Medicare will continue to restrict coverage of a new class of Alzheimer’s drugs, even when 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 it will also require providers to collect data for patient registries about how the drug performs.
The agency telegraphed its policy in previous statements and congressional testimony. Currently, Medicare coverage is even stricter, as the agency will only pay for the drugs if a patient receives them through a clinical trial.
The treatments in question are monoclonal antibody infusions that target brain plaque known as amyloid that’s a signature characteristic of Alzheimer’s disease. The drugs are intended for early stage Alzheimer’s patients and are meant to slow the progression of memory loss, but are not a cure.
They are costly, and there are only two: Eisai’s Leqembi and Biogen’s Aduhelm. Both were granted accelerated approval by FDA, and the agency could grant full approval to Leqembi this summer.
An FDA advisory panel is expected to meet 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-a-month infusion costs $26,500 a year.
If FDA grants full approval, “then Medicare will cover it in appropriate settings that also support the collection of real-world information to study the usefulness of these drugs for people with Medicare,” according to a CMS statement.
Full approvals require more clinical evidence than accelerated approvals. And positive outcomes are tempered by a type of brain swelling or bleeding that is associated with these types of drugs.
CMS has been under pressure from drugmakers, bipartisan lawmakers, attorneys general and advocacy groups to change its decision. They argue that by limiting coverage, the treatments will be far too expensive and out of reach for people who would benefit the 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 prepared to set one up.
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 registries are an unnecessary barrier to a potential hope for Alzheimer’s patients, and no other FDA-approved medication has that type 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 to gather much needed real-world evidence to transform and improve patient care. But, registries should not be a requirement for coverage of a FDA-approved treatment,” the Alzheimer’s Association said in a statement.
“We look forward to learning more details from CMS and we are hopeful for the future of health care access for our constituents. However, we remain concerned that the requirement of clinicians to register and enter data will create unnecessary hurdles,” the group said.
In its statement, CMS defended itself. The agency said registries are “common tools in clinical settings that have successfully gathered information on patient outcomes for decades. There is strong precedent for using registries to gather more information on a newly-approved treatment.”
The agency said it was working with “multiple organizations that are getting ready to open their own registries. More information will be released as they come on line.”