U.S. senators Friday called for Medicare to offer broad coverage of Alzheimer’s treatments approved by the Food and Drug Administration, warning that the current restrictions are costing patients valuable time as their disease progresses.
“Given the progressive nature of this terminal disease, we encourage you to take action now to ensure patients have immediate access to FDA-approved treatments when the patient and physician decide it is right for the patient,” they said the senators to Health and Human Services Secretary Xavier Becerra and Centers for Medicare and Medicaid Services Administrator Chiquita Brooks-LaSure in a letter.
The group consisted of 18 Republicans and two Democrats, led by Sens. Susan Collins, R-Maine, and Shelley Moore Capito, RW.V.
The 20 senators told CMS that Alzheimer’s disease will cost the nation $1 trillion by 2050 unless the US takes decisive action. The population of seniors, who are 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.
Public pressure on Medicare has increased since the FDA granted accelerated approval Eisai And biogenic‘s treatment Leqembi, an antibody that targets brain plaques associated with the disease. The product has shown promise in treating early-stage Alzheimer’s disease, slowing cognitive decline by 27% in a late-stage clinical trial. It also carries the risk of brain swelling and bleeding.
CMS has severely limited coverage of Alzheimer’s treatments like Leqembi, which are receiving accelerated approval. Medicare covers the drug, which Eisai estimates at $26,500 a year, only for people who are in clinical trials approved by the FDA and the National Institutes of Health.
But Eisai has already completed its late-stage study and is no longer accepting participants. As a result, Medicare coverage for the expensive drug is essentially non-existent.
Ivan Cheung, Eisai’s US CEO, told CNBC Thursday that the company is not aware of any seniors who have the drug covered by Medicare.
The senators said delays in treatment can cause massive harm to patients as Alzheimer’s disease progresses.
“Processes that can delay coverage decisions by several months can cause significant delays in access, resulting in irreversible disease progression and additional burdens on caregivers and families,” the senators told CMS.
The senators’ letter comes after more than 70 House lawmakers issued a similar call this month. Representatives said the current restrictions put people living in rural communities at a disadvantage, as trials often take place in larger cities.
“Patients, families and caregivers who live in rural and underserved areas should have equal opportunities to access treatment,” House lawmakers told Becerra and Brooks-LaSure. “It’s a tremendous physical and financial drain on Medicare beneficiaries to spend countless hours traveling to limited research facilities hosting the studies.”
The Alzheimer’s Association wrote to CMS in December, urging the agency to provide Leqembi with unlimited Medicare coverage. 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 clinical trial for late-stage Leqembi was well designed and the data were clinically and statistically significant be. The President of AAN, Dr. Orly Avitzur, asked Medicare to give Leqembi broader access.
Eisai expects to receive full FDA approval for Leqembi as early as this summer. Under CMS policy, Medicare would then provide broader coverage for people participating in agency-sponsored research studies.
“One of the things I want to emphasize is, as you know, in this particular class, [we] We really wanted more information when we learned what these products will do,” Medicare Administrator Brooks-LaSure said Tuesday while speaking with reporters. “But we remain open to new data from manufacturers and advocates.”
Cheung said it’s possible Medicare could offer coverage without restrictions if the agency determines there is significant evidence supporting the benefits of the treatment.
“With a high level of evidence… the restrictions should be very limited, or maybe even no restrictions at all, and that is Eisai’s position,” Cheung said. “We believe that Medicare beneficiaries should have unhindered, broad and easy access to Leqembi because the data meets these criteria.”
Medicare’s restrictive policy stems from controversies involving Aduhelm, another antibody developed by Biogen and Eisai. The FDA granted Aduhelm accelerated approval, although its independent advisors said the data showed no benefit to patients. Three consultants have resigned due to Aduhelm’s FDA approval.
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