Vital Health Podcast

Latest Episodes:

SSR Health’s Richard Evans on Medicare Price Controls Aug 10, 2022

Show notes

With the passage of the Inflation Reduction Act by the US Senate, the US is now on the cusp of implementing very aggressive drug pricing controls within Medicare. Richard Evans is the general manager of SSR Health, which he founded in 2009 to address the complexity of US drug pricing. Before founding SSR, Richard was a senior analyst at Sanford C. Bernstein, and during his tenure, he was ranked first by both Institutional Investor and Bloomberg Markets and was also rated as one of the top 20 stock-pickers globally across all large-cap industries.

Ironically, one of the most challenging questions to answer in US drug pricing is“How much does it cost?” Is it the cost of the drug out of pocket? Perhaps the cost to the insurer, to the PBM, to the hospital, or the total that finally ends up on the company balance sheet as revenue? To each of these value chain actors, the answer will be markedly different and Richard’s knowledge of the interplay of their various competing interests is without peer.

In this podcast, Richard explains the role of PBMs in market access and drug pricing, the perverse incentives that are baked into the US and EU systems, and how all of the actors are simply behaving logically within the odd construct of the current healthcare ecosystems. Often, these outcomes are not aligned to the best interests of patients at the point of sale. As well, we discuss the enormous revenue reductions that are likely to occur within the US biopharma ecosystem if the Inflation Reduction Act is signed into law in its current form, and the ominous implications this has for patients with unmet medical needs requiring cures.

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Michele Oshman – Driving Innovation for the US’ Biotech State Associations Aug 04, 2022

Show notes

Michele Oshman is Vice President of External Affairs of BIO, and the Executive Director of BIO’s Council of State Bioscience Associations (CSBA), advancing public policies that support the bioscience industry in partnership with their state-based member associations.
Before joining BIO in 2020, Michele had a successful 18-year career at Eli Lilly and Company, where she led their federal advocacy. She is a neuroscience researcher working both in clinical development and corporate leadership roles. Uncommon for people working in public policy, Michele earned a Six Sigma Black Belt in statistics in 2005 and is a closeted quant!
This podcast discusses the multitude of challenges facing the US biopharma sector, including proposed changes to the accelerated approval pathway and the broader issues of affordability related to out of pocket costs in Medicare Part D. Michele Oshman outlines the vital role state associations play in both advancing medical innovations and relationships with local and state governments to ensure that patients have access to needed new medicines.

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John M. O'Brien’s Hot Takes on March-in, Co-Pays, PBMs, CMS, and Patient Access Jul 16, 2022

Show notes

John Michael O'Brien was recently appointed as the president and Chief Executive Officer of the National Pharmaceutical Council (NPC), one of the key thought-leading organizations in Washington, DC championing biopharmaceutical innovation.

Prior to joining NPC, Dr. O’Brien was a senior advisor to U.S. Secretary of Health and Human Services' Alex Azar. He has held senior positions at CareFirst BlueCross BlueShield, the Centers for Medicare & Medicaid Services (CMS) and in the U.S. Senate as a policy fellow – he has worn just about every hat in DC related to healthcare that can be worn.

In this podcast, John O’Brien and Duane discuss the multiple and varied assaults currently being lobbed at the US innovative biopharmaceutical sector. It outlines how the ecosystem, which successfully created highly effective and innovative medicines for patients, could be rendered inert by the many and various ill-conceived pricing proposals currently emanating from Washington, DC.

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Rutgers’ Gary Branning Untangles a PBM Web of Complexity Jul 08, 2022

Show notes

On May 5th of this year, a very strange thing happened. For the first time in memory, the Pharmaceutical Benefit Managers, or PBMs, who act as the go-between for patients, insurers, and the biopharma industry, were given a good old fashioned grilling in the US Senate. This will come as no surprise to Gary Branning.

Gary is a Professor at Rutgers Graduate School of Business in Pharmaceutical Management and President of MMR, a health care consulting company that specializes in the reimbursement of medicines in the US healthcare system. With 30 plus years’ expertise in healthcare, Gary is known for his innovative approaches to access and policy issues related to the infinitely complex US healthcare system and the access to new medicines.

