatives from New York in their offices, but then also, as you said, going to government agencies, which was a different experience as well. So I really got to see a broad perspective of how you can advocate for policy issues for ASCO. CH: Dr. Yang, how would you describe your initial advocacy meetings for someone who hasn't participated before? What does it feel like to walk into that first meeting and begin that first discussion? JY: Sure. I've done that for my friends before. I've described these meetings. And they always say, it's really not at all what they expected. And I think that Dr. Daly's description is exactly right. So you go with your group-- usually it's by state-- to the member's office. And then depending on how much room there is and how many meetings are being held that day, your meeting is either going to be in a conference room in the member's office or even, more frequently, in the hall or any room that's available. And the member is not always there, but one of their staffers is, or sometimes multiple staffers, who are always really young but super, super, super knowledgeable about the issue. Basically, you go around, and you introduce yourselves and then describe the issues that you're here to discuss. And it's interesting because ASCO always does a great job of making you exceedingly well-prepared with the facts. But the truth is that most members and most staffers are most interested in hearing the patients' stories, which is why it's so important that oncologists come to the Hill to have these meetings. I think that no matter how well you try to prepare, ultimately, it really just comes down to engaging with the staffer and finding some area of common ground. And cancer is so common that most of the time in these meetings, I find that staffers or members will say, I have a family member or friend or some other loved one who has cancer. And it's really great that you guys are here. CH: My own experience-- I mean, I'm here to talk to you. And the listeners want to hear from you. But I just can't help but share. When I got involved in this before you all were, the key issue that we were confronting was the decade-long flat-- in dollars-- flat funding of the NIH and the NCI. And my first trips to Capitol Hill consisted of virtually beating on doors and explaining why this was a mistake for the country and for our people, and getting what felt like the cold shoulder. Over and over again, the same arguments seemed to fall on deaf ears. But-- and this is an important "but"-- what I have learned is that repeatedly making rational, evidence-based, and appealing anecdotal arguments, just as you describe, can ultimately move the needle. And it does. And so my personal cynicism with regard to politics and making a difference has gone down, not up, with aging. And I think listeners should think about this. You will never go to a congressional office and change a mind in one quick phone call. But when dozens and hundreds of people do it repeatedly over months and years, we actually do have the chance to positively influence policy and legislative actions and regulations in the United States. And you should forgive me for waxing so poetic. You should be proud that you've committed to doing this early. And I hope you start to see the rewards. So I'm sorry to carry on about my own experience here. But it really is part of what has helped motivate all the staff to get behind this program and launch it and support it. Looking back, I'll turn back to you Dr. Daly. You're a couple of years removed now from the program. Can you identify one or several key learnings from your time as an ASCO Policy Fellow that have stuck with you, that you find yourself coming back to in your daily life? RD: Yeah, I mean, I think what you've just said, Dr. Hudis, about how you can really have an impact is something that I learned during this fellowship. It wasn't something that I had been aware of in the past, because I had never done advocacy work before in the past. So I think what this fellowship really trained me to do is to be an effective advocate. And that is something that I can use in a multitude of different areas as an oncologist. So combining the patient stories that we talked about that are so visceral and so needed when you're trying to get through to those legislators or policymakers that you're trying to reach-- but also backing that up with data, and I think ASCO really equipped us well as advocates to have the data, as well as the personal stories, to influence change. So using tools like CancerLinQ to be able to look at broader data sets and say, we know this is impacting our patients. We can see that. And now we need to think of a solution for change. And I think being involved in helping to create some of those solutions was also really valuable for me. So with the pathways, creating the policy paper, but also serving on committees during that fellowship year on MACRA and other issues, like opioid legislation, that were really affecting our patients, and seeing how ASCO is effecting change in those areas, was something that will stay with me throughout my career. CH: And how about you, Dr. Yang? Do you see any practical day-to-day impact, for example, in your work with patients from your time in the fellowship? JY: Yeah, absolutely. I think because I spent most of the past year thinking about high drug costs, both for chemotherapies, immunotherapies, and supportive drugs, I'm much more thoughtful about the costs that are passed on to our patients. And that can actually be really significant. And one of the things that I do much more often is I ask about cost to my patients when I prescribe medications. And that I really attribute directly to work that I was doing with ASCO. The other thing is that working with patients actually often gives me ideas. So I'll see patterns emerging. And I'll think, we really need to work on a policy that addresses this. And the great thing about the Health Policy Fellowship is that you remain involved with ASCO. So when I see these issues, I'm able to take them back to ASCO and to the committees. CH: Well, speaking of the committees, after you and all of our Fellows complete the one-year program, you were automatically added to one of ASCO's relevant committees. And I think you're both members of the Clinical Practice Committee. I'm curious-- I'll start with you, Dr. Daly-- has your time as a Health Policy Fellow helped you in your work on the CPC, and how? RD: I think, absolutely. It's made me more fluent in the issues that the CPC is confronting, the sort of things like the Oncology Care Model, rural cancer care. I now have a foundation where I'm able to contribute in a way on that committee that I never could have before or without the Health Policy Fellowship. CH: Yeah, I think it's often the case that sometimes-- or I shouldn't say often-- I think sometimes it's the case that people get onto committees and really do have a steep learning curve. It seems like maybe this could have accelerated your start on the committee. Is that your experience, Dr. Yang? JY: Yeah, I think so. I think that the Health Policy Fellowship, that first year is a really steep learning curve. But it does, as Dr. Daly said, provide a great foundation to just be aware of all of the issues that affect cancer doctors and cancer patients. CH: So I'm going to go to a little bit of a speed round, if you will, and ask you both to think about the other members of our community who have not had the opportunity to do this and might not ever have thought about it. Dr. Yang, finishing the program last summer of course-- so it's fresher, I think, for you-- why do you think it would be important for oncologists to be aware of and engaged in policy discussions, rather than nose to the grindstone, thinking about their clinical and research responsibilities on a daily basis?

JY: Mainly, I really think that the reason for oncologists to be involved in this is that regardless if you are thinking about it or not, health policy affects you. And it affects oncologists. It affects how they practice. It affects how they are able to care for their patients and the type of care that they're able to provide. And if oncologists aren't involved, their voice is going to be lost. And oftentimes, they're the most important voice for their patients. CH: And Bobby, what would you say to the old version of me, the cynic, who says, this is a waste of time-- I'm not getting involved?

RD: Well, I do think it really makes your career more exciting to be involved in health policy issues. It really broadens your view of how you think about patients and how you think about cancer care, and makes coming to work every day, I think, more exciting because you have this other lens that you're looking at issues with. CH: And looking back more specifically, and not intending to turn this into a sales job for the Policy Fellowship-- we only have two slots a year-- but I wonder what each of you would say to young colleagues thinking about this. What's the best reason to get involved in the Health Policy Fellowship at ASCO? I'll start with you, Dr. Yang. JY: I think that if you're interested in quality of care, the costs of care, access to care, then this fellowship is the right fellowship for you. And I think that being interested in those things doesn't necessarily provide you with the skill set you need to actually do meaningful work in that realm. And I think that the fellowship program really does provide you with tangible skills that you can then use to write policy briefs, to hold meetings, to be an advocate, all of which are really, really, really important. CH: Dr. Daly, is there anything you can add to that? Or does that pretty much sum it up? RD: I think that's absolutely right. I would just add the mentorship of the fellowship is really incredible, so getting to interact with the ASCO leaders, like Robin Zon, or Ray Page, or Blase Polite, but also the ASCO staff as well, who are incredible in the policy area, like Deb Kamin. I think I learned so much from being in their presence for a year and just absorbing all of their knowledge that they had, an experience they had. And when I was at the annual meeting just a couple of weeks ago, it was just such a fun pleasure to be there and see all of them and know that those relationships are something that will be with me throughout my career. And they really influenced me. CH: Wow. I think that's great. And I am so proud of both of you and all the participants in these and the other development programs that we offer. I will share with you that from the perspective of the board of directors, these programs really represent the crown jewel, something that the board members take the light in. And you should be proud to have contributed the way you have. So Dr. Daly, Dr. Yang, I want to thank you again for joining me today for this ASCO in Action podcast.

RD: Thank you so much for having us.

JY: Thank you.

And for all of our listeners, if you want to learn more about ASCO's Health Policy Leadership Development Program, please visit us at asco.org and search for "policy leadership." The application period for the 2020-2021 year is now open, and it will be open through the end of September. So there is time to get those applications in. And with that, until next time, I want to thank everyone for listening to this ASCO in Action podcast.

Director of the FDA’s Oncology Center of Excellence Discusses Expanded Access, Accelerated Drug Approvals Jun 25, 2019

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Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care, and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Dr. Clifford A. Hudis (CH): Welcome to this ASCO in Action podcast. This is ASCO's monthly podcast, series where we explore policy and practice issues that can impact oncologists, the entire cancer care delivery team, and the individuals we care for, people with cancer. My name is Clifford Hudis, and I'm the CEO of ASCO, as well as the host of the ASCO in Action podcast series. For today's podcast, I am delighted to have as my guest, Dr. Richard Pazdur, the Director of the Food and Drug Administration's Oncology Center of Excellence.

The OCE was established to expedite the review of novel cancer therapies and products by bringing together expertise from across the FDA. And we'll touch on this a little bit during our conversation. Dr. Pazdur, welcome and thank you for joining me today.

Dr. Richard Pazdur (RP): It's a pleasure Dr. Hudis.

CH: Thanks. So I want to kick off our discussion by diving right into a hot button issue, expanded access. Can you provide our listeners with some background on this, and explain what the FDA's expanded access program is, and why an oncologist might want to pursue expanded access for an individual patient?

RP: Of course. The FDA's expanded access program provides a way that patients with serious or life-threatening diseases or conditions such as cancer can try investigational medical products for treatment when no satisfactory therapies are available, and when there is no opportunity for the patient to enroll in a clinical trial. The process-- to make a request, the patient's physicians will approach the pharmaceutical company to ask for its agreement that the company will provide the medical product.

The company has the right to approve or disapprove the physician's request. Then the physician needs to send the request to the FDA. This process can be complex to navigate, particularly for oncologists or physicians who don't have experience working with the clinical trials or these types of requests.

FDA allows the vast majority of these requests to proceed. And the FDA has been working to improve the expanded access programs for a number of years, including the development of a more streamlined application process, a more streamlined form. But for many key health care professionals, especially those not familiar with the expanded access program, this process may appear confusing or somewhat burdensome.

CH: And so is this a segue to Project Facilitate, which you announced at our annual meeting a few weeks ago? Can you talk a little bit about that and, its practical implications?

RP: Yes. The Project Facilitate call center is a pilot program only for oncology that will serve a single point of contact. We have FDA oncology staff there, oncology nurses, oncology pharmacists who will assist the physician and their health care team throughout the process to submit and expanded access request for an individual cancer patient.

This is a concierge service to support the patient's medical team throughout the process. It ranges from the initiation of the FDA form 3926. The process will also provide information about IRBs, particularly central IRBs, and really will also follow up on the status of a given patient to determine if that patient has received any benefit from the therapy and if there were any adverse events that need to be reported to the FDA.

CH: So imagine that Project Facilitate works as hoped for. What's the thumbnail before and after experience? That is, how will things appear to be different to the physicians and to the patients?

RP: It should make the process easier for physicians to get information that they need to submit an expanded access request. As I said before, it's often somewhat complicated, especially for physicians don't have experience with either the drug or with the process. And it's obviously easier to talk to somebody over the phone to ask specific questions rather than just being directed to a website.

We're also working in conjunction with Reagan-Udall Foundation for the FDA, which started the expanded access navigator website to educate patients and health care professionals about the expanded access process. This navigator approach offers information provided by companies about their expanded access policy, and now includes the expanded access programs listed in ClinicalTrials.gov.

Patients and physicians can look for treatment options. They could discuss clinical trials, and company information could be provided at the navigator at Navigator.Reagan-Udall.org. So this is really to give patients and their physicians information about what is out there.

Once the patient obviously has this information and their doctor, then the doctor can utilize the Project Facilitate, which allows easier access to actually submitting these forms and going through the actual process. I'd like to emphasize that companies are now required by the 21st Century Cures Act to publicly list their expanded access policy. And the Reagan-Udall Navigator website helps them comply with that requirement.

Again, so once the physician and the patient have identified the investigational therapy they want to try, the physician or other members of the health care team then can contact Project Facillitate for assistance in locating IRB resources and help with the FDA form 3926.

CH: So I think you mentioned this when you launched this or announced it at the annual meeting just now, that physicians do already-- or at least before project facilitate often would successfully go straight to pharmaceutical companies and ask for treatments. And I guess in some cases they'd be denied, and in some cases they would be approved. And that would be through the company's expanded access programs.

Obviously, that means that regulators wouldn't necessarily know the full extent of expanded access use. So assuming that Project Facilitate will allow the FDA to collect much more data on expanded use, how will the data be useful? And obviously, I'm hinting at the fact that some fear that it will be actually a negative.

RP: Well, prior to launching Project Facilitate, the expanded access requests for cancer patients arrived at multiple places within the FDA and were forwarded separately to FDA oncology or hematology

divisions. Sometimes these requests could be delayed, being sent from one place to another in the agency. So this gives a focus point for physicians to contact.

In addition, we're seeing that most of the expanded access requests were coming from patients and physicians at larger academic centers. The patients who don't live near these cancer centers and may not be able to get on clinical trials can also hopefully have access to investigational agents by having a more facile and easier process to use here.

We're also seeing that many companies have turned down requests from patients, and we have no idea what really the number of requests a company may get if they're turning down these requests. Because generally, they don't come to the FDA. So really, by having the initial contact at the FDA we'll be able to determine number one, the number of patients that are requesting a single patient access.

We'll also be able to determine and discuss with the companies their reasons for denying these requests. And there could be multiple reasons. And we also have a process in place that can follow up with what are the benefits that an individual patient may have from this therapy or, as I stated before, were there any adverse events.

We have also heard this kind of urban myth-- and I label that in quotations, "urban myth," that companies fear that perhaps adverse events may be held against them when their drug is coming for drug approval. We have not done that. We take into context where the adverse event reporting is coming from. And there really are no instances that I am aware of in oncology where a report of an adverse event has delayed or curtailed an approval of a drug.

CH: So really, this is a bright ray of sunshine on a dark corner of drug access. And if it works right, you'll just have much more understanding of the overall use of expanded access. Right?

RP: Yeah. I think that gives some clarity to the process here. Here again, we don't know the numbers at this time of actually the number of patients. We only know the numbers of patients that receive a affirmative position from the drug company regarding that the process can continue.

But we don't know the numbers of patients that may be requesting single patient access and are denied by an individual drug company. And also, the reasons. And, as I stated before, there can be very legitimate reasons, including inadequate supply of the drug, lack of support staff to follow up on these drug requests, potential interference with clinical trials that the patient may be eligible for.

CH: You just used a phrase about patients requesting. And I thought as you described this process you were referring to physicians requesting on behalf of patients. And so I do want to ask, are there resources that are aimed directly at patients or is it really solely aimed at the oncologists in this case?

RP: Well, here again, this is a two-prong process. Project Facilitate, the FDA portion of this, is for physicians to call up for assistance in filling out the form and also navigating the process once the decision is made. The other prong of this is, as I stated before, by Reagan-Udall foundation, which patients can call to look at what our options available to them that are potentially listed on ClinicalTrials.gov. And that is also for patients and physicians. However, the portion of the program that is Project Facilitate is for the requesting physician.

CH: All right. Well, that's clear. So once we talk about patient's involvement, and even many physicians I think for that matter, we quickly can drift towards the very heated discussion that took place in public over the last year in the area or that we call Right to Try. And I wonder if you could talk for a minute and help us, for the listeners, make this distinction between expanded access and Right to Try.

RP: Of course. These programs, Right to Try and single patient INDs are really mutually exclusive programs. The main difference between these programs are first, that under Right to Try the drugs have to complete a Phase I trial. For single patient INDs, it could be done anywhere, even within the context that the drug is being conducted in a Phase I trial.

However, the major difference is that the FDA and the IRB does not review Right to Try applications, whereas under a single patient IND, the FDA obviously has to give permission for the patient to proceed as well as an IRB has to review these requests.

CH: So to be very clear, Project Facilitate is supporting the single patient INDs, and Right to Try is a separate matter entirely.

They are distinctly different programs. Project Facilitate does not apply to Right to Try. That is an independent, separate program.

CH: Great. So, you know, one of the problems for a busy clinician is figuring out how to do all this under pressure with a sick patient, and the other pressures of clinic and administration and research. If our listeners want to learn about this more casually, where can they go not under duress, just to start reading up and learning about how to access the program?

RP: They could go-- physicians can go and learn more about the program at our website, www.FDA.gov/oce. The Project Facilitate phone number is 240-402-0004. That's 240-402-0004. And the email address is ONCProjectFacilitate@FDA.HHS.gov.

CH: That's great. So hopefully, some of our listeners will take advantage of that and learn about this when they're not under pressure so that they're familiar with it if they have to turn to it some months later. Now you mentioned that the host is the Oncology Center of Excellence. And I mentioned in my introduction that we would want to talk a little bit about that.

CH: You've been at the helm of the OCE since it was established a little over two years ago, I think. Now that you've been in the role a while, I wonder if you could talk a little bit about your view of what the OCE should be accomplishing, and maybe how that aim has evolved over these two years.

RP: Yes. The OCE basically was an offshoot of the Moonshot Program several years ago, and was aimed to be the first center that coordinates activity among the therapeutic center. Obviously, at the FDA there is a center for drugs, a center for biologics, and a center for radiologic health and devices.

And they all can review oncology products. The OCE has a designation to really coordinate the activities, particularly in the clinical review of the products that involve the treatment of cancer. So, this is a unique center within the FDA, and is somewhat of an experiment at the FDA to see how we can really coordinate the activities of drugs that affect cancer patients.

And here again, the oncology center is primarily designated for the clinical review. And we don't really get into the manufacturing of drugs. That's handled in the individual centers, whether it be a biologic and CBER, the Center for Biological Evaluation and Research or CDER, the Center for Drug Evaluation and Research.

With that given said, in addition to the actual bread and butter of reviewing applications, we have many research projects that we're doing. We have a big project looking at real world data. We have a project looking at updating labels called Project Renewal.

We have, as I stated before, this project that we launched at this year's ASCO, Project Facilitate. We also have a project aimed at really improving our relationships with international drug regulators. We have monthly meetings, teleconferences with five different regulatory agencies throughout the world to go over applications and discuss different regulatory policies.

We have a host of a symposium that we conduct both here at the FDA, inviting external stakeholders including physicians, leading academics, patients to come to the FDA really to discuss important topics to our drug reviewers and the entire discipline of regulatory and oncology, so to speak, how we make decisions in medicine.

We have a whole, also, program that we're developing aimed at educating physicians and other health care professionals for educating other health care professionals on how we evaluate drugs, what our thought processes are here at the FDA. So, in addition to the regulatory work, there is a whole body of scientific work that we're also doing, including independent research on different databases, looking at patient populations more likely to respond to different drugs, ways of evaluating and describing toxicities, ways of really looking at patient experiences while they're getting drugs, and different ways of reporting patient reported outcomes.

We'd like to thank ASCO, obviously, for their assistance during and helping us with many of these projects throughout the year, especially the educational projects involving fellows, involving different topics that we've found of interest that needed to really have a public disclosure in the community, really, to get input from leading academics, as well as treating physicians.

CH: Wow. You are busy. And there's a lot we could unpack there. But I do want to pick up on a couple of things. First of all, you described this as an experiment, so I'm curious. And not to put you on the spot, but if you have an experiment, I presume that just some metric that you would use to call it a success or failure. And I wonder where you think you are right now in that regard.

It sounds like you've gotten a tremendous amount done. But are you satisfied, for example? Have you covered the ground you wanted to or do you think that you could be doing more?

RP: Well, people who know me realize that I'm never satisfied. So, I think we're in the middle of this experiment. I think it's going quite well. And I think that this is really going to be aimed at-- and the evaluation of the success or failure of this is going to be really how the individuals that work here at the FDA really evaluate drugs and how we facilitate the evaluation of drugs.

And also the really important of retention of staff here at the FDA is a major issue, also. And I think many of the projects that we have ongoing really develop our reviewers in really having a real world approach to how oncology drugs are used. So it's very difficult to say what success and failure will ultimately be. But I think we're on, really, the correct path, and pretty much a straight path of looking at a successful venture here.

CH: You know, one of the things you said reminded me of another urban myth. And I don't know if you realize this. But when you describe the careful coordination with, I think you said five regulatory agencies around the world, it raises the myth, I believe, but you can address this with some facts, that many people in the United States believe that others around the world have faster access to a broader range of effective therapies. I wonder if you want to expand on that or comment on that at all before we move on.

RP: Well, that is an urban myth, and probably was generated 20, 30, 40 years ago when that may have been the fact. Obviously, that antedated my coming to the FDA. But I can say the vast majority of drugs are approved first in the United States.

And those include very important drugs such as the PD1 drugs, the targeted drugs, et cetera. They are approved first in the United States. We have taken a very active approach to really rapid approvals of our drugs without sacrificing quality, by having a smarter approach to how we review these drugs, with putting multiple reviewers on particular applications, by cutting down on unnecessary paperwork that many of our reviewers had to do, and really focusing on really the core material that we have at hand, and really emphasizing does this drug really demonstrate safety and efficacy.

At the end of the day, I charge all of our reviewers with the following statement. Would the American public be better with this drug than without it? And that's the ultimate decision that we have to make at the time of approval.

CH: Well, that's another perfect segue to a hot topic, which you and I have discussed actually offline before this. But I'm going to come back to it. The expedited approval of anticancer therapies was recently the subject of a paper in The Journal of the American Medical Association.

And if I remember correctly, they looked at 93 cancer drugs that had been approved through accelerated approval process. But what they claimed is that only 19 of the 93 clearly extended the lives of the patients taking them. That's a value judgment, obviously, about why drugs are approved and introduced to the market. But I wonder if you would want to talk a little bit about your view of some of the complexities and challenges that are inherent in accelerated drug approval, and what your view is of this particular study of the approval outcomes.

RP: I think many times people don't understand that it isn't just about overall survival. Obviously, that's the gold standard. But we've had very careful discussions throughout the years that there are many ways to evaluate benefit to the patient.

And that includes reduction of the size of the tumor, delay in the progression of the disease, the establishment of complete response rates in hematological diseases. So we have to have some flexibility, both in terms of how we approve drugs and what clinical trials we're going to ask for after drugs have been approved on the accelerated approval pathway.

Although overall survival is a very important end point, it's an important efficacy endpoint as well as a safety endpoint, it does have limitations. As we move more toward a targeted therapy and subsegment common diseases into molecular subtypes, many times we find that we have very limited populations.

And simply, we don't have the size of a population that we approve the drug on to really do a large, randomized trial.

So we have to weigh that issue with what type of trial we're going to ask for, both with the initial approval of the drug as well as with, perhaps, the subsequent studies that we ask for after an accelerated approval. In addition to that, many times we find that we have situations where the disease itself may have a very long natural history, such as CLL or other diseases that may have very long natural histories, where one cannot really do a long-term survival study because it would extend many, many, many years.

And many times-- and I think we have to be realistic about this, that there may not be equipoise here to allow a randomized trial to be done looking at overall survival as a primary end point. For example, if we already have information that a drug may have a response rate of 50% or 60% and the comparator drug may have a response rate of 10%, patients will not want to go on a study that looks at overall survival as the primary end point.

And many times, we have to take a look at time to progression or progression free survival and those end points, and actually allow for a switch in therapies or crossover at the time of disease progression, which renders the evaluation of overall survival somewhat difficult, and may confound that evaluation.

So, there are many reasons why overall survival, although a gold standard, may not be applicable to all situations. And I think that's going to be increasingly so as we get into a more targeted therapy approach and have better definitions of who is going to respond. So here again, it's long natural history of diseases either by its natural history or by the therapies that have been approved that prolong disease.

It could be due to the limited populations, which preclude a randomized trial. And it could be due to the lack of equipoise, which really bands that patients have access during the course of disease. I think a much more important question, and one that we are constantly looking at, is not so much what does an individual drug do to the natural history of the disease and prolonging survival in patients that have metastatic disease, but what is the impact over the years of multiple drugs being approved on the basis of progression-free survival or response rates when they are used either in combination or sequentially.

And we could see that, for example, in multiple myeloma, where the course of that disease has been significantly changed, and patients' lives have been prolonged. And the vast majority of the drugs that have been approved have been on non-survival endpoints. And this is true not only for multiple myeloma, but also probably for renal cell cancer.

CH: Yeah. That's interesting. It's a challenging analysis, of course. But that would be a very interesting, essentially public health roll up of all of these incremental decisions. Right?

RP: Correct.

CH: Yeah. So, as I said before, the OCE has been in operation just over two years. During that time, more than 80 therapies and products have been approved, I think. Right? And there've been more than a dozen guidance documents approved, 60 workshops and symposia for oncologists and for patients.

And there were several of those workshops that we at ASCO were privileged to co-sponsor along with you. This is the favorite child question. But what's your proudest achievement so far?

RP: A difficult question, but an easy question, too. It's about the people that work here and the patients that we serve. And I think my brightest moments are when we see the development of our people coming in and taking leadership positions both within the agency in a regulatory context of their job, but also in the academic fields and participating in conferences, publishing papers, and really finding enjoyment in the job that they have outside of the day-to-day regulatory activity.

One of the things that I have always emphasized since I came here 20 years ago from an academic medicine position at M.D. Anderson is really to give the agency a much more academic perspective. And I've always stated that I think we do much more academic work here at the FDA than many academic centers. And I'm not talking about the generation simply of papers or research grants.

I'm talking about actually critical thinking of what goes on at an application, since we have a multi-disciplinary team of statisticians, clinicians, clinical pharmacologists, toxicologists, manufacturing people that all work together. So it's really about-- my greatest accomplishment is really about the young people that have come in that I've mentored, and really have assumed roles, and really will be my lasting legacy here.

But I also want to emphasize that one of the things that I have repeatedly highlighted to this staff is really to consider the patient in really any regulatory decision. Here again, it's not about a P value. It's not about a primary end point. Granted, those things are important, but we really have to bring together the whole body of information about a drug in making a regulatory decision and making that a patient-focused thing. And as I stated before, at the end of the day will the American patient-- will the American public be better off with this drug than without it?

CH: Well, Rick, I got to say that's an inspiring description. It makes me wish I were younger, and maybe I could come and be mentored. But alas, it may be too late for me. But we really are proud to work with you, and to work with so many of your staff in many productive collaborations.

I want to thank you again for joining me today for this ASCO in Action podcast. We always appreciate your expertise and your perspectives. And we look forward to continuing to work with you to ensure that patients with cancer have access to safe and effective treatments.

RP: And thank you, Cliff. It's been a pleasure. And here again, I really think ASCO for providing a lot of resources to us in conducting symposium, and really in fostering better cancer care for patients. I think that's the ultimate goal of both organizations.

CH: It sure is. And I want to remind our listeners that you can follow the FDA Oncology Center of Excellence on Twitter. Their handle is @FDAOncology. That's one word. You can follow me @CliffordHudis, and you can follow ASCO @ASCO. For more information on the latest cancer policy news and updates, visit ASCOAction.ASCO.org. And Rick, I'm going to ask you once more to remind the listeners of the way they can access Project Facilitate.

RP: They can learn about Project Facilitate from our website at www.FDA.gov/OCE. And our project facilitate phone number is 240-402-0004. And the email address is ONCProjectFacili tate@FDA.HHS.gov. ONCProjectFacilitate is spelled O N C P R O J E C T F A C I L I T A T E @FDA.HHS.gov.

CH: That's great. So until next time, I want to thank everyone for listening to this ASCO in Action podcast.

ASCO President Shares Struggles and Solutions to Closing Rural Cancer Care Gap May 28, 2019

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In the latest ASCO in Action Podcast, ASCO’s President, Dr. Monica Bertagnolli, FACS, FASCO sat down with ASCO CEO Dr. Clifford A. Hudis to discuss cancer care in rural America. Improving cancer care access in rural America has been a signature issue in Dr. Bertagnolli’s presidential year, during which she has held town halls in communities across the country to discuss the real-world challenges facing patients in rural America and their cancer care teams. The podcast reveals some of Dr. Bertagnolli’s learnings from her town halls, and she explains what rural cancer care in America looks like today and offers steps to improve rural cancer outcomes in the future.

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

For today's podcast, I am delighted to have with me today ASCO's current president, Dr. Monica Bertagnolli. And we're going to be talking about cancer care in rural America. Dr. Bertagnolli has long been a champion for improving access to cancer care in rural America, and it has been a signature issue for her throughout her presidency at ASCO. Indeed, she has held town halls in communities across the US to discuss the real-world challenges that face patients and the entire care team in these locations.

