COVID monoclonal antibodies are available under emergency use authorization by the FDA for the treatment of COVID. Health care providers should evaluate patients’ medical history to determine if they are eligible for this treatment, or for prophylaxis.
Banner Health is offering monoclonal antibody infusions in our outpatient infusion centers for patients who are eligible for treatment or prophylaxis. View our COVID-19 Monoclonal Antibody Infusion Order or COVID-19 Pediatric Monoclonal Antibody Infusion Order. These antibody treatments have not been approved, but have been authorized for emergency use by the FDA, to treat mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older, weighing at least 40 kg) with positive results of SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This authorization is only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of these antibodies under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
You can refer a patient by following these steps, which includes completing the our COVID-19 Monoclonal Antibody Infusion Order or COVID-19 Pediatric Monoclonal Antibody Infusion Order and faxing to an outpatient infusion center currently offering this treatment, along with the documents listed below, which must be completed and signed by a physician, physician assistant or nurse practitioner.
- Clinical note
- COVID lab result
- Patient demographic information
Patient Referral Process for Monoclonal Antibody Treatment
Information regarding the FDA’s Emergency Use Authorization for approved COVID monoclonal antibodies can be found on the FDA’s website.
To refer an eligible patient for monoclonal antibody treatment, you must have:
- Patient has documentation of a positive PCR or direct antigen COVID test, or complete the COVID test questions within the referral order set.
- Confirm that your patient is at least 12 years old and has mild to moderate COVID-19 symptoms that began less than 7 days ago.
- Confirm that your patient is at high risk for developing severe symptoms or requiring hospitalization.
- Evaluate and identify what high-risk criteria is present:
- Older age
- Obesity or being overweight
- Chronic kidney disease
- Immunosuppressive disease or immunosuppressive treatment
- Cardiovascular disease or hypertension
- Chronic lung diseases
- Sickle cell disease
- Neurodevelopmental disorders or other conditions that confer medical complexity
- Having a medical-related technological dependence
- Patients who are not eligible to receive monoclonal antibody treatment are those:
- 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 comorbidity).
- Review the EUA patient fact sheet, including risks and benefits with the patient who will receive the monoclonal antibody treatment. Information can be found using the links below.
- Complete a Clinical Note that indicates which high-risk factors the patient has, as well as documentation that you reviewed risks and benefits with the patient.
- Complete the our COVID-19 Monoclonal Antibody Infusion Order or COVID-19 Pediatric Monoclonal Antibody Infusion Order and fax, along with the following documentation, to the preferred Banner Health outpatient infusion site.