In this issue: 340B reform, FDA accelerated approvals, and more.
National Pharmaceutical Council
Health policy research on value, evidence, innovation & access for patients.
December 10, 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.
- Michael Pratt, Devon Bortz, and Haley McKeefer
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NPC Highlights
ICER UPI Reports Misrepresent Spending Changes: Ahead of the 2024 Unsupported Price Increase (UPI) reports, a new NPC study published in the Journal of Medical Economics evaluates how these reports lacked critical inflation adjustments, overstating estimates of drug spending. As a result, NPC continues to view ICER’s UPI reports as doing more harm than good.
Value Viewpoint: In her latest "Value Viewpoint," NPC Chief Strategy Officer Kimberly Westrich reviews a Value in Health article on the challenges of quality-of-life estimation when health states fluctuate, as well as new research — co-authored by NPC Chief Science Officer Jon Campbell — on the tradeoffs between cost-effectiveness analysis modeling approaches.
Industry News
340B in the News: Yesterday, Bloomberg Law reported that the U.S. Supreme Court decided not to review a challenge to an Arkansas law that removes manufacturers’ ability to impose conditions on the use of contract pharmacies under the 340B Drug Pricing Program.
Recommended by LinkedIn
New Guidelines on Accelerated Approval: The FDA has issued new draft guidance on accelerated approval that sets guidelines for conducting confirmatory trials and considering surrogate endpoints. The guidance would also establish new procedures for withdrawing products from the market if they fail to demonstrate clinical benefit.
NPC on Accelerated Approval: An NPC analysis published by the AJMC - The American Journal of Managed Care in August details how the Accelerated Approval Program is succeeding in expediting new treatments for patients with serious conditions and areas of high unmet medical needs.
ICYMI
Cuban Discusses “Battle with PBMs”: Mark Cuban of Cost Plus Drugs Marketplace (For Business) recently participated in a fireside chat with Zeke Emanuel of Penn’s Leonard Davis Institute of Health Economics to discuss the misaligned incentives of the pharmacy benefit manager (PBM) system. Cost Plus CEO Alex Oshmyansky, MD, PhD also appeared on the Rapid Response podcast presented by Fast Company .
Analysis of Ultra-Orphan Drugs: A new study published in Value in Health by researchers at the Center for the Evaluation of Value and Risk in Health (CEVR) indicates that ultra-orphan drugs offer larger incremental health gains compared to nonorphan therapies for more prevalent conditions.
Same Drug, 2,200 Different Prices: Jared Hopkins and Josh Ulick of The Wall Street Journal highlight new research on the complicated network of PBMs and how the system can result in varied drug pricing in Medicare plans by negotiating several different rates for the same medicine.
RSV Vaccination Is Cost-Effective: Two studies in Pediatrics report that seasonal maternal RSV vaccination and nirsevimab for infants are cost-effective. Overall, researchers found that broad delivery of these immunizations could significantly reduce the burden of disease.
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.” More information to come.