Medicare Coverage For Aduhelm Conditioned On Randomized Trial Would Be ‘Unusual’ – McClellan

Former CMS chief Mark McClellan discusses what kind of study requirements Medicare might impose if it decides to only cover the new Alzheimer’s drug if in the context of further evidence generation.

Medicare Grappling With Difficult Coverage Decision

The Centers for Medicare and Medicaid Services seems unlikely to require a randomized study for Biogen, Inc. and Eisai Co., Ltd.’s Aduhelm as a condition of Medicare reimbursement based on the agency’s past national coverage decisions, former CMS administrator and current Duke Margolis Center for Health Policy director Mark McClellan suggests.

CMS announced on 12 July it is initiating a national coverage analysis for Aduhelm (aducanumab-avwa) and other amyloid-directed monoclonal antibody...

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