The Centers for Medicare and Medicaid Services’ draft decision to condition Medicare coverage for amyloid-directed monoclonal antibody drugs for Alzheimer’s disease on patient participation in qualifying randomized clinical trials signals we may be entering an era where Medicare reimbursement is no longer a given for a drug once it is approved by the US Food and Drug Administration.
The decision if finalized will govern reimbursement by the largest US payer for the Alzheimer’s drugs. It will apply to Biogen, Inc. and Eisai Co., Ltd.’s currently marketed Aduhelm (aducanumab) as well as drugs still in development, like Eli Lilly and Company’s donanemab, Eisai’s lecanemab and Roche Holding AG’s gantenerumab