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Lecanemab Data On Benefit In Alzheimer’s Might Satisfy FDA – But What About Medicare?

 
• By Cathy Kelly

Centers for Medicare and Medicaid Services’ standard for determining whether drugs produce a clinically meaningful improvement in cognition that would allow for broader Medicare coverage is unclear. But Eisai/Biogen’s lecanemab is likely to serve as a first test.

CMS Will Face Significant Pressure To Allow Broader Access To Lecanemab • Source: Shutterstock

The new data for Eisai Co., Ltd./Biogen, Inc.’s Alzheimer’s candidate lecanemab appears sufficient to win FDA approval despite its safety signals, but whether the results are sufficient to clear the next critical hurdle – Medicare reimbursement – remains an open question.

In its final Medicare national coverage determination (NCD) limiting reimbursement for Alzheimer’s drugs to patients enrolled in a study, the...

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