• Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA 02215
  • 617-667-4074
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On June 7, 2021, the Food and Drug Administration (FDA) announced the approval of the medication aducanumab (Aduhelm) to treat people with Alzheimer’s disease.

FDA Announcement

FDA Aducanumab Information

FDA Aducanumab Label

We at BIDMC, having been an active part of the development of aducanumab (Aduhelm), share in the excitement of the Alzheimer’s community regarding the FDA approval for its use in early Alzheimer’s disease. It is truly historic as the first new Alzheimer’s therapy approved since 2003, and the first approved therapy to work directly on amyloid, one of the two proteins that builds up in the brain to cause Alzheimer’s disease. We are also aware of the controversy surrounding the approval of this drug, and are prepared to provide more information about this in the future.

 We have been planning for this news and are building out the processes to determine who might benefit from this therapy; how to administer it safely (given the potential for significant side effects); how to provide it equitably; and how to properly monitor patients to determine their response.

Patients: If you would like to express interest in learning more about Aduhelm, please call 617-667-4074, option #5. Please leave your name, date of birth, and email address on this voicemail. You will be contacted once we are ready to screen and schedule patients for evaluation.

Healthcare providers: If you have patients who are interested in learning more about Aduhelm, please email MemoryA2Z@bidmc.harvard.edu. Please provide your name and the patient’s name, date of birth, and email address. Alternatively, you can have your patients contact us directly by phone. Patients will be contacted once we are ready to screen and schedule patients for evaluation.

We plan on updating you regularly by email and through this webpage to keep our community informed as we take these next steps in treating Alzheimer’s disease together.  Please stay tuned for additional information. 

Updates

July 8, 2021

The US Food and Drug Administration approved changes to the prescribing information for aducanumab, restricting use to patients with mild cognitive impairment or mild dementia stage of disease.

July 12, 2021

CMS (Medicare) Opens National Coverage Determination Analysis on Treatment for Alzheimer’s Disease.

The Centers for Medicare & Medicaid Services (CMS) is opening a National Coverage Determination (NCD) analysis, a process that will allow the agency to carefully review and determine whether Medicare will establish a national Medicare coverage policy for monoclonal antibodies targeting amyloid for the treatment of Alzheimer’s disease. A proposed decision is expected to be posted within 6 months and a final within 9 months.

FAQs

What is aducanumab?

Aducanumab, trade name Aduhelm, is a monoclonal antibody developed by Biogen that removes a protein called beta-amyloid from the brain. It is infused through a vein every four weeks.

How does aducanumab work? 

Patients with Alzheimer’s disease have a build-up of the proteins, beta-amyloid and tau in their brain. The accumulation of these proteins is thought to result in the degeneration of neurons and the associated cognitive decline. With the help of your immune system, aducanumab selectively targets and removes the beta-amyloid from the brain.

How much does aducanumab cost?  

The drug costs $56,000 per year per person. Additional costs such as, but not limited to, amyloid PET and MRI scans and related blood tests are not included in the cost.Currently, there is no information available on how insurers, including Medicare, will cover aducanumab, nor is there a timeline for this decision to be made. We will monitor this closely.  

Currently, there is no information available on how insurers, including Medicare, will cover aducanumab, nor is there a timeline for this decision to be made. We will monitor this closely.  

When will aducanumab be available?  

We anticipate it may take a few months from the time it was approved by the FDA to when it will be available to patients at the BIDMC. The CNU, BIDMC, and the BI-Lahey 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?  

Aducanumab has been approved by the FDA for the treatment of mild cognitive impairment or mild dementia stage of disease caused by Alzheimer’s. There is no evidence that it would be effective in the treatment of other types of dementia or in later stages of Alzheimer’s dementia. Alzheimer’s disease is currently best confirmed by detecting brain accumulation of Alzheimer’s disease proteins with either a lumbar puncture or amyloid beta positron emission tomography (PET) scan of the brain.

What are some potential risks of aducanumab?

Patients who receive aducanumab are at risk for developing a kind of brain inflammation called amyloid-related imaging abnormalities (ARIA), which involves brain bleeding, brain swelling, or a combination of the two. A few of these will need to discontinue their treatment due to concerns related to ARIA. Before and after aducanumab is started, patients must receive special monitoring (including brain MRI scans) to screen for ARIA.

What if I am enrolled in a clinical trial?  

We would encourage you to continue participation in ongoing clinical trials. If you have any questions or concerns about how starting aducanumab may impact your continued participation in the clinical trial, please discuss them with the principal investigator of your clinical trial or your physician.

Does aducanumab work?

Based on some promising results of a small phase 1 safety study (study 103), the makers of aducanumab, Biogen, initiated two identical phase 3 studies, ENGAGE (study 301) and EMERGE (study 302). Both studies were stopped because interim analysis showed that aducanumab was not effective in treating Alzheimer’s disease. Upon further analysis of the two phase 3 studies, Biogen applied for and received FDA approval for the use of aducanumab in the treatment of Alzheimer’s disease. Please click here for results of Biogen’s phase 3 trials.

Next steps at BIDMC

Within the next few months, we plan to enable and organize aducanumab treatments in appropriate patients who receive care at the BIDMC Cognitive Neurology Unit. Our team will keep this webpage up to date with information about our aducanumab program as it develops, and we will update patients through our Memory A2Z clinic email list (see above for instructions on getting added to this list). We will also include updated educational materials as they become available.

If you or your loved one is worried about new and progressive concerns with memory, language or behavior, the first best step is to consult with a doctor and specifically consider a referral to a neurologist. If you are specifically interested in receiving diagnostic assessment and care at BIDMC, please contact the BIDMC Cognitive Neurology Unit at 617-667-4074.