An MRI scan of the brain of an Alzheimer’s patient.
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According to the federal agency that administers the program for seniors, Medicare Part B will cover treatments for Alzheimer’s disease that receive U.S. Food and Drug Administration approval.
Anyone who has Medicare Part B and meets the “eligibility criteria” will be insured for new antibody treatments like Leqembi once the FDA approves them, Chiquita Brooks-LaSure, the Centers for Medicare & Medicaid Services administrator, said Thursday.
Part B is an optional part of the Medicare program for seniors that typically covers the cost of medications that patients cannot self-administer, such as IV fluids.
The new guideline will allow wider access to treatments like Leqembi, which slow cognitive decline.
But patients have to participate in so-called registries, which collect real data on how the drugs work.
Brooks-LaSure said the extended coverage will take effect the same day the FDA approves an Alzheimer’s antibody treatment. The FDA is expected to make a decision on Leqembi on July 6.
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The Drugs Regulatory Agency’s committee of independent advisors will meet on June 9 to discuss the data supporting Eisai’s and Biogen’s application for full FDA approval of Leqembi.
The expanded coverage policy would apply to all other Alzheimer’s antibody treatments that are fully approved by the FDA. Eli Lilly plans to submit such an application for its antibody donanemab.
The FDA granted Leqembi accelerated approval in January, but Medicare is severely limiting coverage for Alzheimer’s antibody treatments approved under this accelerated approval process.
As such, seniors currently do not have access to Leqembi unless they can personally afford the drug’s annual price of $26,500.
The Alzheimer’s Association, which works to help patients with the disease, has been urging Medicare for months to lift restrictions on Leqembi and fully adopt the drug.
“We continue to believe that registration as a condition of insurance coverage is an unnecessary obstacle,” said Robert Egge, the association’s chief public policy officer.
Brooks-LaSure told Congress in April that a registry “in no way restricts people’s access to the drug.” She said at the time the goal was to have the system in place when the FDA made its decision on Leqembi on July 6.
CMS will enable a nationwide portal for physicians to enter the required data, Brooks-LaSure said Thursday.
Her agency is also in talks with several organizations planning to set up their own registers, she said.
According to a study recently published in a leading medical journal, Leqembi could cost Medicare up to $5 billion a year.