Plan to Limit Medicare Coverage of Aduhelm Called ‘Not Patient-centered’

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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A recent proposal that Medicare only cover Aduhelm (aducanumab) for patients with Alzheimer’s disease who are enrolled in clinical trials is needlessly restrictive, and will prevent many people from accessing a medication that may be able to help them.

That’s the argument made by Jeffrey Cummings, MD, a professor of brain health at the University of Nevada Las Vegas. Cummings’s paper, “Public Policy Should Foster Alzheimer’s Treatment Availability: Comment on the Draft US Medicare Decision to Limit Payment for Aducanumab (Aduhelm) to Patients Participating in Clinical Trials,” was published in The Journal of Prevention of Alzheimer’s Disease.

Aduhelm is an antibody-based therapy designed to clear the brain of irregular clumps of amyloid plaque proteins that are believed to contribute to Alzheimer’s progression.

Co-developed by Biogen and Eisai, the therapy received accelerated approval in June 2021 from the U.S. Food and Drug Administration (FDA), which quickly amended its decision to specify that the medication should only be used in early disease. The approval has been highly contentious, prompting members of an FDA advisory committee to resign and sparking a congressional inquiry.

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Early clinical trial data had shown that Aduhelm could clear amyloid plaques as designed. The FDA’s accelerated approval was based on this early data, and carried a requirement that the medicine’s manufacturers conduct additional testing of clinical efficacy.

The U.S. Centers for Medicare and Medicaid Services (CMS) recently issued a draft National Coverage Determination for Aduhelm and other medications in its class. If approved, the determination would mean that Medicare, which provides health insurance to elderly people in the U.S., would only help cover the cost of Aduhelm for patients taking the medication as part of clinical trials.

“This approach is not patient-centered and will greatly delay access to treatment for individuals with early AD [Alzheimer’s disease],” Cummings wrote.

Discounting efficacy, exaggerating safety concerns

Cummings says the draft coverage determination doesn’t line up with the FDA’s intent in giving accelerated approval.

“Accelerated approval is intended to make drugs available to patients with life-threatening diseases such as AD while additional evidence to confirm efficacy and safety is generated,” Cummings wrote, noting that this pathway is often used for other deadly conditions like cancer.

“The decision of CMS to limit aducanumab to clinical trials is at variance with the purpose of this approach and inconsistent with the intent of the FDA to provide a mechanism for accelerated access to aducanumab for appropriate patients,” Cummings said.

Cummings argued that the CMS proposal discounts the evidence for Aduhelm’s benefit, but exaggerates safety concerns. Two large Phase 3 trials found conflicting results on whether Aduhelm treatment could slow a decline in cognition, which Cummings said may be partly explained by differences in dosing.

According to Cummings, the most optimistic interpretation of available data for Aduhelm’s effect on cognition suggests that patients might get six years in the earliest stages of dementia, rather than the more usual five. While he acknowledged that additional research is needed to be sure of Aduhelm’s effect on cognition, “patients should be empowered to decide if this degree of slowing is desirable for them,” Cummings wrote.

The main safety concern with Aduhelm is a form of brain swelling called ARIA, which occurred in more than a third of participants given the now-approved dose of Aduhelm in trials. ARIA usually doesn’t cause significant symptoms, though it can be serious, so monitoring is recommended during treatment.

Cummings wrote that the risks of ARIA posed by Aduhelm “do not exceed those of cancer therapies that are routinely covered by CMS.” He called limiting treatment coverage for AD patients “disease-based discrimination.”

‘An approved treatment that could be available now’

Limiting Medicare coverage for Aduhelm only to trial participants would make the treatment less accessible — particularly for traditionally underserved populations, Cummings said.

“Academic trials sites are rarely in minority neighborhoods and are not situated to allow recruitment of rural populations (also under-represented in clinical trials),” Cummings wrote. “Trials as proposed by CMS would require 1-2 years to secure funding plus 3-5 years to conduct and analyze, delaying the availability of an approved treatment that could be available now.”

The restrictions also would mean that people who can afford to pay for Aduhelm out of pocket will have access to the drug, while those who cannot would have to try to enter clinical trials.

“Limitation of treatment coverage to those in trials means that persons in limited financial circumstances will have limited access to therapy while those with financial means will have access to treatment. CMS requirements will increase the lack of equity in AD care in the US,” he wrote.

Cummings also noted that in many trials some participants are given an inactive placebo, so even getting into a trial doesn’t guarantee that patients will have access to Aduhelm. And some may even end up paying for the placebo since CMS usually doesn’t cover the full cost of treatments.

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There also is a greater proportion of white participants in U.S. trials than there is in the general population. Cummings called the draft proposal’s requirement that all trials have a representative group of participants a “noble aspiration,” but not realistic given how difficult it can be to recruit “underrepresented and underserved populations” for trials.

“We must improve inclusion of diverse populations in trials; this is a long-term goal requiring trial infrastructure not currently available and trust that has not been built,” he wrote. “Requiring a representative sample in the CMS trial will delay the trial and limit the availability of drug treatment to both minority and majority culture patients.”

Cummings said he also worries that the CMS decision would dampen the pharmaceutical industry’s willingness to invest in potential Alzheimer’s therapies that would not be made reasonably available. He also noted that the CMS’s decision covering all amyloid-targeting antibody therapies does not recognize the diversity of different therapies in this class that are in development, which could pose problems in the future.

The CMS draft proposal is available online. Public comment can be submitted online through Feb 10.