Medicare is not going to provide broader coverage of the Alzheimer’s drug Leqembi until it receives more evidence that the treatment is cheap and crucial, based on the federal agency that runs this system for seniors.
The Centers for Medicare and Medicaid Services rejected a request from the Alzheimer’s Association for unrestricted coverage of antibody treatments approved by the Food and Drug Administration that concentrate on brain plaque related to the devastating disease.
“After careful review of the request and supporting documentation, we’re making this decision because, as of the date of this letter, there shouldn’t be yet evidence meeting the standards for reconsideration,” CMS said in an announcement on Wednesday.
The FDA cleared Leqembi on an expedited basis in January after clinical trial results showed that the treatment slowed cognitive decline by 27% in patients with early Alzheimer’s disease. The drug also carries risks of brain swelling and bleeding.
Leqembi was developed by the Japanese pharmaceutical company Eisai and its partner Biogen. When drugs like Leqembi are approved on expedited basis, Medicare will only cover them for patients who’re participating in clinical trials.
 “As defined in statute, to offer coverage nationally, CMS is required to look at whether a medicine is cheap and crucial,” the agency said in its statement. “This standard differs from the standards utilized by the FDA to evaluate whether medications are secure and effective.”Â
Eisai, which accomplished its phase three trial, has priced Leqembi at $26,500 per yr. As a consequence of the drug’s high price and Medicare’s coverage restrictions, seniors are unable to access the treatment.
The Alzheimer’s Association, in an announcement Wednesday, said it was “appalled” by CMS’ decision.
“CMS’ role is to offer health care coverage. Their role shouldn’t be to face between a patient and a physician when deciding what FDA-approved treatments are appropriate. Their role shouldn’t be to single out people living with Alzheimer’s and choose that their lives, their independence and their memories will not be crucial,” said the association’s president Joanne Pike.
The letter the Alzheimer’s Association sent to CMS in December calling for unrestricted coverage was signed by greater than 200 researchers and experts. The American Academy of Neurology has also told CMS that its experts reviewed Eisai’s clinical trial and concluded that the study was well designed and Leqembi provides a clinical profit.
The Alzheimer’s Association estimates that 2,000 people ages 65 and older progress from mild dementia to a more advanced stage of the disease per day, which might make them ineligible for Leqembi.
CMS said it would supply broader coverage of Leqembi on the identical day should the FDA fully approve the treatment. Eisai U.S. CEO Ivan Cheung told CNBC last week that the corporate expects to receive full FDA approval this summer.
But even with full approval, Medicare’s policy is to cover Alzheimer’s treatments for patients who comply with take part in research studies that collect real-world data. While coverage can be broader, such studies should be arrange and health-care providers need to comply with participate. This is able to likely still limit the number of people that can access the drug.
But Cheung told CNBC that Medicare could comply with even broader coverage, possibly with no restrictions, if CMS determines that there is a high level of evidence supporting the treatment.
“With a high level of evidence … the restrictions needs to be very limited, or perhaps even no restrictions and that’s Eisai’s position,” Cheung said. “We imagine Medicare beneficiaries must have unimpeded access, broad and easy access to Leqembi because the info fulfill those criteria.”
Members of Congress, including 20 senators and greater than 70 House members, have called on CMS to alter its policy and offer broader coverage of Alzheimer’s antibody treatments. People living in rural and underserved communities face a drawback since the institutions that host clinical trials are often 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 Health and Human Services Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure. “It’s an infinite physical and financial burden for Medicare beneficiaries to spend countless hours traveling to limited research institutions that host the trials.”
Medicare adopted the coverage restrictions after controversy over the Alzheimer’s antibody treatment Aduhelm, which was also developed by Eisai and Biogen. The FDA approved that treatment over the objections of its independent advisors, who said the info didn’t exhibit a profit for patients. Three advisors resigned over the FDA decision, and a congressional investigation found irregularities within the approval process.
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