Medicare Requirements for New FDA-Approved Alzheimer’s Drug Raise Alarms for Seniors

Alzheimer’s advocacy organizations have praised the Food and Drug Administration’s approval of the new treatment for the debilitating disease, but they have equally condemned the Centers for Medicare and Medicaid Services for attaching significant burdens to access the care.

The Centers for Medicare and Medicaid Services announced on Thursday that, for Medicare to cover these expensive treatments, Medicare patients must be diagnosed with amyloid plaques on the brain and be treated by a physician who would be required to upload patient information into a federal database to monitor the real-world efficacy of the treatments.

After granting accelerated pathway approval for Biogen and Eisai’s drug, Leqembi, in January, the FDA announced full approval of the infusion treatment that clinical trials demonstrate slows cognitive decline caused by Alzheimer’s disease progression in mild, early onset patients by 27%. Leqembi, which is called lecanemab-irmb generically, works by reducing amyloid plaques in the brain, which is a key feature of the disease.

As with many new drugs in high demand, the commercial cost of Leqembi is a staggering $26,500 annually for the drug itself. Added to this cost is the amount of time and travel costs to receive the treatment at licensed infusion centers. CMS promised earlier this year that it would explore coverage options upon the FDA granting full approval. (Read more from “Medicare Requirements for New FDA-Approved Alzheimer’s Drug Raise Alarms for Seniors” HERE)

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