In 2022, Medicare announced it would only cover Aduhelm™ for patients participating in qualifying clinical trials.

NCOA supports the Medicare coverage decisions made by the Centers for Medicare & Medicaid Services (CMS) regarding this controversial and 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 high cost, which originally was $56,000 a year and then later reduced to $28,000 a year

Aduhelm—administered by infusion through a vein once monthly—is a monoclonal antibody that targets the beta-amyloid plaques in the brain. These plaques are considered a hallmark or possible cause of Alzheimer’s disease.

In 2022, CMS  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 uncommon decision, as CMS does not often tie participation in clinical studies to Medicare coverage of medications. Medicare almost always covers drugs if the FDA approves them.

Why is Aduhelm different? It's because the FDA approved the treatment without a guarantee that patients will actually experience slower cognitive decline. 

Get the facts about the CMS coverage policy decision onAduhelm that impacts 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 (NIH). 
• Medicare will limit Aduhelm access 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 submitted to FDA for approval (donanemab). 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.

The new limited coverage policy for Aduhelm means the drug will put less of a financial burden on the Medicare program. 

How do I know if I can participate in the Aduhelm clinical trials?

The situation surrounding Aduhelm clinical trials is constantly changing. If you or a family member has been diagnosed with mild cognitive impairment and you are interested in participating in an Aduhelm clinical trial, contact your primary care physician or neurologist for more information.

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.