Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off harmful antigens such as viruses. Monoclonal antibodies to treat COVID-19 are directed against the spike protein of SARS-COV2, designed to block the virus' attachment and entry into human cells.
Casirivimab and imdevimab (administered together) (i.e., REGEN-COV) has received Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) and is currently available in California.
Given the sustained increase in variants resistant to bamlanivimab alone and bamlanivimab/etesevimab, the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) stopped the distribution of both products to California.
The FDA recommends that health care providers in California instead use casirivimab plus imdevimab (i.e., REGEN-COV) therapy until further notice. All treatment sites can continue ordering casirivimab plus imdevimab from the authorized distributer using the direct ordering process.
The EUA for casirivimab/imdevimab is for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
The treatment should be administered as soon as possible after positive results of direct SARS-CoV2 viral testing AND within 10 days of symptom onset.
High-risk criteria include older age, being overweight/obese, pregnancy, chronic kidney disease, diabetes, immunosuppression, cardiovascular disease or hypertension, chronic lung diseases, sickle cell disease, neurodevelopmental disorders, having a medical-related technological dependence, or other medical conditions or factors (for example, race or ethnicity) that may also place individual patients at high risk for progression to severe COVID-19.
Authorization for use of monoclonal antibody treatment is not limited to the medical conditions or factors listed above. Healthcare providers should consider the benefit-risk for an individual patient.
Please review the Casirivimab/Imdevimab Fact Sheet for Health Care Providers for more information.
No, the Emergency Use Authorizations (EUAs) for monoclonal antibody treatments are for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
Monoclonal antibody treatments are not authorized for use in patients who are hospitalized due to COVID-19 OR who require oxygen therapy due to COVID-19 OR who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related morbidity.
No, the Emergency Use Authorizations (EUAs) for monoclonal antibody treatments are for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
Monoclonal antibody treatments are not authorized for use in patients who are hospitalized due to COVID-19 OR who require oxygen therapy due to COVID-19 OR who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related morbidity.
No, the Emergency Use Authorizations (EUAs) for monoclonal antibody treatments are for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
Monoclonal antibody treatments are not authorized for use in patients who are hospitalized due to COVID-19 OR who require oxygen therapy due to COVID-19 OR who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related morbidity.
No, the Emergency Use Authorizations (EUAs) for monoclonal antibody treatments are for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
Monoclonal antibody treatments are not authorized for use in patients who are hospitalized due to COVID-19 OR who require oxygen therapy due to COVID-19 OR who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related morbidity.
This treatment should only be administered in settings where health care providers have immediate access to medications to treat severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system, if necessary. Required elements for administering monoclonal treatment can be found in the Casirivimab/Imdevimab Fact Sheet for Health Care Providers.
Given the limitations to using existing acute care hospital infrastructure during surges, California Department of Public Health (CDPH) encourages the use of these products in non-hospital outpatient settings (e.g., skilled nursing facilities, community clinics/FQHCs, state hospitals, jails, and other congregate/outpatient settings that have the clinical capacity to use).
Appropriate candidates should be referred to the nearest facility accepting patients for monoclonal antibody treatment. To find a location near you, there are two locator tools:
The cost of these products remains free, paid for by the federal government. The administration cost is billed through the usual claiming process, based on each patient's health care coverage.
For Medi-Cal, the following reimbursement codes for services rendered for monoclonal antibody infusions may be used for billing:
Medi-Cal Reimbursement Codes for Monoclonal Antibody Administration
M0243
Intravenous infusion, casirivimab and imdevimab, includes infusion and post administration monitoring
Effective date of 11/21/20
Maximum allowable rate of $309.60
For more information, please see: Medi-Cal NewsFlash: Reimbursement of COVID-19 Vaccine and Monoclonal Antibody Administration for Medical Providers
For Medicare, the following reimbursement codes for services rendered for monoclonal antibody infusions may be used for billing:
Medicare Reimbursement Codes for Monoclonal Antibody Administration
M0243
- Intravenous infusion, casirivimab and imdevimab includes infusion and post administration monitoring
For more information regarding Medicare coding and billing for monoclonal antibody infusions, please see: Monoclonal Antibody COVID-19 Infusion | CMS
All treatment sites can order casirivimab/imdevimab directly from AmerisourceBergen Corporation (ABC). The products remain 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 the U.S Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response (HHS/ASPR) at COVID19Therapeutics@hhs.gov or ABC at C19therapies@amerisourcebergen.com.
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 a Combat Covid webpage as a resource for your patients.
Additionally, if trying to set up a standalone Monoclonal Antibody Infusion Center, please see Monoclonal Antibody Infusion Center Model.
HHS/ASPR also has a call center for questions and information related to monoclonal antibodies. Please share broadly with your networks of patients and providers.
- English: 1-877-332-6585
Spanish:1-877-366-0310
Finally, particularly hard-hit local jurisdictions can submit resource requests through CalOES for additional supplies and/or staffing. These requests can then be escalated to the appropriate state and federal authorities whereby they can assist with additional resources, if available.
Additional resources:
Originally Published on March 9, 2021