Aducanumab Resources
In This Section
The US Food and Drug Administration (FDA) announced on June 7, 2021, the approval of aducanumab (Aduhelm). The drug was approved under the Accelerated Approval pathway, one of the alternative drug approval pathways.
The Academy provides resources to help its members understand the current landscape of the new Alzheimer’s disease drug, and how members can discuss it with patients.
Aducanumab (Aduhelm) Update
Biogen announced on January 31, 2024, they are discontinuing the production of aducanumab (Aduhelm). Clinical trial participants may continue in their studies through May 1, 2024 and patients with prescriptions can continue to receive treatments through November 1, 2024. Biogen has encouraged patients to contact treating physicians about next steps.
What the AAN Is Doing
The AAN formed a work group of experts in health policy, science, and education in July 2020 to prepare for a potential release of aducanumab and its implications for neurologists and their patients. While the AAN did not weigh in on whether the drug should be approved, we did submit comments in October 2020 for the FDA to consider around labeling.
Evidence in Focus
The Academy’s Evidence in Focus document summarizes the level of evidence for patients with Alzheimer’s disease and reviews clinical considerations regarding use. This is not a guideline and does not include recommendation statements. This is a narrowed assessment of the evidence that is developed more quickly than a traditional guideline.
Top Resources
Decisions With Patients and Families Regarding Aducanumab in Alzheimer’s Disease, with Recommendations for Consent: AAN Position Statement | November 17, 2021
NeuroBytes: Aducanumab for Alzheimer’s Disease | October 1, 2021
NeuroBytes: Ethical Issues Relating to Informed Consent for Aducanumab | May 27, 2022
View the free August 16, 2021, webinar recording: “Practice Perspectives for Aducanumab”
Recent News
What's Next for Patients Treated With Aducanumab? (Neurology Today®) |May 16, 2024
CMS Proposes Coverage with Evidence Development for Aducanumab What Does This Mean for Anti-Amyloid Therapies? (Neurology Today®) | April 7, 2022
AAN summary of final coverage determination for aducanumab | April 7, 2022
AAN provides public comments on proposed national coverage determination (NCD) | February 4, 2022
Mixed Response to the CMS Decision on Coverage for Aducanumab (Neurology Today®) | February 3, 2022
Navigating Aducanumab Decisions With Families: An AAN Position Statement (Neurology® podcast) | January 25, 2022
AAN summary of proposed coverage determination for aducanumab | January 12, 2022
Cost-Effectiveness and Value-Based Pricing of Aducanumab for Patients With Early Alzheimer Disease (Neurology®) | January 12, 2022
Advocacy and Payer Relations
AAN provides public comments on proposed national coverage determination (NCD) | February 4, 2022
AAN, Geriatrics, and Nuclear Medicine provide comments to CMS on coverage for aducanumab | November 22, 2021
AAN provides comments to CMS on coverage for aducanumab | August 9, 2021
AAN, Geriatrics, and Nuclear Medicine request CMS cover beta amyloid PET | July 19, 2021
AAN provides public comment to ICER on aducanumab | July 15, 2021
Capitol Hill Report: FDA Approves Aducanumab for Alzheimer’s Disease | June 7, 2021
AAN Comments to FDA Advisory Committee on Aducanumab Labeling | October 22, 2020
Questions?
Have questions or need additional resources?
External Resources
CMS fact sheet for coverage for aducanumab | April 11, 2022
FDA revises aducanumab label to narrow the eligible patients | July 8, 2021
"Dialogue: Current Perspectives on Aducanumab" Alzheimer's Association webinar | June 21, 2021
FDA Statement on Aducanumab Approval | June 7, 2021
FDA Label | June 7, 2021