In this podcast, Gary unpacks the complex web of how drugs are actually paid for, and outlines the role played by PBMs in keeping money following and controlling the cost of premiums. However, he also outlines how the system of ‘rebates’ driven by beneficiaries and managed by the PBMs is creating confusion and controversy in the delivery of new specialty pharmaceutical products to patients.

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Joe Panetta Steers Biocom California’s Members Through Increasingly Stormy Seas Jul 01, 2022

Show notes

It seems every week we hear of another new proposal out of Washington DC to ‘fix’ drug pricing, and many of the companies that would be impacted by these proposals are in California, arguably, the globe’s leading biotech hub, and where the sector was born. Joe Panetta is President & CEO of Biocom California, the association representing the life science industry in California. With offices in San Diego, Los Angeles, Sacramento, and the Bay Area, Biocom California advocates for more than 1,600 companies, service sector firms, universities, and research institutes working across the state in the biotechnology sector. Joe’s been the head of Biocom California since 1999 and is universally regarded as one of the world’s thought leaders in innovative biopharma.

In this podcast, Joe provides insightful comments about the birth of the biotechnology industry, the current business climate, and what continues to make California such an attractive and vibrant life science cluster, in spite of the turbulent equity markets and near double digit inflation. He’ll also discuss the ever-increasing challenges and storm waves being hurled at innovative biotech companies by Congress, including proposals to change the criteria of the accelerated approval pathway, CMS’ ability to limit access to treatments by requesting more evidence, proposed pricing negotiations resurrected from Build Back Better, and the recent statements by Senator Elizabeth Warren (D-Mass) to use march-in rights to lower the price of therapies

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Accelerated Approval Study Release - A Vital Pathway for Patients Jun 22, 2022

Show notes

Recorded live at the 2022 BIO International Conference in San Diego, this podcast discusses the results of Vital Transformation's latest research study outlining the impact of proposed changes to the Accelerated Approval pathway, and what this would mean for patients with rare conditions. The study quantifies the impact of the Accelerated Approval pathway in bringing new therapies for unmet needs to market, and the vital role played by small innovative biotech firms in that process.

As well, with the use of the US Government's 'march-in rights' for NIH funded research being discussed as an option to influence pricing and patient access, this podcast also touches on the relative role that private and public R&D serves in the creation of needed new therapies via groundbreaking intellectual property. The podcast features contributions by Nick Shipley, the Executive Vice President of BIO, John Murphy, BIO's Chief Policy Officer & Deputy Counsel, and Joseph Hammang Ph.D., Vital Transformation's US Business Director.

This research was made possible with the support of BIO, Rare Disease Company Coalition (RDCC), Global CEO Initiative on Alzheimer's Disease (CEOi), Sarepta, Travere, Gilead, Alexion and Bristol Meyers Squibb.

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Danny Seiden leads Arizona’s push against march-in rights Jun 15, 2022

Show notes

With the Center for Medicare and Medicaid Services’ recent decision to limit access to Biogen’s Alzheimer’s treatment, and with drug pricing sure to be one of the central issues of the looming mid-term elections, Arizona Senator Kyrsten Sinema’s support of the biopharma sector places her state at ground zero of the drug pricing debate.

Stepping directly into the fray, Danny Seiden, CEO of the Arizona Chamber of Commerce, recently published an article for Real Clear Policy titled Bye-bye Bayh. In it, Danny argues that the recent threats by members of the US Senate to exercise little-known and rarely used legal provisions called march-in rights contained in the Bayh-Dole legislation would, “crush American innovation, creating a new avenue for government to punish companies for bringing products – including lifesaving treatments – successfully to market.”

Phoenix is one of the fastest growing biopharma regions in America, and this is in no small part due to Danny Seiden and the Arizona Chamber of Commerce working with their state and federal representatives to ensure that their economy balances the needs of business and the public. Danny makes a compelling case that the current discussions on drug pricing are rarely based on evidence, and to address rising healthcare costs there is a critical need for market driven solutions which also promote scientific innovation.

