1. Pink Sheet
  2. >>Market Access

Medicare Coverage For Leqembi: Timeline For Reconsideration Of Restrictions

 
• By Cathy Kelly

After getting a formal request for Medicare to reconsider coverage for Eisai’s new drug and other mAbs, CMS must decide by mid February whether to undertake the process. The formal timeline for reconsideration runs six to 12 months; past reviews have taken around nine months.

Eisai Optimistic That Reconsideration Won't Take Too Long • Source: Shutterstock

One indication of how swiftly the Centers for Medicare and Medicaid Services may be prepared to revise its national coverage determination for monoclonal antibodies to treat Alzheimer’s will come by 17 February. That’s the date by which CMS must officially accept or reject a request by the the Alzheimer’s Association to reconsider its NCD, which essentially limits Medicare coverage to fully approved drugs, and only then when there is additional evidence collection.

The Alzheimer’s Association submitted its request in a 19 December letter citing Phase III data from Eisai Co., Ltd./Biogen, Inc

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Market Access

More from Pink Sheet

FDA Adcomms Are Back: Four Cancer Drugs, COVID-19 Vaccine Formulations To Get Reviews

 
• By Sue Sutter and Bridget Silverman

The Oncologic Drugs Advisory Committee will meet for two days in mid-May, followed by a Vaccines and Related Biological Products Advisory Committee’s review of the 2025-2026 COVID-19 vaccine formulation.

Brazil To Upgrade Pricing Framework To Keep Up With Market Developments

 
• By Francesca Bruce

Brazil plans to clarify its medicine pricing framework, for example by outlining the procedures for setting medicine prices and bring it up to date with recent developments in the sector.

England: HTA Sandbox Helping To Assess ‘Challenging’ Drugs And Indications

 
• By Eliza Slawther

England’s health technology assessment institute explains how its sandbox environment is helping to test new evaluation methods for drugs or indications with which it does not have experience, such as metabolic dysfunction-associated steatohepatitis.