Health Affairs June 23, 2023
On July 6, 2023, the Food and Drug Administration (FDA) is expected to decide whether to grant traditional approval for Leqembi (lecanemab), a monoclonal antibody (mAb) for patients with mild cognitive impairment or mild Alzheimer’s disease. Lecanemab received accelerated approval in January 2023. Assuming the FDA grants traditional approval, as most experts anticipate (a prospect made more likely by the FDA Advisory Committee 6-0 vote on June 9 that the drug shows “clinical benefit”), all eyes will turn to the Centers for Medicare and Medicaid Services (CMS), the payer responsible for most patients eligible for the product. The case has enormous implications for patients and caregivers, as well as substantial access, budgetary, policy, and political ramifications.
On June 1, 2023,...
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