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Geriatrics

Anti–SARS-CoV-2 Monoclonal Antibody Distribution to High-risk Medicare Beneficiaries, 2020-2021

Educational Objective
To identify the key insights or developments described in this article

1 Credit CME

JAMA

Published Online: February 4, 2022

Research Letter

Article Information and Disclosures

Caroline L. Behr, AB¹;

Karen E. Joynt Maddox, MD, MPH^2,3;

Ellen Meara, PhD⁴;

Arnold M. Epstein, MD, MA⁵;

E. John Orav, PhD⁵;

Michael L. Barnett, MD, MS⁵

Author Affiliations

¹Harvard Medical School, Boston, Massachusetts
²Department of Internal Medicine, Washington University School of Medicine in St Louis, St Louis, Missouri
³Associate Editor, JAMA
⁴Geisel School of Medicine at Dartmouth College, Lebanon, New Hampshire
⁵Department of Health Policy and Management, Harvard T.H. Chan School of Public Health, Boston, Massachusetts

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Monoclonal antibodies (mAbs) are highly effective in treating mild to moderate COVID-19 among nonhospitalized patients.¹ Given limited supply, federal guidelines prioritize patients at higher risk of progression to hospitalization or mortality from COVID-19, with risk factors including age and comorbid conditions.²^,3 Antibodies were initially allocated to states by the federal government,⁴ then distributed through suppliers in 2021.⁵ We assessed how the limited supply of mAb therapy was allocated to patients at highest risk of severe disease.

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Article Information

Accepted for Publication: January 22, 2022.

Published Online: February 4, 2022. doi:10.1001/jama.2022.1243

Corresponding Author: Michael L. Barnett, MD, MS, Harvard T.H. Chan School of Public Health, Department of Health Policy and Management, 677 Huntington Ave, Kresge 411, Boston, MA 02115 (mbarnett@hsph.harvard.edu).

Author Contributions: Dr Barnett had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Behr, Barnett.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Behr.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Orav, Barnett.

Obtained funding: Meara, Epstein, Barnett.

Administrative, technical, or material support: Meara, Epstein, Barnett.

Supervision: Meara, Barnett.

Conflict of Interest Disclosures: Dr Joynt Maddox reported receipt of grants from the National Institutes of Health (NIH)/National Institute on Aging (NIA) and the NIH/National Heart, Lung, and Blood Institute and personal fees from Centene Corp for serving on a health policy advisory committee. No other disclosures were reported.

Funding/Support: This work was supported by grant K23 AG058806 from the NIA to Dr Barnett and award U19 HS024075 from the Agency for Healthcare Research and Quality to Drs Meara and Barnett.

Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.

Disclaimer: Dr Joynt Maddox is Associate Editor for JAMA but was not involved in any of the decisions regarding review of the manuscript or its acceptance.

Additional Contributions: We gratefully acknowledge analytic support from Jie Zheng, PhD, Harvard T.H. Chan School of Public Health, and Deanna Chyn, MPH, Dartmouth Institute for Health Policy and Clinical Practice in the Geisel School of Medicine; both were compensated for this work as employees of Harvard University and Dartmouth College, respectively.

References

Gottlieb RL , Nirula A , Chen P , et al. Effect of bamlanivimab as monotherapy or in combination with etesevimab on viral load in patients with mild to moderate COVID-19: a randomized clinical trial. JAMA. 2021;325(7):632-644. doi:10.1001/jama.2021.0202 PubMed Google Scholar Crossref

National Institutes of Health. Therapeutic management of nonhospitalized adults with COVID-19. In: Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. Updated October 19, 2021. Accessed November 5, 2021. https://files.covid19treatmentguidelines.nih.gov/guidelines/archive/covid19treatmentguidelines-10-27-2021.pdf

National Institutes of Health. Updated COVID-19 Treatment Guidelines Panel’s statement on the prioritization of anti-SARS-CoV-2 monoclonal antibodies for the treatment or prevention of SARS-CoV-2 infection when there are logistical or supply constraints. Updated October 7, 2021. Accessed November 5, 2021. https://www.covid19treatmentguidelines.nih.gov/therapies/updated-statement-on-the-prioritization-of-anti-sars-cov-2-mabs/

Office of the Assistant Secretary for Preparedness and Response. Update: distribution and administration of COVID-19 therapeutics. Updated September 15, 2021. Accessed November 5, 2021. https://www.phe.gov/emergency/events/COVID19/investigation-MCM/Bamlanivimab-etesevimab/Pages/Update-13Sept21.aspx

US Department of Health and Human Services. HHS announces state/territory-coordinated distribution system for monoclonal antibody therapeutics. Updated September 13, 2021. Accessed November 5, 2021. https://www.phe.gov/emergency/events/COVID19/investigation-MCM/Bamlanivimab-etesevimab/Pages/Update-13Sept21.aspx

AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
1.00 CME points in the American Board of Surgery’s (ABS) Continuing Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.