1. Pink Sheet
  2. >>Market Access

Merck’s Winrevair Well Positioned To Benefit From Medicare Part D Redesign

 
• By Cathy Kelly

Significant cost sharing reductions under the redesign will enhance uptake of the pulmonary arterial hypertension drug. The trade-off is a 20% mandatory price discount in the catastrophic phase.

Merck's PAH Drug Is Priced Well Above ICER-Recommended Range • Source: Shutterstock

Merck & Co., Inc.’s new treatment for pulmonary arterial disease, Winrevair, is launching at a time when the burden of patient cost sharing in Medicare Part D is easing considerably, removing a significant potential barrier to access.

Key Takeaways

  • Medicare Part D expected to be important market for Winrevair.

  • Beneficiary cost sharing benefits implemented this year and next in Part D under the redesign will greatly decrease the impact of a high list prices on patients. The drug is priced nearly seven times higher than ICER's top end of the cost-effectiveness threshold

Winrevair (sotatercept) is a first-in-class activin signaling inhibitor for PAH, a rare, progressive disease that affects approximately 40,000 people in the US. It was approved by the US Food and Drug Administration on 26 March and will launch at the end of April as the first drug approved to address the underlying cause of PAH

More from Market Access

More from Pink Sheet

Blenrep’s Revival Gains Steam: EMA Decision Imminent As Japan Approves New Regimen

 
• By Neena Brizmohun

The European Medicines Agency is due to decide whether GSK’s previously approved multiple myeloma drug that was withdrawn from the market in 2022 should be approved again for use in combination with BorDex or PomDex. Meanwhile, Japan today became the second major regulator to approve the Blenrep combinations.

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Smoldering Myeloma Endpoint Questions Carry J&J’s Darzalex Faspro To US FDA AdComm

 
• By Bridget Silverman

The US FDA seeks advice on the clinical meaningfulness of the endpoints of J&J’s AQUILA trial in smoldering multiple myeloma, highlighting the pitfalls of being the first candidate for the precancerous condition.