US senators on Friday called on Medicare to offer broader coverage of Alzheimer’s treatments approved by the Food and Drug Administration, warning that current restrictions cost patients precious time as their disease progresses.
The senators told the Secretary of Health and Human Services, “Given the progressive nature of this incurable disease, we encourage you to take steps to ensure that patients have immediate access to FDA-approved treatments if patients And the physicians decide whether it’s right for the patient.” Javier Becerra and Centers for Medicare and Medicaid Services Administrator Chiquita Brooks-Lasur wrote in a letter.
The group included 18 Republicans and two Democrats, led by Sens. Susan Collins, R-Maine, and Shelley Moore Capito, R-V.
20 senators told CMS that Alzheimer’s will cost the country $1 trillion by 2050 if America doesn’t take decisive action. According to the Census Bureau, the population of seniors, who are most affected by the disease, is expected to grow by 50% to 86 million over the next 30 years.
The population of senior citizens, who are most affected by the disease, is expected to nearly double to 83 million in the next 30 years.
Public pressure on Medicare mounts after FDA grants expedited approval Christian And biogenTreatment with Lekembi, an antibody that targets the brain plaques associated with the disease. The product has shown promise in treating early Alzheimer’s, slowing cognitive decline by 27% in a phase III clinical trial. There is also a risk of brain swelling and bleeding.
CMS has severely limited coverage of Alzheimer’s treatments like Leqembi that receive accelerated approval. Medicare will only cover the drug for people in clinical trials approved by the FDA and the National Institutes of Health, which cost Christian $26,500 a year.
But Eisai has already completed its phase three trial and is no longer enrolling participants. As a result, Medicare coverage for the expensive drug is basically nonexistent.
Eisai’s US CEO Evan Cheung told CNBC on Thursday that the company does not know of any seniors who have had the drug covered through Medicare.
The senators said that delay in receiving treatment as Alzheimer’s progresses can result in enormous harm for patients.
“Processes that delay coverage decisions for many months can delay critical access, resulting in irreversible disease progression and increased burdens for caregivers and loved ones,” the senators told CMS.
The senators’ letter comes after more than 70 House lawmakers issued similar calls this month. Representatives said the current restrictions put people living in rural communities at a disadvantage because testing often takes place in large cities.
“Patients, families and caregivers who live in rural and underserved areas should have equal opportunities for treatment,” House lawmakers told Becerra and Brooks-Lasur. “It is an enormous physical and financial burden for Medicare beneficiaries to spend countless hours traveling to the limited research institutions hosting the trials.”
The Alzheimer’s Association wrote to CMS in December asking the agency to provide unrestricted Medicare coverage for Lekambi. 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 Christian’s phase three clinical trial for Lekembi was well designed. were performed and the data was clinically and statistically significant. Dr. Orly Awitzur, president of the AAN, called on Medicare to provide wider access for Lakenby.
Eisai expects to receive full FDA approval for Leqembi as early as this summer. Under CMS policy, Medicare would then provide comprehensive coverage for people participating in research studies supported by the agency.
“One of the things I’d just like to emphasize is, as you know, in this particular class, [we] really wanted to get more information as we learn what these products are going to do,” Medicare Administrator Brooks-Lasur said Tuesday during a call with reporters. “But we’re open to hearing new data from manufacturers and advocates Are.”
Cheung said it’s possible that Medicare could offer coverage without restrictions if the agency determines there is significant evidence supporting the treatment’s benefits.
“With a high level of evidence … the ban should be very limited, or maybe no ban at all, and that is Christian’s position,” Cheung said. “We believe that Medicare beneficiaries should have seamless, comprehensive and easy access to Lekambi because the data meets those criteria.”
Medicare’s restrictive policy stems from the controversy surrounding Adhelmin, another antibody developed by Biogen and Christian. The FDA granted Adhelm accelerated approval, although its independent advisers said the data did not demonstrate a benefit for patients. Three advisors resign over FDA approval of Adhelmin.