Biogen’s Plea To Medicare: Just Cover The Aduhelm Clinical Trial Population
Company discusses its strategy for negotiating a change in the recently-proposed Medicare coverage decision for Alzheimer’s drugs during a presentation to analysts.
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Califf Plans US FDA, NIH Collaboration On Postmarket Evidence Generation
NIH Director Nominee Monica Bertagnolli is on board with both agencies working to better determine how approved treatments work in the real-world, FDA Commissioner Robert Califf said.
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.
Medicare’s Final Coverage Decision On Alzheimer’s Drugs: Thoughts From A Former CMS Chief
Mark McClellan discusses whether CMS’s pending final version of the Medicare national coverage determination on Alzheimer’s drugs might change from the draft and whether the decision should be viewed as a precedent for drugs granted accelerated approvals.