FDA approves Alzheimer’s treatment Leqembi, clearing the way for Medicare coverage

The U.S. Food and Drug Administration on Thursday granted full approval to the Biogen BIIB and Eisai Co. Ltd. ESALF Alzheimer’s treatment Leqembi, a step that secures Medicare reimbursement for the first drug shown to slow the progress of the disease, rather than just treating its symptoms.

Leqembi, also known as lecanemab, is a monoclonal antibody designed to reduce the buildup of amyloid beta plaque in the brain, a marker of Alzheimer’s disease. The FDA in January granted Leqembi accelerated approval, which allows for earlier approval of drugs that treat serious conditions where there is an unmet medical need, even while studies to confirm the expected clinical benefit are ongoing. In a late-stage trial, the treatment slowed declines in cognition and function by 27% compared with a placebo over 18 months.

Even with Medicare coverage, however, Leqembi may remain out of reach for many patients, policy experts say. With a list price of $26,500, Medicare patients taking the drug will have to pay more than $5,000 per year out of pocket, based on the 20% coinsurance required in traditional Medicare — and Medicare beneficiaries have a median income of about $30,000, according to health policy nonprofit KFF. People with supplemental insurance, such as Medigap, may have lower out-of-pocket costs.

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