Medicare will not provide more coverage for the Alzheimer’s drug Leqembi until it gets more evidence that the treatment is adequate and necessary, according to the federal agency that runs the program for seniors.
The Centers for Medicare and Medicaid Services has rejected a request from the Alzheimer’s Association for unlimited coverage of a Food and Drug Administration-approved antibody treatment that targets the brain plaques associated with the devastating disease.
“After careful review of the request and supporting documentation, we are making this decision because, as of the date of this letter, there is no evidence that meets the criteria for reconsideration,” CMS said in a statement Wednesday.
The FDA quickly cleared Leqembi in January after clinical trial results showed the treatment reduced cognitive decline by 27% in patients with early Alzheimer’s disease. The drug also carries the risk of brain swelling and bleeding.
Leqembi was developed by a Japanese pharmaceutical company Eisai and his partner Biogen. When a drug like Leqembi is approved quickly, Medicare will only cover it for patients participating in clinical trials.
“As established in the statute, in order to provide national coverage, CMS is required to review whether the remedy is reasonable and necessary,” the agency said in a statement. “This standard differs from the criteria used by the FDA to assess whether a drug is safe and effective.”
Eisai, which completed a phase three trial, has cost Leqembi $26,500 per year. Due to high drug prices and Medicare coverage limitations, older people cannot access these treatments.
The Alzheimer’s Association, in a statement Wednesday, said it was “surprised” by the CMS decision.
“The role of CMS is to provide health care coverage. Their role is not to stand between patients and doctors when deciding which FDA-approved treatment is appropriate. Their role is not to be the only person living with Alzheimer’s and deciding that life, freedom and memories are not necessary,” said the president Joanne Pike association.
The Alzheimer’s Association sent a letter to CMS in December asking for unrestricted coverage signed by more than 200 researchers and experts. The American Academy of Neurology also told CMS that experts reviewed Eisai’s clinical trials and concluded that the studies were well designed and that Leqembi provided clinical benefit.
The Alzheimer’s Association estimates that 2,000 people aged 65 and over progress from mild dementia to advanced stages of the disease every day, making them ineligible for Leqembi.
CMS said it would provide more coverage of Leqembi on the same day if the FDA approves the treatment. Eisai US CEO Ivan Cheung told CNBC last week that the company expects to receive full FDA approval this summer.
But even with full approval, Medicare’s policy is to cover Alzheimer’s treatment for patients who agree to participate in research studies that collect real-world data. While the coverage will be broader, the study must be prepared and health care providers must agree to participate. This will likely still limit the number of people who can access the drug.
But Cheung told CNBC that Medicare could agree to broader, possibly unlimited, coverage if CMS determines there is evidence to support the treatment.
“With high-level evidence … the limit should be very limited, or there may be no limit at all and that is Eisai’s position,” Cheung said. “We believe Medicare beneficiaries should have unhindered, broad and easy access to Leqembi because the data meets these criteria.”
Members of Congress, including 20 senators and more than 70 members of the House of Representatives, are calling on CMS to change its policy and offer more coverage of Alzheimer’s antibody treatments. People living in rural and underserved communities are at a disadvantage because institutions that host clinical trials are usually located in large cities.
“Patients, families, and caregivers living in rural and underserved areas must have equal opportunities to access care,” the House lawmakers told Health and Human Services Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure. “It is an enormous physical and financial burden for Medicare beneficiaries to spend countless hours traveling to the limited research institutions that are hosting the trials.”
Medicare imposed coverage restrictions after controversy over the Alzheimer’s antibody treatment Aduhelm, which was also developed by Eisai and Biogen. The FDA approved the treatment over the objections of independent advisers, who said the data did not show any benefit to patients. Three advisors resigned from the FDA’s decision, and a congressional investigation found irregularities in the approval process.
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