This clears the way for Medicare and other insurance plans to begin covering the treatment.
WASHINGTON -- U.S. officials granted full approval to a closely watched Alzheimer's drug on Thursday, clearing the way for Medicare and other insurance plans to begin covering the treatment for people with the brain-robbing disease.
The FDA confirmed those results by reviewing data from a larger, 1,800-patient study in which the drug slowed memory and thinking decline by about five months in those who got the treatment, compared to those who got a dummy drug. by signing up you agree to our terms of service The process of converting a drug to full FDA approval usually attracts little attention. But Alzheimer's patients and advocates have been lobbying the federal government for months after Medicare officials announced last year they wouldn't pay for routine use of Leqembi until it received FDA's full approval.
Medicare administrator, Chiquita Brooks-LaSure, said in a statement Thursday the program will begin paying for the drug now that it has full FDA approval. But the government is also setting extra requirements, including enrollment in a federal registry to track the drug's real-world safety and effectiveness.
Hospitals and medical clinics have cautioned that it may take time to get people started on the drug.
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