Physician COVID-19 Treatment Information

There is limited supply of sotrovimab, a monoclonal antibody infusion treatment that is 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. However, based on very limited supplies, not all eligible patients will receive it.

Banner Health is offering monoclonal antibody infusions in our outpatient infusion centers for patients who are eligible for treatment. View ourCOVID-19 Monoclonal Antibody Infusion Order。这些抗体治疗尚未批准, 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 theCOVID-19 Monoclonal Antibody Infusion Orderand 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.

1. Clinical note
2. COVID lab result
3. 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 10 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
  • Pregnancy
  • Chronic kidney disease
  • Diabetes
  • 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
  • Other medical conditions or factors (for example, race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19, and authorization of sotrovimab under the EUA is not limited to the medical conditions or factors listed above.
• 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.
  
  • Sotrovimab
• 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 theCOVID-19 Monoclonal Antibody Infusion Orderand fax, along with the following documentation, to the preferred Banner Health outpatient infusion site.