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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.’s as-of-then-still-unapproved Leqembi (lecanemab) of a clinical benefit...

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