Senators urge Medicare to offer broad coverage of Alzheimer’s disease treatment as public pressure mounts

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US senators on Friday called on Medicare to offer broad coverage of Alzheimer’s treatments approved by the Food and Drug Administration, warning that current restrictions cost patients valuable time as their disease progresses.

“Given the progressive nature of this terminal illness, we encourage you to take immediate action to ensure patients have immediate access to FDA-approved treatments if the patient and physician decide it is right for the patient,” the senators told the health secretary and social affairs. Xavier Becerra and Centers for Medicare and Medicaid Administrator Chiquita Brooks-LaSure in the letter.

The panel included 18 Republicans and two Democrats, led by Sens. Susan Collins, R-Maine, and Shelley Moore Capito, R-W.V.

20 senators told CMS that Alzheimer’s disease will cost the country $1 trillion by 2050 if the U.S. does not act decisively. The elderly population, most affected by the disease, is expected to increase by more than 50% to 86 million over the next 30 years, according to the Census Bureau.

The elderly population, most affected by the disease, is expected to nearly double to 83 million over the next 30 years.

Public pressure on Medicare has increased since the FDA expedited approval granted from Eisai and BiogenLeqembi, an antibody that targets brain plaques associated with the disease. The product shows promise in the treatment of early Alzheimer’s disease, slowing cognitive decline by 27% in a third phase clinical trial. It also poses a risk of brain swelling and bleeding.

CMS has very limited coverage for Alzheimer’s treatments like Leqembi that receive accelerated approval. Medicare will only cover the drug, which Eisai values ​​at $26,500 a year, for people in clinical trials approved by the FDA and the National Institutes of Health.

But Eisai has already completed its third phase of the trial and is no longer enrolling participants. As a result, Medicare coverage for the expensive drug is essentially non-existent.

Ivan Cheung, Eisai’s U.S. CEO, told CNBC on Thursday that the company is not aware of any seniors getting the drug through Medicare.

The senators said delays in treatment can cause significant harm to patients as Alzheimer’s progresses.

“Procedures that can delay coverage decisions for months can result in significant delays in access, resulting in irreversible disease progression and additional burden for caregivers and loved ones,” the senators told CMS.

The senators’ letter comes after more than 70 members of the House of Representatives issued a similar call this month. Representatives said the current restrictions put people living in rural communities at a disadvantage because trials are often held in larger cities.

“Patients, families and carers living in rural and underserved areas should have equal opportunities to access treatment,” Members of the House said Becerra and Brooks-LaSure. “It is a tremendous physical and financial burden for Medicare beneficiaries to spend countless hours traveling to limited research facilities that host trials.”

The Alzheimer’s Association wrote to CMS in December urging the agency to provide unlimited Medicare coverage for Leqembi. The association’s letter was signed by more than 200 Alzheimer’s researchers and experts.

The American Academy of Neurology, the world’s largest association of neurologists, told Medicare in a letter earlier this month that its experts concluded that Eisai’s phase 3 clinical trial for Leqembi was well designed and that the data were clinically and statistically significant . President of AAN dr. Orly Avitzur asked Medicare to provide wider access for Leqembi.

Eisai pending full FDA approval for Leqembi already this summer. Under CMS policy, Medicare would then provide broader coverage for people participating in agency-supported research studies.

“One of the things I would just point out is, you know, in this particular class, [we] I really wanted to have more information once we know what these products are going to do,” Medicare Administrator Brooks-LaSure said Tuesday during a call with reporters. “But we remain open to new information from manufacturers and advocates.”

Cheung said it’s possible that Medicare could offer coverage without limits if the agency determines there is significant evidence to support the treatment’s benefits.

“With a high level of evidence … the restrictions should be very limited or maybe even no restrictions and that is Eisai’s position,” Cheung said. “We believe that Medicare beneficiaries should have unfettered access, broad and easy access to Leqembi because the data meets these criteria.”

Medicare’s restrictive policy stems from the controversy surrounding aduhelm, another antibody developed by Biogen and Eisai. The FDA fast-tracked approval for aduhelm, even though its independent advisers said the data did not show a benefit for patients. Three consultants resigned over FDA approval of aduhelm.

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