Medicare coverage of the new Alzheimer’s drug Aduhelm, will be limited to beneficiaries enrolled in approved clinical trials, under an April 7 decision by the Centers for Medicare & Medicaid Services (CMS) that essentially confirms a plan the agency outlined in January.
The final ruling comes almost a year after the U.S. Food and Drug Administration (FDA) granted the hotly debated monoclonal antibody treatment a so-called accelerated approval. That approval was issued because the FDA found that the drug can reduce amyloid beta plaques in the brain — a hallmark associated with Alzheimer’s disease. Still, there’s scant proof that the medication stops or slows a person’s cognitive decline. The other FDA-approved Alzheimer’s drugs on the market are designed to help manage some symptoms of the disease, not disrupt its progression, making Aduhelm a first-of-its-kind treatment and the first new Alzheimer’s drug to get federal approval since 2003.
The decision, however, is not specific to Aduhelm. The CMS national policy plan includes a road map for future monoclonal antibodies aimed at tackling Alzheimer’s. Drugs in this class that receive “traditional approval” from the FDA and show a clear clinical benefit will be covered more broadly, while coverage for others that get accelerated approval, like Aduhelm, will be restricted to participants in clinical trials approved by the FDA or the National Institutes of Health and that are representative of the national Alzheimer’s population. Individuals must have a clinical diagnosis of mild cognitive impairment (MCI) due to Alzheimer’s disease or mild dementia with a confirmed presence of plaque on the brain to qualify for coverage. It’s estimated that more than 6 million Americans are living with Alzheimer’s, though only a portion are in the early and mild stages. Barring any effective interventions, that number is expected to rise to 14 million by 2060.
“There is the potential for promise with this treatment; however, there is not currently enough evidence of demonstrating improved health outcomes to say that it is reasonable and necessary for people with Medicare, which is a key consideration for CMS when making national coverage determinations,” Lee Fleisher, M.D., CMS chief medical officer and director of the Center for Clinical Standards and Quality, said in a statement. He added that the agency “weighed the potential for patient benefit against the significance of serious unknown factors that could lead to harm.” Side effects of the drug include headache, confusion, dizziness, falls and vision changes, as well as swelling and bleeding in the brain.
The news was a blow to some patient advocacy groups that had pushed for more broad coverage. Drugmaker Biogen also balked at the decision. Yet, several prominent health systems have refused to use the drug, which is given as a monthly infusion, based on its safety and efficacy data. Its cost has also been a point of controversy. Aduhelm was originally listed at $56,000 a year — a price tag that contributed to a record-high Medicare Part B increase for 2022. Since then, Biogen has slashed the price in half to roughly $28,000 a year. CMS is now reevaluating the premium increase.