In June 2021, aducanumab received accelerated approval by the U.S. Food and Drug Administration (FDA), becoming the first drug to treat some of the underlying brain changes associated with Alzheimer’s disease. Since then, two of the big questions have been “Who is eligible?” and “Is it covered by insurance?”

Those questions were answered by the Centers for Medicare and Medicaid Services (CMS) on April 7, when CMS announced that it would cover the costs of aducanumab and other drugs that target amyloid (or plaque), the hallmark characteristics of Alzheimer’s disease, but only for those who participate in clinical trials approved by CMS or the National Institutes of Health (NIH). And it would cover the costs of PET scans and related services if required as part of those approved studies.

Aducanumab is intended for patients with relatively mild memory problems—not patients with moderate to severe problems. Side effects are common with aducanumab use, and patients taking this drug will need to be monitored often for side effects. Aducanumab is a new drug, so what to expect with long-term treatment is unknown.

If your clinician suggests that you consider using aducanumab, or if you wish to discuss aducanumab with your provider, the following questions and answers may help to guide your discussions.

How do you pronounce aducanumab?

Aducanumab is pronounced “add-yoo-CAN-yoo-mab.” It is marketed under the brand name Aduhelm.

How does aducanumab work?

• Aducanumab removes amyloid-β plaques from the brain. Accumulation of amyloid-β is thought to play a role in the development of Alzheimer’s disease, and memory problems (mild cognitive impairment or dementia) due to Alzheimer’s disease.

Who should use aducanumab?

• The FDA approved aducanumab only for people with brain changes due to Alzheimer’s disease who are at the mild cognitive impairment or initial stages of dementia. Mild cognitive impairment is when a person’s memory is worse, but they can still do day-to-day activities on their own. Dementia is when a person’s memory and thinking are more severely affected and the person needs help with day-to-day activities. Dementia is often thought of as occurring in older adults; however, it can occur in younger adults as well (young-onset dementia).
• The FDA did not specify who should not receive aducanumab. However, studies of aducanumab did not include:
  • People with dementia that is not related to Alzheimer disease
  • People who take blood thinners or have a history of bleeding disorders, brain bleeding, or stroke
  • People with diabetes

Also, traditionally underrepresented minority groups were not well represented in the studies.

How is aducanumab administered?

• Aducanumab is given through a process called intravenous infusion during which the medicine is slowly administered through a needle that is inserted into a vein. Aducanumab infusion usually takes one to three hours.

Infusions are given every month. To reduce the chance of side effects, the dose of this medication is gradually increased over the first seven to eight treatments to reach the target dose of 10 mg of medication per kilogram of weight.

What are the side effects of aducanumab?

• Up to 40% of patients receiving aducanumab may develop brain swelling or bleeding. In most patients, this brain swelling or bleeding was identified on routine brain imaging and did not cause symptoms. One-fourth of patients with these brain changes had mild symptoms, most commonly headache. A smaller number of patients had more severe symptoms and signs (for example, confusion or weakness), requiring the patients to be hospitalized.
• In most patients, symptoms of brain swelling or bleeding went away when the medication was stopped. A small number of patients had severe swelling and experienced persistent side effects, such as weakness and confusion, even after the medication was stopped. One patient died from brain swelling and bleeding thought to be caused by this medication.
• Your clinician may ask you to have routine brain MRIs, one before treatment and at least two during the first year after starting this medication, to look for brain changes that may suggest swelling or bleeding.

How much does aducanumab cost?

• In the United States, aducanumab is expected to cost about $56,000 per year (for a person of average weight).
• These drug costs do not include the costs for the hospital visits when the procedure is done, the costs of physicians who give the medications, the clinic visits to monitor the treatment, or the cost of brain MRIs that need to be done while this drug is being given. When these costs are included, the yearly cost of treatment may be as much as $100,000.

How long do you need to take aducanumab?

• In the studies of aducanumab, it was given for up to 1.5 years.
• We do not know how long aducanumab should be administered or how to decide when to stop it. Studies are being done to answer these questions.

Will insurance companies cover aducanumab?

• Each insurance company has different policies about paying for aducanumab.
• Because not all clinics offer aducanumab, you may have to pay extra costs (for example, out-of-network costs, travel expenses, additional lost work time) if the treatment center you need to use is not in your insurance company’s provider network or is far from where you live.

Read the full evidence-in-focus article.

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