CurrentCareSourcePolicy N/A

Cabenuva (cabotegravir/rilpivirine) coverage

Defines prior authorization, coverage criteria, dosing, and reauthorization requirements for Cabenuva (cabotegravir/rilpivirine) as a medical benefit for treatment of HIV-1 in adults who are virologically suppressed.

Policy Summary

PayerCareSource

PolicyCabenuva (cabotegravir/rilpivirine) coverage

Policy CodePolicy N/A

Change TypeOperational (billing update)

Effective DateJul 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization and provide documentation of age, HIV-1 diagnosis, and virologic suppression (HIV-1 RNA <50 copies/mL for ≥3 months).

SourceLink

POLICY UPDATE CHANGES

Added J code and changed to medical benefit only.

>=18minimum member age (years)

<50virologic suppression threshold (HIV-1 RNA)

6initial approval (months)

12reauthorization (months)

J0741billing code

Coverage Criteria for Cabenuva (cabotegravir/rilpivirine)

Initial Authorization

Covered when ALL of the following are met:

Initial Authorization: Member is ≥18 years of age; medication is prescribed by or in consultation with an HIV specialist; diagnosis of HIV-1; currently virologically suppressed (HIV-1 RNA < 50 copies/mL) for at least 3 months; stable on a complete oral antiretroviral therapy (ART) regimen with a documented clinical reason for switching to Cabenuva; absence of baseline resistance to cabotegravir or rilpivirine, no prior virologic failure, and no active hepatitis B infection; oral lead-in with cabotegravir and rilpivirine for at least 28 days to assess tolerability, initiate injectable therapy on the last day of lead-in and continue monthly injections (400 mg cabotegravir + 600 mg rilpivirine).see node text

If met, approve for 6 months

Reauthorization

Covered when ALL of the following are met:

Reauthorization:

Policy Summary

PayerCareSource

PolicyCabenuva (cabotegravir/rilpivirine) coverage

Policy CodePolicy N/A

Change TypeOperational (billing update)

Effective DateJul 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization and provide documentation of age, HIV-1 diagnosis, and virologic suppression (HIV-1 RNA <50 copies/mL for ≥3 months).

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Use of Cabenuva is not medically necessary when any of the following apply: baseline resistance to either cabotegravir or rilpivirine; prior virologic failure with any antiretroviral therapy; active hepatitis B virus (HBV) infection; or the member is not virologically suppressed as specified in this policy. Requests will be denied if the member is under 18 years of age, is not virologically suppressed (HIV‑1 RNA ≥ 50 copies/mL) for the required period, or does not meet the other coverage requirements described herein.

Providers must document absence of baseline resistance to cabotegravir and rilpivirine, no prior virologic failure, and no active HBV when requesting coverage. See the Reauthorization section for required documentation of ongoing virologic suppression after initiating injectable therapy.

Billing and Coding

Covered HCPCSHCPCSCovered

J0741

Cabenuva (cabotegravir/rilpivirine) billing code

inv-06: Virologic suppression threshold (HIV-1 RNA)

ThresholdHIV-1 RNA < 50 copies/mL

Required duration for initial authorizationVirologically suppressed (HIV-1 RNA < 50 copies/mL) for at least 3 months

Reauthorization requirementChart notes must demonstrate member remains virologically suppressed (HIV-1 RNA < 50 copies/mL) after initiation of treatment

inv-07: Oral lead-in duration

Minimum oral lead-in duration>= 28 days (use oral cabotegravir + rilpivirine to assess tolerability)

Timing to initiate injectionsInitiate injections on the last day of the oral lead-in

PurposeAssess tolerability of cabotegravir and rilpivirine prior to monthly intramuscular injections

Provider Requirements and Operational Steps

Prior Authorization

Prior Authorization Required

Prior authorization is required. Cabenuva (cabotegravir/rilpivirine) is a medical benefit (billing code J0741) and is administered in the office. Submit PA requests to CareSource and include all required documentation to avoid delays.

Billing code: J0741
Benefit type: Medical
Site of service: Office
Status: Prior Authorization Required

Billing Rule

Oral Lead-In Required

An oral lead-in with cabotegravir + rilpivirine is required to assess tolerability before starting injections. Use the oral lead-in for at least 28 days; initiate the first injections (600 mg cabotegravir + 900 mg rilpivirine) on the last day of the oral lead-in, then continue monthly injections (400 mg cabotegravir + 600 mg rilpivirine).

Oral lead-in duration: ≥ 28 days
Initial injection dosing (on last day of lead-in): cabotegravir 600 mg + rilpivirine 900 mg
Maintenance injection dosing: cabotegravir 400 mg + rilpivirine 600 mg monthly

Documentation Required

Required Documentation

Include the following documentation with the prior authorization request to demonstrate criteria are met and to support approval: age, HIV-1 diagnosis, evidence of virologic suppression, prior ART history and stability, documentation of clinical reason for switch, absence of baseline resistance or prior virologic failure, hepatitis B status, and prescribing clinician specialty.

Member age (≥ 18 years)
Diagnosis of HIV-1
Evidence of virologic suppression: HIV-1 RNA < 50 copies/mL for ≥ 3 months (initial) and ongoing suppression for reauthorization
Documentation that member is stable on a complete oral ART regimen and clinical reason for switching to Cabenuva
HIV resistance testing results showing no baseline resistance to cabotegravir or rilpivirine
History showing no prior virologic failure with ART
Hepatitis B virus (HBV) status showing no active HBV infection
Prescriber is an HIV specialist or documentation of consultation with an HIV specialist
Relevant chart notes for reauthorization demonstrating continued virologic suppression

Denial Risk

Triggers for Denial

The following conditions are triggers for denial — do not submit or expect approval if any apply. Ensure documentation clearly addresses these items before requesting authorization.

Member is under 18 years of age
Member is not virologically suppressed (HIV-1 RNA ≥ 50 copies/mL) or insufficient evidence of suppression for the required timeframe
Insufficient documentation of stability on a complete oral ART regimen or lack of documented clinical reason for switching to Cabenuva
Evidence of baseline resistance to cabotegravir (Vocabria) or rilpivirine (Edurant)
Prior virologic failure with any antiretroviral therapy
Active hepatitis B virus (HBV) infection
Missing required documentation or prescribing clinician not an HIV specialist and no documented consultation

Background

Cabenuva is supplied as a co‑packaged, long‑acting injectable antiretroviral regimen consisting of cabotegravir (an integrase strand transfer inhibitor) and rilpivirine (a non‑nucleoside reverse transcriptase inhibitor). The regimen is administered as separate intramuscular injections on a monthly schedule as a complete regimen to replace a current antiretroviral regimen in virologically suppressed adults.

An oral lead‑in with oral cabotegravir and rilpivirine for at least 28 days is required to assess tolerability; injections are initiated on the last day of the oral lead‑in (initial dosing per policy: 600 mg cabotegravir + 900 mg rilpivirine on the first injection), with subsequent monthly maintenance injections of 400 mg cabotegravir + 600 mg rilpivirine.

OpenPayer

Cabenuva (cabotegravir/rilpivirine) coverage

Coverage Criteria for Cabenuva (cabotegravir/rilpivirine)

Billing and Coding

Provider Requirements and Operational Steps

Background

Definitions