She shared some of those learnings recently at ASCO's State of Cancer Care in America event, which we entitled Closing the Rural Cancer Care Gap. Today, we're going to talk about what rural cancer care looks like in America and how we can take steps to improve outcomes in these many communities. Dr. Bertagnolli, welcome and thank you for joining me today to discuss this important topic.

It's great to be here, Cliff.

So, to kick off our discussion, I'm going to ask you to describe briefly some of the disparities that currently exist between patients with cancer in rural areas compared to those who live in urban or suburban areas.

Well, just imagine that you live in a town where most things are certainly like they are anywhere else, except the hospital is a very small one. The medical care is a primary care physician and maybe a general surgeon. They can do X-rays. They can diagnose most things. But if you have a need for anything beyond the basics of care, you have to drive three, four, six hours in order to reach it.

I think, throughout our country, we really do have a health care system that gets to most people. But particularly when it's an issue of specialty care, such as a cancer diagnosis, that's not always available.

Finally, there's a lot of our country that fits in this category. By the one government agency that looks at these things, the Federal Office for Rural Health Policy, 84% of the country, of the geographic area of the United States, is a rural location. And in that 84%, 18% of the population lives. So, we think, in oncology, it's very important that we understand more about the people who live in these locations so that we can figure out how to get them what they need.

So, starting in a quantitative way is an interesting mathematical representation, that about a fifth of the country in population is distributed over more than 4/5 of the landmass. And I think that's a way of visualizing the lack of density. But there are common challenges that patients in rural areas face that go beyond just distance and geography. What are some of those that you have uncovered and thought about this year?

You know, it's important not to overgeneralize, because certainly, there are people from every single socioeconomic status and walk of life that live in rural locations, no question. But when you go into big generalities, people who live in rural locations tend to have less education level. They tend to be less affluent. They tend to have more risky behaviors, more smoking and alcohol use. And some of the things that we know are associated with cancer development in general seem to be more predominant in rural locations. And finally, citizens who live in rural locations are, again, generally less likely than those who live in urban locations to have health insurance.

Yeah, so that's a long list of challenges that are only compounded by the geographic challenges that we spoke about before. We go and look at the most recent data that I think you shared at ASCO's State of Cancer Care in America. As we noted a moment ago, just under a fifth of the US population lives in these rural areas. But going one step further, not focusing on landmass but now focusing on the oncology workforce, fewer than 10%-- in fact, we think it's about 7%-- of oncologists practice in those areas. So, on the one hand, there's a lower distribution of American citizens into that space, but there's even proportionately a lower distribution of oncologists. How does this impact patients with cancer?

Well, it's a little bit of what I was referring to before. Going to see a specialist when you've got a disease such as cancer, where knowledge outside of the usual primary care physician's scope is really important, and by the fact that such a small percentage of oncologists live in rural areas and the fact that, in rural areas, distance is so great between various locations means that patients who have cancer just don't have access to the experts that they need.

To get that access, they have to travel. And there's not really public transportation that works between cities that might be 100 miles apart in some rural locations. So, the single greatest issue I hear from many patients in rural locations is the challenge of distance.

Yeah, it's really amazing. So of course, as I'm sure we're going to talk about, at ASCO, we don't enumerate these problems just to make a list. We do this to try to take action, to do something about it. And I guess the first question, and I know one that you've started to think about with ASCO volunteers and staff, is the fundamental one. How can we support the existing infrastructure, the existing oncology workforce in those areas? And taking it a step further, what can we do to possibly expand this workforce, at least bring it to parity with the population distribution?

We were really fortunate to have a very talented team of physicians within ASCO take this task to heart over the last year. And they formed a task force to look at issues of rural access to cancer care. It was led by Dr. Bhatia, who's from the University of Alabama-- Birmingham. And they produced a really great roadmap for us. The one area you're alluding to now is workforce. How do we get care providers? Or how do we get our patients in rural locations access to the care providers that they need?

There's a couple of different approaches the task force identified. The first is to think about education opportunities for rural health care providers. For example, one of the gaps that the task force identified is people with knowledge for the particular needs of cancer patients who live in rural locations.

Well, knowledge is something that ASCO is-- that's our core mission to provide. And so, the task force brought together a whole list of things like expanding ASCO meetings to locations throughout the United States, making it easier for rural care providers to attend, designing and implementing virtual tumor boards. Telephones are everywhere, either web-based or telephone-based communication networks that will allow those taking care of patients in rural locations to get information that they need specifically and support them there.

And then finally, every community is different. Every rural location is different. And one of the things we realized we needed to do as an organization is reach out more to everyone and just find out, what are the individual needs of our care providers?

So, in a way, you're raising the issue of complexity in terms of the built and available infrastructure. But that's paralleled, as was pointed out in the State of Cancer Care in America event, by complexity in terms of our understanding of cancer and how we treat it. So, what challenges does this increased complexity bring to those oncologists and other clinicians who care for patients in rural areas. That is, is it different for them or just more of the same?

So, I can give you some snapshots, because I visited seven different rural communities during my year as ASCO president. And some of the common things all have to do with distance and have to do with access to specialists. But there are other specific issues to each location. Let me just give you some quick examples.

In South Dakota, near the Pine Ridge Indian Reservation, there was a great need for programs that could help address cancer control, screening for cancer, smoking cessation, education for diet and overall wellness, and providers who could engage with the Native American population in order to educate the population and provide those services.

At the complete other end of the spectrum for that community, there was no access whatsoever to palliative care services. So the oncologists, who were about 100 miles away in Rapid City, were struggling with, what do we do when we have an elderly resident of Pine Ridge who has a terminal illness, and we don't have the ability to support them to get palliative care?

And what the community is doing is partnering with health providers that work through the tribal council to provide these services. But when someone needs advice, needs a consult, they have to have someone to reach out to. And that is networking through the teams in Rapid City. That's the way they're beginning to solve those problems, kind of a regional network of support and help.

Another quick example I can give you is in Appalachia. There is a rural community I visited with Electra Paskett in the Appalachian counties of Ohio, where, again, it's about a two-hour drive to the nearest large cancer center. There, it's a combination of regional hospitals who provide services to cancer patients and the Ohio State University, where the most acute patients with very high-level specialty needs can go for consultation.

A patient, let's say, with acute leukemia who's from rural Appalachia and needs to be treated would be transported to Ohio State. Others with more routine care are cared for by providers who are oncologists locally.

So, it's different in every location. I think the underlying theme is collaboration with whatever resources are closest, and finally, the ability to have people who really go deep into the community and problem solve. They all kind of have the whatever-it-takes attitude and come up with very creative solutions particular to the patients that they're serving.

It sounds like, as you described all that, that it's awareness, knowing your limits, and then it's networks and connections that really are the pieces of the solution. Does that make sense to you?

Yeah, that's very well said. And one size absolutely does not fit all. The other thing that you notice is, it's about the whole community, not just the individual patients and their doctor. I heard so many stories of neighbors helping out, somebody arranging to drive someone who was ill to a doctor's visit hours away, neighbors being willing to take care of-- one situation was where the neighbors chipped in to take care of an entire family while the mother was away having radiation therapy for her cancer at a city two hours away. These are the kinds of special challenges that you see in rural locations.

Yeah, I mean, you're really just drifting back and forth in and out of conventional, mainstream medical system infrastructure into the broader community. As I think about that, everybody who's listening to this, of course, knows you because of your years of leadership in the realm of clinical research, which is another component of all this we haven't yet touched on. But often, access to clinical research is a surrogate marker for access to high-quality care-- not always, but often-- and it's certainly an indicator of access to cutting-edge care. So I wonder if you want to talk a little bit about access to clinical research in these disadvantaged rural communities?

I'm so glad you brought that up, Cliff, because we're completely in the dark without research. Like I said, I've gone around and visited these various locations and realized that even though I grew up in a rural area, very rural area of Wyoming, when I visited rural Appalachia and rural Texas and rural even North Dakota, which is very similar to Wyoming, I realized that I really couldn't fully understand the challenges in those different locations. And the only way to understand what patients really need, what they're facing, and how to best help is by research.

It's a way-- in this, I'm saying that one of the most important things we can offer our cancer patients everywhere is the ability to have their challenges addressed by research so that we truly understand them. That's the only way we're ever going to make progress.

So, one of the things that the US government, I think, has done well is the National Cancer Institute has a network of research groups under the National Clinical Trials Network that are centered within community practices and community locations. It's the National Clinical Oncology Research Program, or the NCORP. And almost all of the NCORP sites spread throughout the United States have at least significant outreach components into rural communities for cancer research.

Finally, the US Comprehensive Cancer Centers also have a really important mandate to serve their community, and their community for most of the Comprehensive Cancer Centers includes rural locations. So, it's a hub-and-spoke model that's been developed for research. I won't say that it's perfect, because it certainly could be broader and more comprehensive. But it's a very, very good start, and right now, it definitely covers a large portion of rural America.

And I'm just curious. Is it too soon, or do we yet have data that shows that there's been an uptick or a change in registration out of those rural communities to clinical research trials?

We do know that we have more-- that when you look at the National Clinical Trials Network participants, the patients who enroll on those studies, that the proportion from rural locations is higher than it is in most clinical trials that are done by, say, the industry. So we do definitely know that it's been helpful.

We still don't have the numbers of rural residents in clinical research that meet their population needs. I mean, the patients who live in rural locations are still vastly underrepresented in clinical research. But this goes along with the multifactorial issues of being in a rural location. We know that it's harder for uninsured patients to be in clinical trials. It's harder for anyone who has to travel to participate in clinical trials. And it's certainly harder for individuals of lower socioeconomic status to be in trials. So we've still got a long way to go.

Well, you raised the one that's always in these discussions, the 800-pound gorilla, and that's insurance. Residents in rural areas are less likely to have employer-sponsored health insurance. They're more likely to live in states that have not chosen to expand Medicaid. And the issue, of course, is that when we don't have adequate insurance, that puts a strain on the system in terms of access to care and reimbursement to those who are in the area trying to care for them. So how does that reality affect patients? Is that just another layer on top of everything we've said? Or are there specific places where you see that impact?

Oh, it's another part of this very multifactorial problem of citizens living in rural locations. And it translates into something very, very real. So one of the best data that I've seen recently is that from 2011 to 2015-- I believe this is the last time it was looked at comprehensively-- the CDC looked at death rates from cancer and compared death rates in cancer between urban and rural areas. And the death rates in rural areas were 180 deaths per 100,000 patients, persons, people-- sorry-- to cancer compared to urban areas where it was 158.

So there's a significantly higher death rate from cancer for citizens who live in rural areas. So it's not just access to research. It's not just the availability of specialists. It truly is access to care in a way that translates into survival.

Well, as I mentioned earlier, enumerating all of these challenges is just a first step. And I want to talk a little bit about what we can do to start to address them. Before I make that pivot with you, I just want to make sure that we don't leave anything important behind.

You've been in communities all around the country. You've interacted with patients, other caregivers, oncologists about the challenges of delivering care in rural communities, and you've already detailed a lot of this. Is there anything that we haven't touched on that you want to essentially put on the board before we pivot to solutions?

Only that the overwhelmingly positive thing I found in all of my travels is that the communities-- the rural communities-- truly value the interaction with their care providers. And it is very moving to see how medical care providers in a rural setting are absolutely essential components of the community.

We take it for granted when you live in an urban location that if you have appendicitis or you have a cancer diagnosis, somebody's going to be there to take care of you. That is never taken for granted in these rural locations. And it's very moving and very special as a physician to be able to witness that.

Well, so we'd like to have more of those places, in a sense, where they're lucky enough to take care for granted. And to that end, last fall, ASCO convened a group of our volunteers and board members-- you alluded to this already-- to take a closer look at the issue of rural cancer care. The group identified four primary areas where ASCO could better support rural oncology providers and their patients. And these included-- you touched on this already-- provider education and training, but also workforce development, a tighter embrace, if you will, of tele-oncology, and a focus on rural cancer research.

Further, as you know, during the recent State of Cancer Care in America event, we kicked it off with an announcement that ASCO was convening a Rural Cancer Care Task Force. This is different from the board task force earlier in the year. This one is going to focus on building on that work and making recommendations for specific tools and projects that we can launch.

So knowing what a priority this has been for you throughout your presidential year, I have a question for you, which is, where do you think ASCO can best serve patients in rural areas? That is, what resources would be most useful to our members, the providers who are serving those populations?

So I think ASCO is in a wonderful position to be in a forum, to listen to and enlist the help of those providers who really work with patients from rural locations, and to be able to hear from them directly what they need to better support their patients.

In South Dakota, I heard it was better support for palliative care and better support for access to preventive cancer prevention and cancer control programs. In Laredo, Texas, it was about figuring out how to get people health insurance coverage for the very expensive medications that were involved in cancer care. In other places, it was about being able to have someone available for consultation when they needed it, either by a telemedicine approach or by something as simple as being able to know exactly who to pick up the phone and contact when someone on the front lines had a specific patient need.

Finally, there are a lot of problem-solving strategies that certain providers and provider groups are implementing that are working well for them, but they seem to be still in a bit of a vacuum. Getting providers from across the United States to be able to come together and talk about these issues and share what's working for them, I think, will be very powerful for everyone else in this field.

It sounds like at least part of this is something I've taken to calling ORFA, which is organized resources for access. That is fundamentally what I think we find is a repetitive, recurrent need across all communities, but maybe even more pointed in rural communities in America. Is that fair?

I think that's very fair. And I think there are going to be some things that are truly unique to the rural locations, that are decisions that are going to be made that will be different than medicine practiced in more urban locations. For example, there are different ways to deliver radiation therapy. That may be a trade-off that someone who lives in a very rural location will pick rather than someone who lives in an urban area, where they have the ability to have five weeks of radiation therapy.

Some of the brachytherapy approaches, for instance, to breast cancer or to prostate cancer would be more-- might be chosen by patients who live in rural locations more than they would someone who lives in an urban area. I mean, there are even very specific modalities such as this that we may end up seeing practiced differently in a rural versus an urban setting.

Well, I can't thank you enough for taking the time to talk to me and enlighten our listeners on the topic of cancer care in rural America. As I've remarked throughout the year, your presidential year has been both consequential and engaging. And you manage to not only focus on, I think, critical problems, but also on plausible solutions. And I think that's the mark of a real leader, and we're very grateful to you for that.

Cliff, thank you so much. It's been a great honor, and I really enjoyed talking to you today.

I want to encourage our listeners to go and watch a recording of the State of Cancer Care in America event Closing the Rural Cancer Gap. The full-length recording is available on our Facebook page, or you can find it directly at ASCO.org/stateofcancercare. Until next time, thank you for listening to this ASCO in Action podcast.

Ensuring Response to Opioid Crisis Doesn’t Harm Patients with Cancer May 14, 2019

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Welcome to this ASCO in Action podcast. This is ASCO's podcast series where we explore policy and practice issues that impact oncologists, the entire cancer care delivery team, and most importantly, the patients we care for, people with cancer. My name is Cliff Hudis. And I'm the CEO of ASCO, as well as the host of this ASCO in Action podcast series.

For today's podcast, we're going to do something a little different. We don't have a guest today. Instead, we're going to spend some time going over a quick update on an important clarification issued recently by the CDC, the Center for Disease Control and Prevention, and specifically, their guidelines for prescribing opioids for chronic pain, a very topical issue.

The clarification they issued was the form of a letter from the agency to ASCO, as well as to ASH and the NCCN. And in this letter, the clarification affirmed that the CDC guideline was never intended to deny access to clinically appropriate opioid therapy for patients suffering with acute or chronic pain from conditions like cancer and sickle cell disease.

But I want to explain first why it was important that they issue this clarification and then talk about what we have to do next. Opioid abuse in the United States is clearly a very serious issue. And the tremendous toll that it's been extracting on individuals and families across the nation is well-reported. Indeed, it was one of the reasons originally given for the passage of the 21st Century Cures Act. In fact, one of the motivations had to do with addressing some parts of the opioid crisis.

And so this just makes the point that finding a solution to the problem is among the very highest priorities that government and really the general public, as well as professional societies and advocacy groups and all stakeholders, have to be working towards. However, we do have to, at the same time, be careful that we don't overreach and cause additional harm, especially to vulnerable populations, as we take steps to reduce opioid abuse. What happened before was that there was a misinterpretation of the opioid prescribing recommendations that had been issued by the CDC.

And this resulted in part in new laws and regulations, as well as third-party payment policies that severely limited essential pain medications from patients with cancer and sickle cell disease. The consequence for them was suffering and even more prolonged hospitalizations and health care expenses.

So the challenge here was to fix this mistake. As we talk about how this happened, I want to take a moment and provide a little bit of background on this. Last spring, about a year ago I think, there were papers published, at least one in particular, that highlighted seeming discrepancies-- and I emphasize the word seeming-- between opioid use guidelines that had been issued by the CDC, the NCCN, ASCO, and others.

To their credit, the NCCN, led by Bob Carlson, responded to this by reaching out to us at ASCO and asking if we would be willing to collaborate on a meeting of the minds to identify what was true and not true in terms of those supposedly conflicting guidelines and then issue some sort of a unified statement to help address the situation.

In November of 2018, hosted here at ASCO headquarters, representatives from ASCO, the National Comprehensive Cancer Network or NCCN, the American Society of Hematology, ASH, and the CDC met to discuss the similarities, as well as the differences, among our various published respective guidelines in the area of managing chronic pain. We also discussed how to more clearly communicate to all of our respective memberships how and when practice guidelines should be applied in patient care.

While discussing the CDC guideline, it became very clear to all of us that it was necessary to issue at some point a clarification on the question of where the CDC guideline applied to patients with cancer and sickle cell. And indeed, the first action item we took after this November meeting was that ASCO, ASH, and the NCCN sent a letter to the CDC asking for clarification.

We're really happy, again, to report that this collaboration worked. Very soon after they received this letter from us, the CDC responded favorably. And in their response letter, they noted that their guideline, that is, the CDC's guideline, was initially developed to provide recommendations for primary care clinicians who prescribe opioids for patients with chronic pain outside of active cancer treatment, outside of palliative care, and outside of end of life care.

So I want to pause for just a second and make very clear the aim of their original publication was primary care docs, not oncologists or hematologists, and the patients they were talking about were by and large not the patients who are seen and cared for in oncologists' offices. So the letter really did clarify that the CDC's guideline was never intended to deny clinically appropriate opioid therapy to any patients with acute or chronic pain from conditions like cancer and sickle cell disease.

But instead, it was intended to ensure that physicians and patients consider all safe and effective treatment options for all patients with pain. And underneath all this remained the shared goal of reducing inappropriate use. Beyond this, the CDC also noted that the treatment guidelines from disease-specific experts-- and that means ASCO, NCCN, and ASH-- should be the guide to treatment and reimbursement decisions in the specific circumstances they cover.

So let's just spend another 30 seconds on this idea. They did issue a guideline. It does apply to the general population. They never intended for it to apply to cancer patients or sickle cell patients. And they further called out in a sense the primacy of the disease special list in terms of the guideline priority.

So it's great that we got this clarification. It's wonderful news. But I would submit to you that it's really just the first step towards ensuring that our patients don't suffer needlessly. So with this clarification in hand, we can and I would say we must act swiftly to correct existing policies that have already resulted in some areas in blanket restrictions on opioid prescribing, again, based on a misinterpretation over application of the CDC guideline. Every single day that goes by, there are Americans who are experiencing debilitating pain that could be avoided with appropriate treatment. We have some evidence for this. In 2018, as you may know, the American Cancer Society Cancer Action Network, that's ACS CAN, reported that 30% of cancer patients and survivors said that they were unable to obtain their prescribed opioid medication because of insurance denials. And that was a significant increase almost threefold from the 11% reported in 2016.

So if you remember what we were talking about a moment ago, here's a set of guidelines that come out. They're not meant to be applied to cancer patients. And yet, we saw that as they were being misinterpreted and misapplied, there was a tripling in the number of patients reporting trouble getting indicated medications, and I mean cancer patients.

Furthermore, 48% of individuals with cancer reported that their options for pain management were being limited by laws, guidelines, or insurance coverage denials. So this was, again, an external hand influencing their care coming from outside of their doctor's office.

And even in states that exempt patients undergoing cancer treatment, there are significant administrative hurdles that are delaying access to much needed pain relief, not to mention that such exemptions often excluded cancer survivors. And survivors can have chronic pain for years sometimes from the disease or treatment. And without that exemption, they would, in fact, be suffering in a way that should be avoided.

So it goes without saying, but I'll say it, that we really appreciate the CDC's leadership on this complex crisis. The agency has rightly noted that the opioid epidemic will continue to need ongoing collaboration and leadership. And we all need this as we work towards resolving the crisis. But they also acknowledge the importance of making sure that cancer patients and patients with sickle cell disease get the care and caring that they need and they deserve.

I'll also point out that the US Food and Drug Administration plays an important role in advancing the use of evidence-based prescribing guidelines so that they are able to more accurately and appropriately direct the prescription of opioids. Former FDA commissioner Dr. Scott Gottlieb recognized this. And we look forward to continuing this important partnership with acting FDA commissioner Dr. Ned Sharpless.

I think it's fair to say that the opioid crisis requires a response that protects the public, limits abuse, and ensures access for individuals who live with severe chronic pain. That's a vulnerable group. Clinicians, legislators, regulators, insurers, guideline developers, and patients have to join forces to make sure that we establish sensible, evidence-based approaches that confront opioid abuse but do not add a new group that suffers unnecessarily. We don't want to have one national crisis become two.

So I want to close by extending my deepest appreciation to NCCN and ASH for collaborating with us to address this critically important issue and to ensure that our respective members are able to provide the highest quality care that their patients expect and deserve.

If you want more information on our efforts to ensure access to appropriate pain control for patients with cancer and our other policy priorities, please visit ASCO in Action on our website at asco.org/ascoaction all one word. And until next time, I thank you for listening to this ASCO in Action podcast.

The Impact of Utilization Management on Patients and Practices Apr 16, 2019

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Welcome to this ASCO in Action podcast. This is ASCO's podcast series where we explore policy and practice issues that have impact on oncologists, the entire cancer care delivery team, and most importantly the individuals who care for people with cancer. My name is Clifford Hudis, and I'm the CEO of ASCO, as well as the host of the ASCO in Action podcast series. For today's podcast, I am delighted to have as my guest Dr. Jeffrey Ward. He's the chair of ASCO's Government Relations Committee, and a longtime active member in that area. In addition to his important contributions to ASCO over the years, Dr. Ward is a medical oncologist and a hematologist at the Swedish Cancer Institute in Edmonds, Washington.

Our conversation today will focus on utilization management in cancer care, or the policies that public and private insurers use to control the use of anticancer drug therapies, such as prior authorization requirements, restrictive formularies, step therapy, or fail first requirements, and specialty specific tiers. These are all new and complex topics for some listeners. For others, there's great familiarity. And we're going to explore all of them in the coming discussion.

In September of 2017, ASCO published in the Journal of Oncology Practice a policy statement on the impact of utilization management practices specifically directed at cancer drug therapies. In that statement, ASCO outlined its opposition to payer imposed utilization management policies that restrict patient access to high quality, high value cancer care. The statement also points to high quality clinical pathways as the best first option for ensuring the appropriate utilization of anticancer drugs and the delivery of the highest quality cancer care.

So with that as introduction, Dr. Ward, I'm delighted to welcome you to the podcast, and really looking forward to hearing your thoughts on utilization management. Thank you for being here.

It's a pleasure. Thanks for inviting me.

So to get the conversation started, can you just define first exactly what we mean by the phrase utilization management? Utilization management is classically when insurers or payers put controls over what care a patient may receive. And in our case, that usually means control of the drug therapies that they're going to get. I think that utilization management more strictly could also include when providers themselves use practices that try to strive for the highest quality care at the best price.

So that already raises the possibility that there are a number of utilization management policies that payers could employ focusing, for example, on the use of specific prescription medications or other interventions. What are some of the more common utilization management practices that are being used specifically in cancer care?

Well, I think the one that we run into every day is specialty care pricing. I was talking to the MedPack folks at Congress just a couple of months ago and began telling them the contortions we go through in a practice, where in my practice, we have seven docs. We have two full-time people who their whole job is to get authorization for drugs, and then to figure out how the people are going to pay for their co-pays that can sometimes be several thousand dollars a month. It's a restriction that I suspect the drug companies actually utilize to try and market their drug by providing co-pay support.

At the same time, I think payers build it into the pricing of their insurance. So it's become a big part of what happens. And it's almost a dance between practices and payers. But it takes a tremendous amount of time and effort. And I'm not sure that it accomplishes a whole lot.

Wow. I mean, I think there's a lot that we could unpack there. And I think for some of our listeners, it would help to frame this in even more realistic terms. We shouldn't use specific drugs or drug names. But I'm curious if you could provide a more concrete example of what exactly would happen to Mr. Smith in your office when you make a recommendation for a treatment, and what then ensues in terms of this specialty tier pricing.

Sure. So Mr. Smith has prostate cancer. And he is appropriately treated with a very expensive oral medication along with his castrate therapy. And in doing so, I write a prescription. I send that prescription to a specialty pharmacy.

They then begin doing a preauthorization process, or that preauthorization process may be done from the doctor's own office. They get preauthorization for the drug, but they find out that the patient has a 20% co-pay. This drug may cost $12,000 a year, and so the patient is now responsible for the other 20% of that cost. If it is a commercial payer, then the patient will-- then the specialty pharmacy will go to the drug company, and the drug company will provide co-pay support. That requires often the patient to give them a copy of their last tax return, and there will be some other requirements to show that they don't have the ability to easily pay for that co-pay.

If that kind of process wasn't in place, the patient would probably in many circumstances deny the treatment and not get the best care that they deserve.

If it's a Medicare patient, then the drug company directly providing co-pay support is called fraud. And so in that circumstance, the pharmacy will then-- or the practice will turn to foundations that help provide co-pay support, and try and get the patient foundation support. You're better apt to do that in January or this time of year in March than you are in November, December, because foundations tend to run out of money.

So you run around scrounging up foundation support for your patient until you're able to do it. That puts delays that can sometimes last weeks before you can initiate a treatment. And not to put too fine a point on it, but in this example, you recommended a specific therapy, and ultimately the patient getting it, the delay is really in scrounging up or managing the co-pay through these various channels. Is that a fair assessment of what you've described? Or did I miss something? That's exactly right. And so the patient will almost always get the drug, but there can be considerable delays.

OK. And so that answers, in a sense, the next question, that the concern about the overall impact of this kind of approach on individual patients is a delay in terms of needed therapies. And sometimes that might be a critically important one, but other times it might be honestly less critical.

But it's also a lot of work. And there's a lot of expense on the side of the practice in navigating this. Is that also a fair assessment? Yes. And none of that is, of course, reimbursed. It's become an expected part of practice, but it is a burden on practices. OK. And just out of curiosity, what do you think the alternative would be? Since all of this seems to boil down to the fact that there is co-pay, and there are multiple ways of mitigating the impact of co-pay on the actual individual patient. What would the alternative to this actually be?

Well, I think in a perfect world, the alternative would be that the patient would not have the co-pay, and the drug companies would admit that they're actually lowering their price significantly when they provide co-pay support. And patients would pay less. And we wouldn't have to go through the dance now. That seems, at this point in time, unrealistic. But I think that right now, the payers really have this locked into their cost of their insurance. So it is a dance that's expected. If there was a way to get rid of that, that would be great. One suggestion that has been made is that part D drugs that are cancer drugs actually get moved to part B, and that they get paid for that way for Medicare patients. And then the co-pay issue with part D drugs goes away for the Medicare patients. And then maybe some policy might follow on the commercial side. Maybe not, right?

Yeah. That may follow. But the commercial side is a little bit easier, because the commercial side, you can get direct support from the pharmaceutical company for their co-pay. And you can't do that for Medicare patients.

OK. So let's-- forgive the pun-- take the next step and talk about step therapy. As I understand it right now, the White House and Congress, along with ASCO and other stakeholders, we are all working-- and I think it's true at this point in a fairly collaborative way to try to talk about and start to address the high cost of prescription drugs here in the US.

One part of these efforts from CMS has been to propose expanded use of step therapy. Can you describe what step therapy would look like for a patient with cancer?

Sure. I think that some of us prefer the word fail first to step therapy, because that's more descriptive of what it is. Step therapy is the idea that before you can get drug B, you have to use and fail drug A. Most step therapy is based on price of the drug. And we don't think that that applies very well to cancer patients.

Most of our patients, there is a best drug for them. And to have to use inferior drugs to get to the best drug is problematic, not just in time and delays, but we know that our disease evolves over time. And if you use an inferior drug first, the superior drug may not work nearly so well as a second line therapy.

So in an ideal situation, hypothetically, were there two drugs that on average offered the same response rate, progression free survival, overall survival, and similar toxicities where one costs less than the other, this approach might make sense, assuming there weren't mitigating factors at the individual patient level. And it's fair to point out, I think, that in other domains outside of oncology, classically blood pressure management, step therapy has been accepted and is reasonably successful.

