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.
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Final Medicare national coverage determination aims to set up a ‘nimble’ system to allow for broad and rapid patient access to drugs for Alzheimer’s disease following traditional approval while retaining a more restrictive approach for accelerated approvals.
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.
Lilly downplays expectations for an US FDA accelerated approval of donanemab, given expectations that Medicare will persist in its plan to withhold coverage for Alzheimer's drugs outside of clinical trials. Policy experts are divided on whether the decision sets a precedent for future accelerated approvals.