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)
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)
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

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.

OpenPayer

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

Coverage Summary & Criteria

Applicable Codes

Prior Authorization, Billing & Documentation

Clinical Context & Definitions

Evidence & Rationale

Policy Revision History