Background

Cabenuva® is a long-acting injectable antiretroviral regimen consisting of cabotegravir, an integrase strand transfer inhibitor (INSTI), and rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI). It is administered by intramuscular injection either monthly or every two months as a complete regimen for the treatment of HIV-1 infection. CABENUVA is indicated for adults and adolescents aged 12 years and older who weigh at least 35 kg, are virologically suppressed on a stable antiretroviral regimen, have no history of treatment failure, and have no known or suspected resistance to cabotegravir or rilpivirine.

Long-acting injectable therapy may improve treatment adherence and reduce the burden associated with daily oral antiretroviral therapy in appropriate patients.

Policy (Criteria)

Initial Authorization Criteria

Coverage of Cabenuva may be considered medically necessary when all of the following criteria are met:

1. Diagnosis of HIV-1 infection
2. Patient is 12 years of age or older
3. Patient weighs ≥ 35 kg
4. Patient is currently virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable, uninterrupted antiretroviral regimen for at least 6 months
5. Patient has no history of treatment failure and no known or suspected resistance to either cabotegravir or rilpivirine
6. Provider attests that the patient would benefit from long-acting injectable therapy over standard oral antiretroviral regimens
7. Prescribed by or in consultation with a clinician experienced in the management of HIV infection

Authorization Duration

Initial approval may be granted for up to 12 months.

Reauthorization Criteria

Coverage may be renewed when either of the following is met:

1. Paid claims or submission of medical records (e.g., chart notes) confirming continuation of therapy, defined as no more than a 70-day gap in treatment

2. Documentation demonstrates continued clinical benefit with maintenance of virologic suppression and ongoing use of Cabenuva

Authorization Duration

Reauthorization may be granted for up to 12 months.

References

1. CABENUVA (cabotegravir extended-release injectable suspension; rilpivirine extended-release injectable suspension) Prescribing Information. ViiV Healthcare. Revised 2024.
2. CABENUVA Prescribing Information. U.S. Food and Drug Administration. Updated 2024.
3. CABENUVA Dosing and Administration Guide. ViiV Healthcare. 2025.

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each Policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

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