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FDA Changes: Some Monoclonal Antibody Treatments No Longer Covered
January 27, 2022

This article is for ALL PROVIDERS caring for our members

On January 24, 2022 the Food and Drug Administration (FDA) revoked emergency use authorization (EUA) for two monoclonal antibody treatments—bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) because they are not effective against circulating COVID variants. As a result, these treatments are no longer covered by Blue Cross until further notice from the FDA.

According to the FDA statement: “Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time. In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions.”