FDA Issues Emergency Use Authorizations (EUAs) for COVID-19 Treatments
The U.S. Food & Drug Administration (FDA) has issued additional Emergency Use Authorizations (EUAs) for drugs to treat the COVID-19 disease. Baricitinib (Olumiant) is approved for inpatient use only, while the combination of the drugs casirivimab and imdevimab has been approved for outpatient use.
Baricitinib is authorized for use under an Emergency Use Authorization (EUA) in combination with remdesivir, for treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients 2 years of age or older, requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). The recommended dosage for adults and pediatric patients is 4 mg once daily for 14 days or until hospital discharge, whichever is first.
Baricitinib, in combination with remdesivir, was shown to reduce time to recovery within 29 days after initiating treatment compared to patients who received a placebo with remdesivir. The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated. Baricitinib is not authorized or approved as a stand-alone treatment for COVID-19.
Casirivimab and Imdevimab
Casirivimab and imdevimab is used to treat mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. Casirivimab and imdevimab may only be administered together. Casirivimab and imdevimab may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS). Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.
The recommended dose is 1200 mg of casirivimab and 1200 mg of imdevimab administered as a single intravenous infusion over at least 60 minutes as soon as possible after positive viral test for COVID-19 and within 10 days of symptom onset. Since the optimal dosing regimen has not yet been established, it might be updated as new data becomes available. Patients should be monitored for at least 1 hour after the infusion is complete.
Distribution of the authorized casirivimab and imdevimab will be controlled by the government for use consistent with the terms and conditions of this EUA. Regeneron will supply casirivimab and imdevimab to authorized distributor(s), who will distribute to healthcare facilities or healthcare providers as directed by the government, in collaboration with state and local government authorities, as needed.
At this time, there are no specific Healthcare Common Procedure Coding System (HCPCS) codes for casirivimab and imdevimab. The Centers for Medicare & Medicaid Services (CMS) should follow the same type of coding convention as they did for bamlanivimab and the last four characters of the drug and the administration will match.
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