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New Model For Real World Evidence? Leqembi Registry Data Will Be Bolstered By Medicare Claims

 
• By Cathy Kelly

Senior Centers for Medicare and Medicaid Services official Lee Fleisher described the game plan behind the CMS-facilitated patient registry for the new Alzheimer’s disease treatment, but former CMS official Sean Tunis is still concerned the approach won’t meet data expectations in the planned two-year window.

CMS is Using Its Coverage Clout and Medicare Claims To Generate Real World Evidence. • Source: Shutterstock

The Centers for Medicare and Medicaid Services will link Medicare claims data on Alzheimer's to supplement the data from its bare-bones registry on Eisai Co., Ltd. and Biogen, Inc.’s Leqembi, a new treatment for the disease.

CMS announced specifics on its patient registry after the US Food and Drug Administration’s traditional approval of Leqembi on 6 July. (Also see "Broader Medicare Coverage For Leqembi Begins As CMS-Backed Registry Opens For Business" - Pink Sheet, 7 July, 2023

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