Medicare details plan to cover Alzheimer’s treatments

Medicare Part B will cover Alzheimer’s disease treatments that receive approval from the US Food and Drug Administration, 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, Chiquita Brooks-LaSure, the administrator of the Centers for Medicare & Medicaid Services.

Part B is an optional part of the Medicare program for seniors that generally covers the costs of medications that patients cannot administer themselves, such as infusions.

The new policy will provide wider access to treatments, such as Leqembi, that slow cognitive decline.

But patients will have to participate in so-called registries that collect real data on how the drugs work.

Brooks-LaSure said the expanded coverage will take effect the same day the FDA approves an antibody treatment for Alzheimer’s disease. The FDA is expected to make a decision on Leqembi on July 6.

The drug regulator’s committee of independent advisors is due to meet on June 9 to discuss the data supporting Eisai and Biogen’s request for the FDA to fully approve Leqembi.

The expanded coverage policy would apply to any other Alzheimer’s disease antibody treatments that receive full FDA approval. Eli Lilly is considering submitting such an application for its donanemab antibody.

The FDA granted fast-track approval to Leqembi in January, but Medicare severely restricts coverage for Alzheimer’s antibody treatments that are allowed under that fast-track.

Therefore, seniors currently cannot access Leqembi unless they are able to personally pay the $26,500 annual price of the drug.

The Alzheimer’s Association, which lobbies for patients living with the disease, has for months called on Medicare to drop restrictions on Leqembi and fully cover the drug.

“We continue to believe that the registry as a condition of coverage is an unnecessary barrier,” said Robert Egge, director of public policy for the association.

Brooks-LaSure told Congress in April that a registry “in no way limits people’s access to the drug.” She said at the time that the goal was to have the system in place when the FDA makes its decision on Leqembi on July 6.

CMS will facilitate a national portal where clinicians can enter required data, Brooks-LaSure said Thursday.

Her agency is also in talks with several organizations planning to create their own registries, she said.

A study in a leading medical journal recently projected that Leqembi could cost Medicare up to $5 billion a year.