- Medicare on Thursday affirmed plans to limit coverage for certain Alzheimer’s disease drugs, but signaled it’s taking steps to ensure broader access should one of the medicines receive full Food and Drug Administration approval.
- In a statement, the Centers for Medicare and Medicaid Services said they would cover drugs like Eisai and Biogen’s Leqembi when patients and their doctors participate in a registry for collecting data on how the treatments work in the real world. The stance is in line with the agency’s current policy, but describes a process that analysts viewed as relatively straightforward to fulfill.
- However, the nonprofit Alzheimer’s Association, which has previously attacked Medicare’s policy, criticized the registry requirement and said it “will create unnecessary hurdles to coverage.” The agency’s plan will soon be tested as Leqembi — currently cleared on a conditional basis in the U.S. — is up for full FDA approval, with a decision expected by July.
Medicare has limited coverage of Leqembi and Biogen’s earlier approved drug Aduhelm to patients enrolled in randomized clinical trials, a highly restrictive policy it adopted after the FDA’s controversial OK of Aduhelm in 2021. The policy established a two-tier plan for reimbursing the drugs based on whether they were cleared conditionally, such as on the basis of a disease biomarker, or fully.
The agency has faced pressure to relax its rules, especially after more recent data showed clearer benefits to Leqembi, which was granted accelerated approval in January, and another, similar drug from Eli Lilly. In contrast to Medicare, the Department of Veteran Affairs added broad coverage of Leqembi in March.
The update from CMS Thursday keeps the agency’s policy intact, but fills in the details of how reimbursement would work following a full, or traditional approval. In that event, CMS will reimburse treatment for patients who are enrolled in Medicare Part B, diagnosed with mild cognitive impairment or early dementia caused by the disease, and have a physician who is participating in a registry.
The agency added that it is facilitating a “nationwide portal,” through which doctors would be able to submit data for patients who are on treatment, and that it’s working with other organizations that are setting up their own registries.
“We think CMS’s proactive approach here to reassure the community that the current [national coverage determination] will not limit coverage once Leqembi is fully approved indicates that these hurdles are relatively insignificant,” wrote Brian Skorney, an analyst at Baird, in a note to clients Thursday.
Still, the Alzheimer’s Association said it views registries as an “unnecessary barrier,” adding that, while they are important tools for monitoring care, they “should not be a requirement for coverage of a FDA-approved treatment.”