COVID-19: Monoclonal Antibody Treatment

An antibody is a protein that the body’s immune system makes to fight off viruses and other foreign substances. Monoclonal antibodies are man-made antibodies produced in a laboratory that can mimic the human immune system response to infection.

There are three different mAbs. One is made by Eli Lilly, Bamlanivimab, and Regeneron has developed Casirivimab and Imdevimab. All three have been authorized by the Food and Drug Administration for emergency use for patients age 12 and older.

MAbs must be given by intravenous (IV) infusion. They can only be administered in settings with immediate access to medications to treat severe infusion reactions, such as allergic reaction.

The FDA allows the use of mAbs for adults and children who have mild to moderate COVID-19 symptoms. The patient must test positive for COVID-19, are within 10 days since they first had symptoms, are at least 12 years of age or older and are at a high risk for progressing to severe COVID-19 and/or hospitalization.

MAbs have not been sufficiently studied to make a recommendation for use while pregnant. You should discuss the use of mAbs with your physician.

MAbs are not authorized for use in patients who meet any of the following:

• Are hospitalized due to COVID-19
• Require oxygen therapy due to COVID-19
• 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 comorbidity

Providers can bill the patient’s insurance carrier for a facility/service charge to the patients insurance. Patients should check with their insurance company or healthcare provider for information about costs for mAb services.

The federal government has developed a searchable national map that show locations that have received shipments of monoclonal antibody therapeutics. See this link for a searchable map. You can also call 1-877-332-6585 (English); 1-877-366-0310 (Spanish).

Patients need to be referred by their doctor or other healthcare provider to a facility that offers mAb therapy such as a hospital or an infusion center.

Patients with a positive COVID-19 viral test should speak with their healthcare provider to determine whether they are eligible for mAb treatment and to discuss potential benefits and side effects.