Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

CMS coverage decision on anti-amyloid monoclonal antibodies for Alzheimer disease

Nature Reviews Neurology (2022)Cite this article

Subjects

On the basis of a coverage decision for anti-amyloid monoclonal antibodies recently issued by the US Centers for Medicare and Medicaid Services, Medicare will offer ‘coverage with evidence development’ to allow more information on the clinical benefits of these antibodies to be gathered. Here, we discuss the implications of this decision for future clinical trials and Alzheimer disease care.

The regulatory pathway for aducanumab — an anti-amyloid monoclonal antibody (AAMA) developed by Biogen for the treatment of Alzheimer disease (AD) — was controversial from the start. In an Advisory Committee meeting convened by the FDA in November 2020, the FDA and Biogen spoke strongly in favour of aducanumab approval, but the Advisory Committee disagreed and voted overwhelmingly to reject a claim of substantial efficacy. While acknowledging the lack of clinical benefit, the FDA issued an accelerated approval for aducanumab on 7 June 2021 on the basis of the amyloid-lowering properties of the drug1.

This is a preview of subscription content

Access options

Buy article

Get time limited or full article access on ReadCube.

$32.00

Buy

All prices are NET prices.

References

  1. Liu, K. Y. & Howard, R. Can we learn lessons from the FDA’s approval of aducanumab? Nat. Rev. Neurol. 17, 715–722 (2021).

    Article  Google Scholar 

  2. Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=305 (Centers for Medicare and Medicaid Services, 2022).

  3. Day, G. S. et al. Aducanumab use in symptomatic Alzheimer disease evidence in focus: a report of the AAN Guidelines Subcommittee. Neurology 98, 619–631 (2022).

    CAS  Article  Google Scholar 

  4. Cummings, J. et al. Aducanumab: appropriate use recommendations. J. Prev. Alzheimers Dis. 8, 398–410 (2021).

    CAS  PubMed  PubMed Central  Google Scholar 

  5. Hlavka, J. P., Mattke, S. & Liu, J. L. Assessing the preparedness of the health care system infrastructure in six European countries for an Alzheimer’s treatment. Rand Health Q. 8, 2 (2019).

    PubMed  PubMed Central  Google Scholar 

  6. Biogen Submits Final Protocol for ADUHELM® (aducanumab-avwa) Phase 4 ENVISION Trial to FDA https://investors.biogen.com/news-releases/news-release-details/biogen-submits-final-protocol-aduhelmr-aducanumab-avwa-phase-4 (Biogen, 2022).

Download references

Author information

Authors and Affiliations

  1. Department of Neurology, Mayo Clinic, Rochester, MN, USA

    David Knopman

  2. Department of Neurology, Icahn School of Medicine at Mt Sinai, New York, NY, USA

    Mary Sano

  3. Department of Neurosciences, University of California San Diego, La Jolla, CA, USA

    Howard H. Feldman

Authors
  1. David Knopman
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Mary Sano
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Howard H. Feldman
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to David Knopman.

Ethics declarations

Competing interests

D.K. serves on a Data Safety Monitoring Board (DSMB) for the Dominantly Inherited Alzheimer Network (DIAN) study. He served on a data safety monitoring board for a tau therapeutic for Biogen but received no personal compensation. He is an investigator in clinical trials sponsored by Biogen, Lilly Pharmaceuticals and the University of Southern California. He has served as a consultant for Roche, Samus Therapeutics, Magellan Health and Alzeca Biosciences but receives no personal compensation. He receives funding from the NIH. M.S. serves as a consultant for Eisai, Avenir, vTv, Biogen, BioXcel, Hoffman LaRoche, NovoNordisk, Novartis and Merck. She chairs the DSMB for the Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer’s Disease (SESAD), sponsored by the University of Colorado. She receives funding from the NIH. H.H.F. serves as a member of a DSMB/Data Monitoring Committee for Janssen Research and Development and the Roche/Banner Institute, for which he does not receive personal compensation. He receives grant funding through the University of California San Diego (UCSD) from Biohaven Pharmaceuticals, Annovis (QR Pharma), AC Immune, Vivoryon (Probiodrug) and LuMind Foundation and has service agreements for consulting through UCSanD with Novo Nordisk, Samus Therapeutics, Samumed, Tau Consortium & Rainwater Charitable Foundation and Axon Neurosciences, for which he does not receive personal compensation. He holds grant funding from the NIH and the Canadian Institutes of Health Research.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Knopman, D., Sano, M. & Feldman, H.H. CMS coverage decision on anti-amyloid monoclonal antibodies for Alzheimer disease. Nat Rev Neurol (2022). https://doi.org/10.1038/s41582-022-00672-3

Download citation

  • Published:

  • DOI: https://doi.org/10.1038/s41582-022-00672-3

Search

Advanced search

Quick links

Nature Briefing

Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily.

Get the most important science stories of the day, free in your inbox. Sign up for Nature Briefing