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What You Need to Know About Aducanumab
The New FDA-Approved Drug for Alzheimer’s Disease
An Update from Duke Health
October 29, 2021
After careful review and thoughtful deliberation, Duke Health has decided it will not provide aducanumab for the treatment of Alzheimer’s disease at this time.
This decision was made after evaluation by Duke’s Pharmacy Medication Management Committee, which includes providers from various specialties and medication experts, who review all medications for their availability at Duke Health.
We understand that some patients may be disappointed, but based on current data including information on safety and clinical benefit, we believe this is the best decision for our patients. If new research or data become available, we may reconsider our decision in the future.
We are committed to caring for patients with Alzheimer’s, their families, and caregivers. Duke recently announced a collaboration with the University of North Carolina at Chapel Hill to establish an Alzheimer’s Disease Research Center (ADRC), part of a federally funded national network of similar centers. We hope that this research will benefit patients, as well as their loved ones, that are affected by Alzheimer’s disease.
What You Need to Know About Aducanumab
The recent FDA approval of aducanumab for the treatment of Alzheimer’s disease has left people with a lot of questions. As the first drug authorized to treat Alzheimer’s since 2003, it has given hope to people who have had few treatment options for this devastating disease. However, aducanumab is not a cure for Alzheimer’s disease and it is not for all people with memory loss or Alzheimer’s disease. Here, Duke geriatric psychiatrist Kim Johnson, MD, answers some frequently asked questions about the new drug and how to find out if it might be an option for you.
What is aducanumab?
Aducanumab (brand name Aduhelm) is an intravenous drug that aims to slow the progression of Alzheimer’s disease. It’s given through a vein in a monthly infusion that lasts one to three hours to administer.
How does aducanumab work?
Amyloid is a protein that can build up in the brain and may cause Alzheimer’s disease. Aducanumab travels to the brain, sticks to amyloid, and removes it.
Am I eligible to receive aducanumab?
The clinical trials of aducanumab studied a limited, specific group of people. You may be eligible to receive the drug if you:
- Are younger than 85 years old
- Have confirmed mild cognitive impairment, defined as a mild decrease in memory and/or thinking that occurs daily but does not yet affect functioning
- Have amyloid present in the brain (determined by lumbar puncture or imaging scan)
- Do not have a history of microbleeds, transient ischemic attacks, or stroke due to bleeding (an MRI will be needed to confirm this)
- Do not take blood-thinning medications
What are the possible side effects of aducanumab?
The most common side effects include areas of brain swelling, small brain bleeding, headache, or falls. The areas of brain swelling and small brain bleeding are usually temporary and resolve over time. Everyone who receives aducanumab will have periodic MRIs to monitor for these side effects, which can cause headache, confusion, dizziness, vision changes, or nausea but may not cause any symptoms.
How much will aducanumab cost?
Right now, the cost to patients is unknown. Biogen, the pharmaceutical company that created aducanumab, has set a price of $56,000 per year. Medicare and private insurers are in the process of deciding if and/or how much of that cost they will cover.
Why does there seem to be controversy about aducanumab?
The FDA’s approval of aducanumab is controversial for several reasons.
- Clinical trials studying the effectiveness of aducanumab did not prove that the drug improved cognition. In fact, two trials were stopped early because no clinical benefit was shown. Biogen reviewed the data again and noted a small improvement of symptoms in one subgroup of patients.
- Aducanumab is shown to reduce amyloid in the brain, but it is still unclear whether amyloid causes memory loss or Alzheimer’s disease. Therefore, the direct link between amyloid reduction and improvement of memory loss or other Alzheimer’s symptoms has not been established, and the clinical benefit for memory loss needs to be further explored.
- All but one member of an independent expert panel -- enlisted to review the drug’s effectiveness and make a recommendation to the FDA -- voted against approving the drug.
- The FDA approved aducanumab through an accelerated pathway that is designed to bring the drug to market sooner, compared with the traditional pathway that most drugs take. This accelerated pathway can be used for drugs that treat diseases with no known cure, even if the clinical benefit is unclear and needs more investigation. As part of the accelerated FDA approval, Biogen is required to perform more research studies to answer some important questions related to clinical benefit. Duke plans to participate in these studies.
- The wholesale cost of the drug is high, meaning it could be too expensive for many patients.
How can I find out more about how to receive aducanumab?
If you are already being treated for mild cognitive impairment or Alzheimer’s at Duke, talk to your doctor at your next, regularly scheduled appointment. If you don’t have an appointment scheduled, contact your doctor via My Duke Health (previously Duke MyChart). If you are not an existing Duke patient, ask your primary care provider, neurologist, or memory disorder specialist for a referral to one of our Alzheimer providers.
