Mass General Brigham Statement on the Use of Aducanumab for Patients
After careful deliberation and review, Mass General Brigham has decided that it will not provide aducanumab (AduhelmTM) for the treatment of Alzheimer's disease at this time. Like all other drugs used within Mass General Brigham, aducanumab was subject to evaluation by the Mass General Brigham Pharmacy and Therapeutics Committee, a multidisciplinary panel of experts from across the academic health system, that serves as decision-making body to Mass General Brigham on formulary management. The evaluation included a thorough review of clinical, economic, and operational considerations.
This decision was based on the current data regarding aducanumab’s safety and efficacy. We understand that this may be difficult news for some of our patients. However, we fully support continued evaluation of this medication and should new data become available we will re-evaluate this decision.
On June 7, 2021, the Food and Drug Administration (FDA) approved aducanumab (brand name Aduhelm) for the treatment of Alzheimer’s disease. Here at the Brigham, we know that raises both excitement and questions for our patients. Since there are many questions regarding this new treatment, we would like to address the most frequently asked questions we have been receiving from our patients and their loved ones. We expect new information to become available in the coming months, and we will update the information here to include the latest developments.
Click here to read the FDA announcement of approval in June
It is a newly approved medication for the treatment of Alzheimer’s disease. Aducanumab is administered in the form of an intravenous (IV) infusion every 4 weeks. There is no pill form of this medication.
Aducanumab is an antibody that targets a protein called amyloid-beta. Amyloid-beta protein accumulates in the brains of Alzheimer’s disease patients, and it is thought to contribute to the cognitive decline in Alzheimer’s disease. Aducanumab helps patients’ immune systems to remove the amyloid-beta deposits from the brain.
At this time, the specific date it will be available to patients at the Brigham is not known. However, we anticipate it may take a few months from the time it was approved by the FDA. Experts from across the Mass General Brigham system are working together to ensure that the medication can be delivered as safely and effectively as possible to eligible patients.
As with any medication, eligibility depends on a number of individual patient factors. Aducanumab has been approved by the FDA for the treatment of Alzheimer’s disease. There is no evidence that it would be effective in the treatment of other types of dementia. For personalized treatment options, you should discuss further with your doctor.
As with any medication, aducanumab may have side effects. Since aducanumab works by helping the immune system remove amyloid deposits from the brain, some patients may experience an exaggerated immune response in the brain. If this occurs, it may cause blood vessel leakiness leading to localized brain swelling, small spots of bleeding in the brain, or both. These side effects can be seen using MRI imaging of the brain and are called amyloid-related imaging abnormalities (ARIA). As a result, patients receiving aducanumab will require regular monitoring with MRI scans. During the aducanumab clinical trials, those trial patients (~35%) who developed ARIA had clearing of the focal brain swelling within 2-3 months and most did not develop symptoms. Another potential side effect is an allergic response during the infusion of aducanumab.
We take patient care and the battle against Alzheimer’s very seriously here at the Brigham. We understand that there have been no new medications in over 18 years and that some patients are eager to receive treatment as soon as possible. We will provide updates regarding aducanumab and its availability via this website and Patient Gateway.
You are always welcome to speak with your Brigham doctor to discuss any questions or concerns you may have. You may connect with your doctor via Patient Gateway or calling our clinic phone number (617-732-8060). Please note that your doctor may have limited information specifically regarding aducanumab availability in the months following approval, as discussed above.
We would encourage you to continue participation in ongoing clinical trials at this time. If you have any questions or concerns about how starting aducanumab may impact your continued participation in the clinical trial, please discuss them with your doctor.
The phone number to initiate becoming a patient through our Neurology Patient Access Center at the Brigham is 617-732-8060. Your current doctor will be asked to send a referral. The coordinators in our center will help you schedule an appointment with the most appropriate doctor for your care and assist you through the process of becoming a new patient.
We understand you may have additional questions about the potential of this drug. We will continue to keep you updated as soon as information becomes available, and we thank you for your patience.
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