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Leqembi Coverage Expansion: US Medicare Head Promises Light Touch On Registry

 
• By Michael McCaughan

Medicare is not envisioning an overly burdensome process to fulfill its requirement for a registry as a condition for coverage of ‘fully’ approved beta amyloid Alzheimer’s therapies, the head of the agency tells Congress. Biogen and Eisai still hope to have the registry obligation removed altogether.

CMS Leqembi Registry
Chiquita Brooks-LaSure's testimony suggests that the registry already listed in FDA's Leqembi label might satisfy CMS's requirements. • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock, Alamy images and FDA label

The US Medicare agency is telling Congress that all Alzheimer’s patients covered by the approved indication will have access to the beta amyloid therapy Leqembi once it is converted from Accelerated Approval to traditional approval.

A registry required for “fully” approved beta amyloid therapies under a coverage policy adopted by the Centers for Medicare & Medicaid Services in 2022 “in no way limits people from...

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