On Jun 7, 2021, the U.S. Food & Drug Administration (FDA) announced the approval of aducanumab (brand name Aduhelm™) for treatment of dementia caused by Alzheimer Disease (AD). Aduhelm is a new medication that is given as a monthly infusion and directly targets amyloid plaques, one of the hallmarks of AD. Aduhelm is the first approved medication to address one of the underlying causes of AD, as current therapies only target symptoms. In making its decision, the FDA indicated that the clinical trials adequately demonstrated that Aduhelm can decrease amyloid plaque burden, which may slow the disease process. Biogen, the company that makes Aduhelm, is required to perform another trial to determine if Aduhelm slows the clinical progression of the AD. It is important to note that aducanumab has not been yet been approved for the prevention of AD, or for other forms of dementia.
This announcement understandably has generated much interest from patients with AD dementia and their families. We at Washington University’s Memory Diagnostic Center and Knight Alzheimer Disease Research Center are working hard to put all necessary processes in place to make this new medication available to those of our patients who are eligible for it. However, we ask for your patience as we await critical information from Medicare and other insurers regarding the precise guidelines for use of this new medication. It is likely to take several months for all of these regulatory processes to occur and for aducanumab to be available to our patients. Aduhelm has only been tested in patients with very mild, early-stage AD dementia, and will likely not be appropriate for or available to all of our patients. Thus, we are anxiously awaiting the specific criteria for eligibility for Aduhelm, so that we can begin the process of contacting patients who meet these criteria.
It is also expected that patients will need to have positive results from AD biomarker testing to be eligible for the drug. Many of these biomarkers were developed at the Knight Alzheimer Disease Research Center, and this testing is available to existing patients through the Memory Diagnostic Center. Please note that the Knight Alzheimer Disease Research Center cannot prescribe aducanumab or other medical tests for research participants (including those involved in the Memory and Aging Project, the Adult Children Study, and Dominantly Inherited Alzheimer Network) outside of a clinical trial. Research participants will need to be evaluated for Aduhelm by a neurologist in the clinical setting, and we can provide contact information for appropriate providers (including those at the Memory Diagnostic Center) as needed. It is also notable that because aducanumab is a monoclonal antibody medication, it will expensive (requiring close cooperation with insurers) and require monthly infusions. Thus, there are some logistical complexities to administering this medication that we are currently working through.
Once we obtain further information from the government and insurers regarding eligibility criteria and coverage, we at the Memory Diagnostic Center will be reaching out to existing patients, either by phone or by letter, regarding their possible eligibility for Aduhelm. We expect that existing patients will need to be re-evaluated (with some cognitive testing) to determine disease severity, and will then be referred for biomarker testing, if not already obtained. If the results of the clinical re-screening and biomarker tests are positive and meet the eligibility criteria for Aduhelm, interested patients will then be scheduled to begin monthly infusions of the drug. We are assembling a team of care providers within the Memory Diagnostic Center to handle this process, and a special hotline will be set up for this purpose (which will be included in future communications from the Memory Diagnostic Center). We appreciate your patience in this matter. If you have questions or concerns, feel free to call the Memory Diagnostic Center at 314-286-1967 or contact your Memory Diagnostic Center physician through MyChart.