If I'm hearing you right though, the problem we see in oncology is that kind of ideal equivalence is rare. And most of the time there really are reasons, good reasons, defensible evidence-based reasons, that oncologists select one treatment or another. Is that a fair summary?

Yes, I think it is. An example where someone I think might inappropriately use step therapy would be in renal cell cancer, where we have a number of TKIs that are available. Someone may say that they all have similar response rates. Of course, none of them have been compared head to head. And so that makes it very difficult to say whether they're really the same or not. But they do have different toxicities. And so even if you would say on average their toxicities are similar, for a given patient, one drug may be better tolerated or more appropriate than another. To use those drugs in a step therapy fashion would be inappropriate, and I think would harm patients.

There are circumstances where I think step therapy is easy to apply in oncology, but they are few and far between. One example where step therapy I think will be applied-- and I wouldn't have problems with it-- is in the biosimilar products.

And my understanding then is that the Medicare Advantage, at least, some of the plans began allowing step therapy just at the beginning of this year, 2019. Have you begun to see or hear about any impact on patients yet as a result of that or is it still too early? I have seen payers doing some step therapy in, for example, the biosimilar realm, or even requiring you to use a filgrastim instead of pegfilgrastim. But I have not yet seen the part D payers using step therapy. I don't know whether ASCO and its state affiliate counsel has begun gathering examples across the country otherwise. The filgrastim-pegfilgrastim issue that you just mentioned, I think, is a good one for highlighting some of the subtle challenges here. It's probably fair to say that the impact on hard measures, like infection or admission to the hospital, will be indistinguishable. But in one case there are multiple either office visits or health care professional interactions or a burden on the part of the family members or patient for regular administration, whereas with the other choice, of course, there's one dose per cycle. So the price, if you will, of that convenience, I think, is another issue that will eventually bubble to the surface. Right?

Yes. And the ironic thing about that step therapy is that if a patient decides that they want to self-administer the drug at home, they have to pay co-pays for the privilege of giving themselves a shot. Right. Well, we could probably fill the whole podcast with perverse incentives and bizarre quirks of the system, I'm sure, in terms of drug administration, right?

I think that that's one of our problems.

So look, we've identified these challenges. Of course, our job here is both to highlight them so that our members and listeners are aware, but even more importantly is to do something about that. So can you start to describe how ASCO is working with Congress and the administration to address some of these issues to encourage policies that would be better for people with cancer?

Well, I think one of the first things that we've done is we've collaborated with our state affiliate societies in individual states where there has been legislation regarding some of these utilization management activities that don't make a lot of sense. There are a number of bills last year in just step therapy itself. In a number of states, I think there were a total of about 90-some odd bills that addressed some kind of utilization management in different states across the country last year.

We have a similar bill that's in the legislature here in Washington state right now that is looking at step therapies, and to put some curbs on it, and more particularly, to make the processes transparent so that when you do have a step therapy in place, you know it. You understand it. And you know what literature has been used so that you have an ability to appeal it if it's appropriate for your patient. So those kind of processes ASCO is facilitating. The big picture, I think, is that we need to somehow develop a reimbursement system that actually incentivizes oncologists and payers to work together instead of being at odds over this. And that would involve developing pathways that are value based, but in our mind, very distinct from step therapy.

Well, I mean, that's a natural segue to the next topic, which is, in fact, ASCO's 2017 policy statement, which addressed utilization management, and pointed to high quality clinical pathways as payers best first option for ensuring appropriate utilization of anticancer drugs. Can you talk a little bit about why we at ASCO have turned to focus on that as the tool to drive the delivery of high quality care?

Well, I think there are several reasons. One, we've staked out a position that we believe that as oncologists we should be responsible for the way we use drugs, and the management of our patients' care, and that part of that responsibility should be to be cognizant of the cost and the value of the drugs we give.

But we don't believe that we should be responsible for the prices that those drugs carry. A system that we have right now in buy and bill makes us responsible for that. And many of the reimbursement reforms that have been done, the oncology care model being one of them, for example, actually makes oncologists responsible for the cost of the drugs in the reimbursement scheme. We think that that is a mistake, and that there are better ways to try and leverage the cost of drugs than making us responsible for them.

Right. I mean, one of the things we say is that we don't set the launch price, and we're not responsible for it. But in these models, it can be the case that expensive new drugs that drive up the cost of care even when they do deliver better outcomes and are the right therapy can become a financial liability for the prescriber, right? And that's a real challenge, I think, for us.

Correct. I mean, I was a lead author on a paper that we published a year or so ago in the Journal of Oncology Practice that used a model to demonstrate what the risks of taking on responsibility for the cost of drugs in a model like OCM would be. And in doing so determined that if you were a small practice of less than 10 doctors, there was a 10% risk that you could have a 30% deficit in your drug costs just on the basis of who happened to walk in your door. The end result would be that if you were in that kind of arrangement and taking on risk for the cost of your drugs, whether you were successful or not would depend less on the skill and the choices you made, but on who walked in your front door. Yeah. And that's a real problem, because we certainly don't want a system where there's an incentive and disincentive to select or select against certain sick patients, obviously.

So I guess the one question that some people may ask as they think about this is whether there are any situations where the utilization management policies we're seeing now do provide a benefit. That is, are there patients or outcomes that are improved because of the current utilization management tools? Are there places where costs are controlled or there's more effective management of resources in general? Meaning, are there any silver linings in this right now? I think that for individual payers, particularly large payers, there may be a silver lining that we don't see. So I'm guessing as to whether this exists or not. Many of them, I believe, get rebates, often volume rebates, based on step therapy. Whether that actually computes into lower premiums for patients or not or simply higher profits for the insurer, that would be well out of my realm of knowledge.

But I think that there is some leverage. I think there'd be a better way to develop leverage. And that would be if we were using routinely value-based pathways and partnering with insurers to be able to put downward price on drug-- downward pressure on drug prices.

Right. So alignment of incentives is what you're describing at the end there. And I think that's ultimately the best solution for many of the problems that plague us in the health care system. With that, I want to thank you, Dr. Ward, once again for joining me on this ASCO in Action podcast. It was a real delight to hear your thoughts, and to gain a little bit of deeper knowledge. Thanks for doing that.

You're great. It was fun to be here.

For listeners who want more information on utilization management policies and the latest cancer policy news and updates, visit ASCO in Action, which is literally ascoaction.asco.org on the web. And otherwise, until next time, thank you for listening to this ASCO in Action podcast.

Joint Assessment of ASCO, ESMO Value Frameworks in Focus on ASCO in Action Podcast Mar 26, 2019

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Dr. Clifford A. Hudis (CH): Welcome to this ASCO in Action Podcast. This is ASCO's podcast series where we explore policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for-- people with cancer. My name is Cliff Hudis, and I'm the CEO of ASCO, as well as the host of the ASCO in Action Podcast series.

For today's podcast, I am really delighted to have Dr. Lowell Schnipper, chair of ASCO's Value of Cancer Care Task Force as my guest today. In addition to his extensive service to ASCO, Dr. Schnipper is the Theodore W. And Evelyn G. Berenson Professor of Medicine at Harvard Medical School, Chief of the Division of Hematology/Oncology at the Beth Israel Deaconess Medical Center, and Clinical Director of the Beth Israel Deaconess Cancer Center. He is also an Associate Director of the Dana-Farber Harvard Cancer Center and a member of the Cancer Center's Executive Committee.

Now, to provide some background for our listeners, I do want to highlight a couple of related points. First, as early as 2007, ASCO, led by Dr. Schnipper, was already focusing on rising drug and health care costs. And two, as detailed in our five-year strategic plan, almost everything we do at ASCO is aimed at helping our members and all of society achieve high-quality, high-value care for all people with cancer. Examples of the latter include our Patient-Centered Oncology Payment model, our participation in the Choosing Wisely campaign, our entire CancerLinQ project, and ASCO's Quality Oncology Practice Initiative, or QOPI, which is now available internationally.

So our conversation today will focus on one longstanding project that's part of all of this effort. And this is one that's been a critical component of our efforts going back really, starting in 2007, ASCO's Value Framework. Here, I want to note that both ASCO and ESMO have developed algorithmic scales that are designed to evaluate the benefit of new cancer therapies.

Again, ASCO's is called the Value Framework. And it was developed primarily as a physician-guided tool to facilitate shared decision making by patients and their oncologists as they select among high-value treatment options for individual patients. In our framework, the clinical benefit of a specific treatment and its known toxicity are combined, and they produce a score that we call the Net Health Benefit.

So after years of building, testing, and refinement, we recently conducted an analysis that compared the output of ASCO's Value Framework against the European Society for Medical Oncology, or ESMO's tool, which they call the Magnitude of Clinical Benefit Scale.

Dr. Schnipper, you co-authored the assessment that we're going to discuss today. And that's why I'm so delighted to welcome you to the podcast. I want to thank you, in advance, for sharing your insights with us here today. Thanks for joining us.

Dr. Lowell Schnipper (LS): It's my pleasure to join you. This is a terrific opportunity to explain a bit about what ASCO is doing and put it in the context of what other groups are doing, in particular, a group like ESMO. We started this effort, as you were pointing out, approximately a decade ago, not the Value effort, but our emphasis, as a society, on the increasing cost of cancer care for our patients.

And we wrote several manuscripts detailing the importance of doctors being sensitive to cost and, of course, providing the patients with the best opportunity for high-value care. As the years evolve, and some of the initiatives that you've already mentioned, Cliff, we felt it really important to develop a formulaic way of approaching how we, as an oncology community, might assess the clinical value of the drugs we use to treat patients with cancer and convey that, then, to our patients in the context of shared decision making.

That's really the background of this effort. And the Value Framework itself has actually evolved over about three or four years in a number of iterations. And I'm hoping that as the discussion ensues, we'll be able to get into that in more detail.

That's great. So let's actually start with the main topic today, which is the comparison between ASCO's work and ESMO's. Why, exactly, did you decide to pursue this comparison and then publish it?

We became aware that ESMO was undertaking a very similar initiative, namely an attempt at developing an algorithm with which to assess the value, the clinical value, of oncologic therapies representing all of the European nations. That's about 27 nations. In parallel, but actually quite independently, we at ASCO were developing our own Value Framework.

And as one can see when reading about either of them, in many ways, they're quite different. But they have overwhelming similarities, specifically based on assessments of how much good a given therapy does for the patient when compared with a control treatment and, of course, how negative any of the effects of our therapies are to that patient population. And we integrated that, at ASCO, in our Value Framework in a concept that you rightly referred to as the Net Health Benefit.

Well, ESMO, we came to learn as we were readying to publish our framework, that they had worked on something very similar, looking at clinical benefit and toxicity somewhat differently. And they, of course, published theirs in the Annals of Oncology. And we published our framework in the Journal of Clinical Oncology.

These frameworks were met with an enormous amount of interest by every component of the oncologic community. And by that I mean patients, of course, are exceedingly interested in this. And we can get, I hope, to the patient perspective in a little while. But in addition, manufacturers were quite interested in how we were going about assessing the products that they bring forth and we put into clinical trial.

And of course, ultimately, the oncologist, him or herself, is the deciding factor in recommending or not recommending a particular therapy. So we elicited tremendous interest. And I didn't even mention the payer community which, of course, was very, very interested because of the rising cost of oncologic therapies.

In fact, I will say that one of the motivating factors for the ASCO community, and I think for the ESMO community as well, is the awareness that oncologic therapies are very, very costly, sometimes eliciting huge out-of-pocket payments for our patients. And now, I speak for the American health consumer, not so much those in Europe. And this becomes a major factor in the patient's and the patient's family's well-being, as in this risk we know for financial toxicity.

So we felt it very important to establish points of overlap and similarity, as well as points of difference with the ESMO framework in order to understand and improve each other's work. And so while we don't view this necessarily as a planned collaboration with which we'll modify each of ours after arguing about different points in a scholarly way, what we really wanted to do was see how each framework performs when looked at through the same lens of a number of trials.

And so that led to this comparison of, well, we started out with over 100 trials and focused on 97 that were being done in a prospective randomized clinical trial context for palliative purposes, meaning for non-curative situations. And that really is the background of how it came about.

CH: So before we dive into that aspect of the results, I think it might help to clarify, for just a moment more, the comparative effort on two planes. On the one plane, which you touched on, there is the actual design of the tool, what it takes into consideration, and what it weights. And on the other plane, there is how it actually evaluates specific treatment options. So can we just circle back, for a second, at a high level, what is it about the two tools that you would say is similar to overlapping? And what is it that is, perhaps, different, if anything, about the two tools methodologically?

LS: Both tools are premised on using a prospective clinical trial in which a comparator is compared in a specific clinical disease setting, clinical cancer disease setting, with a test agent, or a test regimen. And so both of them look at that particular subset. And, in fact, that is the case for these 97 trials that I just alluded to.

The ASCO clinical benefit, when comparing a test regimen to a control, is literally measuring the difference between the two in the hazard ratio, or the overall survival. So, for example, if the overall survival is measured in months, but no hazard ratio were given, if the overall survival for the control was 10 months, and the overall survival for the test agent was 20 months, in fact, we would register basically a doubling, or a very high degree of clinical benefit.

And if the hazard ratios are such that there's a very low hazard ratio for death, meaning a high likelihood of survival, then the ASCO Clinical Benefit Score would register a large number, accordingly. Our attempt at finding, numerically, the difference between a clinical comparator and a test regimen differs from ESMO where they have reduced categorical differences. In other words, they ultimately arrive at a score of 1, 2, 3, 4, 5 rather than measuring the quantifiable difference between the comparator and the test agent.

So we actually differ in how we go about defining the clinical benefit. We are trying to be a little bit more precise. And ESMO, I think, feels that that attempt at precision may not always be completely valid, because studies vary in terms of sample size and that could influence the variability around the mean or the median. So there's some technical differences, or biostatistical differences.

But basically, we each are trying to develop a magnitude of clinical benefit and have done so in our frameworks. We differ from ESMO in the sense that we have developed a rather elaborate toxicity scoring system. And that's largely because we have, in developing the framework, interviewed many, many patients or leaders of advocacy groups.

And they impressed upon us that it's not just grades three and four, or heaven forbid, grade five toxicity that worries them. It's often low level of chronic toxicity that also impacts on the quality of their lives. And we felt we needed to develop a tool that reflected the patient's perspective as it was explained to us.

And so we have a much more elaborate, and I will confess probably more difficult to pull out of the literature and score, than the ESMO toxicity assessment in which they more or less say, this is highly toxic, not so toxic, or very minimally toxic. So we feel that we needed to do that and that it makes sense because it reflects our patient's input. And again, this is a tool we keep coming back to that's to help patients and docs make decisions. So those are a couple of the ways in which we actually differ appreciably.

In addition, ESMO practically ignores progression-free survival, which, as you know, many, many prospective randomized trials use as a primary endpoint. I think we, at ASCO, completely agree it's not the very best surrogate endpoint. And as such, if [INAUDIBLE] namely, the better endpoint, is not the primary endpoint in a given trial, we will utilize the progression-free survival in our value assessment, but we actually downgrade its value.

So, in other words, if the value of a score for overall survival as opposed to the value of a score for progression-free survival differs, we indicate it by about 20% less for progression-free survival. So the differences in the toxicity parameters we felt were important to maintain and the difference in the progression-free survival measurement, or I should say downgrading its importance, that, too, was also difficult to at least-- well, I should say progression-free survival turned out to be a less valuable endpoint than overall survival.

And we felt quite legitimized in reducing it. ESMO agrees, but they basically give very little credit for progression-free survival unless the improvement in progression-free survival is associated with virtually no toxicity. So we differ a little bit in that. But again, we're circling around the same sets of variables, but coming at them somewhat differently.

CH: All right. So let's talk about the results for a moment. That background, I think, is really helpful to audiences who are trying to put these in context. But a couple of points that I would make, and then I have a question, or maybe one point I would make is, there have been a number of prior studies that have been conducted by external researchers.

They've looked at and compared the two frameworks. And they reported lower levels of agreement between ASCO and the ESMO frameworks than you and your colleagues are reporting now. What's fundamentally changed? I mean, how was your analysis performed? And why does it show a greater degree of concordance than earlier external investigators found?

LS: I'm glad you asked that. That's a key question. And of course, we were initially kind of dismayed when we saw published results in which there was some degree of disagreement between the ASCO and the ESMO scales. Well, it turns out that there was one, out of about four or five that were in the literature, that actually found a high degree of concordance, although it looked at a relatively small number of trials within the same disease area-- lung cancer.

So what we realized was that these are complicated frameworks to work with, that they're not trivial. And the reason I arrive at that is because we are blessed with a very, very bright, talented staff within ASCO who embraced the task of applying our Value Framework to these 103 trials. What we learned is that for people who weren't involved in generating the framework, but were called upon to apply it, they literally had to get onto a learning curve in order to produce consistent assessments after culling out the relevant data from a given paper.

So we are pretty sure that the low levels of concordance really had to do with people misapplying the scales in many, many cases. And the proof of the pudding, I think, is in the eating because while we didn't find perfect concordance, and that gives us additional food for thought, we actually did pretty well, because 65% to 70% of the trials actually came out with an agreeable scoring, meaning that what ESMO concluded was reasonable to recommend incorporating into a European nations Pharmacopoeia for cancer drugs, represented the upper half above, let's say, a Net Health Benefit score of 45 for ASCO.

So those 65%, 70% of trials actually scored pretty much concurrent with one another in terms of identifying drug regimens as useful. The outliers, those that differ, were actually another cause for our scratching our heads and, ultimately, teasing apart the differences. And we do understand some of the reasons why the scales are different, which isn't to say one is better than the other, but it probably just rests on bedrock assumptions in terms of incorporating various variables into the Value Framework.

CH: So that's great. A couple of follow-up questions, I suppose. And I'm just curious, either from the ASCO side or, if you know, from the ESMO side, based on this effort to compare them, is there any plan to actually tweak them to increase their alignment? Or is everybody happy that they're each fulfilling their planned functions and this little bit of discordance is OK?

LS: That's a great question. I can say that, at the very start, this goes back a couple of years, I had meetings with counterparts at our annual meeting, or at the ESMO meeting, just talking about whether or not it would be desirable to essentially arrive at a transatlantic consensus of what would be thought to be a clinically useful addition to our Pharmacopoeia versus not. And I think we are all motivated by exactly that, although I think we don't necessarily have a plan at the moment to try to develop a single uniform framework, at least not for the foreseeable future.

And the reason for that is that we are trying, in the US environment, to utilize our framework in some of the organs that we, as oncologists, typically go to in order to assist with clinical decision making. And so here, I'm referring to the JCO when we publish prospective randomized trials or, for that matter, other high-impact journals like New England Journal of Medicine or perhaps JAMA. We would like to actually begin a catalog of ASCO Value Framework Net Health Benefit scores as these trials accumulate over the next 6 to 12 months.

And that's because we'd like to actually get a feel for that which oncologists are comfortable using and recommending to patients and how our Value Framework stacks up against that. We're thinking that that could be a very, very helpful way of us understanding if we're throwing fastballs right over the plate, or are we missing the mark sometimes and do we need to make some mid-course corrections.

And as you can imagine, the Value Task Force, at the moment, is viewing where we are with the framework as pretty far down an iterative process that's not yet complete, because we need to incorporate this assessment into the real oncologic literature, see how well it performs with what doctors think and patients think are useful drugs. And at that point, I think, we'll be able to utilize it more effectively.

The other thing that I will say that we need to do, and we already have a sub-task force or a subcommittee working on this, is to essentially address the issue of, in breast cancer or in colorectal cancer, if there are three or four trials for a given specific clinical scenario, but each is using a different comparator, a different control, can they ever be compared if the test agents are the same, or the test regimens are the same?

And the answer is, of course, they really can't because you can't easily do cross-trial comparisons. And so we have been working with methodologists who are advising us on doing network meta analysis, a way of at least statistically looking at trials in the same patient population testing the same regimen or novel agent, but if using different controls, to essentially come up with what amounts to a reasonable sort of summarize, or summative control, against which we can then look to see how impactful a new therapy is or is not.

Statistically, it's never all that pleasant, as you know because you're a very experienced investigator, it's never all that easy to even think about cross-trial comparisons. But rigorous statistical techniques, I'm told, are available to at least help us do that.

CH: Yeah, it's interesting. There's a little bit of overlap with the synthetic control arm discussions we have in the context of CancerLinQ. But that's probably a topic best left for another day. I want to come back, though, to a core issue that I think circles all of our discussion and that is financial toxicity, which you raised earlier. And very specifically, in your dreams, how do you see that this process, both our tool and ESMO's for that matter, how do you see them actually having an influence on drug price, which is, I think, fairly summarized as the elephant in the room here?

LS: I'm glad you asked that, but I continue to struggle with what I would think would be an acceptable answer in its broadest dimensions. But my sense is the following. There has been incremental improvements in cancer therapy from the very start of our field. And you'll remember in Charles Moertel's work, the increment of 5-FU in colon cancer was trivial, a few months.

But now we know that patients with metastatic colon cancer can survive for 27 months, on average, perhaps more in many cases. So how do you judge incremental benefit? That becomes a real thorny, almost a societal issue because therein lies the rub. We know our patients are being almost asked to pay out-of-pocket quite a substantial sum for many of the novel drugs that we have.

Some of them, you and I would absolutely agree, are a slam dunk benefit. But we know, as well, that there are many that add very, very small degrees of benefit in comparison with a much more affordable, perhaps generic drug, or set of drugs. What I have hoped for is that if we arrive at what our peer group, the oncologic community and patients, feel is a credible value framework that market forces will be able to get to work and actually modulate what the price that's being asked for a given drug.

And that really goes back to the first thing we wrote in 2009 when we issued a guidance statement from the founding members of the task force. And that is that we recognize that oncologic drugs and, in fact, health care, in general, is not a market in the usual sense of the word. And the fact that it is a perverse market makes us worry, if ever, we'll get to a point where if we can show value, that will be reflected in the cost of the drug.

If you have an innovative drug that is a slam dunk, like trastuzumab, of course, that should have and merit lots different value than a drug that has a very small incremental benefit. And how that can be reflected by a value framework influencing a real world market scenario I'm hopeful about, but I don't quite know the path to get there.

CH: Yeah. I think that's actually a great summary of the frustration that so many of us feel as we think about how rational market forces should work and then what we actually see in our reality. So thank you for at least trying to put this in perspective.

Thank you. It's been my pleasure to participate. And I'm really happy that ASCO is producing vehicles like this to broaden the understanding of the efforts that we're undertaking.

As we wrap up, I want to just remind our listeners that the joint Value Framework assessment that we've been discussing is available online. You can find it at ASCO.org/value. And the ASCO Value Framework is, again, as I said in the introduction, just one part of ASCO's broader and multifaceted effort to help all of our members, and everyone, achieve high-quality, high-value care for people with cancer.

The other efforts that we touched on before and you hear about in the podcast series at various times are the Patient-Centered Oncology Payment model, the Choosing Wisely campaign, CancerLinQ, and ASCO's QOPI, or Quality Oncology Practice Initiative. For more information on any, or all, of these initiatives and for the latest cancer policy news and updates, I ask you to visit ascoaction.asco.org and you can find links out to these programs and more there.

Dr. Schnipper, I want to thank you again for joining me today for this ASCO in Action Podcast . And for everyone listening, until next time. Thanks for joining us.

Exclusive Interview: NCI Director Talks Big Data, Clinical Trials, the Cancer Research Workforce—and Why He Lives to Conquer Cancer Mar 06, 2019

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Dr. Clifford A. Hudis: Welcome to this ASCO in Action podcast. This is ASCO's podcast series where we explore policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for-- people with cancer. My name is Clifford Hudis, and I'm the CEO of ASCO as well as the host of the ASCO in Action podcast series. For today's podcast, I am delighted to have as my guest Dr. Ned Sharpless, the director of the National Cancer Institute.

The NCI is the largest funder of cancer research in the world, and it has helped to drive many of the major prevention and treatment advances we've seen over the past 50 years. This includes things like HPV vaccination and the identification of the link between HER2 status and breast cancer outcomes and treatment, as well as new discoveries that have dramatically improved outcomes for childhood cancer.

Dr. Sharpless, welcome, and thank you for joining me today. Now, we really have a whole lot to discuss, but before we get to our planned topics, I have to jump ahead and start with the president's State of the Union address, when President Trump mentioned that he wants to see $500 million appropriated for childhood cancers over the next decade.

Can you talk a little bit about how you expect that, specifically, to play out? What will the NCI be able to do with those new specified funds for pediatric research?

Dr. Ned Sharpless: Sure. I think childhood cancer-- childhood cancer is an area where the National Cancer Institute has had a long interest and a robust portfolio of research. And I think it is an area where we've made some progress, in terms of mortality, over the last few decades. But you have to say two things about childhood cancer. While progress has been good, and we're making-- more kids are surviving cancer therapy today than ever-- there's still a long way to go. Too many kids dying of cancer in the United States, and even the kids that we're able to cure have these significant lifelong survivorship challenges, in some cases.

So the therapy that is curative may leave patients with side effects of surgery and chemotherapy and radiation for the rest of their lives. So better treatments for kids and less toxic treatments for kids are what we are really looking for. And with that amount of money, I think a good-- the thing that it appears to me that one could do to most quickly move the needle in childhood cancer-- which, as you know, is a collection of less common cancers, even rare cancers-- is really a more intentional effort at aggregating and using and linking clinical data with molecular data and other sorts of patient data, so that we can really learn from every child with cancer in the United States, so that we can really figure out what's working in certain populations and then disseminate that information as rapidly as possible-- without having, in all cases, to rely on slower clinical trial structures that are challenged for certain populations where accrual can be difficult.

So I think that is the vision for the president's initiative, is to, with additional funding, allow for very aggressive, intentional, and organized data linkages and data aggregation so that we can learn from every trial and therefore treat every child's cancer in a better, more effective way.

Dr. Clifford A. Hudis: You know, I think that's great. And that actually provides two different segues-- one I'm going to pick up right now, and one I want to come back to. The first is about data-- big data, specifically. We'll come back to that. The second is about the way the pediatric oncology community for years has really led in designing studies that could accrue the majority of children diagnosed with various specific diseases.

And that leads me, that idea of eligibility and the structure of research, to ask about the way that you're thinking about modernizing clinical trials. This is something I know you wrote about in JAMA Viewpoint in the last couple of months. You addressed financial pressures, the need to increase overall rates of accrual to the trials, especially representing patients from underserved populations. Can you expand a little bit on that effort and what kind of progress you see as possible in the coming months and years?

Dr. Ned Sharpless: Yeah, I think everything we do successfully in cancer today is in some ways the results of a clinical trial. And this is clearly one of the most important things the NCI does, in terms of moving basic science into patient care through experimental clinical trials. And it's an area where we-- frankly, a lot's changed in the last couple of decades. When I was a wee fellow, the clinical trials apparatus was very different from the way it is 20 years later today. And we need to make sure that we modernize the clinical trials process to keep up with the changes in our understanding of the biology and the new kinds of therapy we have for cancer.

So that brings up a bunch of items that are areas where the NCI is really doing a lot of things. So, for example, one of the first problems I noticed when coming to the National Cancer Institute was that the clinical trials infrastructure, the big networks that we have for doing these kinds of trials, were under-resourced, that they had a funding problem. And they were becoming non-competitive with the trials sponsored by industry.

And this showed itself in many ways, in accrual fees for patients, or the wait times to get the trial open, or the slow accrual once the trial was open. And so they were laboring under a number of problems. And so we decided we had to invest in the Clinical Trials Network and have been doing that and will be continuing to doing that in a number of ways-- through direct funding to attempt something like the National Clinical Trials Network or the NCORP, for example, the NCORP organization, but also by additional funding for biobanks and data aggregation initiatives, targeted clinical trials, et cetera.

I think we've also-- there are some structural problems with the clinical trials that you alluded to. For example, eligibility criteria, I think, hadn't really kept pace with modern clinical trials. And I think ASCO and other groups have played a really important leadership role in identifying what are good eligibility criteria and which ones are not as necessary anymore.

And then, do we have to have the same criteria in all the trials, and be more thoughtful about how those are used as a way to enhance accrual, because often we have a-- superfluous eligibility criteria can limit accrual. And increasing accrual by a variety of measures is really important. And we've thought a lot about how to do this through novel ways of clinical [? house ?] matching.

I think one of the more successful efforts we've had in clinical trials accrual recently has been the MATCH trial, the NCI MATCH trial, which was able to accrue 6,000 patients at 1,100 sites in the United States, filling a targeted accrual two years ahead of schedule. It's the fastest-accruing trial in the history of the NCI.

And I think one of the things MATCH teaches you is that if you have an interesting trial that's written in a nimble way that is open in the community-- that patients don't have to drive six hours to a cancer center, but can go to a local NCORP site, for example-- then those trials will accrue. We can accrue quickly, and we can accrue underserved populations, and we can accrue rare cancers. And that framework is more nimble than, say, the large phase III randomized trial run only at cancer centers that we had 10 years ago.

