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Biogen Asks Medicare For Aduhelm Coverage With Real-World Evidence Development

 
• By Nielsen Hobbs

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.

MRI scan of human brain
• Source: Alamy

Biogen, Inc. is proposing that Medicare provide “full coverage” of Aduhelm and is offering to conduct several real-world evidence studies to collect additional data about its Alzheimer’s drug.

If adopted, the proposal would represent a significant reversal of the Centers for Medicare and Medicaid Services’ draft national coverage determination, which offered extremely limited coverage of Aduhelm in narrowly tailored randomized controlled trials

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