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.
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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.
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.
The company's comments to CMS on the proposed NCD for amyloid-targeting therapies for Alzheimer's disease says the differences between Alzheimer's and other areas could represent a legal issue.