There is still a role for large, randomized, phase III trials. The NCI is not backing away from that, or where we will support those. But I think, as we discussed in the JAMA piece, we really have to be thoughtful about where the NCI needs to be involved with those kinds of trials, compared to which of those should be supported by industry, for example.

Dr. Clifford A. Hudis: It sounds like you're alluding to something I think you and I discussed even when you first got into your current role, which is the identification of those trials that industry should run, essentially, itself, and those trials that the NCI should support as complementary to industry trials. Can you expand a little bit on how you see that distinction and where you draw that line?

Dr. Ned Sharpless: Yeah, the thing to know about clinical trials in oncology in the United States right now is most are actually paid for by industry. There's a huge pharmaceutical industry spend on clinical trials, and from my point of view, that's great. The fact that industry is paying for trials to develop therapies for cancer patients-- that's less money the NCI has to spend on those same questions. So we think that's a wonderful development and healthy for cancer research.

But if that's the way it's going to be, then the NCI has to ask itself-- for the precious moneys that we have to spend on clinical trials, we need to use those in a way that's maximally effective and, in particular, not duplicative with what industry sponsors are doing. It's important to say, we do a lot of work with industry. So it's not just us either-or.

Many of our trials, through these agreement processes called CRADAs, allow us to do trials with pharma sponsors and use their compounds in our trials. And that's a real boon to our research effort, as well. But there are certain kinds of trials that are very important where we really want to know the answer, but they're a bad fit for what industry is going to fund.

For example, a de-escalation trial-- that's a trial where there's a standard of care that's pretty good, but the therapy is toxic. And so we'd like to see if we can get the same good outcome in a population using less aggressive therapy. A very important example of this was the TAILORx trial recently, where we showed that based on a genetic risk score, an RNA-based risk score of the breast cancer, women with estrogen receptor positive breast cancer-- many of them could forego cytotoxic chemotherapy and just take anti-hormonal agents and have the same good outcome in terms of their long-term survival.

So that's a trial that is not going to be industry-led, for a variety of reasons. But I think it is the kind of question that's really important for patients. It's important, also, to say that de-escalation trials are hard to do. They require a lot of thought. They don't always work. And so they require these comprehensive thoughtfulness and infrastructure that the National Clinical Trials Network can provide.

So an additional example is these multi-modality trials we have, where maybe two different agents come from two different pharmaceutical companies, and then there's some surgery and some radiation. There's very complex, multi-integrated care. And those can be very hard for a single sponsor to run, but, again, can be a very good fit for the NCI. And there are many other examples like this.

But I think the real question we have to ask is, if our budget is limited and finite, what are the trials that the NCI really should do and lead on?

Dr. Clifford A. Hudis: Yeah. And I think one of the points there is you need to conduct-- we need to conduct-- trials as efficiently as possible, getting the most so-called bang for the buck. You alluded to the fact that the NCI, along with ASCO, has been working on making trials essentially more efficient by making them more representative of the actual cancer population we end up treating.

And a specific area of focus for us at ASCO, in this collaboration and also in our TAPUR trial, has been driving the eligibility age down below 18. My understanding is that this is something that you're adopting as a recommendation across the NCI, as well. I guess my question is, how broad and how quickly do you expect to see this implemented?

Dr. Ned Sharpless: We have a number of efforts related to these barriers to accrual. You mentioned age as one of them and other sorts of exclusion criteria. And we've looked deeply and thought about this sort of care across the continuum of life-- both age limits on the less than 18 side, but also at the greater than 65-year-old side, where we see, often, eligibility criteria structured around a maximum age that don't often make a lot of sense.

So that is one of several topics that we are addressing. As you know, we have a variety of networks and programs, and we fund a variety of kinds of trials. Some are led predominantly by the academic institution. Some are led through NCI networks. And so we are rolling out these policies, not in a one shot fits all way, but across these networks at different scales. They often require scientific buy-in from the other participants, and you know how that process works.

I think this is an area, fortunately, where there is a lot of buy-in, where we're not having lengthy debates about whether or not we should do this. Really, the question is how we operationalize it and make it happen as quickly as possible.

Dr. Clifford A. Hudis: That's great. And you know how strongly supportive we are, on lots of levels, for this effort and the related ones, in terms of barriers to accrual. I want to pivot, though, back to something that you introduced earlier about the big data. And my understanding is, in the annual plan and your bypass budget for 2020, you specifically called out the need to harness big data to speed up all of our work across the cancer research enterprise.

And there are many companies, organizations-- we ourselves at ASCO have CancerLinQ-- that are involved in trying to collect data, share it, analyze it, and advance science and clinical care. But what exactly do you see as the NCI's role in facilitating this, and what do you think is our biggest challenge going forward?

Dr. Ned Sharpless: Yeah, it's an interesting topic. I think the-- it's maybe two things to say off the top about big data in cancer research. The first is the NCI already has one very important example of how big data can transform a field, and that's The Cancer Genome Atlas, which later became the Genomic Data Commons. This is petabytes of genomic data that we make available in the cloud now to any researcher, basically, who is interested in cancer.

And that set of data has led to thousands of papers and just a fundamental reorganization of how we think about cancer biology in many ways. And it's been a huge success, I would argue, and well worth the investment of the NCI to do it. And the data has been used in ways we never envisioned. We never thought of some of the papers and applications that would come out of the analysis of the Cancer Genome Atlas, for example.

But the problem, then, one quickly sees, is that while that data set is great, it's limited. It doesn't have the clinical data, it doesn't have radiology and histology, it doesn't have-- we don't really have a way of binning big epidemiologic cohort data, for example. So the GDC, the TCGA, the Genomic Data Commons, proves how useful these kinds of data aggregation efforts can be, but also makes very clear what the shortcomings of our modern efforts are.

The second thing to say is that this is a problem where the NCI is well-poised to be a leader, right? There are a number of issues around data sharing and data aggregation that really benefit from a Switzerland-like federal entity, a non-conflicted, dispassionate entity like the NCI that just wants to create the data structure in a way that's maximally beneficial for everyone, so that there are-- this is an area where the imprimatur of the federal government really allows us to play a role that would be hard for other groups to take on directly. And so I think this is a reason why so many groups have been looking to the NCI for leadership on this topic.

So what are the challenges to big data? Well, I think that one challenge that has been spoken about a lot publicly is this issue of data hoarding by scientists and physicians and people who have these sets of data they don't want to share for academic competitive reasons. That is a problem. I'm not going to say that doesn't exist. But I don't actually think that's the biggest problem.

I think a bigger problem around data sharing is just it turns out to be really hard to do. And by hard, I mean expensive. It turns out to be-- these various data sets were not created, initially, with the intent of sharing them. They're often in different formats. They're often governed by different kinds of data use agreements, which are governed by the consent form that the patient signed to have their data included.

And so linking them can be both very technically difficult, from just a computer science point of view, and can also provide a lot of administrative and logistical hassles from the data sharing, data use agreement point of view. And so each one of these things is just something the NCI has got to work through, or someone like the NCI-- is figuring out how to link disparate data sets, how to get the right kind of data abstracted from charts that we want, how to develop the right work force to study big data with big data analytics, and then that is a big problem.

So there are a number of areas where the NCI can address the challenges. And I think we'll make progress. I mean, the good news is that we understand these problems. This is not like we need to-- there's some fundamental problem of biology that we need to figure out. The bad news is that the problems are weedy, complex, and many, many layered, and require us working through them.

But that's what we can do. We have support from the government for this. The moonshot had a lot of funding for data initiatives, which we've been employing to get these structures going. And now the Childhood Cancer Data Initiative, for example, I think could really-- that's a nice demonstration project, if you will, because it's the right size. Childhood cancer is about 16,000 cases a year.

And so I think we can show what this radical data sharing, if you will, this data liberation project can do-- you know, that population and how useful it could be to larger groups of patients like lung cancer, breast cancer, things like that. So I think that these are the kinds of things the NCI can do with help from other federal agencies and academic partners and groups like ASCO.

This is certainly not an area where we plan to go it alone. There are a lot of stakeholders and a lot of great ideas. And I think that by organizing and convening these initiatives, we'll make progress.

Dr. Clifford A. Hudis: Well, I really, first of all, appreciate your calling out the fact that data hoarding in isolation is not the single biggest problem, because I think that's a frequently-cited limit. And I agree with you that it's less of an issue than all of the other ones that you highlighted. In that regard, I understand that you just announced a new office. I think it's the Office of Data Sharing? Can you expand on or explain how that relates to these challenges and what it's going to, hopefully, accomplish for us?

Dr. Ned Sharpless: Sure. The Office of Data Sharing is something within our Center for Bioinformatics and Information Technology. It's getting stood up now. It's been around for about a year, even less than that. It has a new leader and a few FTs, and it has a number of jobs intended for it. I mean, there are a number of ways that we would like the Office of Data sharing to-- a number of problems that we think that the ODS can help serve with the external community in terms of data sharing, like these issues around consent and data privacy that I mentioned.

But right now, an intense focus of that office, because it's something we really need to solve, are related, really, to the issue of accepting data and allowing access to NCI data at present. So we have this complex structure whereby academic investigators can give data sets to the NCI. That's harder than it sounds, because we have to make sure the data are of good quality and they're properly consented, and we understand the data usage agreements and that kind of stuff. And then we have a means to allow access to those data to accredentialed investigators. And there are a bunch of issues with that that are more complicated than you and I would want to go into right now.

But I think that's consuming a lot of the bandwidth at that office right now, is the problems around, for example, the dbGaP entity, whereby different investigators give data to the NCI and the rest of the NIH. That has caused a bit of a bottleneck, and so we're trying to work through some of those issues.

One thing, for example, that I think the ODS can do and is doing already is this sort of concierge-like function. For people who have large, valuable data sets that they'd like to give to the NCI, we should be able to take those data sets as quickly as possible. But something that's happened in the transmission of those data is that we've realized the quality isn't quite what we wanted or the format isn't exactly right, and so we have these questions, and they go back to the investigator. And there's this sort of cyclical loop that can take months and really substantially delay the process.

And so the ODS is jumping in there early on and intervening on that loop and making sure the data are the right format and the right quality at the time of initial submission, so that we don't have this back and forth that wastes a lot of time. So I think those data access and data transmission issues are a prime focus for the office right now, although it has a much larger mission as it gets stood up.

Dr. Clifford A. Hudis: Yeah, a little bit like CENTRA that Rich Schilsky runs for us here at ASCO, in terms of access. But at any rate, I want to take the remaining time we have, and maybe this is a speed round on the cancer research workforce. So a couple of quick questions, perhaps-- first of all, has the Cancer Moonshot Initiative had an impact directly on the kinds of awards that you're making available to researchers? And if so, how do you think that might evolve in the next couple of years?

Dr. Ned Sharpless: I think the moonshot, as you know, was intended to focus on these 10 areas identified by a blue-ribbon panel that were thought to be ripe for clinical translation, just about ready to go into clinic and to benefit patients in a very direct, immediate way. So the moonshot per se didn't include funds for things like really hardcore basic science or training, although certainly moonshot moneys are being used to some extent in both those areas, as necessary, as part of these translational efforts.

So I think that what the moonshot has done-- it's done a couple of things. So first of all, that most of the awards granted by the moonshot mechanisms are more these-- are not the traditional R01, but are more of these consortia and network grants. And I think we've built a lot of infrastructure for research efforts, say, in immuno-oncology or in pediatric cancer or in survivorship. And those networks will both-- well, they will live on beyond the moonshot in some cases, I'm sure.

And those networks will provide integrated research efforts, but also some training opportunities. So most of those include junior scientists and junior clinical investigators, and so there will be some opportunity for the moonshot both to drive the scientific area of study and also provide some training opportunity for the new people coming up.

Dr. Clifford A. Hudis: Well, speaking of junior and new, I listened to your conference call, I guess, about a week or two ago talking about the pay line. Can you expand on your plans to support young investigators right now, given the always-present constraints in funding?

Dr. Ned Sharpless: Right. This is a particular problem for the National Cancer Institute, because we've seen this relatively-- there's no other word than "massive" influx in the number of applications for the so-called R01 grants, the independent investigator-initiated award at the NCI. And this is-- our award number is something up like 60% over the last nine years or so.

So this rapid increase-- which is, in most ways, a very good thing. I mean, that says that new scientists are coming to our field with new ideas and new ways to treat cancer, and the NCI can pick among these many applications and fund the very best ones. But it has this pernicious bad effect for the academic investigator community, and that is that their individual chances of getting a grant are lower.

If paylines are really the number of funded awards divided by the number of applications, and the denominator goes up faster than the numerator-- both are going up, but the denominator goes up faster-- then the paylines are going to go down. And we think this is particularly a problem for junior scientists, because established scientists have seen paylines come and go and funding realities change.

But new scientists aren't as used to the life of the independent researcher and, we think, are most likely to either leave science or move out of cancer research to another area of science. And we'll have to try and minimize that from happening, to the extent possible. So one of the things we've done at the behest, in fact, of 21st Century Cures, which included language asking the NCI in the United States to do this, was really focused on these so-called early stage investigator, the ESI.

So the ESI is faculty. That's someone who's gotten a job, generally in an academic institution, and is now writing their first R01 grant, their first independent scientist grant. And we've done a few things for this population. One thing that's really important is we give them a special payline. We give them, effectively, a higher chance of getting funding.

So if, say, paylines are on the order of 8% now for all Comer grants, for ESIs they'll be more like 14%, right? So a significant-- or 12%, in that range. So, significantly higher than what the general community is. I want to point out, also, that paylines are lower than the actual success rates of the NCI, which is a better number. The reason success rates are higher is because we do fund a lot of grants outside of the score. It's a little bit of inside baseball. But generally, if you write a grant to the NCI, your chance of getting it is more like 12%. And if you're an early stage investigator, it's more like 16%.

Dr. Clifford A. Hudis: Thanks, Ned. To switch gears a bit, I know you've worked with the NCI throughout your career. But now you've been at the Institute's helm for nearly a year and a half. Has your understanding of the NCI and its role in cancer research changed or evolved in this newest assignment?

Dr. Ned Sharpless: I think it has to be said that I was an NCI watcher my entire research career, and I thought I knew the National Cancer Institute and the National Institutes of Health pretty well-- as well as one can know these organizations from the external perspective. But since starting at the NCI, I've really learned that this amazing organization is much larger than even I realized, and that the scale and scope of the NCI is truly both awe-inspiring and, in some ways, daunting.

I had a series of meetings as I started as NCI director where I would learn about these sprawling comprehensive cancer prevention and control efforts or new areas of basic research or clinical trials. And I just really had had no idea that the NCI was involved in some of these activities. So it was very illuminating.

In some ways, it's thrilling, the things the NCI is doing. But I think it also made very clear to me another thing that I think I knew at some level, but didn't really appreciate the full scale of this until becoming NCI director, and that's the issue of-- although the NCI is huge and has this great reach and comprehensive nature, we are limited in scale. Our resources are finite, and the NCI, therefore, is really forced to make these difficult choices about which areas of cancer research to fund and how best to address our mission of reducing cancer suffering.

So I think I was surprised both by the scale and scope of the NCI, but also by the fact that, despite how big the NCI is, it still has significant limitations on what it's able to do and has to make these difficult choices.

Dr. Clifford A. Hudis: ASCO recently launched the "I lived to conquer cancer" awareness campaign that spotlights federally-funded cancer researchers and the patients who inspire them. I want to close out our conversation today by asking you, why do you live to conquer cancer?

Dr. Ned Sharpless: Yeah, I think like just about everybody in the United States, my life has been personally touched by cancer. I've had friends and family members get cancer, and my father even died from cancer. Both of my sisters are cancer survivors. So I think I have a real personal stake-- like everyone in the United States, almost-- in seeing the reduction of cancer suffering and conquering cancer, if you will.

I also find the problem fascinating from an academic point of view. I was drawn to cancer research because I found the biological questions of cancer research so fascinating. So I live to conquer cancer from this intellectual point of view, as well.

And lastly, I have the experience of being a doctor, of being a medical oncologist taking care of patients with cancer. And I've had the frustrating experience of having patients not do well who I thought, I wish we could have done more for-- as well as the experience of taking someone who has a pretty terrible cancer but yet driving it into remission with therapy and then watching that person effectively survive the disease and become cured of it over years. And that is so special and so thrilling to be a part of that as a physician.

So I live to cure cancer because it's personally touched my life, because I am a scientist who is fascinated by the biology of cancer, and as a doctor I've had the experience of helping people survive their cancer. And once you do that once, you just want to do that over and over again.

Dr. Clifford A. Hudis: That's really great, Ned. It's fascinating to hear why progress against cancer is personally so important to you. And I'm sure all of our listeners enjoy hearing that, as well. I want to thank you again for joining me for this ASCO in Action podcast and for all the work you do at the NCI and across the entire cancer care community.

Well, thank you for having me. As you know, one of NCI's most important partners in this effort against cancer is really ASCO. And so it's great to speak to you today. And thanks for all the things that you guys do for patients with cancer.

Again, thanks to all of you for listening today. Those of you who want to follow Dr. Sharpless on Twitter, he's @NCIDirector. And you can always follow me @CliffordHudis, as well as ASCO @cancer. If you do that, you can stay connected to our work, of course, on social media. You can also go to the NCI's website, which is NCI.gov. With that, again, I want to thank Dr. Sharpless for joining me today. And thanks to all of you for tuning in.

ASCO Chief Medical Officer Highlights Top Clinical Advances and Nine Research Priorities to Accelerate Progress in New Podcast Feb 12, 2019

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Welcome to this ASCO in Action podcast. This is ASCO's podcast series where we explore policy and practice issues that can impact oncologists, the entire cancer care delivery team, and those individuals we care for, people with cancer. My name is Clifford Hudis, and I'm the CEO of the American Society of Clinical Oncology.

I serve as the host of the ASCO in Action podcast series. And today, I am really pleased to have as my guest Dr. Richard Schilsky. He is ASCO's senior vice president. And chief medical officer, and Rich is here to talk about our new clinical cancer advances report, which was just released. In clinical cancer advances, ASCO identifies the most important clinical research advances of the past year across the full range of cancers, and from prevention to screening to treatment and survivorship.

The report also announces what ASCO has identified as our advance of the year. And for the first time in this year's report, we will debut what we believe are the research priorities with greatest potential to advance progress against cancer. Rich, welcome and thank you for joining me today.

Thanks, Cliff. Great to be back.

now let's start with what we always do. Every year, we announced the advance of the year, the one area of clinical cancer research that has demonstrated the most significant progress in a year's time. And we've seen tremendous progress in the treatment of rare cancers, earning it the 2019 advance of the year recognition. Rich, can you talk about why this area was chosen? Why is this particular line of research so important for individuals with cancer?

Well, first, let me start with a definition of what we mean by rare cancers. And generally, what we're talking about are cancers that are diagnosed with a frequency of less than six cases per 100,000 cancer diagnoses each year. Collectively, though, because there are many kinds of rare cancers, overall rare cancers comprise about 20% of all new cancer diagnoses every year.

But those numbers may not even tell the full story, because as we learn more and more about the molecular subtyping of cancer, what we're learning, of course, is that there are many very, very rare mutations and fusions and other genomic alterations that occur in a very small proportion of even common cancer diagnoses. So the patient with lung cancer, who has a RET fusion that occurs in about 1% of all lung cancer cases, that begins to become a very rare subset, even though it's overall a common disease. So we're going to be dealing more and more with this general area of rare cancers. But the reason that it's so important to single this area out, of course, is because historically, we haven't been able to learn very much about these rare cancers, simply because they are rare. There aren't very many of them that occur each year. Therefore, they're difficult to study. It's difficult to complete clinical trials. It's difficult to find patient samples to be able to understand the underlying biology of these diseases.

And yet, many of them are refractory to standard treatments. Many of them have a very aggressive clinical course. And for patients who are affected by one of these rare cancers, they desperately need new treatments. And this year, we're seeing, for the first time, some real progress being made in a number of these rare cancers. I'll give you some specific examples that we called out in the report. So for example, although thyroid cancer is a very common form of cancer, anaplastic thyroid cancer represents only about 2% of all thyroid cancers. And of those anaplastic thyroid cancers, about 16%-- so now we're talking 16% of 2% have a BRAF mutation. But it's clear now that treatment with BRAF directed therapy produces a very high response rate in this rare group of individuals who have BRAF mutant anaplastic thyroid cancer.

Another example, take the drug we're all familiar with, trastuzumab. We know now, of course, that trastuzumab is effective not only in breast cancer, but also in gastroesophageal adenocarcinoma that's HER2 amplified. And there's emerging data that HER2 directed therapy may be active in other tumor types, where the HER2 gene is amplified. And one of those is uterine serous carcinoma. So uterine serous carcinoma is a rare subtype of endometrial cancer. And about 20% or 30% of those patients have a HER2 amplified gene driving their tumor. And trastuzumab has been shown to be an effective therapy in those patients as well. Last example I'll give you right now. A tumor that most oncologists probably will never confront in their practice, tenosynovial giant cell tumor. This is a very rare soft tissue tumor that occurs in the joints, typically of young adults, typically is refractory to all standard known cancer treatments. And yet, this year, we saw very promising results reported for a new class of anticancer drug, a CSF 1 inhibitor, called pexidartinib, that produced a 40% objective response rate in patients with these advanced tumors, compared to a placebo treated control group.

So we're starting to make real progress in treating these rare cancers, particularly when we can begin to understand their underlying biology, and develop a therapy that's directed at the key drivers.

It sounds to me-- I mean, in listening to that wonderful list of successes, that we've rolled up a process and an approach to drug development and science into a category that is appropriately called rare cancers. Because when you think about the way you presented it, which I think is lovely, first, rare cancers, as a group, aren't rare is what you said. Two, rare cancers cross from the rare histologies to include some of the common histologies.

But the underlying theme, if I think about the way we present this, is a deeper understanding of the driver mutations, allowing us to move a little bit off of histology towards genomics to define these diseases. And that's not to say that genomics is the only way we're going to make progress. But the unifying theme in these cancers is probably that shared trait of an alteration and a driver mutation and an available drug. And that's the advance that's helping us with rare cancers. Is that a fair roll up of that?

I think that is very fair. And you can think about it in terms of a common histology, like lung adenocarcinoma, having a large number of rare genomic subtypes, each of which comprises a rare cancer, if you will. Alternatively, you could think about it as in the trastuzumab example, of saying, well, if you look at the universe of HER2 driven tumors, those HER2 driven tumors comprise a whole bunch of different histologies. But they all are responsive to HER2 directed therapy.

And so you know, as we understand the underlying biology of cancer much more clearly, it's moving us away from the long held view that the way you diagnose cancer is looking under the microscope. And if you see something that you see only very rarely, you say it's a rare cancer, to we're not going to interrogate the cancer if we see a rare genomic alteration that occurs infrequently in the population of cancer patients. That's what we're going to call a rare cancer.

Yeah, I just say think it's almost like an introduction or a preview of an interesting future where more and more of the cancers we treat may be selected on this basis, rather than their conventional light microscopy appearance, right?

To be sure. I mean, we know still that context is important. Not all of these molecular drivers behave in the same way in every tumor type. We already have examples where not all the targeted therapies work equally well against the same alteration, again, in every tumor type. But slowly, but surely, I think the science is moving us toward a day where we will be identifying cancers, primarily, if not exclusively, by their genomic profile.

It may not be a single driver. It may be a signature. But that is ultimately is what we use to direct therapy.

So to some degree, this is a fulfillment of a multi-year view that we've had about where to invest in cancer research, and the fruits, I think, are obvious. But this wasn't the only advance that we reported on last year. It's the one we named as the advance of the year. But what were some of the other advances that we called out for recognition?

So as in the last several years, where we named some aspect of immunotherapy as the advance of the year, this year we continue to see progress in immunotherapy of cancer, particularly with extending the range of indications for many of the immune checkpoint inhibitor drugs, as well as new indications for CAR T cell therapies. So that continues to be a rapidly emerging area where there's a lot of progress continuing to be made. We continue to make progress how with the introduction of second and third generation targeted therapies.

We've come to understand, of course, that many targeted therapies although they work well for a period of time, cancers ultimately develop resistance, patients need additional treatment options after the first line of targeted therapy. And of course, the science has responded by giving us the insight as to the mechanisms of resistance, which has led to the development of second and third generation inhibitors that can effectively overcome the treatment resistance.

We're seeing this particularly in lung cancer, particularly with drugs recently introduced like osimertinib, which is effective against the T790M mutation, the common resistance mutation in EGFR mutated non small cell lung cancer. And interestingly, some of these drugs are also now showing much greater effectiveness in treating or even preventing the onset of brain metastases in lung cancers that commonly spread to the brain.

So this has opened up actually a whole new area of research on effectively treating and preventing brain metastases in those tumor types, where there's a high propensity for such metastases to occur. The last thing I'll mention as another area of continuing progress is the continuing development of new biomarker strategies to help us refine the way in which we select patients to receive treatment. And certainly, this last year, the big news were the results of the so-called TLRX trial in breast cancer, a test, a gene expression profiling test, that clearly indicates that there is a substantial proportion of women with hormone receptor positive early stage breast cancer who can safely forego treatment with adjuvant chemotherapy with no detrimental effect.

And this type of test I think is now going to really move us even further down the road of precision medicine, because it's allowing us to identify those patients who are most likely to benefit from adjuvant chemotherapy. They should get treated, and they will certainly benefit. But it also is allowing us to identify those patients for whom adjuvant chemotherapy is unnecessary, and who can be spared both the physical toxicity and the financial toxicity of adjuvant treatment.

The more of those tests that we can develop, going forward, the better we'll be able to refine prognosis, the better we'll be able to apply adjuvant therapy in the future.

I think one of the subtleties here is this highlights something we almost touched on before, which is precision medicine doesn't have to be only about gene rearrangements. There are multiple paths towards some degree of precision in treatment selection for individual patients. And this is, I think, a good example of that. It also is a good example of the fact that precision medicine is not actually just about treatment selection. It's about risk assessment, risk stratification, assessment of prognosis, identifying early recurrence, as well as directing patients to the right therapy at the right time, based on the biological characteristics of their cancer. So one of the things that we've done this year, and it's a first for us, is to announce a set of research priorities. These represent areas that our leading volunteers and others have identified as needing urgent attention. They are areas where the progress is promising, but not fulfilled completely. Can you talk a little bit about the motivation for creating this kind of a research agenda, as well as a criteria for actually selecting the specific research priorities? So obviously, you know, our field is advancing very rapidly. But there are still very many unmet medical needs. There are many clinical conundrums that oncologists face every day in practice. And we felt that given all the potential directions that research could take, ASCO is in a strong position to be able to at least begin to describe those areas, where we thought the potential benefits in patient care would be greatest, and could be realized soonest. ASCO, because we are the physicians who treat patients with cancer, we have a pretty good sense as to what the unmet medical needs of our patients are, what the lack of evidence is that our doctors struggle with every day in making clinical decisions with patients, where the field needs to continue to grow and to develop new information, to help fill those evidence gaps.

So we felt that we could take a stab at setting a research agenda, and putting out there where we thought the unmet needs, where we thought the opportunities were ripe for investment in research, and trying to articulate how, if we were successful in fulfilling those research needs and priorities, the field would ultimately be transformed. So that's what we've done with the nine research priorities that we are offering this year.

So the nine priorities that's important for readers in a moment, if they go look at this or pick up our publication to recognize, they're not rank ordered. They just happen to be nine. Maybe next year, there'll be fewer or more. And the second thing is in no particular order, as I understand it, we've divided them into a couple or maybe three big buckets.

One is essentially the issue of who really benefits from IO, the advance that you already talked about, as a multi-year call out from us. The second is really a little bit about health care disparities and precision medicine all rolled up in the concept of special populations. And related to that is access to research itself.

And then the third is something which we always worry about, but have, I think struggled with as a field for decades, and that is reducing cancer risk, along with screening, which is surprisingly still controversial in many settings. We'll talk a little bit more about some of the specifics, but I would just remind everybody listening that you can find a list of these nine research priorities if you go to our website asco.org/cca.

So Rich, as you think about the nine areas that are rolled up in those three broad areas, can you talk a little bit about how specific research would potentially transform patient care? And you've set a relatively short timeline for results in introducing this. And what kind of resources might these projects need?

If you take the first area, for example, of essentially getting the right treatment to the right patient at the right time, you know, we've touched on some of these themes already. Look at the results so far with immune therapy for cancer. It's remarkable that a significant, although still small fraction of patients across multiple tumor types, who receive an immune checkpoint inhibitor, will have prolonged disease control, 20% or so of patients apparently surviving, without disease progression, or even disease free for many, many years in melanoma and diseases that previously were death sentences for patients.

The question is why is it only 20%, and who are they? Because these drugs are toxic. They're expensive. And what we'd like to be able to understand is, what are the characteristics of the tumor or of the host or of the treatment that makes the treatment so effective in a proportion of patients, so that we can then learn how to increase its effectiveness in those groups of individuals, where it has so far been less effective.

