CurrentCommunity-CarePolicy N/A

Pemgarda (pemivibart) pre-exposure prophylaxis for COVID-19

Defines medical benefit coverage criteria, exclusions, quantity limits, authorization period, and applicable HCPCS code for pemivibart (Pemgarda) when used for pre-exposure prophylaxis of COVID-19 in eligible adolescents and adults.

Policy Summary

PayerCommunity-Care

PolicyPemgarda (pemivibart) pre-exposure prophylaxis for COVID-19

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionApproval requires documentation that all approval criteria are met (indication, lack of current infection/exposure, immunocompromise criteria, age/weight thresholds) and will be authorized per quantity limits and authorization period.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes

1Approved Indication (pre-exposure prophylaxis)

9 vials/90 daysQuantity Limit

12 yrsMinimum Age

40 kgMinimum Weight

Coverage Summary & Criteria

This policy defines medical benefit coverage for pemivibart (Pemgarda) when used as pre-exposure prophylaxis for COVID-19 in eligible adolescents and adults. Coverage is limited to use for pre-exposure prophylaxis in individuals ≥ 12 years of age and weighing at least 40 kg (≈88 lbs), who are not currently infected with SARS-CoV-2, have no known recent exposure, and are unlikely to mount an adequate immune response to COVID-19 vaccination due to moderate-to-severe immunocompromise. The policy explicitly excludes use to treat COVID-19 or for post-exposure prophylaxis, and excludes children < 12 years or weighing < 40 kg.

Pre-exposure prophylaxis of COVID-19 - Approval Criteria

Covered when ALL of the following are met:

ALL of the following

Indication: Will be used for the pre-exposure prophylaxis of COVID-19
Not currently infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

Policy Summary

PayerCommunity-Care

PolicyPemgarda (pemivibart) pre-exposure prophylaxis for COVID-19

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

On This Page

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No known recent exposure to an individual infected with SARS-CoV-2

Is unlikely to mount an adequate immune response to COVID-19 vaccination

Age ≥ 12 years≥ 12 years

Has moderate-to-severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments including at least ONE of the following

Active treatment for solid tumor or hematologic malignancy
Hematologic malignancy associated with poor responses to COVID-19 vaccines regardless of current treatment status (e.g., chronic lymphocytic leukemia, non-Hodgkin lymphoma, multiple myeloma, acute leukemia)
Receipt of solid-organ transplant or an islet transplant and taking immunosuppressive therapy
Receipt of chimeric antigen receptor (CAR)-T-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppressive therapy)
Moderate or severe primary immunodeficiency (e.g., common variable immunodeficiency disease, severe combined immunodeficiency, DiGeorge syndrome, Wiskott-Aldrich syndrome)
Advanced or untreated HIV infection (people with HIV and CD4 cell counts < 200/mm3, history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV)

OR active treatment with at least ONE of the following immunosuppressive therapies

High-dose corticosteroids (i.e., ≥ 20 mg prednisone or equivalent per day for ≥ 2 weeks)≥ 20 mg prednisone or equivalent per day for ≥ 2 weeks
Alkylating agents
Antimetabolites
Transplant-related immunosuppressive drugs
Cancer chemotherapeutic agents classified as severely immunosuppressive
Biologic agents that are immunosuppressive or immunomodulatory (e.g., B-cell depleting agents)

Not covered

Coverage will not be allowed for the following conditions or populations:

ANY of the following

To treat COVID-19
To prevent COVID-19 after being exposed to someone infected with SARS-CoV-2 (post-exposure prophylaxis)
For use in children < 12 years old or weighing < 88 lbs (40 kg)< 12 years or < 88 lbs (40 kg)

Key Thresholds

Minimum age≥ 12 years

Minimum weight≥ 40 kg (≥ 88 lbs)

High-dose corticosteroids threshold≥ 20 mg prednisone (or equivalent) per day for ≥ 2 weeks

Applicable Codes

Applicable HCPCSHCPCSCovered

Q0224

Injection, pemivibart, for the pre-exposure prophylaxis only, for certain adults and adolescents (12 years of age and older weighing at least 40 kg) with no known SARS-CoV-2 exposure, and who either have moderate-to-severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments, and are unlikely to mount an adequate immune response to COVID-19 vaccination, 4500 mg

Prior Authorization, Billing & Documentation

Prior Authorization

Prior authorization required for pemivibart

Approval requires documentation that all approval criteria are met, including: indication for pre-exposure prophylaxis of COVID-19; no current SARS-CoV-2 infection; no known recent exposure; documentation the patient is unlikely to mount an adequate immune response to COVID-19 vaccination; and that age and weight thresholds and immunocompromise criteria are satisfied.

Q0224

Billing Rule

Quantity limits

If approved, pemivibart will be authorized for quantities of up to 9 vials per 90 days (1 vial = 4 mL or 500 mg).

Q0224
9 vials/90 days

Billing Rule

Authorization period

If approved, coverage is allowed for one year (subject to benefit changes).

Q0224
1 year

Clinical Context & Definitions

This policy governs medical-benefit use of pemivibart for COVID-19 pre-exposure prophylaxis in individuals who are unlikely to mount an adequate vaccine response because of moderate-to-severe immunocompromise. It requires that recipients are not currently infected with SARS-CoV-2 and have no known recent exposure. The policy excludes use of pemivibart for treatment of COVID-19, for post-exposure prophylaxis, and for children < 12 years or those weighing < 40 kg.

Definitions:

High-dose corticosteroids: ≥ 20 mg prednisone or equivalent per day for ≥ 2 weeks.

Evidence & Rationale

No evidence items are attached to this brief. The policy’s clinical rationale is reflected implicitly in the eligibility criteria — namely that pembivibart is intended for pre-exposure prophylaxis in persons with moderate-to-severe immunocompromise who are unlikely to respond to COVID-19 vaccination — rather than by citing specific trial metrics.

Policy Revision History

2024-06Last reviewLatest

Policy last reviewed