Medicare coverage for the new Alzheimer’s medication Aduhelm™ is limited to patients participating in clinical trials.
The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) will oversee the clinical trials, which will be conducted in a number of settings and will include recruitment of racially diverse participants.
NCOA is supportive of the Medicare coverage decisions made by the Centers for Medicare & Medicaid Services (CMS) regarding this controversial and very expensive medication.
In early April, based on feedback from 10,000 stakeholders and 250 peer-reviewed documents, federal regulators issued a final decision on Medicare coverage of Aduhelm™ and similar drugs designed to treat Alzheimer's disease and related dementias: Medicare will only cover Alduhelm™ for patients participating in clinical trials.
NCOA is supportive of the Medicare coverage decisions made by the Centers for Medicare & Medicaid Services (CMS) regarding this controversial and very expensive medication, and similar medications in the future. We believe more information is needed on the effectiveness and safety of Aduhelm before it is more widely available.
What is Aduhelm, and why is it controversial?
In 2021, the drug Aduhelm (generic name aducanumab) was approved by the Food and Drug Administration (FDA) for the treatment of Alzheimer’s disease and related dementias. This decision was controversial for several reasons, including:
- The lack of evidence on the medication’s benefits or effectiveness on slowing cognitive decline
- The medication's risks, including brain swelling and bleeding, that can be significant
- The medication's very high cost, which originally was $56,000 a year and then later reduced to $28,000 a year
Yet FDA’s approval of this medication provided hope for millions of people with Alzheimer’s disease and related dementias and their families that a new treatment would soon be available. Aduhelm—administered by infusion through a vein once monthly—is a monoclonal antibody that targets the beta-amyloid plaques in the brain, which is considered a hallmark or possible cause of Alzheimer’s disease.
In January, CMS (the federal agency that oversees Medicare) proposed that Aduhelm and other medications in this category in the future be covered for people with Medicare only if they are enrolled in qualifying clinical trials or approved studies of the drugs.
This decision was based the opinions of experts who reviewed publicly available evidence about Aduhelm™ and feedback provided by a variety of stakeholders. This is an infrequent decision as CMS does not often tie participation in clinical studies to Medicare coverage of medications.
Aduhelm’s limited Medicare coverage is unprecedented, as Medicare almost always covers drugs if the FDA approves them.
Aduhelm has been different because the FDA approved the treatment without a guarantee that patients will actually see slower cognitive decline.
The facts about the CMS coverage policy decision over Aduhelm that will impact those on Medicare:
- Medicare will provide coverage of Aduhelm for patients enrolled in any trial or study approved by the FDA or the National Institute of Health. This is an important change from the original proposal that will expand access for more patients to get the drug in additional settings, and not just major medical centers typically located in metropolitan areas.
- The clinical trials will include recruitment of racially diverse participants who were lacking from the original studies conducted by Aduhelm’s manufacturer, Biogen.
- Medicare will limit those who can get Aduhelm to people who have mild forms of cognitive impairment or mild dementia, and who have amyloid plaques, the proteins Aduhelm™ is designed to target, in their brain. The patient population is narrower than the one the FDA approved the drug to treat, as the FDA did not require proof of amyloid plaques.
- This coverage decision is not specific to Aduhelm. It applies to all drugs in the class, including a new treatment Eli Lilly has begun to submit to FDA for approval. In a major change from the initial CMS proposal, Medicare created a shortened path for drugs that clearly demonstrate a clinical benefit for patients before they are approved. Medicare will cover those medicines for a broader group of patients. Data will still be collected on those medications, but the design of the studies will be more flexible, including data collection through regular clinical practice or registries that will provide data on patient outcomes.
- Medicare will also allow patients with other medical conditions, like Down syndrome, to participate in the trials.
Medicare officials had increased premiums for Medicare beneficiaries in anticipation of a possible influx of patients taking the very expensive medication. But the new limited coverage policy for Aduhelm mean the drug will put less of a financial burden on the Medicare program. Health and Human Services Secretary Xavier Becerra said he will make a decision on whether to lower Medicare premiums for older adults after Medicare’s coverage decision for Aduhelm. Stay tuned for more information on this decision.
How do I know if I can participate in the Aduhelm clinical trials?
If you or a family member has been diagnosed with mild cognitive impairment and you are interested in participating in one of the Aduhelm trials, contact your primary care physician or neurologist. Your health care providers will determine if you are appropriate for a clinical trial and, if so, how to access the trials.
Please note that Medicare covers routine care costs associated with clinical trials and patients may have coinsurance or copayments for routine care. Clinical trial research costs are not usually covered by health insurers, including Medicare, but are often covered by the trial sponsor.