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Lecanemab And Medicare: Could Better FDA/CMS Communication Improve Coverage Chances?

 
• By Cathy Kelly

Eisai/Biogen’s promising Phase III data fueling the companies’ hopes that Medicare will relax coverage restrictions for their Alzheimer’s treatment candidate. If the sponsors fail to change the NCD, lecanemab will need to rely on a registry for reimbursement after full approval.

After Impact On Cognition Finally Demonstrated In Phase III Trial, will FDA, CMS and sponsors have a meeting of the minds? • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

Eisai Co., Ltd. and partner Biogen, Inc. plan to seek a revision of the Medicare coverage restrictions facing their Alzheimer’s drug lecanemab, assuming it obtains a traditional approval from the US Food and Drug Administration, on the strength of new Phase III data, which was announced 27 September.

How quickly the Centers for Medicare and Medicaid Services responds to that request may depend in part on whether CMS and FDA engage in much better communication about the drug...

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