Medicare’s Final Coverage Decision On Alzheimer’s Drugs: Thoughts From A Former CMS Chief

Mark McClellan discusses whether CMS’s pending final version of the Medicare national coverage determination on Alzheimer’s drugs might change from the draft and whether the decision should be viewed as a precedent for drugs granted accelerated approvals.

National Medicare Coverage Policy Coming In April • Source: Alamy

In its upcoming final national coverage determination, the Centers for Medicare and Medicaid Services seems unlikely to withdraw its decision that Medicare will only cover amyloid-directed monoclonal antibody drugs for Alzheimer’s disease in the context of a randomized clinical trial, former CMS administrator Mark McClellan suggests.

A draft version of the national coverage determination on the drug class was released on 11 January, triggering concerns that it would effectively shut down access to Biogen, Inc. and Eisai Co., Ltd.’s currently marketed Aduhelm (aducanumab) for at least four years, while threatening prospects for similar drugs in development from Eisai, Eli Lilly and Company and Roche Holding AG/Genentech, Inc

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