Doctor, clinician wearing surgical gloves, readying an intravenous infusion

Medicare may cover the high cost of treatment with the Alzheimer’s drug Aduhelm only for highly qualified participants in approved clinical trials, the Centers for Medicare & Medicaid Services announced Tuesday.

The move to limit drug coverage in this way is unusual, but appropriate for the Medicare population, CMS officials said in a press briefing.

Aduhelm is a monoclonal antibody that is recommended for patients in the early stages of dementia and is delivered using repeat infusions. The FDA approved it in 2021 under a cloud of controversy over its efficacy, soaring cost and accessibility. Aduhelm costs $28,000 per patient per year, according to maker Biogen, which recently cut the cost from $56,000.

CMS’s new coverage proposal also applies to other FDA-approved monoclonal antibody drugs in the same class that — like Aduhelm — specifically target amyloid brain plaques for the treatment of Alzheimer’s disease, the agency said. If the coverage decision is finalized in April, it would apply to both CMS-approved and National Institutes of Health-sponsored clinical trials for early-stage patients who have evidence of Alzheimer’s brain abnormalities.

A CMS review process has found evidence of both potential benefit and harm for Aduhelm patients, prompting the decision to limit coverage, according to Lee Fleisher, M.D., CMS chief medical officer. 

“Therefore … we have determined that coverage with evidence development through clinical trials is the right decision for Medicare patients, clinicians and caregivers, and we look forward to receiving feedback on the proposal,” he said in a statement.

The FDA greenlit Aduhelm under a relatively new, accelerated approval program that required drugmaker Biogen to conduct further clinical trials to verify that the drug indeed reduces brain amyloid plaques, Fleisher further noted in the press briefing. 

“So CMS is using its authority provided by Congress to determine if the drug is considered reasonable and necessary, meaning that the benefits of improvement of cognition outweigh the harms in the Medicare population and therefore should be covered,” he said.

Detractors call proposal discriminatory, unethical 

The “coverage with evidence” proposal, which is open to public comment for 30 days, immediately drew detractors. The Alzheimer’s Association, which was supportive of the FDA’s original approval of Aduhelm, said it will leave potential patients out in the cold. 

The draft decision will confine treatment to patients who have access to research institutions and other advantages, resulting in a “shocking discrimination against everyone with Alzheimer’s disease,” especially groups that are already disproportionately impacted, the organization said in a statement. These include women, Blacks and Hispanics, it said. 

“People living with Alzheimer’s disease deserve the same access to therapies given to those living with other conditions like cancer, heart disease and HIV/AIDS,” it added.

Similarly, the patient advocacy group the Alliance for Aging Research called the coverage proposal “overly restrictive, medically unethical,” and “unlikely to meet the agency’s goal to address health equity.” 

Studies supported by the plan would end up directly competing with clinical trial recruitment for other FDA-required post-market studies, prolonging evidence collection and harming research, it stated.

“This decision is not about furthering clinical evidence, it is about CMS severely rationing Alzheimer’s patients’ treatment access to save Medicare costs, full stop.”

In related news, CMS has been ordered to review a large proposed increase to Medicare Part B premiums for 2022 that are designed in part to cover Aduhelm’s potential future costs. Biogen initially set the annual cost per patient at $56,000 but has recently cut that price in half. The U.S. health secretary said the lower price supports a reconsideration of the premium’s cost hike.