Medicare will not offer broader coverage of Alzheimer’s drug Leqembi 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 denied an Alzheimer’s Association request for unrestricted coverage of antibody treatments approved by the Food and Drug Administration that target brain plaques associated with the devastating disease.
“After carefully reviewing the application and supporting documentation, we are making this decision because, as of the date of this letter, there is no evidence meeting the criteria for a re-examination,” CMS said in a statement Wednesday.
The FDA accelerated approval of Leqembi in January after clinical trial results showed the treatment slowed 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 the Japanese pharmaceutical company Eisai and his partner biogenic. If drugs like Leqembi are accelerated, Medicare will only cover them for patients who are in clinical trials.
“As defined by law, CMS must assess whether a drug is appropriate and necessary to provide national coverage,” 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 3 trial, has valued Leqembi at $26,500 per year. Due to the drug’s high price and Medicare coverage limitations, seniors do not have access to treatment.
The Alzheimer’s Association said in a statement Wednesday it was “appalled” by CMS’ decision.
“CMS’s role is to provide healthcare. Your role is not to stand between a patient and a doctor when it comes to which FDA-approved treatments are appropriate. Their role is not to single out people with Alzheimer’s and decide that their lives, independence and memory are not necessary,” said Association President Joanne Pike.
The letter that the Alzheimer’s Association sent to CMS in December calling for unrestricted health insurance was signed by more than 200 researchers and experts. The American Academy of Neurology also informed CMS that its experts reviewed Eisai’s clinical trial and concluded that the trial was well designed and that Leqembi offered clinical benefit.
The Alzheimer’s Association estimates that 2,000 people aged 65 and over are progressing from mild dementia to a more advanced stage of the disease every day, which would make them unsuitable for Leqembi.
CMS said it would provide broader coverage of Leqembi on the same day should the FDA fully approve 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 treatments for patients who agree to participate in research studies that collect real-world data. While coverage would be broader, such studies must be set up and healthcare providers must agree to participate. This would likely still limit the number of people who have access to the drug.
But Cheung told CNBC that Medicare could agree to even broader coverage, possibly without restrictions, if CMS determines there is a high level of evidence supporting the treatment.
“With a high level of evidence… the restrictions should be very limited, or maybe even no restrictions at all, and that is Eisai’s position,” Cheung said. “We believe that 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, have called on CMS to change its policy and offer broader coverage of Alzheimer’s antibody treatments. People living in rural and underserved communities are disadvantaged because the facilities that conduct clinical trials are usually located in larger cities.
“Patients, families and carers who live in rural and underserved areas should have equal opportunities to access treatment,” House lawmakers told Health and Human Services Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure. “It’s a tremendous physical and financial drain on Medicare beneficiaries to spend countless hours traveling to limited research facilities hosting the studies.”
Medicare introduced the coverage limitations following controversy over Alzheimer’s antibody treatment Aduhelm, also developed by Eisai and Biogen. The FDA approved the treatment despite objections from its independent advisors, who said the data showed no benefit to patients. Three advisors resigned over the FDA decision, and a congressional investigation found irregularities in the approval process.
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