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Point32 Covid-19 Monoclonal Antibody Therapy Form


Covid-19 Monoclonal Antibody Therapy

Indications

(887201) Has the patient been diagnosed with COVID-19? 
(887202) Does the documentation confirm FDA EUA indication for the specific monoclonal antibody (mAB) product is met for the patient? 
(887203) Are the dosing requirements for the specific mAB product met according to FDA EUA guidelines for the patient? 

Contraindications

(887204) Is the patient seeking monoclonal antibody therapy for non-authorized indications? 
(887205) Does the documentation fail to support FDA authorized and EUA indications and dosing specific to mAB for the patient? 
Effective Date

08/01/2023

Last Reviewed

06/21/2023

Original Document

  Reference



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Several mABs have had limited effectiveness against certain disease variants and FDA EUA indications have been revoked.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