In this issue: What will PBM reform look like, 340B in the states, the IRA’s impact on postapproval research, NPC’s 2025 board leadership, and more.

December 17, 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.

Note: NPC This Week will pause over the holidays. Look for us again in your inbox on Tuesday, January 7, 2025!

Happy Holidays!

- Michael Pratt, Devon Bortz, and Haley McKeefer

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NPC Highlights

ICER UPI Report Continues to Do More Harm Than Good: The Institute for Clinical and Economic Review released the latest iteration of its consistently flawed Unsupported Price Increase report, and once again, the report has substantial methodological limitations that undermine the reliability and applicability of the findings. NPC published a blog outlining the limitations of the report and shared our evidence with STAT and Endpoints News.

• NPC Quoted in STAT: “If ICER simply followed this best practice for economic analysis and inflation-adjusted their findings using the CPI-U (for all urban consumers), the estimated $815 million ‘increase’ in this year’s report disappears, becoming instead a $10 million decrease, causing the premise of the entire report to collapse.”

• Importance of Inflation Adjustment: An NPC study published earlier this month in the Journal of Medical Economics evaluates how ICER’s UPI previous reports lacked critical inflation adjustments, therefore producing overstated estimates of drug spending.

The Risks of Government Price Setting: NPC Senior Director of Research Julie Patterson writes in CQ Researcher about how the regulation of U.S. drug prices can have unintended consequences on patient access and reduce the number of new breakthroughs.

• From Dr. Patterson: “Good policy based on sound evidence should focus on the true long-term problem — patient access to medicines — without compromising access to future innovation.”

CMS Model for Sickle Cell Gene Therapies: Medicare administrators announced that two manufacturers will participate in a new access model for cell and gene therapies to expand access to sickle cell disease treatments. The Evidence Base cited recent NPC research that identified treatments for sickle cell disease as a potential test case for outcomes-based agreements.

• NPC Perspective: “SCD could serve as a reasonable test case for [outcomes-based agreements], as it is a disease with outcomes that can potentially be tracked efficiently and objectively. However, selecting appropriate outcomes for SCD poses several challenges.”

340B Debate in Colorado: In an article for Colorado Politics, journalist Thelma Grimes discusses how Colorado state legislators and healthcare groups are preparing for a robust policy debate about the 340B program. The article cites comments from NPC Chief Science Officer Jon Campbell at a November forum sharing the cost of the program to self-insured employers.

NPC Announces New Board: NPC announced its Board Leadership for 2025, including that Jen Norton, Senior Vice President, Head of U.S. Patient and Market Access, Takeda, will serve as Chair of NPC’s Board of Directors. The announcement was covered by Chain Drug Review, and more information about the 2025 NPC Board of Directors and Executive Committee can be found on the NPC website.

Industry News

PBMs and Congress: Everyone is waiting to see what final provisions will be included in the continuing resolution that emerges from Congressional negotiations this week — and reading stories like this from reporters including STAT Chief Washington Correspondent Rachel Cohrs Zhang while they wait.

Potential IRA Impacts on Postapproval Cancer Research: Experts writing for Health Affairs Forefront reviewed the body of research around the potential dampening effects of the Medicare Drug Price Negotiation Program (DPNP) on postapproval research in oncology — spotlighting how the program will hinder the development of small molecule and orphan drugs.

• Go Deeper: An NPC study in Therapeutic Innovation & Regulatory Science offers drug-level insights about development pathways in oncology and how the Medicare DPNP may negatively impact subsequent indications.

Part D Preferred Tiers Lacking Majority of Generics: A new Avalere analysis found the number of generic prescription drugs included in Medicare Part D plans' preferred formulary tiers declined from 65% to 43% over the last nine years.

U.S. Leads EU in Speed of Approvals: Between 2014 and 2022, new medicines were approved an average of 0.4 years faster in the United States compared to the European Union; a difference IQVIA attributes, in part, to the use of expedited review programs.

ICYMI

“Best 8% of Our Healthcare Dollar”: As highlighted by Drug Channels Institute, an HMP Global Company's Adam Fein on LinkedIn, biotechnology investor Dr. Peter Kolchinsky wrote a piece for Rapport this week about the “incredible bargain” of novel branded medicines in the U.S. and how their value creates a long-term impact on biopharmaceutical innovation, and ultimately, their benefit to American society.

Podcast on Advancing Patient Priorities: In the latest episode of Patient Advocacy Voices, hosts Eric Racine, PharmD, MBA and Demetra Anastasiadis, PharmD, BPS welcome Randall Rutta, CEO of the National Health Council, to discuss NHC’s resource hub for patient advocacy communities and how the organization develops a matrix of policy priorities on behalf of nearly 200 members.

RAND Analysis of Net Prices & Rebates: An initial RAND analysis of Prescription Drug Data Collection (RxDC) data reported to the U.S. government by commercial insurers and group health plans estimates the net-to-gross bubble for prescription costs in the commercial market; however, data inconsistencies limit the report’s findings.

340B Duplicate Discounts: Two fellows from the Pioneer Institute for Public Policy Research, a Massachusetts-based public policy research organization, wrote an op-ed for RealClearHealth on the issue of duplicate discounts in the 340B program and how drug manufacturers and third-party administrators are left to “resolve the issue” despite the “many actors in the system” profiting from the unlawful practice.

Lawmakers Will Unveil Hep C Bill: A pair of bipartisan lawmakers plan to introduce a bill to create a national subscription-type model for hepatitis C medication that could save the government more than $6 billion.

Value Viewpoint: In her latest "Value Viewpoint," NPC Chief Strategy Officer Kimberly Westrich updates the “Eye on ICER” calendar and reviews ICER’s Draft Evidence Report’s assessment of suzetrigine for treating acute pain.

Mark Your Calendar

January 13-16: NPC President and CEO John O’Brien will speak at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, CA. This premier investment symposium connects global industry leaders, emerging fast-growth companies, innovative technology creators, and members of the investment community.

February 28: NPC President and CEO John O’Brien will speak at the Wharton Health Care Business Conference in Philadelphia, PA. The theme of this year’s conference is “Beyond Disruption: Building Lasting Health Care Transformation.”