The TCMS would like to thank our St. David's, Ascension, and Baylor Scott & White hospital networks who are working diligently to provide our outpatient medical community with available options for monoclonal antibody infusion centers. Here is the first of our MAB treatment protocols. Stay tuned for more!



To: Austin/Travis County Physicians
From: Kenneth W. Mitchell, MD (Chief Medical Officer) 
  
As we face yet another COVID surge and with the rise of variants, there is renewed interest in providing monoclonal antibody (mAb) therapies for COVID-positive outpatients. As you are aware, COVID mAb therapies are indicated for outpatients with risk factors for progression to severe disease and hospitalization. In coordination with Austin Public Health, St. David’s HealthCare has designated two free-standing emergency department (FSED) locations for infusions, Bee Cave and Cedar Park. While both FSEDs remain open for non-COVID patients, the teams have a process in place to support the limited administration of COVID mAbs.
  
Background/information regarding attachments:
  
• Healthcare Provider Scheduling Instructions – This document provides instructions on where to send the completed order form for scheduling. If you are not privileged with St. David’s HealthCare, you can still order therapy – include your DEA number and practice name where indicated on the order form. The DEA number is needed to enter the order in our system and to complete the State of Texas reporting requirements. The goal is to infuse the drug as soon as possible to slow progression of the illness; however, same day appointments may not be available. There is some flexibility, as appropriate patients are eligible for the therapy within 10 days of the onset of symptoms according to the FDA Emergency Use Authorization. We will make every effort to schedule the infusion appointment as soon as possible and will coordinate first-available appointments at our facilities.

• COVID mAb Infusion Order Form  
o Provider completing the form must comply with FDA Emergency Use Authorization requirements by attesting to provision of patient education material and that the patient meets high-risk use criteria. If ordering from within St. David’s HealthCare, the form can be generated using patient information from within their account (nursing can assist). Otherwise, complete the attached order form, and follow attached scheduling instructions for where to send the completed form. 

o The FDA, along with St. David’s HealthCare Pharmacy and Therapeutics, has deemed therapies comparable with regard to safety and efficacy. Therefore, the choice of COVID mAb will depend on the availability of product at the time of administration. Per FDA guidance, only REGEN-COV (casirivimab + imdevimab) or sotrovimab will be available; the bamlanavimab/etesevimab combination is no longer available due to resistance among variants in the United States. 
o The drugs themselves are presently free of charge. An outpatient infusion charge will be billed to the patient.

• Factsheet for Healthcare Providers – All COVID mAbs have the same inclusion/exclusion criteria as approved by the FDA, and the same potential side effects (infusion-related: itching, flushing, dizziness, shortness of breath, fever). 
o REGEN-COV Factsheet Healthcare Providers  
o SOTROVIMAB Factsheet Healthcare Providers 

• Patient/Caregiver Factsheets
o REGEN-COV Patient Factsheet  
o REGEN-COV Patient Factsheet (Spanish)
o SOTROVIMAB Patient Factsheet
o SOTROVIMAB Patient Factsheet (Spanish)

• Product Websites
o REGEN-COV (casirivimab/imdevimab ) 
o Sotrovimab