Full approval would likely prompt the Centers for Medicare and Medicaid Services to change how it covers the drug, broadening access for up to about a million people with early onset Alzheimer’s.
Leqembi got accelerated approval in January, but it hasn’t been widely used because of an earlier coverage decision by the Centers for Medicare and Medicaid Services, which provides insurance for many elderly Alzheimer’s patients through Medicare.Centers for Medicare and Medicaid Services
said this year it would provide broader coverage for Leqembi if it receives traditional FDA approval. However, Medicare will only cover it when a physician and clinical team participate in the collection of evidence of real-world efficacy.
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