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.
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Medicare Draft NCD For Alzheimer's Drugs: When 'Reasonable And Necessary' And 'Safe And Effective' No Longer Align
Proposed decision withholds Medicare coverage from current and future amyloid-directed monoclonal antibody drugs for Alzheimer’s disease unless patients are enrolled in a randomized clinical trial.
US biopharma stakeholders are getting a taste of how a single payer health care system can shape the fate of a new treatment with Medicare’s national coverage determination for amyloid-directed Alzheimer’s drugs including Biogen/Eisai’s Aduhelm.
Biogen suggests potential precedents in past coverage decisions for upcoming Medicare determination on Aduhelm and other amyloid-directed monoclonal antibodies during earnings call.