Could Aduhelm Be Taken Off Market If CMS Proposal Stands? ‘Everything Is On The Table,’ Biogen Says
Company execs say there has been four-fold increase in doctors infusing the Alzheimer’s drug and despite lack of support from major institutions, individual physicians at Cleveland Clinic and elsewhere have voiced support for Aduhelm. Biogen is “cautiously optimistic” about lecanemab Phase III trial.
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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.
The Alzheimer’s drug’s price was cut to $28,200 per year just one month before CMS is expected to issue a draft national coverage determination for amyloid-clearing antibodies, raising questions about the timing.
Following Biogen’s lead with Aduhelm, the first disease-modifying Alzheimer’s therapy approved in the US, Eisai began a rolling BLA submission for lecanemab (BAN2401) ahead of next year’s Phase III results.