American Association for Geriatric Psychiatry (AAGP) Statement on Aducanumab
McLean, VA - On June 7th, 2021, the US FDA (Food and Drug Administration) approved aducanumab (brand name: Aduhelm), introducing the first new drug for Alzheimer’s disease in nearly two decades. This approval has created a great deal of excitement for the millions of patients and families living with Alzheimer’s disease. It has also raised many questions for patients, families and providers.
Aducanumab is administered through an intravenous (IV) infusion. It works by binding to the beta-amyloid protein in plaques in the brains of patients with Alzheimer‘s disease and helping to clear it from the brain. It is believed that beta-amyloid protein is one of the primary drivers of Alzheimer’s disease and that its presence along with another abnormal protein (tau) is the major cause of brain cell loss, memory impairment, and other symptoms of this disease.
Two large clinical trials conducted by Biogen showed that treatment with aducanumab clearly reduced brain beta-amyloid levels in patients with early-stage Alzheimer’s disease. However, controversy arose about the effects of this drug because while one trial showed aducanumab slowed cognitive and functional decline, the other trial did not show the same benefits. The FDA’s approval of aducanumab was based on its ability to clear beta-amyloid from the brain. This was considered a positive step forward, as it is believed that removal of beta-amyloid will slow the process of Alzheimer disease progression. However, because of conflicting findings from the two trials, it remains uncertain how much long-term clinical benefit that patients will experience. Biogen is required to complete a third large clinical trial by 2030 to clarify the effects of aducanumab on memory and functioning to confirm the clinical benefit to patients of beta-amyloid reduction.
Aducanumab is different from any previously approved treatment for Alzheimer’s disease. It is an antibody-based drug that requires monthly IV infusions of the drug. Studies of this type of medication (antibodies) in Alzheimer’s disease have shown that a proportion of patients develop swelling or bleeding in small areas of the brain; this side effect is called ARIA (amyloid related imaging abnormality). While this usually does not produce symptoms and goes away with time, patients require close monitoring with brain scans. It is also notable that the costs of this treatment appear to be substantial (estimated $56,000 per year for the drug), and there may be additional expenses beyond the cost of the drug, such as brain scans. Medicare and insurance coverage for aducanumab remains to be determined. Medicare has announced a national coverage determination process that will take time to complete, but there is likely to be substantial out-of-pocket costs for many patients. Issues of risk/benefit balance for patients and matters of healthcare cost, fairness, access, and equity must all be addressed.
Physicians and other clinicians believe that the evidence indicates aducanumab’s potential benefit is only likely for those with early stages of Alzheimer’s disease. The ability of aducanumab to make a meaningful impact on the long-term course of illness in Alzheimer’s disease remains uncertain. To balance potential benefits and safety risks it is important to determine for which patients this new treatment is appropriate. Expert specialists will need to develop protocols for selecting patients, providing the treatment, and monitoring for side effects. Ultimately, decisions about whether this treatment is appropriate for individual patients will depend on many factors and will need to be personalized. Therefore, we encourage patients and their care partners to have discussions about aducanumab with their doctors.
As physicians, clinicians, and scientists dedicated to the care of patients and families affected by Alzheimer’s disease, we recognize that we are in an exciting new era of Alzheimer’s disease treatment. We will continue to encourage investigations of all promising paths for prevention and treatment of this terrible disease, and we will work to ensure that all patients have affordable and equitable access to new treatments as they become available.
Individuals wanting more information should talk with their health care professional.
The American Association for Geriatric Psychiatry (www.AAGPonline.org) is a national association representing and serving its members and the field of geriatric psychiatry. AAGP’s mission is to enhance the knowledge base and standard of practice in geriatric psychiatry through education and research and to advocate for meeting the mental health needs of older Americans.
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