The FDA has issued Emergency Use Authorization (EUA) for several monoclonal antibody treatments to prevent hospitalization from COVID-19. A brief overview is provided below. For additional information, see these clinician handouts:
All treatments re neutralizing IgG1 monoclonal antibodies that bind to the receptor binding domain of the spike protein of SARS-CoV-2.They are investigational drugs and not currently approved for any indication. The data supporting the EUA for casirivimab/imdevimab was based on an interim analysis from a phase two randomized, double-blind, placebo-controlled clinical trial in non-hospitalized adults with mild to moderate COVID-19 symptoms. The EUA for the combined treatment with bamlanivimab/etesevimab was based on phase III clinical trial data showing a reduction in hospitalizations in patients with mild to moderate COVID-19 symptoms.
All treatments have been authorized for use by clinicians in an outpatient setting to treat 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 (e.g. body mass index (BMI) ≥35, chronic kidney disease, diabetes, immunosuppressed, over 65 years of age). The antibody treatments will need to be mixed and transfused at health care facilities with this capability. The treatments are most effective early in the course of infection so they will need to be prescribed and dispensed within 10 days of symptom onset.
NOTE: bamlanivimab alone is not effective against the newer variants of SARS-CoV-2. The FDA has revoked its emergency use authorization for bamlanivimab alone. Read more. The combined treatment options of bamlanivimab/etesevimab and casirvimab/imdevimab are still available and authorized for use.
The NIH treatment guidelines have been updated to recommend the use of bamlanivimab 700 mg plus etesevimab 1,400 mg and Casirivimab 1,200 mg plus imdevimab 1,200 mg for the treatment of outpatients with mild to moderate COVID-19 who are at high risk of clinical progression as defined by the EUA criteria.
None of the treatments are authorized for use in patients who are hospitalized or experience anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary.
The federal government, in conjunction with state health departments, will allocate supply of the treatments to individual sites of care across the United States proportionally based on confirmed COVID-19 cases and hospitalization rates. Sites that have been allocated product will be contacted by and can agree to accept shipments from AmerisourceBergen, a distributor. If you are a healthcare provider and have questions about whether or not your site of care has been allocated product, you may contact your state health department directly. View the list of state health departments.
Additional resources including an allocation dashboard, distribution playbook, and information for clinicians are available.
The treatment will be available with no out-of-pocket costs for patients. CPT codes will be issued for reimbursement of clinicians administering the infusion. CMS has released billing and payment guidance for Medicare beneficiaries.