The Food and Drug Administration (FDA) has fully approved the Alzheimer’s Disease treatment Leqembi, a pivotal decision that will expand access to the expensive drug for older Americans.
Leqembi is the first Alzheimer’s antibody treatment to receive full FDA approval. It is also the first such drug that to receive broad coverage through Medicare. Medicare announced shortly after the FDA approval that it is now covering the antibody treatment for patients enrolled in the insurance program for seniors, though several conditions apply.
Medicare coverage is a crucial step to help older Americans with early Alzheimer’s disease pay for the treatment. With a median income of about $30,000, most people on Medicare cannot afford the $26,500 annual price of Leqembi set by Eisai without insurance coverage. Medicare had previously only agreed to cover Leqembi for patients participating in clinical trials after the treatment received expedited approval in January. This policy had severely restricted access to the drug.
To be eligible for coverage, patients must be enrolled in Medicare, diagnosed with mild cognitive impairment or mild Alzheimer’s disease, and have a doctor who is participating in a data-collection system the federal government has established to monitor the treatment’s benefits and risks.
Leqembi is not a cure. The treatment slowed cognitive decline from early Alzheimer’s disease by 27% over 18 months during Eisai’s clinical trial. The antibody, administered twice monthly through intravenous infusion, targets a protein called amyloid that is associated with Alzheimer’s disease.
Joanna Pike, president of the Alzheimer’s Association, the lobby group that advocates on behalf of people living with the disease, says that Leqembi will help patients in the early stages of the disease: “This gives people more months of recognizing their spouse, children and grandchildren. This also means more time for a person to drive safely, accurately and promptly take care of family finances, and participate fully in hobbies and interests.”
Leqembi is not a cure. The treatment slowed cognitive decline from early Alzheimer’s disease by 27% over 18 months during Eisai’s clinical trial.
The antibody, administered twice monthly through intravenous infusion, targets a protein called amyloid that is associated with Alzheimer’s disease. The treatment carries serious risks of brain swelling and bleeding. Three patients who participated in Eisai’s study died, but FDA scientists have said it is unclear if Leqembi played a role in these deaths.
The Centers for Medicare and Medicaid Services has set up a nationwide portal to make it easy for healthcare providers to submit the required data on patients receiving Leqembi.