Medicare Price Offers, Due Feb. 1, Will Be Informed By Therapeutic Alternatives; That’s A Tall Order

 
• By Cathy Kelly
  
Generate a summary of this article
Listen to this article
Beta

Analysis of therapeutic alternatives to Amgen’s Enbrel highlights the complexities involved in identifying appropriate comparators.

It's A Lot More Complicated Than It May Have Seemed • Source: Shutterstock

The Centers for Medicare and Medicaid Services has said it will begin the process of identifying a “maximum fair price” for the 10 drugs chosen for Medicare price negotiation by considering their therapeutic alternatives as a reference point. Researchers at Brigham and Women’s Hospital explored how that process might work using US clinical guidelines and focusing on Amgen, Inc.’s anti-inflammatory Enbrel as a test case.

“We faced several challenges in selecting therapeutic alternatives using clinical guidelines, such as how to reconcile strong recommendations that were...

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

SpotifyApple PodcastsWebsite

More from Medicare

CMS Should ‘Clarify’ That Part B Inflation Rebates Do Not Apply In Medicare Advantage, Pharma Urges

The Centers for Medicare and Medicaid Services is considering imposing price inflation rebates on Part B drugs furnished to enrollees in Medicare Advantage plans in addition to those covered by fee-for-service Medicare.

PS-MarketAccess (Premium-2): Why Financial Scammers Are So Successful Targeting Doctors

 
• By Nabil

Doctors are increasingly falling victim to financial scams due to their high incomes, busy schedules, and trust in professional networks. Recognizing the tactics scammers use and the reasons behind physicians’ susceptibility is essential for protecting medical professionals.

PBM Legislation: Medicare Rebate Reform May Be Challenging Amid Disruption From Redesign

 
• By Cathy Kelly

US lawmakers will undoubtedly continue to work on pharmacy benefit manager reform legislation in 2025, given its bipartisan support. But policies impacting rebates that could lead to higher premiums in Part D may be a tough sell in the midst of the benefit redesign.

Accelerated Approvals In Medicare: CED Guidance Notes Ongoing Concern With Surrogate Endpoints

 
• By Cathy Kelly

Medicare coverage with evidence development final guidance includes few substantive changes from the proposed version despite biopharma stakeholder concerns.

More from Government Payers

PBMs and Vertical Integration: CBO Adds To Growing Concerns About Negative Impacts

 
• By Sarah Karlin-Smith

Congressional Budget Office responses to questions from US lawmakers on pharmacy benefit managers could add to the momentum for PBM reforms to go further than the current leading proposals.

Pink Sheet Podcast: What We Learned From The First Batch Of Medicare Negotiated Drug Prices

 
• By Derrick Gingery, Sarah Karlin-Smith, and Cathy Kelly

Pink Sheet reporter and editors discuss the take-aways from the landmark first Medicare negotiated drug prices and what additional information remains outstanding.

A Better Deal: Medicare Discounts Surpass Estimated PBM-Negotiated Rebates

 
• By Cathy Kelly

But the amount of savings realized when the Medicare negotiated prices go into effect in 2026 remains the subject of debate.