Healthcare Policy Pop - Patients Rising Now

Latest Episodes:

Accelerated Approval Misconceptions + IRA Investing Impacts Sep 14, 2023

Show notes

Joseph Hammang, Ph.D., Partner at Vital Transformation Healthcare Consultancy, says some of the backlash against accelerated approval comes from those not informed on the process; Hammang also says impacts from the Inflation Reduction Act have some investors wary; and The Wall Street Journal has a new article stating generic drugs should be cheaper, but insurers are charging thousands of dollars for them.

Vital Transformation Webpage

The Wall Street Journal News Article: Generic Drugs Should Be Cheap, but Insurers Are Charging Thousands of Dollars for Them

IRA’s Impact on Drug Development Sep 12, 2023

Show notes

John Stanford with Incubate explains how the Inflation Reduction Act has already begun to deter investments in drug research and development; Patients Rising issues a statement calling for progress on several key healthcare issues, including PBMs; and a new white paper from Sen. Bill Cassidy looks at the impacts of AI on healthcare, including patient privacy.

Incubate Webpage

Axios: Drugmakers, investors say they’ve already changed bets in IRA’s first year

Patients Rising Now Webpage: Patients Rising Now Issues ‘Must Pass for Patients’ List for Congress

Ranking Member Cassidy Releases White Paper on Artificial Intelligence

Listen: AI Privacy Concerns + Accelerated Approval Benefits

CMS Price Negotiations + Patient-Centered Outcomes Sep 07, 2023

Show notes

In the wake of Medicare’s announcement of the first 10 drugs subject to price negotiations, Patients Rising CEO Terry Wilcox outlines the need for greater patient involvement in this process; Taylor Schwartz of Avalere explains a new white paper that analyzes the use of patient-centered outcomes in ICER reviews; CMS issues draft guidance on new Medicare Part D smoothing program.

Patients Rising Calls on CMS to Engage with Patients in Drug Price Negotiations

Patients Rising Now Comments: Medicare Drug Price Negotiation Program Guidance Memo

CMS Webpage: Medicare Drug Price Negotiation Program

Avalere Webpage: Use of Patient-Centered Outcomes in ICER Assessments

Biosimilars Reshape the Market Jul 27, 2023

Show notes

Avalere releases a study focused on ICER assessments and whether or not they take into account the patient experience when creating their reports; Wayne Winegarden, a Senior Fellow with the Pacific Research Institute explains how new Humira biosimilars have affected the market and their possible effect on PBMs; and drug shortages are worsening, and this time they’re affecting diabetes medications.

Avalere Webpage: Use of Patient-Centered Outcomes in ICER Assessments

Patients Rising Now Comments

Fierce Pharma News Article: Eli Lilly's Mounjaro shortage worsens ahead of potential obesity FDA approval

Prior Authorization Consequences + Fast-Tracked FDA Approvals Jul 25, 2023

Show notes

MacKay Jimeson, Acting Executive Director of Patients Rising Now, wants lawmakers to stand behind the accelerated approval program; Jody Quinn, a patient from Massachusetts’ 13th congressional district who lives with psoriatic disease, says prior authorization led to long-term joint damage after her treatment was denied three times; and the Patients Rising community will observe the 33rd anniversary of the Americans with Disabilities Act on July 26th.

Patients Rising Now Report: The Value of Accelerated Approval for Patient Access & Future Medical Advances

Bloomberg Law News Article: Alzheimer’s Drug Approval Fuels Debate on Medicare’s Decisions

House Committee on Energy & Commerce Meeting

Health Leaders News Article: Most Patients Experiencee Barriers to Care from Insurers

ADA Anniversary

Accelerated Approval on the Hill Jul 20, 2023

Show notes

MacKay Jimeson, Acting Executive Director of Patients Rising Now, previews Monday’s accelerated approval hill briefing, which is open for staff to attend; Mel Mann, the longest-living Gleevec patient, discusses how accelerated approval saved his life and will speak at Monday’s hill briefing.

House Energy and Commerce Committee: Chair Rodgers Opening Statement on Spurring Lifesaving Medical Innovation

The Mel Mann Story: From Terminal Cancer to 28 Year Survivor (Long Version)

Patients Rising Podcast

340B Fallout + Cancer Drug Shortages Jul 18, 2023

Show notes

Bill Smith, Senior Fellow at the Pioneer Institute, explains a ruling from the Supreme Court regarding the 340B program; Patients Rising Now’s briefing on Accelerated Approval will be held Monday, July 24th; Ted Okon, Executive Director of the Community Oncology Alliance, updates us on where we’re at with the cancer drug shortage and gives policy solutions; the Senate Finance Committee has announced the July 26th markup of their PBM proposal; and the House Energy and Commerce Committee is urging CMS to provide transparency to patients in the coverage determination process.

Pioneer Institute Webinar: The Patient Cost of Copay Accumulator & Maximizer Programs

Senate Finance Committee News Release: Wyden, Crapo Announce Finance Markup of Pharmacy Benefit Manager Proposals

Energy and Commerce Committee News Release: Chairs Rodgers, Smith Lead Members in Urging CMS to Provide Transparency to Patients in Coverage Determination Process

AI Privacy Concerns + Accelerated Approval Benefits Jul 13, 2023

Show notes

Brett Meeks, Executive Director of the Health Innovation Alliance, is working to make sure everyone gets on the same page on the issue of health privacy and AI; The Pioneer Institute on Public Policy Research will host a webinar next week; Patients Rising Now will host a briefing on Accelerated Approval on Monday, July 24th; and Ivy Elkins, a patient advocate from Illinois’ 9th Congressional District, says she wouldn’t be alive without accelerated approval.

Health Innovation Alliance

U.S. Senate Committee on Judiciary Hearing: Artificial Intelligence and Intellectual Property

Pioneer Institute Briefing: The Patient Cost of Copay Accumulator & Maximizer Programs

Patients Rising Stories

Alzheimer’s Breakthrough + Biosimilar Landscape Jul 11, 2023

Show notes

Sue Peschin, President and CEO of the Alliance for Aging Research, says Medicare coverage for Alzheimer’s drugs is something millions across the country truly care about as an election year nears; the Biden Administration is taking action to limit insurance “junk fees” for patients; Patients Rising Now will host a Hill briefing on Accelerated Approval on Monday, July 24th; and Sarah Ikenberry, Senior Communication Advisor for the Office of Therapeutic Biologics and Biosimilars at the FDA, discusses the biosimilar landscape as new Humira biosimilars hit the market.

Alliance for Aging Research Poll: Huge Majorities Want Medicare to Cover Cost of Alzheimer’s Drugs

FDA Webpage: Biosimilars

Real Clear Markets OpEd: Promising New Alzheimer's Drug Calls for CMS to Rethink Access Restrictions

Home Health Hiccup + Rare Disease Priorities Jul 06, 2023

Show notes

Joanne Cunningham, CEO of the Partnership for Quality Home Healthcare, discusses the robust support for home health even as CMS aims to cut funding; Jeffrey Oldham, Director of State Government Relations and Advocacy for the Rare Access Action Project, explains how his group is working to expand access and coverage for patients with rare disease; the Patients Rising’s Patient Access and Affordability Project will host a Hill briefing on accelerated approval on Monday, July 24th; and Patients Rising Now has submitted comments to the FDA on its incorporation of patient experience data when making decisions on new drugs.

Partnership for Quality Home Healthcare Webpage

Rare Access Action Project Webpage

The Value of Accelerated Approval for Patient Access & Future Medical Advances Event