April 22, 2022
On April 5, 2022, the Food and Drug Administration (FDA) announced that Sotrovimab is no longer authorized to treat coronavirus disease 2019 (COVID-19) in any U.S. region due to increases in the proportion of COVID-19 cases caused by the Omicron BA.2 Sub-Variant.
Data from the Centers for Disease Control and Prevention’s (CDC) COVID Tracker estimated that the proportion of COVID-19 cases caused by the Omicron BA.2 variant was above fifty percent in all Health and Human Services (HHS) U.S. regions. Based on data from the health care provider fact sheet, the authorized dose of Sotrovimab is unlikely to be effective against the BA.2 sub-variant. Given this, Sotrovimab is not authorized in any U.S. state or territory at this time.
Providers must not submit claims for the administration of Sotrovimab for dates of service on or after April 5, 2022, as they will be denied.
Providers should note that there are several other therapies that are expected to work against the Omicron variant, which are authorized or approved to treat patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death. Medi-Cal covers these therapies which are listed below:
- Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use)
- Veklury (Remdesivir)
- Lagevrio (molnupiravir)
- Evusheld (tixagevimab co-packaged with cilgavimab)
- Refer to Variant Proportions in the U.S. on the Centers for Disease Control and Prevention (CDC) website for general information.
- Refer to Tracking Variants on the California Department of Public Health (CDPH) website for California-specific information.
For a list of all billable COVID-19 monoclonal antibody services, see the “Reimbursement of COVID-19 Vaccine and Monoclonal Antibody Administration for Medical Providers” article on the Medi-Cal Providers website.