Medicare won’t change coverage for expensive Alzheimer’s drugs

Medicare won't change coverage for expensive Alzheimer's drugs

Medicare will continue to limit coverage of a new class of Alzheimer’s drugs, even after they have been fully approved by the Food and Drug Administration (FDA).

The Centers for Medicare and Medicaid Services (CMS) said in a statement Thursday that it will cover the drugs once they are fully approved but also require providers to collect data for patient registries about how the drug works.

The agency has telegraphed its policy in previous congressional statements and testimony. Currently, Medicare coverage is even more stringent, as the agency will only pay for drugs if a patient receives them through a clinical trial.

The treatments in question are infusions of monoclonal antibodies that target the brain plaque known as amyloid that is a hallmark feature of Alzheimer’s disease. The drugs are intended for early-stage Alzheimer’s patients and are intended to slow the progression of memory loss, but they are not a cure.

They are expensive, and there are only two of them: Leqembi from Eisai and Aduhelm from Biogen. Both have received accelerated approval from the FDA, and the agency could grant full approval to Leqembi this summer.

An FDA advisory committee is expected to meet on June 9 to discuss Leqembi, and the agency’s decision deadline is July 6. It was granted accelerated approval based on data showing it could moderately slow cognitive decline. The twice-monthly infusion costs $26,500 a year.

If the FDA grants full approval, “then Medicare will cover it in appropriate contexts that also support real-world information gathering to study the usefulness of these drugs for people with Medicare,” according to a CMS statement.

Full approvals require more clinical trials than expedited approvals. And the positive results are tempered by a type of brain swelling or bleeding associated with these types of drugs.

CMS has come under pressure from drugmakers, bipartisan lawmakers, attorneys general and advocacy groups to change its decision. They argue that by limiting coverage, treatments will be too expensive and out of reach for the people who would benefit most.

During a House hearing in April, CMS Administrator Chiquita Brooks-LaSure faced pointed questions and criticisms about how a registry would be structured and whether the agency was willing to establish one.

Last month, a bipartisan group of 25 attorneys general wrote to the agency urging “full and unrestricted” Medicare coverage.

Critics of the restrictions also argue that the registries are an unnecessary barrier to potential hope for Alzheimer’s patients, and no other FDA-approved drug has that kind of requirement.

About 6.7 million people in the United States are diagnosed with Alzheimer’s, and that number is expected to rise as the population ages.

“Registries are important tools for gathering the real-world evidence needed to transform and improve patient care. But registries shouldn’t be a requirement for coverage of an FDA-approved treatment,” the Alzheimer’s Association said in a statement.

“We look forward to learning more from CMS and are confident about the future of access to healthcare for our constituents. However, we remain concerned that requiring doctors to register and enter data creates unnecessary hurdles,” the group said.

In its statement, CMS defended itself. The agency said registries are “common tools in clinical settings that have successfully collected information about patient outcomes for decades. There is a strong precedent for using registries to gather more information about a newly approved treatment.” .

The agency said it was working with “more organizations that are preparing to open their registries. More information will be released as it becomes online.

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