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The Food and Drug Administration fully approved the Alzheimer’s antibody treatment Leqembi on Thursday, a pivotal decision that will expand access to the drug.
The key news for patients is that Medicare will now pay for Leqembi.
For months, the program for seniors refused to cover the treatment outside clinical trials, effectively blocking access for most patients because they cannot afford the $26,500 annual price set by Eisai before insurance coverage.
Medicare will now pick up the majority of the bill for beneficiaries who are diagnosed with mild cognitive impairment or mild Alzheimer’s disease, though patients could still face thousands of dollars in annual out-of-pocket costs.
Patients also need to have a doctor who is participating in a registry that collects data on the drug’s benefits and risks to be eligible for coverage.
The registry is controversial. The Alzheimer’s Association is worried the data-collection requirement will create unnecessary red tape.
But the Centers for Medicare and Medicaid Services has set up a nationwide, free-to-use portal that is supposed to make it easy for doctors to enter the required information.
Just how much demand there will be for Leqembi is still unclear. It is the only drug on the market that slowed cognitive decline in a clinical trial.
But Leqembi also carries risks of brain swelling and bleeding. Patients and their doctors will have to weigh the benefits against those risks.
Feel free to send any tips, suggestions, story ideas and data to me at spencer.kimball@nbcuni.com.