The same is true, as we touched on a moment ago, regarding adjuvant post-operative therapy. If you think about solid tumors, broadly speaking, roughly 50% of patients with a newly diagnosed solid tumor are cured by surgery alone. They don't need and can't benefit from adjuvant therapy. Of the remaining group, who are at higher risk of recurrence. Many of them will not benefit from whatever adjuvant therapy they might receive. So what we observe in most clinical trials of adjuvant therapies are relatively small absolute improvements in say disease free and overall survival for the entire population of patients treated. But of course, what that likely represents is a substantial benefit for a small proportion of that population. So what we are suggesting in this research priority is additional research, similar to what we saw presented this year with the TAILORx study, that allows us to understand the biology, the biomarkers, the testing that can be done to identify the patients most likely in need of and those who will most likely benefit from adjuvant therapy.

And then the third area within this general theme goes back to immunotherapy and the enormous promise of CAR T cells, which so far, has been realized almost exclusively in patients with hematological malignancies. So that's wonderful. And we want to extend that benefit as far as it will go.

But the question is, can those treatments be effective in solid tumors, which generally have a much more complex biology than many human hematological malignancies, and how do we develop CAR T cell therapies that can be effective in the solid tumor setting, that can be delivered to a solid tumor patient population, and ideally, and this may still be a bit of a pipe dream, can we develop CAR T cell therapies then that can be developed and administered off the shelf, so that they don't have to be custom made for each individual patient, which drives up the complexity and the cost of treatment. So those are the key elements of this initial theme.

And in a similar way, we would have similar, or we would have short term plans for the other areas that we haven't gone into detail here. And again, I would remind listeners that they can go through our whole list of ideas in terms of areas of focus at asco.org/cca. Right?

Absolutely. And when they do that, what they'll find are that we are calling for increased research in precision medicine and pediatric cancer. We're calling for increased research that's necessary to optimize the care of older adults with cancer. We're calling for research on how to ensure more equitable access to cancer clinical trials, so that all patients can benefit from those studies, and we can make progress more quickly.

And then finally, of course, we're very interested in learning more about how to reduce the long term consequences of cancer treatment. The pediatric oncologists have actually been quite successful at this, because first of all, they've been very successful at curing children. And now, they've been able to show that they can begin to pull back on certain components of therapy in a very thoughtful and well studied way, so as to not diminish the chance of cure, but to diminish the risk of long term side effects of treatment. We, of course, want to have more research done, addressing the challenge of obesity in this country and its link to cancer risk, cancer progression, and cancer treatment, and then finally, to identify strategies to better understand the biology of so-called pre-malignant lesions, so that we can understand which pre-malignant cancers are the ones that are destined, in fact, to become invasive cancer.

That latter touches on a theme we could talk about another day which is the building, the emerging drive to rename some of those cancers, as something less than cancer, because of their lack of at least acute life threatening potential, right?

We could talk about that another day, and we should. Yes. So one of the things that I think is always important to point out is we can do all of this work, but of course, we are part of society, and we're dependent upon various sources of funding and other resources in terms of public policy. We are dependent on government ultimately for support, as well as private support. And I think this clinical cancer advances report highlights that there are policies that would help us improve and accelerate clinical cancer research.

Some of them are obvious. We talk about them in other podcasts, increasing access to clinical trials, covering the routine quest of care for trial participants, and indeed, increasing overall federal funding, not in an unpredictable way, but in a steady way, that allows us to make multi-year plans across our community. Given all of that, what steps do you think ASCO members, specifically, could take to support us? And I would take it a step further. What should they be telling their representatives in Congress in terms of these policies? What should they be telling them in terms of supporting these critical areas of cancer research and how can they make an impact? It's clear that essentially all progress that we make in developing new treatments for cancer ultimately gets linked back to federally funded support for basic science research. All of the insights that we've developed in terms of what causes cancer, how it progresses, which are the high risk populations, so much of that information comes from data sets and other basic laboratory studies, funded by the NIH or the National Cancer Institute.

Of course, the NCI has in place a robust national clinical trials network publicly funded that supports clinical trials that would never be done by a commercial sponsor. In fact, three of the rare cancer studies that I mentioned earlier during this podcast were done with support from federal funding.

Those studies, because they are rare cancer, small populations are not studying tumors that represent a large market for a new pharmaceutical product. They're not going to be done by a commercial sponsor. We need federal support. And we need our members to point out these kinds of examples when they go to talk to their representatives in Congress. And I would urge our members to not only go to talk to your representative, but to bring a patient with you.

The patient tells a story far better than we can. And having the patient at your side and having the patient tell their own story about how they benefited from federally funded research is very powerful. In order to reach your member of Congress, ASCO's trying to make that as easy as possible, and you can do that by going to ASCO's Act network at asco.org/actnetwork. That's great. I mean, we've covered a lot of exciting progress, I think, this year. And readers who take the time can dive far more deeply into this discussion with our publication. But what would you say is the main takeaway, the thematic takeaway that you hope people will get from this year's clinical cancer advances report? To me, I think what we continue to see this year, and we have seen in recent years is that the more deeply we understand cancer biology, the more that will quickly lead us to new therapeutic approaches that will be far more effective, and hopefully, less toxic, and maybe most importantly, more enduring than the common therapies that we've had available to us in the past.

Our field is clearly moving to a day when immunotherapy will be central to cancer care, when every patient will have their cancer genotype well understood, and where therapy decisions will be informed by that deeper understanding of each patient's biology. So you almost did this, but I'm going to push you a little more. In the same way that we're now calling for what should be done next in terms of research, if you could actually look into the future, what areas of progress against cancer would you expect or maybe hope to see, just 12 months from now, when we do this report again? I hope that one of the things we'll see is rapid progress in developing, not necessarily novel biomarkers as unique tests, but novel biomarkers signatures. I think it's becoming increasingly clear that in order to select patients optimally to receive immunotherapy, and even to select patients to receive certain precision medicines, that a single biomarker is not necessarily the optimal selection strategy.

For immunotherapy, we may need to see a signature that represents some characteristics of the tumor, some characteristics of the patient, maybe even some characteristics of that patient's microbiome in order to figure out who is most likely to be susceptible to which immunotherapy approach, and the same is going to be true, I think, for even the now common precision medicine approaches with small molecules. We're trying to understand how molecular pathways and networks work inside the cell can suggest to us not which single targeted therapy to use, but which combination of targeted therapies to use for each individual person.

This kind of work is on the horizon. It's complicated, involves lots of complex algorithms. But my hope is that this will move us to a future where we can take the results of a test on a patient's tumor and integrate information of various sorts and come out with a more precise estimate of what's likely to be the best treatment for that person. And you think that we could see some of those results even as soon as just 12 months from now, or is this a longer term hope? I think we will begin to see some of these types of approaches appearing at an ASCO meeting in 2020.

Well, that's really exciting. I think it's really both uplifting, and I think challenging to hear where we are, because of course, as is always true in science, every answer begets many more questions. And in our world, every bit of progress identifies new challenges. And I think that's what's summed up in a lot of what's in this report now, right?

Absolutely. But you know, I think for the first time, you know, ASCO is trying to articulate where we see the greatest opportunity. And we hope to be able to do this each year in the coming years. As you said earlier, it may not always be nine research priorities. Some of that might even be repeated year to year, because we won't solve every one of these in a year from now.

But we will modify these. We will improve upon them, and they will change as the science advances, as the questions evolve, and as the opportunities continue to develop.

Well, rich I want to thank you for joining me today for this ASCO in Action podcast. I'll remind everybody, we have a mission at ASCO to conquer cancer through research, education, and promotion of the highest quality cancer care. And this clinical cancer advances report really does help us meet that mission, by increasing awareness of the progress we're making, but also, as you point out, identifying the critical importance of the entire community's engagement in research and high quality care. That is pointing out just how important all that is in terms of delivering on the promise of all of our progress.

I encourage listeners, again, to read the full report by visiting asco.org/cca. And until next time, I thank everyone for listening to this ASCO in Action podcast.

Exclusive Interview: FDA Commissioner Talks Drug Pricing, Expanded Access, and Tobacco Jan 29, 2019

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"Welcome to this ASCO In Action podcast. This is ASCO's monthly podcast series where we explore policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we take care of, people with cancer. My name is Clifford Hudis, and I am the CEO of ASCO as well as the host of the ASCO In Action podcast series. For today's podcast, I am delighted to have as my guest Dr. Scott Gottlieb, the commissioner of the United States Food and Drug Administration.

The FDA of course plays a critical role in the delivery of high quality cancer care by reviewing and approving cancer treatments. This continues to generate discussions about the pace of scientific advances, and indeed the regulatory role of the FDA. Given that, we are really lucky to be able to talk today with Dr. Gottlieb about the FDA's efforts to increase overall efficiency by updating or modernizing aspects of our clinical trials conduct and expediting the end to end drug development process.

I will admit that I'm going to take advantage of this opportunity to also ask how his agency is tackling the issue of tobacco control for the next generation of tobacco products, another area of deep concern from our community and others. Dr. Gottlieb, welcome and thank you for joining me today.

Thanks for having me here.

Great. Now as a professional society, we are very focused on the intersection of science and society. Given that, and noting that you've been at the FDA for more than a year following a long career in public service and in private industry, I have to start by asking, for you, has your current experience changed or evolved your view of the FDA's role or functions, and if so, how.

I've been at the agency three previous times. I had a good sense of what the agency's public health mandate was and what its mission was. I think that the nature of the market and the science that we're grappling with has certainly forced or compelled the agency's mandate to evolve. I think what we're seeing right now is, I feel like we're at the inflection point with respect to a lot of new opportunities from technology.

We look at things like gene therapy and cell-based regenerative medicine. Those fields largely didn't exist last time I was at the agency, and now we're an inflection point where we're going to see gene therapies approved to the market, and we saw three CAR-T's approved already, that are going to fundamentally transform the treatment of disease.

When I was last here, we were talking about the ability to advance genomically derived drugs and have more targeted approach to the treatment of patients where you can get the right drug to the right patient at the right time with sort of a drug diagnostic system, yet seeing some early examples of that. But now that is a much more routine development pathway.

With respect even to tobacco, you mentioned tobacco at the beginning, we're at a point right now where we have the opportunity to use new technology potentially to help currently addicted adult smokers transition away from combustible tobacco products onto products that we presume don't have all the same risks associated with them.

And so using new authorities we have to regulate tobacco, including regulate nicotine levels in combustible cigarettes to render them minimally and not addictive, and allowing for a regulatory pathway that puts some of the new technologies like e-cigarettes through an appropriate series of regulatory gates, we have the opportunity to transition adult smokers off of combustible tobacco with all their morbidity and mortality associated with combustible tobacco use more rapidly than we did in the past.

And so across the board, I think we're seeing technological inflection points. Digital health tools are another example that are not only creating significant new opportunities, but I think compelling the agency to rethink its traditional approach to regulation in order to accommodate the opportunities that these new technology platforms create.

So is it fair to sum all that up as, the agency is recognizing that technology in many domains is defining and driving the need for new regulatory frameworks, and in turn, we have to educate Congress and others to make sure that the agency actually has the appropriate authorities. Is that the virtuous cycle you're describing, you think?

I think that's exactly right. I think that there are areas of profound technological change where the traditional approach to regulation doesn't apply well. Digital health tools, probably a very obvious example where you can have sort of practical incentives, where you have a digital health tool, you might evolve it almost on a daily if not weekly basis in the marketplace. It's a medical product that's a digital health tool, like a medical lab, for example.

And a regulatory process that requires you to come in and file for premarket approval every time you want to make a modification or have to file a 510(k) supplement, that is antithetical to the rapid cycle of innovation and evolution that those kinds of products undergo.

So we had to think of a new regulatory paradigm for how we would treat these products, and that's where we move towards the Pre-Cert model, where effectively what we're doing is validating the underlying architecture of the platform, of the software platform, and validating the SOPs, how good is the company at certifying its own software and validating its own software products, and then we would allow them after an initial approval to come to market with modifications as well as subsequent approvals without having to seek premarket clearance from the FDA every time.

And we would shift toward the postmarket regulatory regime for subsequent products. So basically, instead of regulating the individual products, in essence we're regulating the firm and taking a firm based approach. That's an example of where we've had to rethink our regulatory model in order to accommodate a much different approach to innovation.

Another example is with cell-based regenerative medicine, where we have very clearly said that we think that there's a lot of opportunity with cell-based regenerative medicine, but we also see a lot of clinics promulgating products based on what we think is incomplete if not poor science and creating substantial risk of patients using cell-based products intrathecally, or for injections into the eye, where they're creating substantial risk and don't have really a scientific basis to argue that there's convincing evidence of a benefit.

And these products are clearly subject to FDA regulation. They cross the line between what is and isn't regulated by FDA, but subject to enforcement discretion of the agency over many, many years. Prior to when I came in here, the agency didn't actively regulate these products. We have said very clearly, we're going to actively step in to regulate this field. In fact, it's going to take a number of enforcement actions, and we'll be taking others. At the same time, we also recognize that a lot of these technologies are being promulgated by small developers, and there's a lot of promise here. And so we've had to again come up with a more accommodative approach. But how do we regulate a field where a lot of the really interesting innovations are being brought forward, for example, by academic investigators working in small clinics. And so what we've said in that case is that we'll allow investigators to pool their data so long as they follow common manufacturing protocols that are doing similar things with cells. And it can file a common BLA, common Biologics License Application. And then we'll give individual licenses to the individual institutions or individual investigators. That's a much different approach to regulation than what we've traditionally done where you think of, we regulate companies, we regulate a biotech or a pharmaceutical company. We had to ask ourselves, how do we regulate small clinics or even institutions, academic investigators in institutions, who want to promulgate these technologies. And we've come up with an approach to do that.

So at the same time that we've said we're going to be taking more enforcement action to make sure patients aren't being put under duress, we're also going to take a more accommodative approach to allow for regulatory approval for products that are being, in many cases, promulgated by smaller entities and individuals.

So that actually lets us pivot, I think, to an area of traditional focus for at least a large group of our members at ASCO. And that would be drug development. And it's clear that you've made it a priority to streamline how new drugs specifically are reviewed and approved. And I think as part of that effort, recently you announced a new office. It's the office of Drug Evaluation Science. And my understanding is the goal is to centralize performance metrics like biomarkers, patient reported outcomes. How do you see this new office specifically helping to support this goal of a more standardized and ultimately more efficient and faster review process?

Well, the Office of Drug Development Science, the goal there is to create an infrastructure here that will help better validate scientific tools that are being used to help advance drug development, like patient reported outcomes, like bioinformatics. What we've seen is that these tools now, there's a lot of hard science behind these tools. And they've become much more commonly used in drug development programs.

And so we need an infrastructure here that not only provides for a more standardized approach to assessing these modalities when they're incorporated into applications, but also helping to advance the science of how to use these tools. I compare it to what happened in 2003 with modeling and simulation. And I was here during the time period.

What we were seeing over that time period was we were seeing more drug developers starting to use modeling and simulation as a component of their overall drug development programs. And we saw modeling being included in applications. Early on, it was often used for dose finding because you wanted to give the dose finding trials. But then you wanted to use the data that you derived from the dose finding trials to simulate what would happen if you picked a dose in between the two doses that you might have tested. And so we said to ourselves, well, this is very interesting. This could really help inform drug review better, give us more information about safety and benefit. We need some standard approach to how we're going to both evaluate these tools as well as help develop them into a harder science so it could be more rigorously used in drug development.

We created a Modeling and Simulation Office when I was here. Mark McClellan was involved in doing it. He helped recruit the guy who stood it up, him and Janet Woodcock. It was Larry Lesko. And it started as a two-man office.

Now, we've got probably 30 or 40 people in the Modeling and Simulation Group in Cedar. And well more than 95% of all applications that we get for new drugs contain a component of modeling and simulation. It's now a routine part of drug development. And we have a rigorous approach to evaluating these components of the applications as well as helping to evolve the field through multiple guidance documents that we've put out. I see the Drug Science Office, this new office that we created within the Office of New Drugs, working in a similar way where it's going to be a holding office, if you will, for new areas of science that can help improve tools used to inform us about the risks and benefits of new products.

So I want to pivot from that to one of the big societal issues. And you and I have been discussing this informally, I think, for more than a year-- drug price. The Trump administration has made it a priority to address the cost of drugs, price specifically. And I guess the question from many will be how confident can we be that ultimately a faster and more effective drug development process will itself actually and favorably impact the costs of drugs. What's your feeling about that, knowing everything that you're doing that's supportive in that way?

Well, I see my role in the drug price debate to be focused around creating product competition. You have price competition. But you can't price competition without product variety and product competition. And we're focused on creating the product competition by facilitating entry into the market of generic drugs, but also, facilitating a pathway that allows for follow on innovation within categories.

And what we've seen-- and we've analyzed this. We're going to be publishing this data soon. But what we've seen over time is that second to market innovation within a category is coming to market much more slowly. We looked at a cohort of approvals from the early 2000s. And then we looked at a more recent cohort of approvals over like a five-year period. And it's very clear that when you look at areas of unmet medical needs, orphan drugs, first in class drugs and oncologies, the second to market innovation is taking much longer to come to market and more categories of drugs are remaining sole source drugs in perpetuity. So to the extent that you're not getting that second to market innovation for new drugs, that is thwarting the opportunity for price competition within those categories. Because you do see price reductions. Oftentimes those price reductions come in the form of rebates that aren't transparent to the consumer. But there are price reductions or discounting nonetheless when you have a second and third to market drug within a category.

And the hepatitis C category was the best example of that. We saw a very dramatic price reductions in negotiations once you had multiple entrants in that category. So we're focused on that. And we're asking questions about why it's become harder to bring second to market innovation to patients. And I think that there are some very specific reasons and there's things we can do to help address that, to make it less costly to bring second to market innovation in an area of unmet medical need.

If the trials are onerous or very costly to bring that second to market drug to the market, sometimes the economic opportunity might not be robust enough after this one entrant, especially when you're talking about very narrow niche categories of unmet medical need, they're might not be enough economic opportunity to incentivize that second to market innovation.

I think where-- just to sort of close, I think where this might be most evident is in some of these inherited diseases. You've seen this play out in gene therapy, for example, where once you come to market with a treatment and you treat the prevalent population, the people who already have the disease, the incidence population, the number of people who are going to get it on an annualized basis, that might not be a big enough market to support a second entrant that's going to split the market with the first in class product. And so I am quite literally seeing investors pull out of these opportunities which we see what we think are applications being slowed down. We see people pull out if they think they're going to be third to market. And that's ultimately bad for patients. Because it's not just robbing patients of product competition, but it's also robbing them of potential product variety. And we know not every patient responds to a treatment the same way. So you want differentiation in the market.

And also if there's a horse race between being first, second, third to market and the third to market pulls out because they don't think they're going to be first or second, sometimes the first or second doesn't pan out. And then you're stuck with nothing. So this is not a healthy development. And if there's things we can do to make the development process more efficient to create more entrants, that's something we're focused on.

So that's great. You raised at least two issues that I want to pursue a little further. Let's start with the first one, which is technology based. Recently you announced specific plans to keep pace with the influx of applications for selling gene therapies. And you've referred to that already in your comments.

But you've raised concerns specifically around, I think, if I understand it, reimbursement environment for CAR-T therapies and a fear that that reimbursement challenge may, in fact, stifle innovation that's needed. Is there more to say about that? Or is that pretty much the issue right there?

Well, I think that that's one of the issues. I think the issue, obviously, is-- and many people who are in this space are acutely aware of this-- is that there's different pay structures on the inpatient and the outpatient side to the extent that some of these products are being labeled for use in inpatient only. The reimbursement on the inpatient side is much lower and more difficult than reimbursement on the outpatient side right now. So that's an unusual situation and something that's artificial. I mean, a drug shouldn't be reimbursed diametrically differently just because it's delivered in one setting versus another and the reason why you're pushing it into an inpatient setting is for safety considerations. And so I think it's something we need to address. We can't allow that sort of artificial differentiation to persist.

There's a lot of late stage CAR-T development. But we're not seeing a lot of early stage CAR-T development. And if you talk to people in the field, they'll say, well, it's because CAR-T hasn't demonstrated its ability to really potentially be effective in solid tumors. And a lot of the liquid tumor opportunities are already being pursued. I'm not sure that's true. I think that there is a reluctance. At least part of it is a reluctance to make significant investments right now because the reimbursement environment is so uncertain for these products. So that ultimately needs to be resolved by others, including CMS. But I think that there are things we can do as well here at FDA.

So for example, we say that a product should be labeled for inpatient use because we believe that with certain risks associated with the delivery of some of these products-- and you're very familiar with those risks and so are all your listeners-- require the ability to deliver intensive care or significant medical services if a patient does have a reaction on an infusion of this product. But that doesn't necessarily mean that you need to be in an inpatient facility. What it means is you need to have within a reasonable period of time-- and you can define that period of time-- access to significant supportive care. I know institutions where the inpatient infusion center is further away from the medical intensive care unit than the outpatient infusion center. So that makes no sense. Why would you say it has to be in an inpatient setting when the inpatient setting actually is further away from the kinds of medical resources that we want accessible to the patient?

So really what we should be considering is defining and labeling the kinds of services that need to be available within a certain period of time, and not necessarily inpatient or outpatient. Because there are a lot of outpatient infusion centers that are adjacent to academic institutions where you can have a significant amount of supportive care delivered very quickly. And the patient is very accessible to a medical intensive care unit if they do have an adverse reaction. So we're rethinking that, how we label these products. But that's a-- it might solve the proximate challenge. But ultimately, I think you need a fundamental solution to the pay structure so there's not an artificial divide between the inpatient and the outpatient with respect to these products.

So just in the interest of time, I want to make sure we cover the monetization of clinical trials because that's the other issue, I think, rightly raised. And you've for a while made this a priority, I know. And I'll just jump ahead and say, and I think if I remember correctly, your agency the FDA issued two draft guidance documents on innovative trial design within the last year. The first focused on master protocols. And the second on specific advice in terms of design and conduct for adaptive trial designs. That's a compressing approach in terms of the phases of traditional studies. Can you talk a little bit about why this is important and what kind of savings you think this could actually deliver as a practical matter?

I think it's important because, first of all, I think a lot of the drugs that are being put into development can't be developed efficiently with the traditional approaches to drug development. So for example, you think of a drug where it's targeting molecular change that's apparent in multiple disease states. This is most obvious in cancer where you have tissue agnostic approvals where you might want to do a basket trial where you test a drug in multiple tumor types where what's driving the tumor is the same genetic alteration, molecular change.

And you want to be able demonstrate that it works across multiple tumor types, especially with rare tumors where you might not-- if you said, well, you have to prove it first in lung cancer and then you go on and prove it in liver cancer. But it might be such a rare genetic change that you're not going to be able to efficiently enroll just in lung cancer and liver cancer. So you want to pool the data across multiple tumor types to demonstrate statistically significant evidence of benefit.

I think because more drugs are being designed that way, we have to rethink how we allow sponsors to conduct clinical trials, structured clinical trials. And so things like basket trials and master protocols and tissue agnostic approvals become very important in this paradigm.

It also can allow for a lot more efficiency. A master protocol can allow you to test multiple drugs within the context of the same trial. If you have a situation where you're looking at targeting a rare disease or a rare subpopulation of a disease, where it's hard to recruit people, if you have a master protocol set up, you can test multiple drugs in the same population much more efficiently. So as we develop drugs that are targeting smaller and smaller populations and delivering, in many cases, outsized benefit and demonstrating earlier evidence of benefit, we need to rethink how we structure trials to take advantage of those opportunities. I think one of the-- we approved a record number of novel drugs this year by a long margin, 59 approvals. The second best year, which was last year, in modern times, I think was 46. We approved 19 new NDA and BLA products focused on cancer and had 38 supplements this year.

If I was to point to one thing that's driving that innovation, it's the fact that more of the drugs, many more of the drugs that are being put into development now not only have a very plausible biologic rationale for why they're going to deliver benefits, but they're so well targeted, so the underlying disease state is so well understood, that we're seeing much more significant benefit much earlier in drug development in much more compelling disease situations. And so, proof of concept is established very early. And you can establish statistically significant evidence of benefit in a very small series. And that's accelerating these products through development. And more of these cases are situations where you're targeting such significant unmet medical needs that even if there is uncertainty around the full scope of the safety profile, the outsized benefit in that clinical setting overwhelms any of that uncertainty. And so you can move these products through development much more efficiently. That's the nature of the science that we're seeing right now. And I think it's going to be the way we see the field move forward, at least for the foreseeable future.

You know, one of the issues that this raises is the issue of targeting and niche subpopulations which you've referred to. We've tried to deal with this within ASCO by launching TAPUR, which takes next gen sequencing, by and large, and matches patients who are theoretically scientifically appropriate for off label use with drugs that are in the market but where the indication doesn't include their histology. And I know your agency is familiar with it.

But that, in turn, generates prospective evidence. The vast majority of patients, as you know, in the United States simply don't have the opportunity for various reasons to participate in clinical research. And that has raised questions about the utility of so-called real world evidence and real world data.

You know that the FDA has been working closely with ASCO, especially with our big data project CancerLinQ, so that your agency has access to our growing big data repository. And that in turn, we all hope, will inform certain aspects of regulatory review, I guess mostly in the area of label extensions.

So your agency recently released a framework providing detail on how the FDA is going to develop guidance for real world data in drug regulation. And we're especially excited by this. We're invested in this, in a sense. And we look forward to working on it as it rolls out.

How do you see this framework being implemented specifically? How is it going to benefit patients?

I think it's going to address one of the things you said right up at the top, which is patients don't have access to clinical trials. I think as we make more rigorous use of real world evidence in the development process and in the regulatory review process, that's hopefully going to open up the opportunity for data collection and clinical trials to move out into the community.

Real world evidence isn't just evidence collected after the fact. You can have real world evidence collected in randomized settings. You can have real world evidence collected in prospective settings where you have large, simple registries and other kinds of constructs. And so, as we're able to make more rigorous use of these kinds of data constructs, I think it's going to push clinical data collection further out into the community so more patients are going to be able to access experimental protocols where the evidence is being generated that's going to help inform regulatory review, either in the pre- or post-market setting.

And we're clearly making widespread use of real world evidence in post market setting, particularly for confirmatory studies post approval. And you're seeing situations where it's also informing decisions on the premarket side as well.

So I guess, since we're talking about access, one has to at least address the question of very ill patients and access to investigational drugs outside of the clinical trial system, what's been called expanded access. And this has been a topic of great discussion and debate for the last couple of years. Can you talk about some of the specific changes that the agency is making and how you see this helping patients and physicians navigate the new expanded access program?

Well, the one that we announced recently is that we're going to create a service here at FDA where we're going to staff it. Initially it's going to be sort of a pilot. And we'll focus it on oncology where we'll help patients navigate the expanded access process soup to nuts where effectively they will be able-- if someone identifies an expanded access protocol that they want to get entry into with their physician, their physician is going to be able to call FDA. And FDA is going to help guide them through the process, soup to nuts. FDA will have people who will make the outreach to the sponsor and do the interface with the patient and provider to make sure the documentation is done in a timely fashion.

This is also going to have the advantage of allowing us to be on the phone with the drug sponsor to understand why drug sponsors might not give access in certain settings. And so what we find is, in some cases, we're willing, we approve the ability for a patient to get access to a product, but the drug sponsor might turn it down. And so this is going to allow us to collect more information about why it might be turned down.

It's also going to allow us to identify situations where there might be a lot of requests of one drug company so that we can intervene to help encourage the development of a true expanded access protocol. If there's a lot of compassionate use requests, for example, of a single sponsor or a single drug, those are situations we might pick up the phone and say, hey, we're approving or we're getting requests for a lot of compassionate use. Why don't you think of starting an expanded access protocol? We can work with you on that.

So I think that having FDA be an interface there is not only going to make it more efficient for the patient and provider to access the system, but hopefully will also allow us to interface better with sponsors to sort of create the conditions where drugs can be made more widely available under appropriate conditions. And just for clarity, I assume that there is a 800 number or web URL for that. Is that right?

Well, we stand it up. It's still in process. So it's something that we're going to do soon. But yeah, this will be widely disseminated to folks.

Great. So the last thing I want to talk about, which brings us in some ways back to our roots, is tobacco. And I said at the top of this that we would touch on this. This is an area where our field saw slow but ultimately critical progress starting in the 1960s. And all of this feels like it might be jeopardized by a recent and alarming uptick in tobacco use in children, essentially kids and young adults. And this is just setting off, as I say, alarm bells across our field. I think there's data from the FDA and the CDC that in 2018, 3.6 million students were e-cigarette users. And this was compared to just 1.5 million about a year earlier.

Now there's still not a lot of research on Electronic Nicotine Delivery Systems or so-called ENDS. But there is at least some reason to believe that they might increase the likelihood of nonsmokers or former smokers converting to combustible tobacco with their known risks.

So last year, I know that the agency announced the Youth Tobacco Prevention Plan to address this alarming trend. And it'd be great if you could talk a little bit about the plan and what you intend to do and update it, as I know you've been talking at least on social media about this issue in particular.

