Medicare details plan to cover Alzheimer's treatments
Patients will have to participate in registries that collect real-world data on how the drug works as a condition of coverage.
An MRI scan of an Alzheimer's patient's brain.
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Medicare Part B will cover treatments for Alzheimer's disease that receive U.S. Food and Drug Administration approval, according to the federal agency that administers the program for seniors.
Anyone who has Medicare Part B and meets "eligibility criteria" will be covered for new antibody treatments such as Leqembi once the FDA approves them, said Chiquita Brooks-LaSure, the administrator of the Centers for Medicare & Medicaid Services, on Thursday.
Part B is an optional part of the Medicare program for seniors that typically covers the costs of drugs patients cannot administer themselves, such as infusions.
The new policy will provide broader access to treatments, such as Leqembi, that slow cognitive decline.
But patients will have to participate in so-called registries that collect real-world data on how the drugs work.
Brooks-LaSure said the expanded coverage will go into effect on the same day the FDA approves an Alzheimer's antibody treatment. The FDA is expected to make a decision about Leqembi on July 6.
The drug regulator's committee of independent advisors is set to meet on June 9 to discuss the data supporting Eisai's and Biogen's application for the FDA to fully approve Leqembi.
The expanded coverage policy would apply to any other Alzheimer's antibody treatment that receive full approval from the FDA. Eli Lilly is planning to submit such an application for its antibody donanemab.
The FDA granted accelerated approval to Leqembi in January, but Medicare severely restricts coverage for Alzheimer's antibody treatments that are cleared under that expedited pathway.
As a result, seniors currently cannot access Leqembi unless they are able to personally afford the drug's $26,500 annual price.
The Alzheimer's Association, which lobbies for patients living with the disease, for months has called on Medicare to drop restrictions on Leqembi and fully cover the drug.
"We continue to believe that registry as a condition of coverage is an unnecessary barrier," said Robert Egge, the association's chief public policy officer.
Brooks-LaSure told Congress in April a registry "in no way limits people getting access to the drug." She said at the time the goal is to set up the system when the FDA makes its decision on Leqembi on July 6.
CMS will facilitate a nationwide portal in which clinicians can enter the required data, Brooks-LaSure said Thursday.
Her agency is also in talks with multiple organizations planning to set up their own registries, she said.
A study in a leading medical journal recently projected Leqembi could cost Medicare up to $5 billion a year.