Should senior living residents and others be restricted in receiving the new Alzheimer’s drug aducanumab (Aduhelm)?

The Centers for Medicare & Medicaid Services believes so, announcing last week a “coverage with evidence development” proposal that would see Medicare limit coverage of the expensive pharmaceutical — and any other Food and Drug Administration-approved monoclonal antibodies that target amyloid brain plaques for the treatment of Alzheimer’s disease — to participants in qualifying clinical trials.

The FDA, you’ll recall, approved aducanumab, meant for use during early stages of the disease, in June under a cloud of controversy over its efficacy, cost and accessibility. The drug originally was priced at $56,000 per patient per year. Last month, drugmaker Biogen halved the cost to $28,000 per patient per year, effective Jan. 1.

“Too many patients are not being offered the choice of Aduhelm due to financial considerations and are thus progressing beyond the point of benefitting from the first treatment to address an underlying pathology of Alzheimer’s disease,” Biogen CEO Michel Vounatsos said at the time. “We recognize that this challenge must be addressed in a way that is perceived to be sustainable for the U.S. healthcare system.”

Now CMS has been ordered to review the Medicare Part B premium increase for 2022, its largest-ever premium increase, which was designed in part to cover aducanumab’s potential future costs.

In last week’s announcement of the national coverage determination by the federal government, CMS Chief Medical Officer Lee Fleisher, M.D., said that an agency review process has found evidence of both potential benefit and harm for people who take the drug. “Therefore … we have determined that coverage with evidence development through clinical trials is the right decision for Medicare patients, clinicians and caregivers,” he said in a statement.

Biogen, however, said that the decision “denies nearly all Medicare beneficiaries from accessing Aduhelm.”

“It is also particularly concerning that this draft implies that some Medicare beneficiaries will receive a placebo instead of a treatment they are seeking,” the company said.

Patient advocacy groups don’t like the proposal either.

Alzheimer’s Association CEO Harry Johns called it “shocking discrimination against everyone with Alzheimer’s disease.”

“With this approach, access to treatment would now only be available to a privileged few, those with access to research institutions, exacerbating and creating further health inequities,” he said in a statement, emphasizing that the draft decision “is not about one treatment but about this class of potential future treatments targeting amyloid for the treatment of Alzheimer’s disease.”

UsAgainstAlzheimer’s co-founder George Vradenburg termed the proposal “absolutely unacceptable.”

“If this decision stands, for the first time in history, millions of Americans will be denied coverage not just to a drug, but to a whole class of drugs — not by the agency that regulates drugs but by the federal insurance bureaucracy,” he said.

Vradenburg, too, said that the proposal represents discrimination against older adults and against people living with dementia. “Why are treatments for Alzheimer’s patients being held to a different standard than those treating cancer, HIV and other illnesses?” he said.

And Alliance for Aging Research President and CEO Sue Peschin, MHS, said her organization was “deeply troubled” by the proposal.

“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,” she said.

Senior living is no stranger to dementia and those living with it. Thirty-four percent of assisted living residents had diagnoses of Alzheimer’s disease and other dementias in 2018, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics. And others surely are living with undiagnosed disease.

How do you feel about the CMS proposal? CMS will announce its final decision April 11, but you have until Feb. 10 to share your comments with the agency here.

Lois A. Bowers is the editor of McKnight’s Senior Living.