Well, we think that the non-combustible products like e-cigarettes provide a potential opportunity for currently addicted adult smokers to transition off of combustible tobacco onto modified risk products. These products, the e-cigarettes, need to be put through an appropriate series of regulatory gates. But I've said many times, if we can transition every adult smoker off of cigarettes, traditional cigarettes, onto e-cigarettes, that's going to provide a significant public health advantage, public health opportunity.

The e-cigarettes are certainly not risk free. Those risks need to be properly defined through a regulatory process. But there is an opportunity there. And what we announced early on last summer of 2017 was that we are seeking to-- and we've advanced the rulemaking to do this. We're seeking to regulate nicotine levels in combustible cigarettes to render them minimally and not addictive so they can no longer sustain addiction.

At the same time, we allow the e-cigarettes to remain on the market while we put them through an appropriate series of regulatory gates with the notion being that if regular cigarettes no longer have nicotine, smokers would more rapidly migrate off of traditional cigarettes, hopefully off of nicotine altogether. But if not off of nicotine, onto either medicinal nicotine products, the safest form of nicotine delivery. Or if they want inhaled forms of nicotine delivery, onto e-cigarettes.

Again, recognizing that e-cigarettes aren't risk free. But on a risk continuum, nicotine exists on a risk continuum, they are lower risk than combustible tobacco. But what I said all along was that that opportunity and that policy framework couldn't come at the expense of addicting a whole generation of young kids onto nicotine through these same products. And that's, in fact, what we're seeing. We are seeing an epidemic growth. And this is what we spoke to last fall in the use of e-cigarettes by children with fully a 78% rise among high school aged kids in e-cigarettes in over one year, from 2017 to 2018. And really no indication that it's going to abate very quickly in the coming year.

So what we set out to do was implement a series of regulatory steps to try to address the access and appeal that these products have to kids. So we are putting in place significantly heightened age verification requirements for the purchase of products in convenience stores. We're particularly targeting the flavored products because we think the flavored products are a primary vehicle by which these products are appealing to children. At the same time, we launched a series of public education campaigns that we think are very effective to try to educate youth about the risks of e-cigarettes. But I'll say in conclusion that if these actions don't have a very immediate effect on these trends-- and you're not going to reverse these trends overnight. These trends are underway. This has become sort of a fashionable item among kids. You're not going to just reverse that overnight.

But if we don't see this growth leveling off and starting to reverse, I think that this is an existential threat for the entire e-cigarette industry. You know, I find myself stuck in conversations where I'm debating with them the merits of selling cherry flavored e-cigarettes at convenience stores or gas stations where it's readily accessible to a kid. And I think what they really should be contemplating is, boy, if these trends go up another year, my entire product's going to be taken off the market.

Because that is the cold, hard reality. We are going to-- whether it's FDA acting to change its enforcement policy or it's Congress stepping in, if you see another year of 50%, 60% growth in e-cigarette use among minors and you see fully 45% of American kids using some form of tobacco products and you see combustible smoking rates trying to go back up again, that's going to be a public health catastrophe. Nobody is going to have patience to tolerate that for another second. And there is going to be dramatic steps taken.

And so I think that the industry ought to wake up to that fact. We've certainly woken up to that fact and recognized it. And it would be a shame. It would be a shame because the e-cigarettes do represent an opportunity for currently addicted adult smokers in a properly regulated market. We don't want to foreclose that opportunity entirely. And we don't want to impede adults unnecessarily from getting access to these products.

But we are not-- collectively, we haven't done all we can and all we should to address the youth use. You're going to see us take more steps going into this year. We have more enforcement activity underway. But the manufacturers also need to stop fighting some of these steps. And they need to start addressing this more seriously. And, you know, it's one big manufacturer in particular that's driving a lot of the youth initiation on these products.

Well, it's great to hear the vigor that is being brought to bear on this. And I know that in our community there's tremendous support for threading this needle just right, as you describe. So thank you for that.

I want to just take a moment now and say, in general, to Dr. Gottlieb, thanks for joining me today for this ASCO In Action podcast. We are really grateful at ASCO for the strong collaboration that exists between us, the entire oncology community, and the FDA. And we look forward to continuing our work together to make sure that patients with cancer have access to safe and ever more effective treatments.

As a reminder to listeners, you can follow Dr. Gottlieb on Twitter @sgottliebfda. That's one word. You can follow me, a little less exciting I think, @cliffordhudis. And you can follow ASCO @asco. To stay connected with the latest updates on the FDA's work, visit fda.gov.

And as always, we will continue to provide here updates on relevant FDA activities at asco.org/ascoaction. Until next time, thanks again to Dr. Gottlieb and thanks to all of you for listening to this ASCO In Action podcast.

ASCO Podcast Coming Soon: Exclusive Interview with FDA Commissioner Scott Gottlieb Jan 25, 2019

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Don’t Miss: Exclusive interview with FDA Commissioner Dr. Scott Gottlieb by ASCO CEO Dr. Clifford A. Hudis on the next ASCO in Action Podcast, coming January 29.

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience and conclusions. The mention of any product, service, organization, activity or therapy should not be construed as an ASCO endorsement.

This is Cliff Hudis, CEO of the American Society of Clinical Oncology and host of the ASCO in Action podcast series. For our next podcast I will be speaking with Dr. Scott Gottlieb, Commissioner of the United States Food and Drug Administration. The FDA plays a critical role in delivery of high-quality cancer care by reviewing and approving new cancer treatments. This discussion is sure to be very interesting. It’s going to highlight what the FDA is doing to modernize clinical trials and expedite drug development, and with all of that I urge you to tune in for upcoming information about this special AiA podcast with Dr. Scott Gottlieb.

What You Need to Know About the Final 2019 Medicare Physician Fee Schedule and Quality Payment Program Rule Jan 08, 2019

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Welcome to this ASCO in Action podcast. This is ASCO's podcast series where we explore policy and practice issues that have an impact on oncologists, the entire cancer care delivery team, and most importantly, the individuals we care for-- people with cancer. My name is Clifford Hudis, and I'm the CEO of ASCO, as well as the host of the ASCO in Action podcast series.

For today's podcast, I'm going to give our listeners a quick update on an important announcement from the Centers for Medicare and Medicaid Services. In an August podcast, I outlined the proposed Medicare Physician Fee Schedule and the Quality Payment Program Rule for 2019. This is commonly referred to as the Physician Fee Schedule. Today, I'm going to provide an update on where we are with this for next year. I have to say in passing, it's probably a good day for me not to have a guest, because I'm here with a terrible cold.

So what is the 2019 Medicare Physician Fee Schedule? This is a fee schedule which consists of a complete listing of all of the fees that Medicare uses to pay doctors or other providers and suppliers. It's a comprehensive listing of the maximum fees. And it's updated each year and then used to provide reimbursement to physicians and other providers working on a fee-for-service basis.

Now at ASCO, we, every year, review this rule very closely. And we try to determine and predict the impact that it will have on our members, and of course, on our patients. There are three provisions in particular that we want to highlight today. The first of these is related to care provided in calendar year 2019. And CMS estimates that there will be, overall, a 1% reimbursement cut for hematology and oncology, as well as radiation oncology specialties. It is important to note, however, that the actual impact on any individual physician or physician practice will depend on their mix of services-- that is, what it is they exactly provide and bill.

Now the administration has publicly stated its aim to reduce the growing administrative burden that we've all been noting and complaining about for the last few years. And the second item we want to point out is there is some evidence of their sensitivity to this issue in the 2019 fee schedule. They intend to reduce the documentation required for evaluation and management services, frequently referred to as E/M.

What CMS did is finalize provisions that consolidate E/M payments. And ASCO had expressed concerns about this previously, which the agency acknowledged, along with other stakeholders, by revising the proposal. And, if fully implemented, they believe that the impact will be delayed-- that is, it will not impact providers until 2021.

But by that time, CMS plans to consolidate what has historically been Levels 2, 3, and 4 into a single billing level, and then to pay for Level 5 E/M services separately. So overall, this represents a simplification. And it fulfills one of their stated aims, again, of reducing some of the administrative burden that practitioners face.

Finally, the third area that I want to highlight is a new rule starting in 2019 that refers to the amount of reimbursement you will receive for new Medicare Part B drugs. Currently, those drugs in Part B are reimbursed at wholesale acquisition cost plus 6%. They will, going forward, be reimbursed at wholesale acquisition cost plus 3%. It's critically important to emphasize that this relates only to those new drugs that are introduced into the supply chain this year.

This new provision will also apply to drugs that have not yet reported an average sales price. But the point is it will not apply to drugs that have already been in use. So it only applies to new drugs, meaning that its reach is going to be relatively limited. However, what you can imagine going forward with each new year and new drugs being introduced is that the percentage over wholesale acquisition cost will translate into more and more absolute dollars. And therefore, this may be a growing concern for practices.

I want to switch our attention and talk about the Quality Payment Program, or QPP. In the final rule, there is an update to QPP for 2019. The final 2019 payment adjustment for Merit-based Incentive Payment System, or MIPS, practices and providers will become plus or minus 7%. And it will have adjustments to maintain budget neutrality, as well as to reward exceptional performance.

Other noteworthy changes will include an increase in the MIPS performance threshold from 15 points, which is where we were in 2018, up to 30 points for 2019. CMS also finalized two new optional opioid-related measures that MIPS providers can use to report on under the Promoting Interoperability category. These measures will give providers an opportunity to earn bonus points and therefore potentially boost their overall MIPS score.

These are the two measures specifically. One allows for checking a prescription drug monitoring program, or PDMP, prior to submitting an electronic opioid prescription for any individual patient. And the second is an attempt to verify an existing opioid treatment agreement with the patient receiving the prescription.

So I hope that this summary of the updates to the Physician Fee Schedule for 2019 is helpful to our listeners. Ultimately, our goal is to make sure that oncologists can provide the right treatment to the right patient at the right time. And we aim to help CMS implement policies that will advance that goal. ASCO will continue to work closely with the administration to ensure that CMS understands the needs of the oncology community and the full impact that the rule is likely to have.

I would encourage you, if you need more information on the Medicare Physician Reimbursement Plan for 2019, to visit ASCO in Action's website. That's at ASCO.org/ASCOaction. And ASCOaction is written as one word. We have a link to the final rule there. And we also have a helpful, I think, webinar that explains the final rule schedule and QPP rule in greater detail. So hoping this is helpful. Until next time, I want to thank you all for listening to this ASCO in Action podcast and hope you don't catch my cold.

How Can Financial Barriers to Patient Participation in Clinical Trials Be Addressed? Dec 04, 2018

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Welcome to this ASCO in Action Podcast. This is ASCO's monthly podcast series where we explore policy and practice issues that impact on oncologists, the entire cancer care delivery team, and the individuals we care for, people with cancer. My name is Clifford Hudis, and I'm the CEO of ASCO, as well as the host of the ASCO in Action Podcast series.

For today's podcast, I'm really delighted to have Dr. Beverly Moy joining us. Dr. Moy is a medical oncologist at the Massachusetts General Hospital who specializes in breast cancer care. She's also an Associate Professor of Medicine at the Harvard Medical School and a longstanding and dedicated ASCO volunteer. She led the ASCO roundtable on addressing financial barriers to clinical trials, and she was one of the authors ASCO's policy statement providing recommendations to address this important issue. So our conversation today will focus on the existing financial barriers to patient participation in clinical trials and how policymakers, trial sponsors, institutional review boards, and other stakeholders can help remove and overcome those barriers Dr. Moy, welcome and thank you for joining me today.

I'm so glad to be here.

By way of background for our audience, only a small percentage of patients with cancer ever participate in clinical research. And yet, we know that certain groups, especially people from low socioeconomic status are underrepresented even in those trials. To give a little bit of shape to that, no more than 3% or 4% of adults with solid tumors participate in research studies. And even then, that number over-represents certain higher socioeconomic groups and underrepresents others. Can you tell us why this issue is important to be addressed, and, furthermore, how we might improve the diversity of clinical trial participation?

So I think it's incredibly important that to improve clinical trial participation among underserved groups. When I think about how we can provide the highest quality cancer care, we really can deliver three basic things-- the best possible standard cancer therapy, the best possible supportive and palliative care, and the best possible novel or experimental therapy. So we know that clinical trials are crucial to the advancement in cancer care. And in the current genomic era, sometimes these trials may even represent the best possible treatment option for some of our patients with cancer. We also know from the medical literature that patients who participate in clinical trials tend to do better and sometimes even live longer.

So when access to the best possible experimental therapy is threatened, optimal cancer care becomes impossible due to financial barriers. And this is an example of social injustice, where poor or underserved patients are being deprived of quality cancer care. So I think that improving the diversity of clinical trial participants is also critically important.

When we determine a new treatment's effectiveness, the cancer clinical trial participants really should reflect the general population of patients with cancer. So as you already said, just a small percentage-- no more than 5%-- of all adult cancer patients in the United States participate in clinical trials, most of whom are white and are from a higher socioeconomic class. That means that the results of our clinical trials are less generalizable, and we need to do better.

So I think that's a longstanding issue, and I know that many listeners are appreciative the efforts to address it. But it raises a question about the underlying reason for this. And one of them, I think, is financial, that is financial barriers to participation, financial barriers to care, and what is now called financial toxicity. As an aside, we recently conducted a national cancer opinion survey-- we do this every year-- and one of the striking observations this year was that 57% of Americans say that if they received a cancer diagnosis, they would be most concerned about financial impact or paying for treatment. And that was compared to 54% who said they'd be most concerned about dying or suffering from the diagnosis. I think it's a remarkable statement that at least a large proportion of people think first and most profoundly about the financial implications of a cancer diagnosis as think about the health consequences.

So if we think about that and then turn back to the clinical trial situation, it is, I think, true that most clinical trial participants will have to face even more additional costs that may prevent them from participating in trials. Can you provide us with an overview of what some of those additional costs are that participants face when they consider a clinical research setting?

So Cliff, I think you're absolutely right and. You know, you're talking about the general financial burden that any cancer patient faces is incredibly high. And I actually would reference listeners to listen to your podcast that you did after the ASCO Quality Symposium, where you actually talked about a few studies looking at really the high rates of financial burden that patients just generally diagnosed with cancer faces.

When you add the complexity of participating in a clinical trial, not only do you have that general financial burden that a cancer patient has, but you add additional potential financial costs that become prohibitive for our poor and underserved patients. So I think of these additional costs related to clinical trials falling into really two basic categories. One is gaps in insurance coverage, and then the second is medical out-of-pocket costs.

So picking the gaps in insurance coverage policies category, we know the Affordable Care Act was passed in 2010, and it does require coverage of routine health care costs for patients participating in clinical trials. But these protections do not extend to patients with Medicare or Medicaid. It's only for patients with private insurers, and there are even restrictions there, which we can go into later. That means our poorer or older patients are more vulnerable to not having these protections.

These potential costs could consist of things like investigational care costs, such as this specific therapeutic drug under investigation, or more likely the cost of additional services that would not have been required if the patient was receiving standard therapy. These services could be things like extra blood draws for safety data or imaging studies that fall outside of the routine staging exams. So these extra services have the danger of either being billed to the patient or forcing the patient to pay more towards their insurance premium due to policies that increase cost sharing to patients in the modern era.

A second important cost category, which is just as important, if not more important, would consist of non-medical out-of-pocket costs resulting from clinical trial participation. So these costs include travel and lodging expenses, or costs due to lost wages because they have clinical trial visits, or the need to pay child care because they have to come into the hospital or the cancer center more often. So patients participating in clinical trials often have far more frequent visits than standard therapy, perhaps at centers that are farther away from their home. If they participate in early phase first in human trials, they could require longer days of things like pharmacokinetic testing that might even require overnight stays in hotels. So these out-of-pocket costs can be considerable, and prohibitive, and make it impossible for poorer patients to enroll into clinical trials. I know that-- and I'm sure many of our listeners know that-- you're actually a day-to-day clinician. You see breast cancer patients, as well as do research at MGH. And I'm interested in the practical ways that you might have seen these costs directly affect your patients. Do patients ask about trial costs when you're talking to studies with them, talking about studies with them? Have you ever had patients hear about a study and then declined to enroll because they thought it would be too expensive? So I think that's a really interesting question, Cliff. And I think, in the past, when we've presented clinical trials to patients, the idea of costs never really came up maybe because it was something that patients didn't feel comfortable bringing up to their physicians. But now, either costs are becoming more considerable, or it's being raised into awareness that I think that patients are much more comfortable talking about it, maybe not at first, but maybe towards the end of the process.

So in my own practice, I've seen people bringing it up more, and more, and more, usually even during the consenting procedure when you're talking about all the extra visits and studies that the patient may need to have to undergo the clinical trial. I've also seen patients who've actually enrolled in trials, and they're on study, and they consider even coming off trial because they didn't anticipate some of the costs that might happen.

So, for example, recently, I treated a young woman with high risk breast cancer on an adjuvant CDK4/6 inhibitor trial. And this trial requires more frequent medical visits and blood testing because of potential toxicities. And she found that the extra co-pays and financial costs toward her insurance deductible were completely prohibitive. And despite conversations, she actually prematurely dropped out of the trial after only about nine months of therapy. And this is a single mother of two young kids. That's really not acceptable that a financial reason was the reason why she couldn't continue on the trial.

So I think patients are asking more and more for financial guarantees even before signing consent for clinical trial screening, and I'm afraid we really can't provide financial guarantees because that's really not possible for us to do.

So one of the reasons that we bring together volunteer groups like you've participated in and then publish results at ASCO is not merely to identify, name, and describe the problem, but in fact to offer solutions or at least potential solutions. So I want to turn and talk a little bit about the recommendations that you've made in the policy statement and through your work.

The most recent policy statement on financial barriers to clinical trial participation focused, as I understand, on three key objectives. One was transparency in terms of clinical trial costs and these gaps in coverage that you've been describing. The second is reducing concerns about inducement, that is making sure that whatever we do does itself in an unreasonable way lead to the perception or reality of induction onto the trial. And finally, improving data in the course of participation in trials. That is studying this scientifically like we do other aspects of care.

So let's start with the first objective, transparency. What are some of the ways that lack of transparency has affected participation in trials? And how can clinical trial sponsors, or sites, or investigators help us address the issue of transparency?

So I think that transparency is a very, very critical issue here. And one of the potential problems is that lack of transparency about who is responsible for the specific costs of clinical trial participation can lead to uncertainty from the patient's part about what he or she might be responsible for paying in the end. So often, insurance payers and research sponsors, whether it be industry or other, they might disagree about who is responsible for which costs. They might argue about what really constitute truly safety assessments, what's really routine costs, so generally the research sponsor covers the costs of additional or more frequent services that the insurance payer may disagree about what services are truly additional or more frequent. You know, what is really standard?

So if a health plan denies coverage for the entire trial or individual services within a trial the sponsor considers routine, this could be problematic. So without transparency or protections the patients run the risk of being billed directly for these services. So these costs need to be addressed specifically so that the financial burden doesn't land on the patients in the end.

One of the reasons for the costs being a barrier, of course, is that clinical research is often very expensive, and at least some of the recommendations focused on clinical trial design is a way to reduce costs. What changes do you think sponsors might make to clinical trials that could directly bring down the costs for patients? And I would add, especially with regard to those traditionally facing greater barriers, the populations we're talking about today.

So clinical trial design is really important because we have to be very cognizant that what this means to the patient and how we're burdening them. So clinical trials really need to be more aware of the financial implications of their study design. So, for example, excessive follow up medical visits, or additional laboratory draws, throwing on more imaging studies, or other procedures that are not absolutely critical to the study really ought to be eliminated because these costs add up. And if they're not critical, they really shouldn't be done. There are costs associated with every test or visit performed. So we really need to reduce the excessiveness of what's required of patients on clinical trials.

So in addition to that-- and I mentioned this earlier-- one of the concerns on the other side is about what happens ethically if we pay patients directly to defray these out of pocket costs? This is referred to as an inducement. And around clinical trials, there's really a high degree of, I think, appropriate concern for inducing patients on to studies. What are some of the concerns? Do you think that they're well-founded or overblown? Is there anything that we can do to remove or address those concerns while defraying the course of participation?

So I could talk about the ethics about this issue all day long, but I'll try not to. But I think the theoretical concern that I've heard often is that financial compensation or reimbursement of clinical trial expenses could represent a form of inducement or coercion to enter into a clinical trial. And this probably stems from FDA and OHRP regulations that clinical trialists should minimize the possibility of coercion or undue influence on patients. There may also be a potential hurdle from CMS that the Social Security Act specifies criminal and civil penalties for offering financial remuneration to a Medicare or Medicaid beneficiary that influences the selection of their medical provider.

So I'm not a lawyer, but I think these concerns are fairly ludicrous because first, coercion, as a principle, is completely irrelevant here. From an ethical perspective, coercion involves a threat that makes a certain choice irresistible, and that is not relevant in the case of cancer clinical trials. Undue inducement is also irrelevant because we have multiple examples in the medical literature that large payments do not disproportionately affect patients' willingness to do medical tasks, for example even donating a kidney.

There was actually even a recent article published in JAMA Oncology, written by some bioethicists from UPenn, that argues that the worry that offering inducements to participate in research is inherently wrong. The authors even go so far as to discuss paying patients for cancer clinical trial participation to make participation more attractive to a wider population of patients. And that's really important for both social justice and trial completion issues. So the idea of paying patients for trial participation was something that was brought up even by the patient advocates who participated at our ASCO roundtable on this subject. The patients thought, if we're doing this to advance science, shouldn't we be paid for it? So to remove these concerns, ASCO's partner in our roundtable, the Lazarex Cancer Foundation who helps fund our roundtable, they worked with the state of California to sign into law identifying trial-related expenses to be reimbursed and are currently working with several other states to do the same, such as Pennsylvania and even my home state of Massachusetts, and Texas, Florida, Ohio. But I do believe that we need federal regulations to remove the specter of inducements and coercion out of this field because it simply doesn't belong. So I guess that's my long-winded way of saying that ethical concerns about paying patients for out-of-pocket costs associated with trial participation are completely overblown. I see.

Sorry if I went on for a while, but I feel pretty strongly about that. I was going to say, do you have an opinion on the matter? But one of the other areas called out in the paper relates to the economic burden on trial participants versus non-trial recipients and says that this economic burden data is more than 20 years old, that is it's not modern. And so it recommends that organizations should, therefore, pivot and support the building of an evidence base, research, on the true costs of patient participation trials now in the current era. So what exactly is the kind of data that we need and, how would better data, in turn, allow us to reduce barriers to participation? So I think that, like all research and data issues associated with cancer equity in general, we need more data about effective interventions that reduce the financial and economic burden of clinical trial participation. We also need data in the modern health care era about how burdened our clinical trial participants really are. This data is starting to come in from various single centers across the United States, but we really need a concerted, comprehensive, and collaborative effort to examine this important issue nationwide. But mainly, I do think we need research about interventions that work to help our poor underserved patients enroll into cancer clinical trials.

So with all of this said, what do you think ASCO's next steps on this issue should be? What do you propose? Or what does your group recommend that we do in a concrete way next?

So I think, first, I want to say that historically I've been extremely proud to have worked with ASCO because ASCO's really been a leader in improving access to care for all patients with cancer. And given ASCO's leadership in the oncology community, ASCO's really in the unique position of being able to convene this roundtable that led to this policy statement. And there are multiple stakeholders at this roundtable, including researchers, clinicians, industry, insurance payers, the NCI, FDA, Biden, Moonshot, ethicists, patient advocates, you name it. And ASCO, as a leading clinical cancer society, really can push this issue forward based on its leadership here.

I think ASCO ought to demand change through federal regulatory policy fixes, and disseminate, and possibly even fund relevant research that we just described earlier today. I think what we're doing today with this podcast is that we're increasing awareness of this issue, which is also something that ASCO is doing, and no one can do better. I would want listeners to become really more aware of this issue.

The most underserved patients the United States are being deprived of one of the most important types of cancer treatment options. This is a social injustice that absolutely needs to be corrected, and we need the oncology community to be united in solving this problem.

And that's a really great summary of, I think, the motive and the ethical drive underneath our work in this. Is there anything else you'd like listeners to know about the ASCO recommendations? Are there any parts of this that we've skipped over or failed to mention? No, I think that the recommendations are kind of a multi-pronged group of recommendations to try to attack this problem, and it's really a first strike in this really important issue. But I think that what our listeners really should understand is that no patients should be denied access to a clinical trial for financial reasons. And no patients should be harmed financially because of their contributions to the advancement of science. So if we're united in this belief, then we really can move forward together.

Well, I love the way you've wrapped that up. And I want to thank Dr. Moy for joining me today for this ASCO in Action Podcast. I want to remind everybody that at ASCO, as you've heard, we are committed to preserving and enhancing access to high-quality cancer care for all individuals with cancer. Our statement on financial barriers to clinical trial participation is just one of many, where ASCO's voice and the collective voice of our members, we hope is helping to share and shape the future of the cancer care delivery system.

I encourage our listeners to read this statement, as well as our other policy and position statements. They're all available on the policy and advocacy pages of our website at asco.org and, in this case, through the JCO. Until next time. I want to thank everyone for listening to this ASCO in Action Podcast and thank Dr. Moy for joining us today.

ASCO CEO Discusses Striking Findings from National Cancer Opinion Survey Nov 13, 2018

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Hello, and welcome to this edition of ASCO in Action. This is ASCO's podcast series where we explore policy and practice issues that are important to oncologists, the entire cancer care delivery team and, most importantly, the patients we care for, people with cancer. My name is Clifford Hudis, and I serve as the CEO of ASCO and the host of the ASCO in Action podcast series.

For today's podcast, I do not have a guest. Instead, I am personally going to share key findings from ASCO's 2018 National Cancer Opinion Survey. We conduct this survey yearly, and we always hope to find interesting information that can help us as we talk to patients, policymakers, and all of the stakeholders in cancer care. This year was no different. Perhaps, the most striking and concerning finding for us this year was this.

Nearly 4 in 10 Americans believe that cancer can be cured solely through alternative therapies. Over the next few moments, I'm going to explore this observation in a bit more detail and then consider some other notable findings from this year's survey. Thanks for listening in. Now, by way of background, ASCO just recently released the results of our second annual National Cancer Opinion Survey.

We conducted the survey in collaboration with the Harris Poll to help us better understand the views held by the US public regarding cancer research and cancer care. One reason that ASCO established this annual survey was our view that by tracking the American public's perceptions of cancer, over time we might be able to better identify opportunities to add useful information and insights that could positively influence public policy.

Therefore, the survey is designed to collect high quality objective data that can be used to understand what the public does and does not know about cancer. We then use this research to help guide ASCO's educational policy and advocacy efforts. This year's survey was conducted online for a one month period. This was between July and August of 2018. Nearly 5,000 US adults over the age of 18 responded to our survey.

This included about 1,000 individuals who currently have cancer or have had cancer in the past. And, as I noted, it always amazes us that we find interesting tidbits in these kinds of surveys, and this year was no exception. I'm going to highlight three areas in particular. These include the role of alternative therapies, access to pain management, and the continued financial burden of care. ASCO's core values, as many of you will know, include evidence, care, and impact. Given that, we start with evidence, and one of the most surprising findings for us is that nearly 4 in 10 Americans believe that cancer can be cured solely through alternative therapies. And I note that given that research has shown that the sole use of alternative therapies for cancer is actually associated with a much higher mortality rate when compared against patients treated with standard evidence based approaches.

Now for clarity, I want to point out that when we say alternative medicines, what we mean specifically are interventions like acupuncture, diet, so-called enzyme therapy, massage, medical marijuana, meditation, vitamins, herbs, and other supplements. All of that and more, perhaps, in this context, we're referring to them as the sole therapy for cancer, not as complementary treatments where they have arguably different roles and different impact. It's this potential reliance on them as the sole therapy for cancer that is so concerning. Now even with direct experience with cancer, respondents don't report a very different perspective. For example, even among those who have had cancer, either themselves or have been close caregivers as a family member, for example, a sizable proportion expressed the belief that cancer can be cured solely through alternative medicine.

Younger people, those age 18 to 37, and, to a slightly lesser extent, those aged 38 to 53, are most likely to believe that cancer can be cured through alternative therapies. Clearly, given this, we have a great opportunity in front of us to help our patients, families, legislators, and everyone understand the real limits and the reality of scientifically valid evidence based treatments. And we have an obligation, given the association with improved overall outcomes, to highlight this.

We cannot ignore this widespread belief. Now I want to turn to another issue that's been getting a lot of attention these days, the opioid crisis, and explore what Americans are thinking about the use of opioids for pain management in cancer care. Our survey found that nearly 75% of Americans do not agree that there should be limits on access to opioids for people with cancer. Specifically, most Americans believe that cancer patients should not have their access to opioids limited at all.

