FDA issues emergency authorization for new COVID-19 antibody treatment
The Food and Drug Administration (FDA) recently issued an emergency use authorization (EUA) for the combination treatment of bamlanivimab and etesevimab for COVID-19 patients at high risk for severe infection.
The EUA was designated based on Phase 3 data from Eli Lilly’s BLAZE-1 trial, which demonstrated that in a sample population, the drug combination reduced the risk of COVID-19 hospitalizations and death by 70%.
According to the EUA, the drug treatment is not authorized for use in patients:
- Who are hospitalized due to COVID-19
- Who require oxygen therapy due to COVID-19
- Who require an increase in baseline oxygen flow rate due to COVID-19
- Who are on chronic oxygen therapy due to underlying non-COVID-19-related comorbidity
The treatment also cannot be applied in hospital settings, as it has not been studied in patients hospitalized due to COVID-19, according to the FDA.
Effective as of February 9, providers may report Eli Lilly’s bamlanivimb-etesevimab combination and its administration using the following HCPCS Level II codes:
- Q0245, injection, bamlanivimab and etesevimab, 2100 mg
- M0245, intravenous infusion, bamlanivimab and etesevimab, includes infusion and post administration monitoring
The FDA urges healthcare providers to review its fact sheet, which includes additional information on EUA limitations, drug dosing, and administration considerations.