Biogen Asks Medicare For Aduhelm Coverage With Real-World Evidence Development
Three-part RWE plan offered as alterative to CMS’ restrictive draft national coverage determination that would require randomized controlled trials. Biogen wants to generate more data on its Alzheimer’s product using a registry, a research network, and Medicare claims data.
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Not All mABs For Alzheimer’s Are Created Equal, Manufacturers Tell Medicare
Lilly, Eisai and Genentech argue against CMS’s class-wide approach in its coverage for amyloid-directed monoclonal antibodies, predicting research on their in-development for Alzheimer’s drugs will provide confirmatory evidence of clinical benefit in the months ahead.
Medicare May Scale Back Coverage Restrictions For Alzheimer’s Drugs; Will It Be Enough?
Even if the final Medicare national coverage decision switches to a registry, Aduhelm access will still be too limited, patient advocates worry, prompting them to ‘move the conversation’ to Congress for relief. Prospects for a new Republican majority in the House could help.
Medicare’s CED For Alzheimer’s Drugs May Exceed Statutory Authority, Former HHS Attorneys Say
Coverage determination should not treat drugs approved through US FDA’s accelerated approval pathway the way Medicare has handled medical devices over the past several years, former Trump and Bush administration officials warn.