In this issue: Improving access to gene therapies, the IRA’s impact on oncology R&D, 340B abuse harm to patients and employers, and more

November 19, 2024

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.

Please note: We will be taking a week off from NPC This Week next Tuesday (November 26) in observance of the Thanksgiving holiday. Look for us in your inbox again on Tuesday, December 3!

- Michael Pratt, Devon Bortz, and Haley McKeefer

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NPC Highlights

A Holistic Examination of Gene Therapy Access: The paradigm shift in science represented by gene therapies poses new challenges that are preventing optimal patient access and failing to fully account for the value of these innovative treatments. A new NPC analysis published today in the Journal of Comparative Effectiveness Research provides a more holistic multistakeholder examination of the unique policy challenges and opportunities for addressing those challenges.

IRA Changes the Math for Oncology R&D: Experts — including NPC Chief Science Officer Jon Campbell — warn Oncology News Central that the Inflation Reduction Act (IRA)’s Medicare Drug Price Negotiation Program (DPNP) may reduce investment in the development of new oncology therapies or the pursuit of subsequent indications.

• NPC Research Cited: “Recent data presented this year by the National Pharmaceutical Council (NPC), which researches health policy related to innovative biopharmaceuticals, suggest that reductions in postapproval trials of various drug classes are already occurring in the wake of the IRA.”
• More From PhRMA: A new PhRMA blog details how the IRA will jeopardize patient access to oncology therapies by discouraging the pursuit of subsequent indications, citing NPC research on the vital role of post-approval R&D in improving outcomes for patients.

Lessons From CMS’s Patient-Focused Listening Sessions: Katie McCool of The Evidence Base reviews NPC’s quantitative analysis of the Fall 2023 CMS-hosted patient-focused listening sessions for each of the first 10 drugs selected for the IRA’s Medicare DPNP. NPC’s analysis highlights several gaps in CMS’s process of obtaining stakeholder input and identifies opportunities for the agency to improve the structure and effectiveness of future events.

Informing the 340B Abuse & Misuse Discussion: Last week, during a webinar hosted by Colorado Politics and sponsored by PhRMA and the Colorado BioScience Association , Dr. Campbell joined a panel to discuss misuse of the 340B program — to the detriment of patients and employers.

Value Viewpoint: In her latest "Value Viewpoint," NPC Chief Strategy Officer Kimberly Westrich reviews new research using the Generalized Cost-Effectiveness Analysis (GCEA) framework to capture broader societal benefits in value assessment, the launch of the Health Economics Methods Advisory (HEMA) group — a new joint undertaking by HTA organizations in the U.S., Canada, and England, and more.

Industry News

Congressional Health Policy in 2025: Pink Sheet’s Cathy Kelly explores what a Republican-controlled White House and Congress might consider on policy issues such as 340B and IRA reform.

• Lame Duck Outlook for PBM Reform: Analysts tell Modern Healthcare that Congress could pass PBM reforms into law during the post-election “lame duck session,” though leaders may opt to wait until the new Congress is sworn in next year.

Importing Drug Pricing Policy Ideas: Kirsten Axelsen , a visiting scholar with the American Enterprise Institute and a Senior Policy Advisor for DLA Piper , writes that policies that would “exert more government pricing power over medications” could damage the U.S. biopharma economy.

ICYMI

Kennedy Nominated as HHS Secretary: On Thursday, Politico scooped that President-elect Donald Trump will nominate Robert F. Kennedy Jr. to lead the U.S. Department of Health and Human Services (HHS) . STAT News shared reactions from scientists and industry executives.

Market Forces Driving Biosimilars Uptake: In Health Affairs, two researchers from the Harvard T.H. Chan School of Public Health examined the regulatory and market forces driving biosimilar uptake in the U.S. and found evidence to suggest “the maturing postapproval biosimilar marketplace is flourishing.”

Survey Reports Low Awareness of PBMs: A Navitus Health Solutions survey of 2,000 people found that nearly half of American adults had difficulty accessing medicines due to price. Though challenges to access are widespread, 75% of respondents age 18 and older could not define what a PBM is, and 84% couldn’t name a single entity.

IRA Impacting Viability of Medicare PDPs: In reviewing CMS data, Drug Channels Institute revealed that the number of Medicare Part D prescription drug plans (PDPs) will hit a historic low as a result of the IRA.