Broader Medicare Coverage For Leqembi Begins As CMS-Backed Registry Opens For Business

There is no fee to participate, and entries to the registry must be made at baseline and then every six months for up to two years.

CMS Seeks Collections Of Data That Align With Leqembi's Approved Label • Source: Shutterstock

The Centers for Medicare and Medicaid Services is sticking with its plan to provide broader Medicare coverage for Eisai Co., Ltd. and Biogen, Inc.’s Leqembi for Alzheimer’s – now that it has obtained a traditional approval – only when patients are enrolled in a registry.

The move is groundbreaking in that it is the first time Medicare coverage for a traditionally approved drug will be conditioned on further evidence generation. It remains to be seen how much the registry as envisioned by CMS will deter access to the drug

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