In this issue: Patient perspectives in payer coverage decisions, the IRA’s impact on oncology at #ASCO2025, and more.
National Pharmaceutical Council
Health policy research on value, evidence, innovation & access for patients.
Welcome to NPC This Week! We hope you'll join us each week for a look-ahead at the policy, research, and industry conversations that matter to the future of biopharmaceutical innovation. The DMs are open if you have suggestions — and please share with your network. - Michael Pratt, Devon Bortz, and Haley McKeefer
New From NPC
The Patient Perspective in Coverage Decisions: A new commentary in Health Affairs Forefront co-authored by NPC Chief Strategy Officer Kimberly Westrich discusses why intentional systems and processes are needed to successfully integrate the patient perspective into payer coverage decisions. The commentary draws on lessons from patient advocacy, patient-centered research, and value assessment to explore how to move beyond token patient inclusion.
Drug Price Evaluations a "Tool, Not a Rule": NPC Chief Science Officer Jon Campbell joined host Dr. Melanie Whittington on the latest episode of the Leerink Partners ’ "Perspectives" podcast for a conversation on drug price evaluations and the importance of recognizing the need for complexity, nuance, and judgment in health technology assessments@. They also discussed recent NPC research collaborations with Dr. Whittington in AJMC and Value in Health. Listen here on Apple Music or here on Spotify.
The IRA and Oncology Treatments: New research from NPC, "Early Signals of Inflation Reduction Act Impact on Small-Molecule versus Biologic Post-Approval Oncology Trials," explores the impact of IRA’s passage on industry-sponsored small-molecule and biologic post-approval clinical trials in oncology. The study abstract will be presented during the May 31 poster session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
A More Detailed Picture of Access to Cancer Treatments: Another new study from NPC, "Access to Initial and Subsequent Indications of New Oncology Drugs: A US-Canada Comparison," compares the access landscapes, including regulatory and HTA submissions and decisions, of both the United States and Canada in multi-indication oncology drugs. The research is also being released this week at ASCO.
Industry News
Updated CDC Recommended Immunization Schedule: FDA leaders Drs. Vinay Prasad and Marty Makary joined HHS Secretary Robert F. Kennedy in announcing that the COVID vaccine has been removed from the CDC recommended immunization schedule for healthy children and pregnant women. The decision follows their editorial in The New England Journal of Medicine ( NEJM Group ) on establishing new requirements for COVID-19 vaccine manufacturers. STAT's story on the updated guidelines cited experts who said the move to bypass consultation with the Advisory Committee on Immunization Practices is unprecedented.
Washington Post Calls Out the "Real Cost" of Most Favored Nation: The Washington Post published two opinion articles from its Editorial Board warning that MFN pricing is "unlikely to deliver better health outcomes" better health outcomes" and "risks choking off global pharmaceutical innovation."
Agency Actions on Drug Pricing and Transparency: Following recent executive orders, several U.S. agencies issued press releases outlining new actions to measure and lower domestic drug prices.
Part B Coinsurance Adjustments Cause Cost Fluctuations: Adam Fein of Drug Channels Institute’s latest analysis of IRA impacts spotlights how inflation-based coinsurance adjustments in Medicare Part B are causing some patients to experience unexpected increases in out-of-pocket costs.
ICYMI
House Passes Package With PBM, Medicare DPNP Reform: In a narrow 215-214 vote, the U.S. House passed the "One Big Beautiful Bill Act" last Friday. It includes provisions to expand the exclusion of orphan drugs from Medicare price negotiations and prohibit PBMs from the practice of spread pricing under Medicaid. Endpoints News, BioSpace, and Fierce Healthcare report more details. In addition to the provisions included in the House Reconciliation Bill, the Orphan Cures Act was introduced in the Senate.
Makary Defends FDA Budget, Staff Cuts at Hearing: FDA Commissioner Martin Makary appeared before a Senate Appropriations subcommittee to discuss a proposed $6.8 billion budget to fund the FDA in FY 2026, down 11.5% from its current budget. Makary assured senators that recent agency actions will not affect user fee goals or delay access to therapies.
Reuters Report Skewed by Ultra-Rare Therapies: Adam Fein of Drug Channels Institute, an HMP Global Company called out the lack of statistical rigor used in a recent Reuters survey, of 45 novel medicines launched in 2024, saying it overweighted "ultra-rare, high-cost therapies."
IRA on Out-of-Pocket Cost Changes: The Pioneer Institute for Public Policy Research published a dashboard that tracks access and affordability of the IRA’s price-controlled medications for Medicare beneficiaries. The findings show that average OOP costs across nine negotiated drugs increased by 32%.
AEI on CBO: American Enterprise Institute ’s Kirsten Axelsen and Brian Miller say that the Congressional Budget Office’s model for drug development is missing key attributes, including post-approval research, capital mobility in a global world, and health impacts.
Value Viewpoint: In her latest "Value Viewpoint," Ms. Westrich reviews ICER’s protocol for their new annual Launch Price and Access Report and shares patient-focused research published in Value in Health.