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Flagship Pioneering’s Tom Dilenge On Accelerated Approvals Apr 21, 2022

Show notes

One of the brightest minds in DC, Tom Dilenge recently joined Flagship Pioneering, the highly respected bio platforms innovation company behind such groundbreaking startups as Moderna. Tom leads Flagship’s public policy, regulatory, and governmental affairs.

Vital Transformation has worked closely with Tom in his previous role as President of the Biotechnology Innovation Organization (BIO), where he was directly responsible for all their policy, advocacy, communications, legal affairs, and Board governance operations – he had the largest desk plaque in DC.

In this podcast, we discuss several DC proposals trying to change the way accelerated approvals are managed by the FDA, and Vital Transformation’s recently released research and analysis of the impact of CMS’ guidance related to Alzheimer’s disease, which was commissioned and funded by Biogen. The podcast highlights the mounting attacks on the accelerated approval pathway, and the negative unintended consequences that would impact the US R&D ecosystem if it were to be regulated out of existence.

This Vital Health Podcast was recorded on April 1st, 2022, before CMS had finalized its National Coverage Determination of Amyloid treatments for Alzheimer’s Disease. However, the now final CMS policy continues what the podcast participants feel is an unfavorable approach towards amyloid products and accelerated approvals. The views expressed in the podcast are purely those of Vital Transformation LLC and our guest, Tom Dilenge. While Biogen commissioned and funded Vital Transformation’s recent report on CMS’ impact on Draft National Coverage Determination on R&D investments, Biogen did not participate in the content creation.

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George Vradenburg, USAgainstAlzheimer's, and CMS' NCD Apr 08, 2022

Show notes

George Vradenburg is the co-founder and chairman of USAgainstAlzheimer's, a patient advocacy organization founded in 2010, which has successfully worked to increase funding for Alzheimer’s and dementia research. Along with his philanthropic activities, George Vradenburg is also a very successful corporate lawyer and has been the Executive Vice President of AOL Time Warner and the Fox Broadcasting Company.

The podcast discusses the current state of Alzheimer's research and the potential impact of CMS guidance requiring confirming clinical trials for new treatments targeting Amyloid plaques in its prevention. We also highlight a growing consensus of concern surrounding CMS' current guidance as unintended consequences will likely be detrimental to future therapy developments in high unmet medical need areas. The FDA's accelerated approval pathway itself is now also at risk as therapies developed for high unmet medical needs have historically utilized this FDA-approved pathway.

The views expressed in the podcast are purely those of Vital Transformation LLC and our guest, George Vradenburg. While Biogen commissioned and funded Vital Transformation’s recent report on CMS’ impact on Draft National Coverage Determination on R&D investments, Biogen did not participate in the content creation.

See omnystudio.com/listener for privacy information.

Sue Peschin - “CMS is in an untenable position” on Alzheimer’s disease Mar 10, 2022

Show notes

When the Centers for Medicare and Medicaid Services (CMS) published its draft determination requiring further clinical trials in Alzheimer’s disease treatments, Sue Peschin was one of the first to state her opposition to the policy. Sue is the President and CEO at the Alliance for Aging Research, the US’ leading non-profit organization dedicated to improving healthy aging for all. In addition, Sue has also had senior roles at the Alzheimer’s Foundation of America and has been critical of the many efforts to implement one-size-fits-all cost controls under Medicare.

In this Vital Health Podcast, Sue digs into the broader implications of Vital Transformation’s research and analysis of the CMS guidance, which was commissioned and funded by Biogen, and its potential impacts on her Alliance members. We also discuss the many potential unintended consequences of the proposal, including risks to the accelerated approval pathway, and to the development of new treatments in areas of high unmet needs such as neurological disorders.

Sue highlights that CMS’ guidance positions them as a de facto health technology assessment agency and spells out the implications for Medicare program participants. Additionally, we discuss existing case law in America which has previously decided that using QALY (quality adjusted life years) for reimbursement is age discriminatory, further bringing into question the viability of CMS’ Alzheimer’s disease guidance.

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