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, based on the federal agency that administers this system for seniors.
Anyone who has Medicare Part B and meets “eligibility criteria” might be covered for brand new antibody treatments akin to 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 a part of the Medicare program for seniors that typically covers the prices of medication patients cannot administer themselves, akin to infusions.
The brand new policy will provide broader access to treatments, akin to Leqembi, that slow cognitive decline.
But patients may have to take part 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 identical day the FDA approves an Alzheimer’s antibody treatment. The FDA is predicted to make a choice about Leqembi on July 6.
The drug regulator’s committee of independent advisors is ready to fulfill on June 9 to debate the information supporting Eisai’s and Biogen’s application for the FDA to completely approve Leqembi.
The expanded coverage policy would apply to some 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 which can be cleared under that expedited pathway.
Because of this, seniors currently cannot access Leqembi unless they’re 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 proceed to imagine 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 “under no circumstances limits people having access to the drug.” She said on the time the goal is to establish the system when the FDA makes its decision on Leqembi on July 6.
CMS will facilitate a nationwide portal by which clinicians can enter the required data, Brooks-LaSure said Thursday.
Her agency can be in talks with multiple organizations planning to establish their very own registries, she said.
A study in a number one medical journal recently projected Leqembi could cost Medicare as much as $5 billion a yr.
