The Alzheimer’s Association is criticizing a new proposal for Medicare to only cover Aduhelm – a controversial new treatment for Alzheimer’s – for patients enrolled in the drug’s continuing clinical trials.
The Centers for Medicare & Medicaid Services revealed a potential National Coverage Determination for Aduhelm (aducanumab) last Tuesday. As currently proposed, Medicare would only cover the treatment in approved clinical trials. Even though the drug was approved by the U.S. Food and Drug Administration in June, the accelerated approval granted by the FDA means Aduhelm must undergo further testing. If this testing does not show the drug improves memory and other Alzheimer’s symptoms, the FDA could withdraw its approval.
Under the proposal, the CMS will individually review clinical trials of the drug and cover patients in trials that meet the standards laid out in its proposed NCD. Among other standards, patients in approved trials must have mild Alzheimer’s and no other conditions that could lead to cognitive decline or adverse outcomes. All National Institutes of Health-sponsored trials would be covered.
Lee Fleisher, MD, chief medical officer for CMS, said in a statement this limited coverage is necessary because questions remain about potential side effects of the drug.
“Based on the public comments submitted previously and evidence CMS reviewed, the potential for harm, and important questions that remain, 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.”
However, the Alzheimer’s Association, a major funder of Alzheimer’s research, released a statement shortly after the CMS proposal criticizing the plan for only potentially covering approved clinical trial patients—and not the general population.
“Today’s announcement from CMS is shocking discrimination against everyone with Alzheimer’s disease, especially those who are already disproportionately impacted by this fatal disease, including women, Blacks and Hispanics,” said Harry Johns, CEO of the organization, in the statement. “With the approach proposed by CMS, access to treatment would now only be available to a privileged few – those with access to research institutions – exacerbating and creating further health inequities.”
This is not the first time the Alzheimer’s Association has raised concerns about equitable access to Aduhelm. Last summer, after the drug was approved by the FDA, the organization called for Medicare to cover all patients eligible to receive the treatment. At the time, a statement from the Association pointed out that “access to the treatment is at risk of being impeded by significant barriers, which may further deepen issues of health equity.” When Aduhelm’s manufacturer announced a price reduction for the drug in December, the Association called it “only a step toward equitable access” for Alzheimer’s treatments.
Medicare coverage of the new treatment
The CMS is accepting public comment on the coverage proposal now through Feb. 10. As of Sunday, there were already more than 130 comments in only six days of availability. A final decision is expected by April 11.
Late last year, Aduhelm was cited specifically by CMS as a reason for a historically high increase in the year-over-year cost of Medicare Part B premiums from 2021 to 2022. The rate hike of over $20 is the largest year-to-year increase in real dollars in the program’s history.
A major sticking point for Aduhelm throughout its existence has been its price tag. Initially estimated at over $50,000 per year, its manufacturer, Biogen, cut its price by approximately 50% in December. As reported by the Associated Press, Medicare is expected to be one of the drug’s primary purchasers.
Why more testing is necessary
Aduhelm is the first new Alzheimer’s drug approved by the FDA since 2003, and the IV treatment is the first to reduce amyloid beta plaque, a hallmark of Alzheimer’s in patients’ brains. However, the initial testing did not show specific evidence of increased cognition in patients, and the drug has the potential for serious side effects, including brain bleeding. CMS cited those risks specifically when announcing the proposed coverage plan and justifying the decision to only cover patients in the drug’s ongoing trials.
“This proposed National Coverage Determination is the result of robust evidence analysis conducted through a thorough review process that found that while there may be the potential for promise with this treatment, there is also the potential for harm to patients,” said Fleisher in the statement. “This harm may range from headaches, dizziness and falls, to other potentially serious complications such as brain bleeds.”
When the FDA approved Aduhelm last summer – going against the advice of one of its own advisory boards – the agency used its accelerated approval process, which requires more testing of an approved treatment. In this case, even though the initial approval acknowledged Aduhelm reduced the brain plaque associated with the disease, the FDA needs to see that the treatment can improve memory and reduce other Alzheimer’s symptoms. Biogen says those phase 4 studies are scheduled to begin this spring.