Dear Colleagues,
The US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for bamlanivimab, a monoclonal antibody developed by Eli Lilly and Company. Bamlanivimab is a recombinant neutralizing human IgG1 monoclonal antibody directed against the spike protein of SARS-CoV-2.
According to Lilly’s Fact Sheet for Healthcare Providers, the EUA is “for the treatment of mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.” High risk patients must meet criteria which are outlined on the Fact Sheet. The criteria are also listed below. Bamlanivimab is not for use in patients who are hospitalized due to COVID-19, or who require oxygen therapy due to COVID-19.
According to Lilly’s Fact Sheet, “the most important evidence that bamlanivimab may be effective came from the predefined secondary endpoint of COVID-19-related hospitalizations or emergency room visits within 28 days after treatment. A lower proportion of bamlanivimab-treated subjects progressed to COVID-19-related hospitalization or emergency room visits compared to placebo-treated subjects.”
Limited quantities of bamlanivimab have been provided to hospitals in our area, including hospitals in the Ascension Seton, Baylor Scott and White, and St. David’s Healthcare networks. The hospitals are rapidly developing protocols to administer bamlanivimab on an outpatient basis. Please note that the process is dependent on supply availability and that our hospital leaders are working hard to solve logistical challenges.
If you would like to refer a patient who meets criteria for bamlanivimab infusion, you may do so by contacting our local hospitals as outlined below:
Ascension Seton: Fax an order for Monoclonal Antibody Infusion Therapy to 512-324-3636.
Baylor Scott and White: Call 512-509-1212
St. David’s Healthcare:Beginning Monday, December 7th, St. David’s HealthCare is providing Monoclonal Antibody Infusion Therapy for patients. The infusion center is located at St. David’s North Austin Medical Center. See the attached Scheduling Instructions and Order Sheet. If you have any questions regarding this service, please call 512-901-1144 for assistance.
- Have a body mass index (BMI) ≥35
- Have chronic kidney disease
- Have diabetes
- Have immunosuppressive disease
- Are currently receiving immunosuppressive treatment
- Are ≥65 years of age
- Are ≥55 years of age AND have
- cardiovascular disease, OR
- hypertension, OR
- chronic obstructive pulmonary disease/other chronic respiratory disease.
- Are 12–17 years of age AND have
- BMI ≥85th percentile for their age and gender based on CDC growth charts, OR
- sickle cell disease, OR
- congenital or acquired heart disease, OR
- neurodevelopmental disorders, for example, cerebral palsy, OR
- a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19), OR
- asthma, reactive airway or other chronic respiratory disease that requires daily medication for control.