Yet the survey shows that accessing opioids right now for cancer pain is difficult for many patients. From the small survey sample that we had of patients with direct experience, 40% of those with cancer who had used opioids within the past year to manage pain or other symptoms reported trouble accessing them. If opioids are an important part of maintaining quality of life and palliating cancer symptoms, then this obviously is an active and real problem. Highlighting the importance of providing optimal palliative care, we also learned that most Americans support alternative methods of managing pain. And, again, I want to emphasize, in this case we're talking about alternative therapies as complements not as the sole approach. 83% of respondents supported the use of medical marijuana among people with cancer, for example. Here again, however, there is an issue with access.

In a small sample of patients who have reported using medical marijuana within the past 12 months, nearly half, 48%, reported difficulty obtaining it. For those patients with cancer or who have had cancer, who are interested in using medical marijuana, almost 60% of them wish that there was more information available about its benefits for symptom relief. This is clearly a research opportunity for our community. We believe these views are likely to be heard both federally and at the level of state houses. And we think, therefore, it's important for you, our listeners, to be aware of this widespread point of view. Finally, I want to turn to one of the biggest and longest standing issues, as well as fastest growing issues in health care in general in cancer care specifically, and that is finance. We find that the financial burden is a specific worry for Americans confronting cancer. On a percentage basis, our survey respondents said they are just as worried about the financial impact of cancer as they are of dying of cancer. Now this doesn't mean that the depth or level of an individuals anxiety is the same, but it does mean that it's on the minds as about as many people. Probing this a little more, if faced with a cancer diagnosis, 57% of Americans say they would be most concerned about the financial impact on their families or about paying for treatment.

And that compares to 54% who said they'd be most concerned about dying or about suffering with pain. So I think this just highlights how central worries about financial toxicity and cost of care have become. Among people who have had cancer, or who have survived it, more than 40% say that they've had barriers. They've experienced barriers accessing care because of health insurance, with deductibles and co-pays specifically being their biggest hurdles.

And what's interesting, as well, is that patients bear a significant burden here, but so too do family caregivers. In fact, among caregivers responsible for paying for cancer care, 3/4 say that they are concerned about affording it. More than half of caregivers say that they or another relative have had to take some kind of an extreme step to help pay for their loved one's care. Examples include working extra hours, postponing their retirement, or taking on an additional job, even, in some cases, selling family heirlooms. Clearly these findings are in line with other research that has shown that financial toxicity is a growing and very real concern for people with cancer and for their families. And, again, we think it's important for our listeners to be aware of these issues since our sense is that some of these don't necessarily come up, at least not overtly, during routine clinical encounters. The bottom line is, more of our patients are suffering degrees of financial distress than we may recognize during our busy clinical days, and we need to be both aware of this and help take steps to address it. So with that, I want to thank you for listening in today. As the world's leading organization for oncology care professionals, ASCO believes that it is critical to understand what the public, including individuals with cancer, think of, expect, and need from the nation's cancer care delivery system.

As I mentioned earlier, this year's findings will help inform ASCO's future educational, policy, and advocacy efforts. And we need all of our members to help, as well. Keeping informed is one critical first step, of course. Looking ahead, please know that ASCO's National Cancer Opinion Survey is scheduled to be conducted again next year. And this will give us one more opportunity to drill down even deeper into findings from this year and explore other emerging issues while tracking potential changes in the focus and concerns of the general public we serve.

If you would like more information about the survey, please visit ASCO's website at asco.org and search for National Cancer Opinion Survey. Until next time, thanks again for listening to this ASCO in Action podcast.

ASCO CEO Discusses New Studies on Patient Financial Toxicity and Opioid Use Risks Oct 23, 2018

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Welcome to this ASCO In Action podcast. This is ASCO's podcast series where we explore policy and practice issues that may impact oncologists, the entire cancer care delivery team, and the quality of care they provide. But most importantly, of course, the patients we care for. My name is Clifford Hudis. And I'm the CEO of ASCO and the host of this ASCO In Action podcast series. For today's podcast, I'm going to share with you some highlights from the research that was featured at this year's recent Quality Care Symposium.

So ASCO is the host and sponsor of the Quality Care Symposium, an annual meeting that brings together oncology leaders, and all of the members of the cancer care team, to share strategies and methods for improving the measurement and the implementation of quality and safety activities in oncology. The recently held 2018 symposium presented a wide range of scientific abstracts, focused on initiatives that aim to improve the quality of care for patients with cancer, and, also, new research in this field.

Today, I want to highlight five of these abstracts from the Quality Care Symposium. These are abstracts that deal with issues I know are of particular concern to ASCO members, financial toxicity for the one and opioid use for the other.

Now, turning first to financial toxicity. As everybody knows, oncologists see the impact of high treatment costs on our patients, many of whom are not taking all of their prescribed medication because of cost. They are drawing down their savings, when they have savings. And they're often not paying their other household bills or taking other drastic measures because the cancer treatment that they have to receive has become so expensive. This distress is now broadly defined as financial toxicity.

Three different studies were presented at the Quality Care Symposium that put a spotlight on this issue. In the first study, by Wheeler, et al, we saw results of a national survey of more than 1,000 patients with metastatic breast cancer drawn from 41 states. What we saw here, was that in these individuals, especially those who are uninsured, there really was significant financial distress. A full third of these patients were uninsured and more often they reported refusing or delaying treatment because of the cost of care. They also reported that they were contacted by collection agencies because of unpaid bills, again, for their cancer care.

The study also found that insured respondents were not immune to financial toxicity. Those with health insurance reported having higher cost-related emotional distress, being stressed, themselves, because they weren't sure about the cost of their treatment, as well as spending a lot of time-- as well as having, I'm sorry, a lot of financial stress placed on their families because of cancer.

The second research study by Arastu, et al, related to the cost of care. And this showed that nearly one in five older patients-- and these patients were defined as age 70 and above-- who had advanced cancer, were experiencing financial difficulties, again, due to the costs of their treatment. They noted that these difficulties negatively affected their care, their quality of life, and mental health. In this study, patients experiencing financial toxicity had a prior higher

prevalence of severe anxiety and depression, poor measured quality of life, than patients who did not report financial hardship.

And finally, there was a third study by Greenup, et al, in which 600 women with a history of breast cancer were surveyed. The majority of them said that they would prefer to discuss the cost of care before beginning treatment, but few of them recalled having such conversations about treatment costs with their cancer care teams. In this survey, fully 79% of these women said that they preferred to have a full understanding of the costs of care prior to starting, but 78% of them said they never actually discussed costs with their cancer care team.

The findings of these three studies, I think, are important. They're a reminder that financial toxicity is real, that it represents a particularly harsh reality for many of our patients, and that we, as oncologists, are expected to initiate and guide conversations about the cost of care with our patients, although it doesn't happen very much yet.

A very good starting point for this seems to be to direct our patients to resources and help our patients prepare for these discussions. So ASCO offers an array of these materials on its patient information website. You can look that up at cancer.net.

Now, the other big area of focus, and, again, one that's been covered in the late news extensively in the last years, is, of course, the opioid crisis. At the Quality Care Symposium there were several aspects of the opioid issue that were addressed. I'll point out in background that although there's evidence clearly available that shows that patients with cancer may be at lower risk for abusing opioids than the general population, we also are aware of the fact that opioids are a controlled substance and they can be addictive. And patients with cancer are not immune to addiction either.

So understanding the size of the problem within the arena of cancer care, and then learning what the best practices are to help control the use of opioids to the most appropriate usages, especially after surgery, are very important matters for us. There were two studies presented during the symposium that provide some important insights on both of these matters.

The first by Chino, et al, was a retrospective study conducted over a 10-year period that comprehensively explored the risks associated with opioid use among cancer patients and compared that to the general population. They analyzed death certificates. And they found that deaths attributed to opioids, in cancer patients, were about 10 times less than in the general population. Although the incidence of opioid deaths had increased significantly in the general population, that increase, again, attributed to the opioids among patients with cancer was much, much smaller. Deaths from opioid use were highest in patients with lung, GI, head and neck, hematologic and GU cancers.

The second study by Stevenson, et al, looked at how oncology care team members could use a two-prong approach to achieve a reduction in opioid use-- in this case, it was 46%-- among cancer patients who underwent a variety of urologic surgical procedures. And they accomplished this without increasing pain or anxiety.

The first part of their strategy involved developing new processes for post-operative pain control that focused on non-opioid medications and therapies. These were interventions provided first line as pain management. Patients could still be prescribed opioids, but when they got these prescriptions, they were at lower doses and dose escalation was only performed if necessary.

The second prong of their two-pronged attack involved post-operative conversations with patients. Talking to them. Rather than having nurses routinely ask patients whether they wanted any pain medication or not-- and this was often a direct reference to opioid medications, specifically-- the nurses, instead, discussed current non-opioid medications that the patients were receiving for pain, along with their frequency and dosage, asked whether these medications were sufficient and discussed their potential side effects, along with the side effects of opioids. The opioids were never withheld, but they were no longer the reflexive standard, thanks in part to this two-pronged approach.

Now, from an ASCO point of view, we are really supportive of efforts to address opioid misuse and abuse. And we counsel our members to discuss the benefits and the risks of opioids with their patients. And then, of course, to prescribe pain treatment for patients responsibly and especially paying attention to those patients who have risk of addiction. At the same time, we keep our primary concern on adequate pain control for cancer patients. This has been a long-term issue for us. And it's an important one. So taking all this into account, we are working continuously with policymakers to ensure that both federal and state initiatives that are implemented do not impede cancer patients access to essential pain medication.

Now in closing, I want to say, again, thanks to all of you for spending some time with me today to learn about ASCO's Quality Care Symposium. The meeting provides a great forum for the entire cancer care delivery team to learn about evidence-based strategies and methods for evaluating and reporting on patient outcomes, provider efficiency, and quality and safety in cancer care. And the abstracts that we've highlighted today point that out nicely, I think.

In the end, all of this is about evaluating which approaches work best and how to continuously improve them so that we can do our best to ensure that every individual patient with cancer continues to receive the highest quality care that's possible. If you would like more information on the research that was presented at this year's Quality Care Symposium, please come to our website, abstracts.asco.org. And until next time, thanks again for listening to this ASCO In Action podcast.

Are Pharmacy Benefit Managers Putting Personal Profits Ahead of Patient Access? Oct 09, 2018

Welcome to this ASCO in Action Podcast. This is ASCO's monthly podcast series where we explore policy and practice issues that impact oncologists, the entire cancer care delivery, and, most importantly, the individuals we care for-- people with cancer. My name is Cliff Hudis and I'm the CEO of ASCO, as well as the host of the ASCO in Action Podcast series.

For today's podcast, I am delighted to welcome Dr. Ray Page who's chair of ASCO's clinical practice committee as our guest today. Ray was recently awarded the prestigious ASCO Advocate of the Year Award for his exceptional efforts to shape health care policies to have a direct impact on our ability to provide high-quality cancer care for our patients. Our conversation today is going to focus on one of those policy-related issues that Ray has spent so much time on, and it's an area of growing concern to all oncology practices, that is, the emergence of pharmacy benefit managers in the cancer care delivery system.

Now some of you will know that ASCO recently released a position statement on pharmacy benefit managers, or PBMs, as they're known, specifically focusing on their impact on cancer care. And as a little bit of background on this, in terms of policy work, ASCO has a formal process for vetting and adopting the society's policy priorities. Typically, we will develop and release a position or policy statement when we learn about an issue or a development that is impacting, or may, in the future, have an impact, on the delivery of and access to cancer care.

We determined that a position statement was necessary on PBMs because serious concerns were being raised by our members through our state affiliate council, our clinical practice committee, and in direct conversation with other ASCO leaders. So as we often do, we analyze the issue carefully. We gather evidence, such as is available.

We describe the issue. And, then, most importantly, we identified steps that could be taken to at least begin to address the challenges. The result was the ASCO position statement on "Pharmacy Benefit Managers and Their Impact on Cancer Care." So with that as background, I want to turn and welcome Dr. Page. And thank you for joining me today to discuss this important topic. Welcome.

Thank you, Cliff, for having me here today.

Great. So I want to start off with a level set, Ray. Some who may be listening today may not be familiar with PBMs, what and who they are, or what purpose they serve. Can you give a general overview of pharmacy benefit managers? How do they work?

Sure, Cliff. In its simplest form, a pharmacy benefit manager, or PBM, is a middleman company that was originally utilized by payers as a third-party manager of prescription drug claims. Why did these companies ever come into being in the first place? Well, this largely developed out of the Medicare Modernization Act of 2003 and when the Medicare Part D program for oral drugs was implemented in 2006.

Cliff, I believe that they had good original intent, as their primary objective was the simplification of the transactions between pharmacies and health plan sponsors. However, over time, they have evolved to where they now include a variety of new business functions in an effort to better manage drug benefits and reduce the overall drug spending cost for plan sponsors. They claim that they're controllers of cost but, in reality, they have created huge and extremely complex business relationships to where they now have put personal profits before patients.

So how extensive is the PBM system? And has it increased in the last few years? And if so, why?

Yeah. Today, PBMs are ubiquitous. They were involved in the transaction of several hundred billion dollars of drugs across the United States. PBMs control the pharmacy benefits of over 253 million Americans. What is concerning is after numerous acquisitions and consolidations, and this is often called horizontal integration, there are now only three behemoth companies that control 85% of the prescription drug benefit transactions in this country.

These three companies are familiar to all of us. They are CVS Health, Express Scripts, and OptumRx. So one may ask, what's wrong with those guys? They're all reputable pharmacies that are managing and distributing drugs. Well, they've grown to be far more. CVS, for example, started out as a drugstore.

But now they are a PBM, specialty pharmacy, a mail-order pharmacy, an insurer, a benefit plan sponsor, and now they have medical clinics and own doctors. So part of the perversity that arises is when PBMs vertically integrate with the sponsors, the insurers, the pharmacies, and clinics all into one big package to now they have complete control of the patients and the flow of all their prescriptions.

Then may make transactional relationships between these entities and the drug manufacturers, distributors, and providers to where they generate enormous profits off the management of these drugs, yet none of these profits are ever passed on to the patients. Practicing oncologists and ASCO have concerns that some of these utilization management policies can have an adverse impact on our nation's most vulnerable patients, which are our cancer patients.

Well, last year, ASCO released a policy statement on utilization management strategies. And these are payer-imposed practices that may, in some cases, restrict access to, or deny coverage for, selected treatments. The major concern, at that time, was that certain payer practices, such as prior authorization, step therapy, specialty tiers, and restricted formularies, all of these could hinder access to high-quality cancer care.

The question we have, I think, with regard to PBMs is whether we share these same concerns when we turn to PBMs. And if that's so, can you explain some of the practices that PBMs might

use and what that might mean to the cancer patient, specifically with regard to access to most appropriate therapies?

Yeah, Cliff. There's several concerns that I have with the PBMs managing drugs that could adversely impact our cancer patients. And let me just describe a few. As cancer doctors, we always want to give what we think is the best personalized drug for that individual patient for the right diagnosis at the right time. I may prescribe a cancer drug that is not on a preferred formulary of the PBM because, perhaps, they have negotiated a better price with another manufacturer that gives them more profit.

So they recommend replacement with another drug. This is called a step edit. And, oftentimes, your preferred drug cannot be prescribed until there is a fail-first policy with an alternative drug. So for such things as nausea and vomiting control with highly emetogenic chemotherapy, I would prefer to have no vomiting with a preferred drug rather than dealing with nausea with a fail-first inferior drug.

Second, we have PBMs that want to deliver storage sensitive toxins, chemotherapy drugs, and injections to the patient's doorstep and then have them brown bag these drugs to our office for administration, although we have no record of the pedigree and the accountability of those dangerous drugs.

Third, we now have PBMs refusing to give such things as IVIg infusions in our office. And for some of our patients, they have to go to the street corner CVS box and get their IVIg at the CVS infusion center. Yet I am accountable for the outcomes of that patient.

Lastly, and worst, we're seeing cost shifting onto the patients. Based on their packaging and dispensing methods, the patients often have to pay multiple huge co-pays because of partial fills of oral chemotherapy drugs.

So if I understand you correctly, while PBMs did not end step therapy, specialty tiers, and restrictions and formularies, they're using these previously recognized tactics as a way of notionally controlling costs, but at least having a downstream effect of potentially restricting access to what is oncologist-driven best care. Is that a fair summary?

That is correct. So it is those utilization management techniques that create significant administrative burdens and impairments on getting patients appropriate, and timely, and affordable access to care.

Well, you must see this firsthand, right? You're in private oncology practice at the Center for Cancer and Blood Disorders in Aledo, Texas. And I know that you have an active practice and you see a large number of patients. I'm wondering if you've had, yourself, firsthand experience of PBMs and what you've seen it has meant for your patients to have their care influence that way. And what it's meant for you and your colleagues as you work to provide highest quality care. Are there vignettes or aspects of this that come to mind?

Yes. In my private practice in Fort Worth, Texas, I have firsthand experience with PBMs every day. What it means for our patients is an interference in the physician-patient relationship, pushing of care outside our Cancer Center, creating an impact on our ability to provide value-based care in an oncology medical home, causing delays in care, alterations in treatment plans, potential increases in toxicities, and more out-of-pocket costs for the patients.

So let me give you a quick case of a patient that I have. Tom was diagnosed with a stage 3 rectal cancer and I recommended capecitabine and radiation therapy. I prescribed, for him, capecitabine 500 milligrams, three tablets BID, on the days of radiation therapy, which would be 180 pills, which he went down to my pharmacy to get. At my pharmacy, he was told that he was out-of-network and he would have to get this through CVS Caremark.

So I saw the patient in his third week of treatment. And I found out that they had filled 120 of the 180 pills. And they told the patient that they only packaged the capecitabine in 120-pill bottles. So his first co-pay, for that first three weeks, was $400. So then he got a second bottle of 120 pills and paid a second co-pay of $400.

And that was a prescription of excess pills. And so CVS, they told him just to throw away the extra 60 pills that he did not use. Now this was financially impactful for both the patient and my practice. The drug cost, if a single script was given through my practice, would have been $3,900.

The drug cost for the two scripts with the extra unused pills was $7,200 through the PBM. Now under the new MACRA, MIPS payment model that we're all subject to, or under the Oncology Care Model, which is an alternative payment model, this kind of thing negatively impacts our resource use. So this process is completely out of my control, yet I get peened for not being a good steward of drug utilization.

Well, that's a pretty compelling example. And I assume there are others, right?

Yes, there is. There's many.

Well, I think if we turn a little bit to one of the points you raised already, it was about the in-office pharmacy in your practice. Can you, for people who might not be familiar with this, can you briefly describe how it works to have an in-office pharmacy? Is this something that all oncology practices have? And how have the PBMs impacted its operation in your experience?

Yes, Cliff. Most all cancer centers across the country have their own retail pharmacy, regardless of whether they're an academic center, a hospital-based practice, or an independent community practice. The impact of the PBMs affects the delivery of cancer care no matter how small or great your cancer center is. More and more cancer centers, as well as large hospital systems, are trying to get specialty pharmacy status to be able to combat some of the PBM tactics of being out-of-network, or having direct and indirect remuneration DIR fees, rebate clawbacks, and gag clauses.

So let me just say that PBMs may be a place for managing common drugs for diabetes, and heart, and thyroid, and infectious diseases. But there are reasons that cancer centers prefer to have complete control of the cancer therapies that we prescribe. In general, cancer drugs not only have the risk of substantial physical toxicities that need close pharmacy management, but they also have tremendous financial toxicities for the patient that we help manage with our pharmacy staff and in which those resources do not exist within the PBMs.

So it's highly preferable that cancer patients get their prescriptions through a highly-trained oncologic pharmacist at the Cancer Center who has access to their full electronic health records and drug lists and who knows them, personally, by name. Our pharmacy staff has resources to educate the patients, to work on foundation and financial assistance, and to be immediately available, by name, to triage further questions or symptoms. It is what is best for the patient.

Unfortunately, PBMs are redirecting our treatments from our pharmacies to theirs, and they are trolling for other drugs that we have historically prescribed to our patients. So this loss of prescription authority and drugs to the PBMs is at a rate that's increasing at about 10% a year to where, currently, 60% of our prescriptions go outside our pharmacy to the PBM.

I see. And, presumably, that has not only concerns raised for you in terms of business, but quality of care. Is that right?

That's exactly right. So there's always a business aspect to the management and control of the drugs. But, most importantly, is that value-based quality care that we feel provides the safest, highest quality, most affordable care to our patients when they have access through our own individual pharmacies at the cancer centers.

Well, at ASCO, as you know, we, last year, spent some time and, ultimately, we declared core values-- evidence, care, and impact. And what derives from that, for us, is we do not write papers or issue statements simply to check a box and say we did that. Instead, what we want to do is go beyond identifying, and analyzing, and reporting on a problem to, in fact, contributing to solutions.

And so, to that end, what we frequently have to do is initiate conversations with stakeholders, propose ideas that might affect real change, and have a positive impact on cancer care and our patients. ASCO's recommendations on health care system changes are often sent directly to Congress. We present them to government agencies.

We speak to payers, certifying bodies, and, really, everybody across the entire health policy environment and health care spectrum. So given that our desire is to make a difference, to have an impact, to effect change, can you, Dr. Page, can you outline some of the recommendations that ASCO has described as a path forward and a way to address the issues that our discussion has raised?

Sure. ASCO has several suggestions. And these can get very complex and have nuances, but I'll just try to make these suggestions as simple as possible. But several things that ASCO has recommended is that PBMs and the payers, in order to address quality of care concerns related to

cancer patients that they serve, they should assure that changes to prescribe therapies for the patients with cancer are made only in the context of prior consultation and approval of their physician.

So, in other words, if I write a prescription for a set number, and duration, and dosing schedule for a patient, it should be given that way. And the PBM should not be making alterations in my prescription, like I gave in my example. Pharmacies should not be prevented from sharing, with the patients, their most cost effective options for purchasing needs of medications.

So in other words, there's gag causes that PBMs have to where there could be a drug that the PBM is going to charge the patient $180 a month for, but the local pharmacy can prescribe that same drug for $30. But they are prohibited from disclosing that they can actually distribute that drug to them cheaper outside the PBM. CVS should leverage its regulatory authority to number one, require that PBMs provide detailed accounting of these DIR fees and instruct contractors and PBMs to use measures and standards that are more appropriate to the specialty.

CMS should also enforce its any willing provider provisions in Medicare Part D preventing PBMs from excluding qualified provider-led pharmacies from its networks. So we, at ASCO, really desire that any cancer center that has a pharmacy would have the opportunity to be included in the PBM network and be able to prescribe the drugs within that network on site. And then, CMS should maximize the accountability of drug waste through the PBMs. Lastly, pharmacy and therapeutic committees of the PBMs should include full and meaningful participation by oncology specialists.

So one issue that was raised in the ASCO statement, and we haven't directly touched on it yet, is simply the lack of transparency, that is, the opaque nature of PBM practices and their policies. How do you think that issue, specifically, can be addressed?

Yeah, Cliff, the transparency issues are being addressed nationally at several legislative levels. There are several federal bills that are in support of the Trump blueprint to address drug costs. And they have to do with safe harbor laws that the PBMs are taking advantage of. They have to do with undoing the gag causes that I previously mentioned. And, also, to examine the fiduciary status of the PBMs. At the state level, there's dozens of bills going after the PBMs, state by state, on all fronts.

And, lastly, as an ASCO delegate to the AMA, a few months ago, we submitted a resolution that we got accepted into AMA policy that requests that our AMA gather more data on the erosion of the physician-led medication therapy management in order to assess the impact of the pharmacy benefit manager tactics that they may have on the patients' timely access to medications, patient outcomes, and the physician-patient relationship, and that the AMA examine issues related to PBM-related clawbacks and those DIR fees to better inform existing advocacy efforts. And so I think it's always good to have the weight of the AMA behind our ASCO advocacy efforts to assure that our cancer patients can continue to get the best, affordable access to care.

Well, that's really great to hear. You've covered a lot, both in terms of background and explanations, the history of the development of the PBMs, and what challenges have now

emerged. Are there any additional steps ahead that ASCO should be taking that you know about? Is there anything else, for example, that listeners should know about pharmacy benefit managers that we've not yet touched on?

Yeah. I think I just want to emphasize that this is really a David and Goliath scenario. It is very difficult to control a rapidly growing, unregulated, complexly integrated $300 billion industry that is benefiting three gargantuan companies more than our patients. And ASCO will continue to partner with fellow like-minded advocates to optimize the affordable delivery of cancer care and conquer cancer.

Well, that's certainly an upbeat-sounding ending. And I'm sure with you fighting the good fight, this effort will go on and will make good progress. That seems clear. I want to thank you, Dr. Page, for joining me today for this ASCO in Action Podcast. I want to remind everybody that at ASCO, we are committed to preserving and enhancing access to high-quality cancer care for everybody with cancer.

This statement on PBMs is just one of many in which ASCO's voice, and the collective voice of our members, is helping to shape the future of cancer care for everybody and refine the delivery system. I encourage our listeners to read the statement, and other policy and position statements, all of which are available on the policy and advocacy pages of our website at ASCO.org. And until next time, again, thanking Dr. Page for joining all of us, I want to thank all of you for listening to this ASCO in Action Podcast.

Medicaid Work Requirements Could Negatively Impact Cancer Care Access, Increase Cost Burden on Patients Sep 18, 2018

Welcome to this "ASCO in Action" podcast. This is ASCO's monthly podcast series where we explore policy and practice issues that can impact oncologists, the entire cancer care delivery team, and most importantly, of course, the patients we care for, people who have cancer. My name is Clifford Hudis, and I'm the CEO of ASCO as well as the host of this "ASCO in Action" podcast series. And for today's podcast, I am really delighted to have with me Dr. Manali Patel, chair elect of ASCO's health equity committee. Dr. Patel is here as our guest today to talk about some interesting issues for that committee and for all of us in ASCO.

Our conversation today is going to focus on ASCO's recent position statement on Medicaid waivers. For those of you who aren't following this or have been tuned out for a little while, there are several states that have recently submitted waivers to the Centers for Medicare and Medicaid Services-- what we generally call CMS-- asking for the agency to approve changes to the Medicaid program in their state individually that would make eligibility, continued coverage for care, cost sharing, and other program benefits dependent on the beneficiary's work status. Some state waivers have also requested the authority to cut coverage for beneficiaries based on them not paying premiums, on eligibility re-determinations, and on other work requirements. Simply put, these are challenges because they could restrict some access to care, and they put ability to work into the mix for oncologists to consider.

So here at ASCO, we're concerned. We're concerned especially that Medicaid work requirements may hinder patient access to essential cancer care services. They may reduce the already limited time that physicians have available to spend with their patients, because they will require, in some cases, doctors to do work related to assessing employability. And our position statement, therefore, recommends that federal and state policymakers take very specific steps to ensure that new Medicaid requirements do not harm patients with cancer.

So to dig deeply into this, Dr. Patel has joined us. And I welcome you, Dr. Patel. And thank you for coming on this discussion today.

Well, it's an honor and a privilege to be here today. Thank you.

So I want to start with a little more background on the type of waivers that we're talking about here. And there's always a nomenclature that's confusing to the outside world. These are called 1115, 1-1-1-5 waivers. What is their intended purpose in the Medicaid program?

Section 1115 of the Social Security Act gives the secretary of health and human services essentially the authority to waive particular provisions of the Medicaid program in hopes to further the Medicaid program's objective. 1115 waivers provide states an avenue to test new approaches in Medicaid that can potentially improve their programs but that may differ from what the federal program rules currently are. These 1115 waivers are subject to public comment. They must be budget neutral for the federal government. And while there is great diversity in how states have used these waivers over time, generally these waivers reflect the priorities that are identified by the states and the current administration.

And just out of curiosity, who submits the terms or the concepts that are being considered in these waivers? Do they bubble up from the state? They come down from the federal government? Do they come from some other source?

What's interesting about these waivers is that they do come from the states themselves. However, there is great encouragement by the administration in terms of what waivers they would encourage states to apply for and which waivers they would approve. The secretary of the health and human services is the one that makes the authority for approving the waivers themselves. But the states themselves are the ones that submit the waiver provisions in hopes that it will align with what the administration's goals and encouragements are.

And just, again, for background, historically, before we get to the present, has it typically been the case that there's heterogeneity in these programs around the country, or is this something new in terms of these waivers encouraging local experimentation and variation?

Historically, most waivers have been very small in scope until the 1990s. There are still a wide range and great diversity in how states have used these waivers over time. But there's been homogeneity in terms of the wide range of purposes for which they've been used. Most of these are to expand eligibility and to help to simplify Medicaid enrollment processes, all with the goal to help improve the Medicaid program.

Historically, many states have applied for waivers to reform care delivery and present an opportunity for states to institute reforms that go beyond just routine medical care, but that focus on providing evidence-based interventions that have an opportunity to improve health outcomes for this particularly disparate patient population. For example, Oregon used its waiver to establish a partnership between managed care plans and community providers to provide behavioral health and oral health services for its Medicaid beneficiaries.