Mark Your Calendar
May 28-30: Join NPC President and CEO John O'Brien at the 25th annual Model N | Rainmaker conference in Austin, TX. Dr. O'Brien will participate in a panel on Thursday, May 29 from 11:00 – 11:45 AM CT on the "Life Sciences Industry Outlook." Jesse Mendelsohn of Model N , John D. Shakow of King & Spalding , and Brian McCartney of McKesson will join Dr. O'Brien for a conversation on the latest trends shaping revenue management, regulatory compliance, and market access. Don't miss out on this unique opportunity to hear diverse perspectives on the key challenges and opportunities facing the industry and gain actionable takeaways to navigate the evolving landscape.
May 30 – June 3: NPC is headed to Chicago for the 2025 ASCO Annual Meeting. The team will share new research on "Access to Initial and Subsequent Indications of New Oncology Drugs: A US-Canada Comparison" and "Early Signals of Inflation Reduction Act Impact on Small-Molecule versus Biologic Post-Approval Oncology Trials" — with a poster presentation of the latter occurring on May 31.
June 8-10: "Healthcare’s Defining Moment" — Join NPC at the US ACCESS Forum 2025. NPC President and CEO John O’Brien will deliver the keynote address at ACCESS US'25 in Austin, TX (June 8-10), exploring the critical challenges facing healthcare access in the new Trump Administration era. As the landscape transforms under Trump 2.0, this isn't just another conference — it's an essential strategic summit for healthcare leaders that will tackle:
Beyond provocative discussions, ACCESS US'25 offers hands-on workshops and executive roundtables to generate real solutions to your most pressing challenges. The question isn't whether healthcare faces disruption in 2025 — it's whether you'll be positioned to transform challenge into opportunity. Will your organization be represented at what has become the "Davos of Access"? See you in Austin to ensure you're shaping healthcare's future, not watching from the sidelines.
On June 9, from 9:15 AM – 10:00 AM CT, Dr. O’Brien will deliver the keynote presentation on "Healthcare Evolution in the Trump Administration." Then, from 10:00 AM – 11:15 AM CT, Dr. O’Brien will join a plenary session panel alongside Mark Hansan of CareMetx, LLC , Sarah Emond of ICER, and Scott Howell of Blue Line Advisors, Inc. . Mr. Hansan and Dr. Howell host the "Prescription for Better Access" podcast, and will record an episode live — covering the panel’s conversation on the "Future of US Drug Pricing and Patient Access."
June 9: NPC Chief Strategy Officer Kimberly Westrich will speak on a panel at the National Alliance of Healthcare Purchaser Coalitions' PBM Hub on “Inside the PBM Maze.” Moderator Cheryl Larson of the Midwest Business Group on Health will lead a discussion between Ms. Westrich, Chris Antypas of Henderson Brothers, Inc. , and Candace Shaffer of Purdue University on the mechanics, incentives, and evolving landscape of PBMs. The PBM Hub is exclusively available to employers and participation is free.
June 10: At the National Alliance of Healthcare Purchaser Coalitions 2025 Strategic Leadership Summit, NPC President and CEO John O’Brien will join Greg Baker of AffirmedRx, a Public Benefit Corporation for a conversation on "Flipping the Script: Employers Driving PBM Transparency and Trust." Learn how employers/plan sponsors can and are flipping the script — pushing PBMs toward greater accountability and rebuilding mutually beneficial and respectful partnerships.
June 15-19: At the DIA 2025 Global Annual Meeting in Washington D.C. on June 16, NPC Senior Director of Research Julie Patterson will join Sarah K. Martin of Eli Lilly and Company , Ryan Gough of Woodberry Associates , and Richard Xie of RA Capital Management for a forum discussion on "Unintended Consequences: Effects of the Inflation Reduction Act on the Future of Pharmaceutical Innovation."
June 16: On June 16, NPC Chief Science Officer Jon Campbell will participate in a debate and networking event hosted by Costello Medical . Dr. Campbell will go head-to-head with Paul Jeffrey of MassHealth on how "The IRA and State PDABs Are Taking Effect — What’s Next?" Discussions will focus on potential effects on R&D, actual savings for CMS, manufacturer engagement, and whether the IRA process is driven by science, value, or politics. The event will take place in downtown Boston from 6:00 – 8:00 PM and is free to attend (but registration is required).
June 16-19: Join NPC President and CEO John O’Brien at the 2025 BIO International Convention, held this year in Boston, MA. On Thursday, June 19, at 9:00 AM ET, Dr. O’Brien will moderate a panel discussion on "Accelerated Approval and Patient Need: The Value of Earlier Access" between Jeff Allen of Friends of Cancer Research , Bradley Campbell of Amicus Therapeutics , Annie Kennedy of the EveryLife Foundation for Rare Diseases , Silas Martin of Johnson & Johnson Innovative Medicine , and Sue Peschin of the Alliance for Aging Research .