As we continue to see high numbers of COVID 19 community cases and hospitalizations in Arkansas, your assistance is requested in recommending and providing monoclonal antibody therapy to patients in need. There are two monoclonal antibody products available, which are highly effective in early treatment of COVID 19. They are REGEN-COV (casirivimab and imdevimab, administered together) and sotrivimab, which are authorized by the U.S. Food and Drug Administration (FDA) for the treatment of mild-to-moderate COVID-19 in patients 12 years of age and older (and weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, who are at high risk for progression to severe COVID-19.
In addition, the FDA recently revised the emergency use authorization (EUA) for REGEN-COV authorizing it for use as post-exposure prophylaxis for COVID-19 in individuals 12 years of age and older (and weighing at least 40 kg) at high risk for progression to severe COVID-19. Regen COV can be administered using the subcutaneous route or as an IV infusion. It is distributed through U.S. Department of Health and Human Services directly to clinics and infusion sites free of cost. Providers may bill for the cost of administration.
Physicians who wish to begin offering monoclonal antibodies through their clinics should consider the following points:
- Can the clinic arrange for COVID-19 positive patients to receive treatment where they will not expose other patients to the illness?
- Which route of administration would be feasible in your practice (IV infusion or subcutaneous route)?
- Do you have sufficient nursing staff available to monitor patients for an hour after the therapy?
- What processes are needed to maintain appropriate medical records and billing information?
If you are interested and want to learn more, please contact Dr. Atul Kothari at Atul.Kothari@Arkansas.gov or Elizabeth Woodland at Elizabeth.Woodland-borella@Arkansas.gov.
Below are links to additional information you may find helpful:
Monoclonal Antibody Playbook (updated July 30, 2021):
To order REGEN-COV, use the smart sheet located here:
REGEN-COV Dosing guide: