MGB Statement on Lecanemab
The Mass General Brigham (MGB) is aware of interest in lecanemab (Leqembi™) that received accelerated approved by the FDA on January 6, 2023 for the treatment of Alzheimer disease in patients with mild cognitive impairment or mild dementia. Accelerated approval was based on reduction in amyloid beta plaques observed in patients treated with lecanemab (https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-disease-treatment).
The results of a Phase 3 randomized, controlled clinical trial to confirm the drug’s clinical benefit have recently been reported (https://www.nejm.org/doi/full/10.1056/NEJMoa2212948). The FDA anticipates receiving the data soon, which will help them to decide whether to give full approval to lecanemab.
The Centers for Medicare & Medicaid Services plan to review lecanemab to determine whether Medicare will cover the cost of this medication (https://www.cms.gov/newsroom/press-releases/cms-statement-fda-accelerated-approval-lecanemab).
Like all other drugs used within the MGB system, lecanemab will be subject to review by the MGB Pharmacy & Therapeutics Committee that is charged with evaluating and providing recommendations for the use of medications. The evaluation will include a review of clinical, economic, and operational considerations. This process, with the goal of ensuring safe and cost-effective use of medications within MGB, is expected to take several months. Additional information will be provided when it becomes available.
The MGB team will provide updates about lecanemab on this website as we learn more details about the status of full FDA approval and Medicare’s decisions about reimbursement.
Call for 2024 MGH MDU Clinical Fellows in Dementia
For details click here.
2023 Call for Development Projects Proposals
For details click here.
Call for MADRC Research Education Component 2022-2023
For details click here
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 (Aduhelm™) 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 Mass General 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.
What is aducanumab?
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.
How does aducanumab work?
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.
When will aducanumab be available?
At this time, the specific date it will be available to patients of Mass General 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.
Who is eligible to receive aducanumab?
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.
What are potential side effects of aducanumab?
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.
How will the most up to date information be communicated to patients and their families?
We take patient care and the battle against Alzheimer’s very seriously at Mass General 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.
If I am enrolled in a clinical trial, should I continue?
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.
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.
Message regarding Aducanumab approval
The Mass General Brigham (MGB) Center for Drug Policy is aware of interest in aducanumab (Aduhelm™) that was approved by the FDA on June 7th for the treatment of Alzheimer disease. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with aducanumab. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s). Link to aducanumab information on FDA website: https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/aducanumab-marketed-aduhelm-information?utm_medium=email&utm_source=govdelivery
Like all other drugs used within the MGB system, aducanumab will be subject to review by the MGB Pharmacy & Therapeutics Committee that is charged with evaluating and providing recommendations for the use of medications. The evaluation will include a review of clinical, economic, and operational considerations. This process, with the goal of ensuring safe and cost-effective use of medications within MGB, is expected to take 3-4 months. Additional information will be provided when it becomes available.
For individuals who receive care in the MGB system, and want further updates about possible availability of this drug, please visit:
Brigham and Women’s Hospital and affiliated centers: https://www.brighamandwomens.org/neurology/cognitive-and-behavioral-neurology/alzheimers-disease-drug-aducanumab
Massachusetts General Hospital and affiliated centers: https://www.massgeneral.org/neurology/treatments-and-services/memory-disorders-division