Physicians treating certain COVID-19 patients with mild to moderate symptoms should be aware that monoclonal antibody treatments are available at select Texas outpatient facilities.
The Food and Drug Administration (FDA) in November approved emergency use authorizations (EAUs) for Eli Lilly and Co.’s bamlanivimab and Regeneron’s antibody cocktail of casarivimab and imdevimab. The treatments have been shown to reduce SARS-CoV-2 virus levels and to decrease risk of hospitalization due to COVID-19, health officials have said.
Texas has received almost 25,000 treatment courses of these medications, which have been provided primarily to hospitals.
However, certain nursing facilities and other outpatient clinics have received the therapies. They are available via prescription for the treatment of mild to moderate COVID-19 in people 12 years and older who are at high risk of developing more severe disease or requiring hospitalization.
The treatments will be provided free of cost, although facilities can charge an administration fee. Visit the Centers for Medicare & Medicaid Services website for coding and billing information.
In addition, administered doses must be reported through ImmTrac2, the state’s vaccine registry. Facilities also should report the number of doses administered daily, state health officials have said.
The state created a Therapeutics Finder Map to assist physicians in locating facilities where treatments have been distributed. Physicians will need to contact facilities directly to determine availability and to arrange for any infusion.
Additional treatment information:
- The treatments should be administered as soon as possible after a positive viral test for SARS-CoV-2 and within 10 days of symptom onset.
- The products are not authorized for use in hospitalized COVID-19 patients, nor patients who require oxygen therapy, 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.
- The treatments need to be administered via a one-hour infusion process, and patients will need to stay onsite after infusion to check for hypersensitivity reaction.
- Facilities must report all medication errors and severe adverse reactions to FDA MedWatch. No additional post-treatment reporting is required.
Outpatient facilities can register with DSHS online to receive and administer the treatments.
Find more tools, resources, and information on TMA’s COVID-19 Resource Center, which is continually updated.
Last Updated On
December 21, 2020
Originally Published On
December 18, 2020