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EDMUND G. BROWN JR.
Governor

State of Californiaā€”Health and Human Services Agency
California Department of Public Health


June 10, 2021


TO:
All Californians

SUBJECT:
Direct Ordering of Monoclonal Antibodies

ā€‹This Guidance is no longer in effect and is for historical purposes only.



Casirivimab plus imdevimab (i.e., REGEN-COV) is an investigational monoclonal antibody combination available under Emergency Use Authorization (EUA) that has been engineered to bind to and neutralize SARS-CoV-2 and prevent progression to severe illness.

Clinical trial data in outpatients have shown that these therapies may reduce COVID-19-related emergency room visits and hospitalizations in outpatients [1] [2]

Under its EUA, this therapy can be used for the treatment of mild-to-moderate COVID-19 in non-hospitalized adult and pediatric patients who are at risk for progressing to severe COVID-19 and/or hospitalization.

All treatment sites can now order casirivimab plus imdevimab directly from AmerisourceBergen Corporation (ABC). The product remains free of charge to requesting sites. Treatment sites should review the direct ordering process guide and place orders directly with ABC at this site.

Should you have any questions or concerns regarding the direct order process for COVID-19 monoclonal antibodies, you may contact Health and Human Services' (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) at COVID19Therapeutics@hhs.gov or ABC at C19therapies@amerisourcebergen.com.

In addition to direct ordering, California Department of Public Health has a large inventory of casirivimab plus imdevimab that are available via standard Medical/Health Resource Request in Sales Force. Contact your local county Medical and Health Operational Area Coordinator (MHOAC) for more information. 

To provide options for monoclonal antibody treatment beyond acute care hospitals, the federal government has encouraged utilization of these products in non-hospital settings like skilled nursing facilities (SNFs), federally qualified health centers (FQHCs), urgent care centers, and correctional facilities.

For facilities and healthcare providers interested in setting up infusions for high-risk patients with COVID-19, ASPR has many resources available. This includes free digital content that your facility can use on social media platforms to help educate providers and patients. HHS has also provided the Combat Covid webpage as a resource for your patients. 

For more information for providers and facilities regarding monoclonal antibody infusions, please visit Monoclonal Antibody Treatment Information for Providers and Facilities (ca.gov) [3]

Additional resources:

[1] Weinreich, David M, et al. "REGN-COV2, a Neutralizing Antibody Cocktail, in Outpatients with Covid-19: NEJM." New England Journal of Medicine, 21 Jan. 2021, www.nejm.org/doi/10.1056/NEJMoa2035002.

[2] Phase 3 Trial Shows REGEN-COVā„¢ (casirivimab with imdevimab) Antibody Cocktail Reduced Hospitalization or Death by 70% in Non-hospitalized COVID-19 Patients | Regeneron Pharmaceuticals Inc.

[3] Monoclonal Antibody Treatment Information for Providers and Facilities (ca.gov)




ā€‹Originally published on January 4, 2021