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We welcome and celebrate the @US_FDA Advisory Committee’s unanimous endorsement of the efficacy and clinical benefit of lecanemab (Leqembi) as part of the treatment’s traditional approval process. Read our statement: bit.ly/3WXc7jA. 
The next regulatory step toward traditional approval of Leqembi is FDA review, which is required to take place by July 6, 2023.
Last week, @CMSGov said they would cover Alzheimer’s treatments that receive traditional FDA approval if clinicians register and enter data in a registry. We believe registry as a condition of coverage is an unnecessary barrier. We want equitable #AccessNow.
Additionally, @CMSGov has not shared further information about the data submission, registry requirements and details about how patients and physicians can enroll. We eagerly await more information from CMS.
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