Currentmedical mutual - ohioPolicy N/A

Cabenuva (cabotegravir + rilpivirine) long-acting injectable

This policy governs prior authorization, coverage criteria, dosing, and site-of-care requirements for Cabenuva for treatment of HIV-1 in eligible members and applies to both pharmacy and medical benefit claims where specified.

Policy Summary

Payermedical mutual - ohio

PolicyCabenuva (cabotegravir + rilpivirine) long-acting injectable

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review Date01/15/2026

Key ActionSubmit required clinical documentation and obtain prior authorization when billing under HCPCS J3490.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥ 12minimum approved patient age

> 35 kgminimum approved patient weight

<50virologic suppression threshold

J3490prior auth HCPCS

1 yrapproval duration

Coverage Criteria for Cabenuva (cabotegravir + rilpivirine)

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Coverage for Cabenuva does NOT include use for Pre-Exposure Prophylaxis (PrEP). The policy explicitly states that Cabenuva is not indicated for prevention of HIV‑1 infection and therefore PrEP use is a condition not recommended for approval.

Because Cabenuva is a complete antiretroviral regimen, the policy advises against co‑administration with other antiretroviral medications for HIV treatment; such combined use is not recommended for approval. The policy also specifies that Cabenuva is not indicated for HIV‑2 infection and is therefore not covered for treatment of HIV‑2.

Requests for coverage outside the specified recommended authorization criteria are not recommended; the policy notes that coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria and that criteria will be updated as new data become available.

Clinical guidance and non‑covered uses include: PrEP for HIV‑1 (Cabenuva is not indicated for prevention), co‑administration with other antiretrovirals for treatment (Cabenuva functions as a complete regimen and concurrent ARVs for HIV treatment are not recommended), and treatment of HIV‑2 (not indicated and not recommended due to intrinsic resistance concerns).

The policy clarifies that these conditions are examples of circumstances where approval is not recommended and that the list is not exhaustive; providers should refer to the Recommended Authorization Criteria for allowed uses and to updated guidance as new evidence emerges.

Billing and Coding

Prior approval HCPCS CodesHCPCSCovered

J3490

Unclassified drugs (used when Cabenuva is billed as unclassified drug)

Virologic suppression threshold required for eligibility

Virologic suppression thresholdHIV-1 RNA < 50 copies/mL

Context in criteriaRequired for both initial therapy (A.iii) and continuation (B.i)

Source statementListed as viral suppression threshold in FDA-Approved Indications

Minimum approved patient age

Minimum approved patient age≥ 12 years

Source statementIndicated for patients ≥ 12 years of age (FDA-Approved Indications and Overview)

Role in criteriaRequired for initial therapy (A.i)

Minimum approved patient weight

Minimum approved patient weight> 35 kg

Source statementIndicated for patients ≥ 35 kg (Overview) and required in initial therapy (A.ii)

ApplicabilityWeight threshold applies to initiation of Cabenuva formulations

Provider Requirements, Documentation, and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required when billing unclassified HCPCS code J3490 for Cabenuva (cabotegravir and rilpivirine extended-release injectables). Requests submitted with J3490 will pend (Remark Code M3M or M4M) and must be approved prior to coverage. Authorizations may be granted by a nurse reviewer when submitted documentation meets policy criteria; requests failing to meet criteria will be escalated to a physician reviewer.

HCPCS: J3490 (when used for Cabenuva)
Claims may pend with Remark Code M3M or M4M

Documentation Required

Stability on Antiretroviral Regimen Required

Patient must have documented virologic suppression (HIV-1 RNA < 50 copies/mL) and have been on a stable antiretroviral regimen for ≥ 3 months prior to initiating Cabenuva or the one‑month oral lead‑in (Vocabria). For patients currently receiving Cabenuva, documentation of HIV-1 RNA < 50 copies/mL is required for continued approval.

Viral load: HIV-1 RNA < 50 copies/mL
Stable antiretroviral regimen ≥ 3 months prior to initiating Cabenuva or 1‑month Vocabria lead‑in

Documentation Required

Required Clinical Documentation

Submission of supporting clinical documentation (medical records, chart notes, lab results, confirmatory diagnostics, genetic/mutational testing when applicable) is REQUIRED for all prior authorization requests. Provide documentation of diagnosis, prior treatments, and clinical markers via direct upload through the PA web portal or by fax. The Company may request additional records and reserves the right to deny reimbursement if documentation is not provided or if the service is determined not medically necessary, investigational, or outside member benefits.

Include medical records, chart notes, lab results, and confirmatory diagnostics
Provide documentation of diagnosis, step therapy, and relevant genetic/mutational testing when applicable
Upload via PA web portal or fax; additional records may be requested

Denial Risk

Documentation and Adjudication Risks

Requests may be denied or charges written off if required documentation is incomplete or medical necessity cannot be established. Providers are liable for charges denied as not medically necessary. The Company may modify policy interpretations and will adjudicate claims in accordance with Corporate Medical Policy.

Incomplete documentation can lead to denial for inability to establish medical necessity
Participating providers may be required to write off non‑covered charges

Background

Cabenuva is a co‑packaged long‑acting injectable regimen composed of cabotegravir and rilpivirine intended as a complete maintenance regimen for the treatment of HIV‑1. It replaces a current antiretroviral regimen in virologically suppressed patients without prior treatment failure or known/suspected resistance to either agent.

As a complete two‑drug regimen administered as long‑acting intramuscular injections, Cabenuva should not be used in settings where its labeled indications are not met (for example, prevention/PrEP or HIV‑2 infection). Providers must follow the Recommended Authorization Criteria and dosing guidance when seeking coverage.

Definitions

Two-drug co-packaged long-acting injectable regimen of cabotegravir and rilpivirine (Cabenuva)

DefinitionCabenuva is a two-drug co-packaged long-acting injectable regimen containing cabotegravir (an HIV-1 integrase strand-transfer inhibitor) and rilpivirine (an HIV-1 non-nucleoside reverse transcriptase inhibitor)

Indication summaryIndicated as a complete maintenance regimen for treatment of HIV-1 infection

Replacement therapyUsed to replace a current antiretroviral regimen in virologically suppressed patients with no history of treatment failure and no known or suspected resistance to either agent

Virologic suppression (HIV-1 RNA < 50 copies/mL)

Virologic suppression definitionHIV-1 RNA < 50 copies/mL

Use in criteriaRequired for approval as initial therapy (A.iii) and for continuation on Cabenuva (B.i)

Clinical contextRepresents viral suppression on a stable antiretroviral regimen prior to switching to Cabenuva