Currently, monoclonal antibodies are not US Food and Drug Administration (FDA)-approved to treat COVID-19. However, the FDA has issued emergency use authorization (EUA) for certain mABs for the treatment of COVID-19.

Several mABs have had limited effectiveness against certain disease variants and FDA EUA indications have been revoked.

Clinical Guideline Coverage Criteria

The Plan may cover monoclonal antibody therapy for COVID-19 when documentation confirms FDA EUA indication and dosing requirements for the specific mAB product are met.

Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products | FDA

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COVID-19 Monoclonal Antibody Therapy

Limitations

The Plan considers monoclonal antibody therapy as not medically necessary for non-authorized indications and will not cover when documentation does not support FDA authorized and EUA indications and dosing specific to mAB.