COVID-19 Monoclonal Antibody Therapy – For Providers

The U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorizations (EUA) for monoclonal antibody treatment Regeneron's casirivimab/imdevimab for the treatment of mild to moderate COVID-19 in patients with positive results of direct SARS-CoV-2 viral testing.

Treatment eligibility

Patients with positive COVID-19 results who are 12 years of age or older and who have had mild to moderate symptoms for less than 10 days are eligible to receive the treatment. Patients with any of the following indicators may benefit from the monoclonal antibody infusion:

  • Age ≥ 65
  • Body mass index (BMI) ≥ 25 (or for pediatrics BMI ≥ 85th percentile for age)
  • Chronic kidney disease
  • Diabetes
  • Immunosuppressive disease or receiving immunosuppressive treatment
  • Poorly controlled hypertension
  • Cardiovascular disease or Congenital Heart Disease
  • Chronic obstructive pulmonary disease (COPD) or other respiratory diseases
  • Pregnancy
  • Sickle cell disease
  • Neurodevelopmental disorders
  • Medical-related technological dependence (i.e. tracheostomy, gastrostomy)
  • Other medical condition or factor (i.e. race or ethnicity) that may place the patient at a higher risk for progression to severe COVID-19

Treatment is NOT authorized for patients who are:

  • Hospitalized or require oxygen therapy due to COVID-19
  • On chronic oxygen therapy who require an increase in baseline oxygen flow due to COVID-19

How to Screen a patient

MedStar Health Physicians

  • Please use the MedConnect PowerForm (which will automatically pop up in a patient’s chart after a COVID-19 positive test) to properly indicate your patient’s symptom onset, degree of illness, date of COVID-19 testing, and underlying risk factors. A score of 1 or greater indicates your patient meets criteria for treatment. For patients tested outside of MedStar Health who report a positive COVID-19 result, the results of the test can be entered into MedConnect (see job aid here) and the monoclonal scoring form will then pop up as a chart alert for completion.

Physicians Outside of MedStar Health

  • Please complete a referral form here.

FAQs

Please access our provider frequently asked questions here

Information about cost and insurance coverage of monoclonal antibody treatments

The drugs used for the monoclonal antibody therapy are provided free of charge in response to the COVID-19 Public Health Emergency. Any charge for the infusion itself is submitted to a patient’s insurance company with the expectation that patients will not have a balance to pay. People who are uninsured are potentially eligible for reimbursement under the Health Resources and Services Administration and will not receive a bill.

Managing Patient Expectations

Not all COVID-19 positive patients are eligible to receive this treatment. If a patient’s clinical condition changes between the referral and arrival at the infusion center, the patient may no longer be eligible for this treatment. Please discuss this with your patients.

Additional Resources

The U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorizations (EUA) for monoclonal antibody treatment Regeneron's casirivimab/imdevimab for the treatment of mild to moderate COVID-19 in patients with positive results of direct SARS-CoV-2 viral testing.

Treatment eligibility

Patients with positive COVID-19 results who are 12 years of age or older and who have had mild to moderate symptoms for less than 10 days are eligible to receive the treatment. Patients with any of the following indicators may benefit from the monoclonal antibody infusion:

  • Age ≥ 65
  • Body mass index (BMI) ≥ 25 (or for pediatrics BMI ≥ 85th percentile for age)
  • Chronic kidney disease
  • Diabetes
  • Immunosuppressive disease or receiving immunosuppressive treatment
  • Poorly controlled hypertension
  • Cardiovascular disease or Congenital Heart Disease
  • Chronic obstructive pulmonary disease (COPD) or other respiratory diseases
  • Pregnancy
  • Sickle cell disease
  • Neurodevelopmental disorders
  • Medical-related technological dependence (i.e. tracheostomy, gastrostomy)
  • Other medical condition or factor (i.e. race or ethnicity) that may place the patient at a higher risk for progression to severe COVID-19

Treatment is NOT authorized for patients who are:

  • Hospitalized or require oxygen therapy due to COVID-19
  • On chronic oxygen therapy who require an increase in baseline oxygen flow due to COVID-19

How to Screen a patient

MedStar Health Physicians

  • Please use the MedConnect PowerForm (which will automatically pop up in a patient’s chart after a COVID-19 positive test) to properly indicate your patient’s symptom onset, degree of illness, date of COVID-19 testing, and underlying risk factors. A score of 1 or greater indicates your patient meets criteria for treatment. For patients tested outside of MedStar Health who report a positive COVID-19 result, the results of the test can be entered into MedConnect (see job aid here) and the monoclonal scoring form will then pop up as a chart alert for completion.

Physicians Outside of MedStar Health

  • Please complete a referral form here.

Information about cost and insurance coverage of monoclonal antibody treatments

The drugs used for the monoclonal antibody therapy are provided free of charge in response to the COVID-19 Public Health Emergency. Any charge for the infusion itself is submitted to a patient’s insurance company with the expectation that patients will not have a balance to pay. People who are uninsured are potentially eligible for reimbursement under the Health Resources and Services Administration and will not receive a bill.

Please access our provider frequently asked questions here

Managing Patient Expectations

Not all COVID-19 positive patients are eligible to receive this treatment. If a patient’s clinical condition changes between the referral and arrival at the infusion center, the patient may no longer be eligible for this treatment. Please discuss this with your patients.

Additional Resources

Patient receiving COVID-19 Monoclonal Antibody Therapy Infusion at MedStar Southern Maryland Hospital Outpatient Infusion Center