Once Lequembi, Easai’s amyloid-targeting Alzheimer’s drug, is potentially approved by the US Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS) have announced they will expand coverage for the class of drugs. Previously, CMS only covered amyloid therapies in clinical trials, a rule it instantiated with Aduhelm last year.
According to Heather Landi, “CMS issued a statement Thursday that it would cover the costly drugs for patients enrolled in Medicare Part B and meet the criteria for coverage. That criteria includes patients’ physicians and clinical teams participating in registries to collect evidence about how the drugs work in the real world. The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will discuss the results of a confirmatory trial of the Eisai product Leqembi on June 9, with a potential decision on traditional approval possible within weeks. Broader Medicare coverage would begin on the same day the FDA grants traditional approval, CMS said.”
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(Source: Fierce Healthcare, June 1st, 2023)