In 2012, the enactment of the Affordable Care Act allowed a new category of low-income adults to become eligible for Medicaid. And therefore, several states in 2012 applied for demonstration waivers from the Obama administration to test different approaches to expand eligibility and recently included the introduction of premiums and co-payments. Most recently, in 2017, the Centers for Medicaid and Medicare Services encouraged new approval processes, including the potential for many states to obtain a 10-year extension. Previously these were five-year extensions.

In January of 2018, states were encouraged by the administration to apply for waivers to make employment, volunteer work, or the performance of some other service a requirement for Medicaid eligibility, as you discussed earlier in the podcast, and to impose premiums and increases in cost sharing. Now, this is different. A number of states now have waivers that have been approved, as well as ones that have been pending, that include these provisions that have not previously been approved in the past. And also, that includes drug screening and testing, eligibility time limits for patients, and lock-out periods if beneficiaries cannot pay for their premiums or cost sharing.

So there are a couple of concepts that your introduction raises. And I think it may even come as a surprise, at least to some of our listeners, that Medicaid beneficiaries have any premiums. And I want to make sure we're all clear. Are we talking about dollars coming out of the pocket directly of Medicaid recipients in the form of premiums?

We are. And we're also talking about cost sharing in terms of patients being now required to provide cost sharing for services that they are receiving through Medicaid.

And can you expand on each of those areas about what we mean? What kind of dollars would a Medicaid recipient be paying in premiums? And what kind of cost sharing dollars might they be at risk for in a typical program?

The concern now is that Medicaid is state by state. So in any individual state, these premiums and cost sharing can vary greatly. In some cases, it's 50% of cost sharing of the services provided. In other cases, it's less than that. In other states, there are waivers for the premiums or cost sharing and have never been imposed.

So to answer your question, it varies widely. And it can be as great as the premiums and cost sharing that we're seeing in Medicare and patient populations that are enrolled in Medicare. But it can also be as great as the premiums and cost sharing that we see in private health plans.

It will be surprising, I think, to many people to hear this, because I think for most people there's at least a perception that Medicaid represents insurance and access of nearly last resort and is not for people of means. So the idea that there's a cash flow out of the beneficiaries into this program or into their care in this program, I suspect is not something that's widely known.

Right. I would agree. It's not widely known. And it comes as a shock that we would expect patients that would be eligible for Medicaid, given the provisions of what Medicaid has been there to serve and was enacted to serve, that we're seeing patients experience the financial toxicity perhaps even more so than patients that may be in public health plans.

Yeah, that's interesting. And it relates at least tangentially, I'm sure, to some of the recent data that's come out of ASCO addressing the rate of financial toxicity in the form of choices around spending and choices, unfortunately, to go into debt that we've heard from the general population. It's got to be presumably even tighter in this population, right?

Right. And with costs rising at an unsustainable rate for cancer care delivery services, what I think is also a shock to the public is understanding that all of those costs eventually are coming back to the patients themselves to bear the burden of the cost that we're seeing. Every year, my own health care premiums and health insurance premiums are rising. Benefits are being cut in these private health plans. And we're seeing the same occurring for the limited services that are available in Medicaid programs.

And because states have the authority to make these programs reflect what its state's priorities are, there's wide variation in the same way that there is wide variation between each individual public and private health plan outside of these states. Within the states, there's a significant degree of diversity in terms of what services states are providing through Medicaid.

And I guess one last question before we move on is-- it sounds like you've answered this already, but I want to be clear-- the program really is taking shape right now, right? This is not the way it's been historically. Is that a fair roll-up of what you've said?

That is extremely fair. I think prior, as early as the 1990s, these waivers were really to expand eligibility. And they were meant to improve the program for its objectives to increase access, equitable access, to high-quality medical care. And now what we're seeing are provisions that are directly inhibiting this access.

Yeah. This is amazing. So turning now to the current reality and our response to it, we have concerns, as we've already alluded to, specifically regarding the work requirements, in two directions, I would say. First, of course, we're concerned about the direct impact on patients. But I think in addition to that, we're worried about the impact on the system as a whole. And my question to you is what would you like our listeners to know about how these waivers might have an impact on people with cancer?

Right, so I'm deeply concerned about the waivers failing to promote the intended objectives of the Medicaid program, as I've discussed previously in our conversation today. These waivers directly inhibit access to high-quality cancer care. These new provision to waivers can be extremely detrimental by restricting access to coverage for those not only with an ongoing cancer diagnosis, but restricting access to services that can help to prevent cancer. And patients that are enrolled in Medicaid are those patients that may be at highest risk for developing cancer.

Disruptions in care, delays in treatment, dis-enrollment in coverage-- all of these gaps in care delivery have been shown to directly adversely impact cancer care outcomes. And to think that these disruptions are now being imparted and imposed into Medicaid eligibility requirements is quite concerning. Many patients have to stop working entirely. Many are dramatically reducing their work hours to comply with evidence-based treatments. Many have debilitating side effects that prevent them from working and are at risk for life-threatening infections and illnesses when their blood counts may be low.

These worse outcomes also affect patients that are cancer survivors, who face long-term effects and increased health risks related to their cancer. So the imposition, also, of lifetime limits and lock-out periods are detrimental to ensuring that patients have equitable access to cancer care.

And you know, one of the other areas that isn't obvious at first-- I had to look into this as well-- is the downstream impact on the clinicians caring for these patients. Can you explain to our listeners, why would a doctor even become aware of this? How would this take time from the doctor, these kinds of work requirements?

Well, when I think about my own practice and how I spend-- and I think studies have also validated that we spend over 50%, or up to 50%, of our time in front of the computer with administrative paperwork burden. These restrictions, in terms of these new restrictions for Medicaid, will increase the requirement for additional paperwork. And that paperwork is going to have to directly come from the oncology practices and the providers that are seeing these patients. These restrictions and requirements that will be imposed on us are going to exacerbate our already limited time.

Do you think that the assessment of ability to work would also fall to the oncologist? That's a concern, I think, that it might drive our docs to find themselves in a funny relationship, an uncomfortable one, with their own patients?

Oh, certainly. I do believe firmly that it will come to the providers providing care for these patient populations. We are already required to provide disability placards and make that assessment in our clinics. And it does make it-- it interferes with a therapeutic relationship with our patient population.

And you alluded to this already, the fact that many patients diagnosed with cancer ironically have to stop working, both because of the time and effort it takes to get treated, but also because they're just not well. So I've heard, at least, the comment that these work requirements technically might not apply very much to cancer patients because of the-- again, the technical work requirements would be waived for patients who are sick. Do we have any sense, in real-world implementation, how this plays out?

It's unclear if states will be able to make those exceptions. And if you have an exception for patients with cancer, I can list several other terminal illnesses as well as curable illnesses that may similarly have exemptions. And it's unclear if these exemptions will be adhered to. One concern, and I think one of our recommendations have been that if there will be requirements for work requirements, that at least they not occur for a minimum of a year after a patient has undergone active treatment and that caregivers of patients should be seen in a similar light.

But to answer your question, it's really unclear if there will be provisions made and exemptions made for patients with cancer. I do certainly hope that to be the case. And that's certainly why advocating for this and advocating against these work requirements for our patient population is this especially important from all stakeholders.

Well, that's a perfect segue for us to turn to ASCO's recommendations. That is what we're advocating for. And I wonder if we could start, if we think about the recent ASCO position statement on Medicaid waivers, what are the specific recommendations that you want us to know about in terms of what we want policymakers to do? What's our focus?

Our main focus and the underlying mission of ASCO's recommendations are, again, to ensure that all patients have equitable access to high-quality cancer care. And the main focus of these recommendations are that waivers really should not create delays or barriers to receipt of timely and appropriate cancer care. Secondly, states should consider patients that are in active treatment exempt from any work requirements for the reasons that we've discussed and consider the primary caregivers in a similar light.

There should not be lock-out periods or lifetime limits or elimination of retroactive eligibility for at least a year after a patient's last treatment. And additionally, these uncompensated burdens on providers really should not be posed on providers. ASCO also recommends that waiver applications and amendments be open to a full and transparent public comment period.

So that last point, it seems like that's an obvious one for all of us wanting good government, and even in our daily lives. What is it that we're worried about with this transparency? Why is it so important that these 1115 waivers be handled in a transparent way? And I'm almost embarrassed to ask that question, because it's hard to see the argument against transparency. Why do we have to make that argument?

Right. Well, it's key. Transparency is key. We have to make this argument all the time in many other facets of health care as well.

But it's key to ensuring that we all understand what the implications of these waivers have on our patients, on our practices, but also on our personal lives, and that we have a chance to comment publicly on the waiver. I think states may look at each other's waivers and begin to make provisions for their own waivers or apply for waivers based off of what another state has been approved to demonstrate or to test. And so I think it's extremely important that we all have a chance to publicly comment on these waivers and to understand what's in the waivers themselves prior to them being approved.

So I guess in addition to our public statement on the waivers and the position statement and then hopefully having the opportunity to address these in public, are there any other next steps that we need to be taking formally as ASCO? Is there anything else that's on the agenda for us?

ASCO is currently conducting and helping state affiliates develop letters and comments to their own state officials as they design and submit the waivers. I think it's extremely important that we continue to advocate. ASCO's advocacy team from the state level is keeping an eye on waivers and opportunities to partner with state affiliates on problematic waivers that may be coming from their own states. But beyond analysis and these comment letters, ASCO is also coordinating meetings with state affiliate leadership and with state policymakers to discuss concerns about ongoing and the current Medicaid waivers as well as ones that may come up.

So it's just another plug for our regular listeners for engagement through, for example, our Hill Day and our ACT Network and so forth to keep the pressure on and the awareness up with our legislators, right?

Right. Certainly. This is a topic that will continue to evolve, and so it's extremely important that we're keeping ourselves up to date and that ASCO is helping us to keep abreast of what new developments may be occurring on these waivers on a state-based level.

Well, that's great. I don't think there is, but is there anything else that we've left out that listeners should know about the current state of the Medicaid play for us?

Well, I don't think so. I think we covered most. But as we all know, Medicaid is currently evolving. It's always evolving, and currently more so in a direction that I would have never assumed we would be evolving into. The concerns that are always raised are legislative cuts, caps to the program, uncertainty about revenues, federal legislation that may have an effect on state actions on Medicaid. And now there are growing concerns about substance use disorder and opioid epidemic use that may make Medicaid play a larger role in these issues than we had previously considered.

There's a lot to chew on there. I want to thank you, Dr. Patel, for joining me today for this "ASCO in Action" podcast. I hope our listeners find this clear and informative. I think it raises really important issues for all of us.

I want to remind everybody that ASCO's position statement on Medicaid waivers is just one of our many that address policymakers in various ways. Our overall goal is to preserve and enhance access to high-quality care for all Americans. I'll remind you that our 2014 policy statement on Medicaid reform called for major changes to the Medicaid program to ensure access to high-quality cancer care for all low-income individuals. And then, our 2017 principles for patient-centered health care reform called for access to affordable and sufficient health care coverage regardless of income or health status, the point being, this is a long-term commitment by our leadership and our volunteers. And this is something that clearly is going to remain at the top of our agenda.

If you're interested, and I hope you are, you can read the complete ASCO position statement online. It's available at ASCO.org/medicaid-waivers. And this is, again, made available to you on the web. And I hope that this is informative. With that, until next time. I want to thank everybody for listening to this "ASCO in Action" podcast.

The ASCO Delegation to the American Medical Association Discusses Policy Priorities and Process Aug 28, 2018

Disclaimer

Dr. Clifford A. Hudis

Welcome to this ASCO in Action podcast. This is ASCO's monthly podcast series where we explore policy and practice issues that impact oncologists, the entire cancer care delivery team, and most importantly, of course, the individuals we take care of, people with cancer. My name is Clifford Hudis, and I am the CEO of ASCO as well as the host of the ASCO in Action podcast series. For today's podcast, I am really pleased to have as my guests - and you heard that right, plural - Doctor Ed Balaban, one of ASCO's delegates to the American Medication Association House of Delegates and Doctor Kristina Novick, an alternate delegate to the AMA House of Delegates. Both Dr. Balaban and Dr. Novick recently represented ASCO at the AMA House of Delegates meeting where they advocated for cancer policy priorities. During our conversation today, we'll get an update on the AMA meeting, we'll hear more about some of the key issues that we discuss, and then we'll spend some time talking more broadly about ASCO's role at the AMA. Dr. Balaban and Dr. Novak, welcome, and thank you for joining me today. Now, let's start with a general overview of the AMA House of Delegates, what this governance body is and why, as a medical specialty society, ASCO should care about its activities. Dr. Balaban, you have served for many years as an ASCO delegate to the AMA House of Delegates, and I want to take this opportunity first to thank you for that service. But second, I want to ask you what exactly is the role of the House of Delegates? And how does it influence what the AMA actually does?

Dr. Edward Balaban

So Dr. Hudis, thank you very much for inviting both Dr. Novak and myself to speak for a moment about this because it is something that I don't think that the general membership really understands or appreciates. So the AMA House of Delegates, it's an amazing collection. It's also known as the House or the HOD, and it turns out to be the principal policy-making body of the AMA. It is in a democratic forum that represents views and interests of a number of member physicians and, in fact, represents close to 170 or so societies. We meet twice a year, and the whole idea of meeting is to eventually establish policy in medical, professional, and governance matters that have to do with the AMA business activities and principles of the AMA.

Dr. Clifford A. Hudis

And how many members are there? And exactly how are the members selected?

Dr. Edward Balaban

So the delegates right now-- and I say right now because it does change based on the number of AMA members within each representative society. But right now, the delegates number around 620, I believe. ASCO, right now, we have six delegates. Three of them are full delegates and three are alternate delegates.

Dr. Clifford A. Hudis

All right. So ASCO has three delegates who are appointed plus three alternate delegates. Is that right?

Dr. Edward Balaban

That's right. The full delegates are voting delegates. And we'll get into the details of that, I'm sure.

Dr. Clifford A. Hudis

So what actually happens? You have 620 delegates get together. I assume you're in a big ballroom at a hotel in Chicago. And what exactly goes on in that meeting room?

Dr. Edward Balaban

So, again, we meet twice a year. We meet shortly after the ASCO annual meeting in June and spend a fair amount of time in Chicago then. And then we meet once again in November at another site. The meeting itself, each time, lasts maybe three or four days but the preparation for the meeting goes on for months. And in fact, Dr. Novak and myself and the rest of the delegation are beginning to think about November's meeting now. So the way this goes-- the way it all happens is a bit complicated, but it's fairly straightforward nevertheless. We as representing ASCO and I guess medical oncology come to understand some of the more important issues that are facing practice, no matter what setting it might occur in. Those issues then lead to crafted resolutions that are presented eventually to the House of Delegates. We go over them based on ASCO policy as well as the interests that lie within the delegation itself and frankly what we hear from the different committees within ASCO. As we're putting together resolutions, the other societies-- and again, there are a number of societies, 170, 180 societies. They're putting together their resolutions, too. In addition to that, problems that had been discussed in the past at the AMA that have made their way to the board or various committees, those reports are being formed.

Dr. Edward Balaban

And so there is a gathering of all those resolutions and all of those board reports that become available perhaps a month, six weeks, maybe eight weeks prior to the beginning of the meeting itself. Each one of those resolutions and board reports that are then reviewed in our case by ASCO and a staff. And oh, by the way, I should say right off the top that ASCO staff is superb, and nothing happens without their help. But we review each resolution that's pertinent to the world of medical oncology. We develop our own resolutions as best as we can. We start to share them with other societies that we feel might be interested. And then eventually, those are all submitted to the AMA and then we gather. The first day in Chicago or wherever we meet is usually sort of the time to start to politicking. And it really is in the truest sense that. We review those resolutions. We review our thoughts. Others meet us in hallways and meeting rooms and committee spaces that want us to participate and/or get our thoughts on different problems. Those resolutions then make their way to a panel where we testify for them. Either Cristina or myself or one of the delegation stands up and says, "This is what we have our concerns with from ASCO. We would like the AMA House of Delegates to think about this." Those resolutions are then thought through by a committee that is an aside committee. It's made up of maybe five or six people. And again, this occurs the day before the actual House itself meets in that big ballroom that you just mentioned.

Dr. Edward Balaban

That committee then decides, "Well, that resolution that Dr. Balaban just presented, that is already AMA policy," or, "That does hold some water," or, "We need to think about is whether we want to go forward with that or not." The following day, that is when we met in that big ballroom, a whole bunch of us. And it's all the voting delegates, the 600 and so, alternate delegates. There's usually a number of international organizations there. Press is there. Observers from around the country are there. And each one of these resolutions that need to be talked about are then brought forth. The debate sometimes can be very quick but sometimes, it could be fairly contentious and confrontational sometimes but fortunately, that's not always the case. It's done in a very structured, Parliamentarian way. And then at the end of all that, there is a vote that the AMA House of Delegates either accepts or rejects the particular resolution that, in our case, ASCO has presented or reaffirms it into data and/or policy that the AMA already has or wants to re-look at it and send it down the road to be looked at, again, at the board level or at some committee level to come back.

Dr. Edward Balaban

It all sounds terribly complicated. The business of the House of Delegates can spread over two or three days. It is always an amazing process with so many folks with so many different ideas. And you would think that at the end of all that that there has to be great chaos, but year after year, meeting after meeting, I'm always impressed how we walk away from there with a consensus. And it may not be exactly like you wanted but it makes sense at the end of all that meeting. So it is a complicated process. It's a difficult one to explain. It's a bit of a learning curve to be part of it but once you see it happen, you understand that something good has taken place.

Dr. Clifford A. Hudis

Well, that's great. We're going to come back a little bit maybe and talk about execution or implementation, what all of this leads to. But maybe first, I want to ask Dr. Novick-- first of all, I want to say thank you for joining us again today. Your role in all of this is as an ASCO alternate delegate. So tell us, what exactly does that mean?

Dr. Kristina Novick

Well, thank you very much, as well, for having me today. So I think as Dr. Balaban has explained is that ASCO's allocated three delegate positions and three alternate delegate positions. And together, we make up what we call the ASCO Delegation to the AMA. Being an alternate delegate allows me to participate in the House of Delegates and support ASCO's activities. We work together as a group often several months before the meeting to try to create a list of priorities that we can then formulate into resolutions. During that time, we're often working with other specialty societies that have similar priorities. We try to gain their support for our objectives. And likewise, they reach out to us to gain support for their objectives. We then create this list of resolutions that we submit for the meeting. And often, we end up reviewing probably over 100 to 200 resolutions just for each meeting. With the help of ASCO staff, we review these resolutions and we come up with position statements for the resolutions, especially when some of them are related to ASCO's priorities and policies. So as an alternate delegate, really, what I get is pride in being part of the medical oncology community and being an ASCO member. We're a small but mighty delegation. We only make up 0.5% of the delegates but we find that we have friends not only in the cancer caucus but also within other organizations that have similar priorities. And then we have the respect of the House representing our patients who are vulnerable in terms of their cancer diagnoses.

Dr. Clifford A. Hudis

So maybe you could expand a little bit and talk about what some of the policy priorities that we actually worked on to advance in the June meeting. Are there any specific ones that come to mind that you think our listeners should be aware of? I mean, I guess, for example, PBMs or 340B or opioids. Are any of those issues that you could illuminate for us?

Dr. Kristina Novick

We had a number of resolutions that we submitted this year. The ones that really do come to mind are, first of all, the pharmacy benefit managers resolution. We found that there was a lot of interest, not only from our organization and the experience that we've had within oncology with pharmacy benefit managers but also other specialties have also expressed frustration as to what has occurred with their involvement over time. In particular, ASCO's resolution asked for data gathering on the impact of the pharmacy benefit managers, on clawbacks in direct and indirect remuneration fees. The House of Delegates agreed with us on this and also wanted to gather data on the top 25 medical pre-certification requests with exploration as to what percentage of those ultimately were approved after physician appeal. I thought this resolution was really important because we know that pharmacy benefit managers, they end up controlling the drug benefits for over 210 million Americans, many of which are Medicare Part D participants as well. In addition, there were other resolutions that were focused on pharmacy benefit managers such as the state of Michigan was concerned about the regulation of compounded medications by pharmacy benefit managers and requested that the FTC and FDA get involved with increased regulation. And the board of trustees as well further outlined AMA's efforts to combat restrictions that were created on prescription and dispensing of opioid analgesics by pharmacy benefit managers and requested that we oppose their control of dose or duration limits on our prescription and on dispensing.

Dr. Kristina Novick

In addition, we also looked at the 340B program. I think that there's going to be a lot of interest in this as we try to further control drug costs. The 340B program, for those that aren't familiar with it, was a program that was actually created decades ago in an effort to try to increase the affordability of supporting patients who are underinsured or uninsured and have their access to medications that often can be quite expensive which is something that our patients in oncology experience quite often. Over time, the program's been used especially by large hospital systems as a way to try to increase the reimbursement that they receive for medications that they dispense to their patients. And we had questions as an ASCO delegation as to whether this was really going to the benefit of the population that it was originally intended for. So our resolution asked for increased transparency and oversight of the program. We believe that you need to use those savings in order to help the patients that are underinsured and most need that support. Ultimately, the AMA supported this but they also wanted to investigate our request that we no longer use the disproportionate share hospital adjustment to determine the eligibility. So we'll hear back from them in the fall of 2018 as to what the conclusions are of that report.

Dr. Clifford A. Hudis

So I think it sounds like these resolutions and some others that we were promoting were received favorably. I hinted though with this question a moment ago, with them passed, can you tell our listeners exactly what this means? How does the passage of one of these resolutions actually lead to a practical change in our environment? What happens next to make this part of our new reality?

Dr. Kristina Novick

So resolutions typically are either new policy or directives that take action. Essentially, new policy can be used to support further action by the AMA as issues arise within the legislature, within courts, within allocation of resources by the AMA which is a very large organization. They can also be used to help coordinate efforts by other organizations. The directives that take action are more specific, and the AMA will report back as to what actions they have done and also what they've achieved in response to those directives. So essentially, the House of Delegates, because it meets twice a year, directs these directives and the activities of the AMA. And in between the meetings themselves, the board of trustees acts as the body that will make the recommendations as to what the AMA needs to do to achieve the directives if there's any question in that regard. So what will happen from here is the board of trustees will be reviewing the resolutions that have been passed and then create the list of priorities and objectives to pursue over the next year. And the AMA has a tremendous amount of advocacy that it's able to do. But I think the most important thing that it can do is help coordinate these efforts across states, societies, across specialty societies which is something that we wouldn't be able to do just on our own.

Dr. Clifford A. Hudis

So the real boots on the ground as it were amounts to advocacy at the state and national level, talking to legislators, talking to regulators, talking for that matter I guess to other stakeholders in the healthcare ecosystem and trying to influence practical rules and regulation and policy. Is that a fair summation when it's all said and done?

Dr. Kristina Novick

I think that's a great way to summarize. Essentially, if you go meet with a legislator, it's very easy for them to dismiss you although we do have a lot of clout, I think, coming from the oncology perspective. But still, it's easier to divide us up into different specialties and say, "Well, psychiatrists want this and dermatologists want that." But when it turns out that we all share common objectives, we can approach them and say, "The medical community, this is what we want. This is what is best for our patients." It's a lot stronger, I think when it comes from that perspective.

Dr. Clifford A. Hudis

That's great. So before you go and I turn back to Dr. Balaban, I'm just curious as to what your perspective is on the fact that we have this very exciting, new milestone for the oncology community at the last AMA meeting and that was that Dr. Barbara McAneny was sworn in as the president of AMA. She's the first oncologist to serve in that role. What do you think that role means for ASCO and the oncology community?

Dr. Kristina Novick

We are very excited about Dr. McAneny taking over as president of the AMA. She certainly brings not only a medical oncologist perspective to the leadership of the AMA but she also brings the perspective of a physician who is taking care of underserved populations, who is a patient advocate before all else. And I think we're all going to benefit from that leadership that she's shown over the years in that regard. She's also been very good at being a role model in terms of how to practice medicine in a sustainable fashion which is something that we need. So I am incredibly excited about her leadership and her accomplishments of rising to this position within the organization. A lot of leaders within the AMA will come from large delegations. And as I said, we're not a large delegation. We're a specialty society that has three delegates spots, three alternate delegate spots. But the fact, I think, that we have now also as our advocate the president of the AMA, I think that there's going to be a lot of potential opportunities for medical oncology to get additional help from the AMA on our key issues and to be more involved as well. So I think it was very exciting to see her take that position.

Dr. Clifford A. Hudis

So Dr. Balaban, I know you've known Dr. McAneny for many, many years. And I was really touched and I thought it was a thought-provoking comment during her inauguration where, if I remember correctly, she made a plea to move away from the term providers. And I think it was a plea to focus really on physicians. I don't know if I'm misremembering that, but it struck me that it was an important semantic distinction. Knowing her, knowing her passion, knowing her years of service to the community, to ASCO, to her patients, what's your perspective on how she'll be different as an AMA president?

Dr. Edward Balaban

Like you mentioned, she's been involved with the AMA in every facet of the AMA, oh, my gosh, for years. And as Cristina mentioned, this is almost precedent-setting. Neither she nor I can remember a specialty society having a successful campaign for presidency. Barb did say exactly that. She moved away from the idea of provider because to her-- and I shouldn't speak for her but she has shared enough with me and with the AMA. Provider's sort of a tone of a definition that's part of the system. And when I say the system, I mean as it currently is in the medical community. Well, the one thing that she has proposed is that she would like to fix this system. And she'd like to readjust it, reset it, rethink it, re-personalize it that we are just not providers. We are the physicians. We are the people that drive it. We are the people that make those decisions that will make it flounder or be successful. So she has tried to reroute this, and she can do it because she does relate. As Dr. Novak said, she can communicate so well, whether it's the Navajo Indians in New Mexico or with the CEOs in Chicago. She has traveled all those different areas.

Dr. Edward Balaban

And she does not mince ideas or words. She'll say very effectively what needs to be done. And Barb and I, as with most people on the planet, we'll go back and forth on a number of things. But I could tell you that we're all very pleased to be, in a sense, on her coattails. But let me just add to that that when it comes to oncology patients, I have come to learn at the AMA that our patients and our problems tend to be first and foremost almost Barb will say a canary in a coal mine. Maybe it's with the expensive and difficult drugs that we use and the difficult diseases that we face and the multitude of problems that we do run into with each and every one of our patients, whether it's physically or economically or socially or whatever, we tend to run the tip of the iceberg. And so other societies, other world within AMA will come to see what oncology thinks. And Barbara represents a huge spokesman in that area.

Dr. Clifford A. Hudis

Well, that's really great. And I think that we're all excited by this turn of events and the unique opportunities that the year ahead will bring, and also I think the lingering impact in the years that follow we'll be able to have on the AMA. So with that, I want to again thank both Dr. Balaban and Dr. Novak for joining me today for this ASCO in Action podcast. For the listeners, I'd like to remind you that you can always learn more about ASCO's work with the AMA, and you can continue to follow ASCO in Action for news and updates. You can visit ASCO Connection to read great recaps of the meetings that are usually written by Dr. Balaban himself. And you can find them online at connection.asco.org searching for Balaban, and that's B-A-L-A-B-A-N. So until next time, thank you all for listening to this ASCO in Action podcast.

ASCO CEO Addresses Concerns with 2019 Medicare Physician Fee Schedule and Quality Payment Program Proposed Rule Aug 07, 2018

In the latest ASCO in Action Podcast, ASCO CEO Dr. Clifford A. Hudis discusses the recently released Medicare Physician Fee Schedule (MPFS) proposed rule. The MPFS is a complete listing of all fees Medicare uses to reimburse doctors and other providers and suppliers under a fee-for-service payment system.

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In the latest ASCO in Action Podcast, Dr. Edward Kim, Chair of the Department of Solid Tumor Oncology at the Levine Cancer Institute, joined ASCO CEO Dr. Clifford A. Hudis to discuss eligibility criteria for cancer clinical trials.

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With Congress having recently passed federal “right-to-try” (RTT) legislation, the latest ASCO in Action Podcast features ASCO Senior Vice President and Chief Medical Officer Dr. Richard Schilsky, FACP, FASCO, FSCT, who examines the issue and explains the difference between RTT and the Food and Drug Administration’s (FDA) expanded access program with podcast host and ASCO CEO Dr. Clifford A. Hudis.

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Melissa Dillmon, MD, chair of ASCO’s State Affiliate Council, joins ASCO CEO Dr. Clifford A. Hudis in the latest ASCO in Action podcast to examine current cancer-related policies that state lawmakers are considering and discuss how ASCO members can get involved.

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In a new ASCO in Action Podcast, ASCO Vice President of Clinical Affairs Stephen Grubbs, MD, FASCO, joins ASCO CEO Dr. Clifford A. Hudis, FACP, FASCO, to break down the Quality Payment Program (QPP) and discuss the reimbursement changes coming to oncology practices in the United States.

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Congressional Advocacy Feb 12, 2018

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