Alzheimer’s drug Leqembi gets full FDA approval. Medicare coverage should soon follow

The FDA has granted full approval to Alzheimer’s drug Leqembi, indicating that the medication could become accessible under the federal Medicare health insurance program.

Approval background: The FDA’s decision marks the full approval of the first drug shown to slow down Alzheimer’s disease.
* Leqembi, also known as lecanemab, should now be widely available to older adults primarily served by the Medicare health insurance program, enabling more people in early stages of the disease to access and afford it.
* The medication reportedly slowed declines in memory and thinking by about 27% after 18 months of treatment in studies assessed by the FDA.

Drug details: Leqembi, produced by Eisai and Biogen, will reportedly cost approximately $26,500 a year.
* Initial FDA accelerated approval was granted in January, based on the drug’s ability to remove beta-amyloid from the brains of early-stage Alzheimer’s patients. The full approval comes after assessment of the drug’s capacity to preserve thinking and memory.
* Although the treatment was only available under Medicare for patients in certain clinical trials until recently, wider coverage should now make it more widely accessible.

Potential limitations: There are obstacles to Leqembi’s expansive use, despite broader coverage.
* Possible life-threatening side effects, such as bleeding or swelling in the brain, may deter some patients.
* The U.S. healthcare system might not be equipped to diagnose, monitor, and treat a high number of Alzheimer’s patients. Providing this treatment requires initial tests, bi-weekly intravenous infusions, and regular brain scans.

In patient’s words: Alzheimer’s patient Susan Bell, who has been receiving the treatment as part of a clinical trial, encourages those in early Alzheimer’s stages to try Leqembi, considering they have “nothing to lose”.

View original article on NPR

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