The first drug to show that it slows Alzheimer's is on sale, but treatment for most patients is still several months away. Here's why.
The first drug to show that it slows Alzheimer's is on sale, but treatment for most patients is still several months away.
Regulators used the FDA's accelerated pathway, which allows drugs to launch before they're confirmed to benefit patients. In studies, Leqembi modestly slowed the fatal disease, but doctors aren't sure yet how that translates into things like greater independence for patients. There are currently few options outside self-pay. Most of the patients who may be candidates for this drug are on Medicare, and the federal program's coverage is narrow so far. It has said it will cover treatments like Leqembi only for patients enrolled in certain research trials designed to test the drug."There's a theoretical door that's completely slammed shut," said Robert Egge, chief public policy officer for the nonprofit Alzheimer's Association.
Coverage also is likely to change if the drug receives full approval from the FDA. That could happen later this year. If it's related to Alzheimer's disease, doctors must determine whether the patient's brain has an amyloid protein. The new drug aims to slow the progression of Alzheimer's by removing that protein.
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