Medicare will not provide broad coverage of the Alzheimer’s drug Lekambi until there is more evidence that the treatment is appropriate and necessary, according to the federal agency that runs the program 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 target 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 not yet evidence meeting the criteria for reconsideration,” CMS said in a statement on Wednesday.
The FDA approved Lekambi on an accelerated basis in January after clinical trial results showed the treatment slowed cognitive decline by 27% in patients with early-onset Alzheimer’s disease. The drug also carries a risk of brain swelling and bleeding.
Lekambi was developed by the Japanese pharmaceutical company Christian and his partner biogen, When drugs like Lekambi are approved on an expedited basis, Medicare will cover them only for patients who are participating in clinical trials.
“In order to provide coverage nationally, as defined in the statute, CMS is required to examine whether a drug is appropriate and necessary,” the agency said in its statement. “This standard differs from the criteria used by the FDA to assess whether drugs are safe and effective.”
Eisai, which has completed its Phase III trial, has priced Leqembi at $26,500 per year. Due to high drug costs and Medicare’s coverage restrictions, seniors are unable to access treatment.
The Alzheimer’s Association said in a statement Wednesday that it was “appalled” by CMS’s decision.
The role of a “CMS” is to provide health care coverage. Their role is not to stand between a patient and a doctor when deciding what FDA-approved treatments are appropriate. Their role is to differentiate people living with Alzheimer’s. And it’s not to decide that their life, their liberty and their memory are not important,” said Joanne Pike, president of the association.
More than 200 researchers and experts had signed a letter calling for unrestricted coverage to CMS in December. The American Academy of Neurology has also told CMS that its experts reviewed Christian’s clinical trial and concluded that the study was well designed and that Lekembi offers a clinical benefit.
The Alzheimer’s Association estimates that 2,000 people aged 65 and older each day progress from mild dementia to a more advanced stage of the disease, which would make them ineligible for Lekembi.
CMS said it would provide broad coverage of LeKenbi the day the FDA fully approved the treatment. Eisai US CEO Evan Cheung told CNBC last week that the company hopes 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 coverage would be broad, such studies would need to be set up and health care providers would have to agree to participate. This will likely still limit the number of people who can use the drug.
But Cheung told CNBC that if CMS determines there is a high level of evidence supporting the treatment, Medicare could possibly agree to broader coverage with no restrictions.
“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.”
Members of Congress, including 20 senators and more than 70 House members, have called on CMS to change its policy and offer broader coverage of antibody treatments for Alzheimer’s. People living in rural and under-served communities face a disadvantage because the institutions hosting clinical trials are usually in large cities.
“Patients, families and caregivers who live in rural and under-served areas must have equal opportunities for treatment,” House lawmakers told Health and Human Services Secretary Javier Becerra and CMS Administrator Chiquita 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.”
Medicare adopted coverage restrictions after controversy over the Alzheimer’s antibody treatment Adhelmin, which was also developed by Eisai and Biogen. The FDA approved the treatment over objections from its independent advisers, who said the data did not demonstrate a benefit for patients. Three advisers resigned over the FDA’s decision, and a congressional investigation found irregularities in the approval process.
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