Consensus Statement Regarding the Application of Biogen to Health Canada for Approval of Aducanumab.

Alzheimer's disease is a major cause of morbidity and mortality. Currently, there are no disease-modifying pharmacotherapies for this condition. Aducanumab, an amyloid beta-directed monoclonal antibody that targets aggregated forms of amyloid-beta in the brains of people with Alzheimer's disease, has raised hopes that such a therapy has been discovered, but its approval by the US Food and Drug Administration has engendered a good deal of controversy. A similar application for approval has been submitted to Health Canada. In response to this, a group of Canadian clinical dementia experts representing a number of organizations, including the Canadian Geriatrics Society, was convened by the Canadian Consortium on Neurodegeneration in Aging (CCNA) to discuss the evidence currently available on this agent and seek consensus on what advice they would offer Health Canada on the application. There was wide-spread agreement that it would be premature for aducanumab to receive approval for the treatment of Alzheimer's disease. It was also noted that the Canadian health-care system is poorly prepared at this time to deal with a disease-modifying therapeutic with targeting, administration, and monitoring characteristics like aducanumab. In this paper, the consensus reached is presented along with its underlying rationale.

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© 2021 Author(s). Published by the Canadian Geriatrics Society.

Déclaration de conflit d'intérêts

CONFLICT OF INTEREST DISCLOSURES Dr. Chertkow has participated as an unpaid advisor in 2020 for establishment of an international database by Biogen. Rockwood is Co-founder of Ardea Outcomes, which (as DGI Clinical) in the last three years has contracts with pharma and device manufacturers (Biogen, Hollister, Novartis, Nutricia, Roche, Takeda) on individualized outcome measurement. In 2019 he accepted an honorarium from Biogen for taking part in an interview. Dr. Black discloses that in the last 5 years (2016–2021) she has received personal fees for ad hoc consulting from Hoffman LaRoche, Biogen, Pfizer, Eli Lilly, Novartis and Merck. She has also received personal fees for speaking from Biogen, Eli Lilly and Novartis. Dr. Black discloses support to her institution for contract research from Eli Lilly, GE Healthcare, Eisai Biogen, Genentech, Optina, Hoffman LaRoche, NovoNordisk, and UCB. Dr. Borrie is principal investigator for Biogen and a sub-investigator for Eisai for two clinical trials and does not personally receive any compensation from Biogen. Dr. Hsiung has received research support as a clinical trials site investigator from Anavax, Biogen, Eli Lilly and Roche. Dr. Kirk has participated in and been recompensed by advisory boards for Biogen, Genzyme and Roche. He has also received compensation for speaking engagements with Biogen. Dr. Masellis reports consulting fees from Biogen Canada relevant to the submitted work. Dr. Nygaard is a paid, independent consultant to Biogen Canada National Advisory Board. Dr. Verret has received funds from Biogen (for the ENGAGE TRIAL). He is a member and has received funds for the advisory boards of Biogen, Roche, Abbvie; and has received funds from Biogen for continuous medical education. David Hogan, Natalie Phillips, Manuel Montero-Odasso, Shabbir Amanullah, Christian Bocti, Howard Feldman, Morris Freedman, and Tarek Rajji report no conflicts of interest relating to this consensus statement.