CMS as gate­keep­er: Why lecanemab is sim­i­lar but al­so very dif­fer­ent from Aduhelm

Both ad­u­canum­ab and lecanemab — Ei­sai and Bio­gen’s Alzheimer’s drugs — are not on­ly tar­get­ed at re­duc­ing the clumped be­ta-amy­loid that has mys­ti­fied and en­cour­aged re­searchers for decades, us­ing the same FDA ac­cel­er­at­ed ap­proval path­way, and could al­so put a se­ri­ous dent in Medicare’s bud­get.

Last night’s big un­veil­ing of en­cour­ag­ing da­ta for lecanemab — as clear a win as any in Alzheimer’s — al­so brought back mem­o­ries of Aduhelm’s quick ac­cel­er­at­ed ap­proval and tepid launch, thanks in a large part to CMS’ ul­ti­mate de­ci­sion to re­quire ad­di­tion­al RCT da­ta for the en­tire class of an­ti-amy­loid mAbs.

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