U.S. senators on Friday called for Medicare to supply broad coverage of Alzheimer’s treatments approved by the Food and Drug Administration, warning that current restrictions cost patients precious time as their disease progresses.
“Given the progressive nature of this terminal disease, we encourage you to take steps now to make sure patients have immediate access to FDA-approved treatments if the patient and clinician determine it is correct for the patient,” the senators told Health and Human Services Secretary Xavier Becerra and Centers for Medicare and Medicaid Services Administrator Chiquita Brooks-LaSure in a letter.
The group included 18 Republicans and two Democrats, led by Sens. Susan Collins, R-Maine, and Shelley Moore Capito, R-W.V.
The 20 senators told CMS that Alzheimer’s will cost the nation $1 trillion by 2050 if the U.S. doesn’t take decisive motion. The population of seniors, who’re most affected by the disease, is predicted to extend greater than 50% to 86 million over the following 30 years, in line with the Census Bureau.
The population of seniors, who’re most affected by the disease, is predicted to almost double to 83 million over the following 30 years.
Public pressure on Medicare has mounted for the reason that FDA granted accelerated approval of Eisai and Biogen‘s treatment Leqembi, an antibody that targets brain plaque related to the disease. The product has shown promise in treating early Alzheimer’s, slowing cognitive decline by 27% in a phase three clinical trial. It also carries risks 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, priced by Eisai at $26,500 per yr, for people in clinical trials approved by the FDA and the National Institutes of Health.
But Eisai has already accomplished its phase three trial and isn’t any longer enrolling participants. As a consequence, Medicare coverage for the expensive drug is largely nonexistent.
Ivan Cheung, the U.S. CEO of Eisai, told CNBC on Thursday that the corporate doesn’t know of any seniors who’ve gotten the drug covered through Medicare.
The senators said delays in receiving treatment may cause massive harm for patients as Alzheimer’s progresses.
“Processes which will delay coverage decisions by several months can impose significant access delays, leading to irreversible disease progression and added burdens for caregivers and loved one,” the senators told CMS.
The senators’ letter comes after greater than 70 House lawmakers issued an analogous call this month. The representatives said the present restrictions put individuals who live in rural communities at a drawback because trials are sometimes in greater cities.
“Patients, families, and caregivers living in rural and underserved areas must have the identical opportunity for access to treatment,” the House lawmakers told Becerra and Brooks-LaSure. “It’s an unlimited physical and financial burden for Medicare beneficiaries to spend countless hours traveling to limited research institutions that host the trials.”
The Alzheimer’s Association wrote CMS in December calling for the agency to offer unrestricted Medicare coverage for Leqembi. The association’s letter was signed by greater 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 have concluded Eisai’s phase three clinical trial for Leqembi was well designed and the information was clinically and statistically significant. AAN’s President Dr. Orly Avitzur asked Medicare to offer broader access for Leqembi.
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 research studies backed by the agency.
“One in all the things I might just emphasize is as you recognize, on this particular class, [we] really desired to have more information as we learn what these products are going to do,” Medicare Administrator Brooks-LaSure said on Tuesday during a call with reporters. “But we proceed to be open to hearing recent data from manufacturers and advocates.”
Cheung said it’s possible Medicare could offer coverage with no restrictions if the agency determines there’s significant evidence supporting the treatments advantages.
“With a high level of evidence … the restrictions ought to be very limited, or possibly even no restrictions and that’s Eisai’s position,” Cheung said. “We imagine Medicare beneficiaries must have unimpeded access, broad and straightforward access to Leqembi because the information fulfill those criteria.”
Medicare’s restrictive policy stems from controversy surrounding aduhelm, one other antibody developed by Biogen and Eisai. The FDA gave aduhelm accelerated approval regardless that its independent advisors said the information didn’t exhibit a profit for patients. Three advisors resigned over the FDA approval of aduhelm.