CurrentEmblemHealthPolicy MG.MM.PH.328

Medical Policy: Cabenuva (cabotegravir extended-release; rilpivirine extended-release) injectable suspension

Defines medical-benefit coverage, dosing, eligibility (initial and renewal) and limitations for Cabenuva (cabotegravir extended-release; rilpivirine extended-release) as a complete antiretroviral regimen for HIV-1 in adolescents and adults meeting virologic and other criteria. Includes dosing schedules (monthly and every-2-month), length of authorization, applicable NDCs, ICD-10 diagnoses, and exclusion criteria.

Policy Summary

PayerEmblemHealth

PolicyMedical Policy: Cabenuva (cabotegravir extended-release; rilpivirine extended-release) injectable suspension

Policy CodePolicy MG.MM.PH.328

Change TypeAnnual reviews and substantive revisions (dosing, criteria)

Effective Date

Next Review Date

Key ActionTreating physician must submit clinical evidence that the member meets criteria (age, weight, HIV-1 RNA, prior stable ARV regimen duration, specialist involvement) for preauthorization or post-payment review.

SourceLink

POLICY UPDATE CHANGES

Annual Review 3/3/2025: No updates.

3/25/2024: Updated initial criteria to include '≥ 35 kg' and adjusted prior stable ARV duration wording to '>3 months'; added renewal viral suppression criterion and limitations/exclusions.

7/24/2023: Dosing limits updated to specify initial 600 mg/900 mg for one dose only followed by maintenance dosing.

9/22/2022: Policy updated to reflect FDA label: oral lead-in optional (not mandatory); age restriction clarified to include adolescents ≥12 years and ≥35 kg.

Policy originated 4/5/2021.

12Initial authorization (months)

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Coverage Summary

Coverage stance: covered with criteria. Cabenuva (cabotegravir + rilpivirine) is covered as a complete antiretroviral regimen for treatment of HIV-1 in adults and adolescents ≥ 12 years and weighing ≥ 35 kg who are virologically suppressed (HIV‑1 RNA < 50 copies/mL), with no history of treatment failure or known/suspected resistance to cabotegravir or rilpivirine. FDA‑label dosing options included in the policy are an optional oral lead‑in and intramuscular injection schedules of monthly or every‑2‑month administration.

Minimum age≥12 years

Minimum weight≥ 35 kg

Viral suppression thresholdHIV-1 RNA < 50 copies/mL

Prior stable ARV therapy duration≥ 3 months

Initial authorization duration12 months

Initial Therapy Criteria

Continuation (Renewal) Criteria

Renewal Criteria

Coverage may be renewed when ALL of the following are met:

Viral suppression: Patient has HIV-1 RNA < 50 copies/mL (viral suppression)HIV-1 RNA < 50 copies/mL
Tolerability: Absence of unacceptable toxicity from the drug (examples include hypersensitivity reactions, hepatotoxicity with marked transaminase elevations, psychiatric/depressive symptoms)
Examples provided in policy

Limitations and Exclusions

Co‑administration exclusions apply: Cabenuva is not covered when concomitant antiretroviral therapy is not administered per the labeled regimen (i.e., co‑administration with other ARVs outside the label is excluded). The policy also excludes use for Pre‑Exposure Prophylaxis (PrEP) and for HIV‑2 infection.

Applicable Codes

Medical benefit HCPCS code for injectionHCPCSCovered

J0741

Injection, cabotegravir and rilpivirine, 2 mg/3 mg

Applicable NDCsNDCCovered

49702-0240-15	Cabenuva (Cabotegravir; Rilpivirine) 600-mg/900-mg Kit
49702-0253-15	Cabenuva (Cabotegravir; Rilpivirine) 400-mg/600-mg Kit

Applicable ICD-10 diagnosesICD-10Covered

B20	Human immunodeficiency virus [HIV] disease
Z21	Asymptomatic HIV infection status

Provider Actions and Documentation Requirements

Prior Authorization

Preauthorization required with documentation

Treating physician must submit clinical evidence that the member meets the criteria for preauthorization or post-payment review. Required documentation should demonstrate age (≥12 years), weight (≥35 kg), HIV‑1 RNA (viral suppression <50 copies/mL), prior stable ARV regimen duration (≥3 months or 1 month lead-in with Vocabria), and that the medication is prescribed by or in consultation with an HIV specialist.

J0741

Documentation Required

Specialist prescribing requirement

Medication must be prescribed by, or in consultation with, a physician who specializes in the treatment of HIV infection. Documentation of the specialist consultation must be provided.

Clinical Evidence & Definitions

Evidence sources: Policy references the CABENUVA package insert (ViiV Healthcare, August 2022) and the Department of Health and Human Services (DHHS) antiretroviral guidelines as the evidence base. The FDA label–specified dosing options (optional oral lead‑in; monthly and every‑2‑month intramuscular injection schedules) are captured from the package insert and reflected in the background policy content.

Virologic suppressionHIV-1 RNA < 50 copies/mL

Stable ARV regimenPatient treated with a stable antiretroviral regimen for ≥ 3 months prior to initiating Cabenuva or 1 month lead-in with Vocabria

Background

Background: Cabenuva is a co‑packaged long‑acting intramuscular combination of cabotegravir and rilpivirine indicated as a complete regimen to replace a current ARV regimen in patients with HIV‑1 who are ≥ 12 years old and weigh at least 35 kg, and who are virologically suppressed (HIV‑1 RNA < 50 copies/mL) on a stable ARV regimen with no history of treatment failure or known/suspected resistance to either agent. Dosing options per label include an optional oral lead‑in (cabotegravir 30 mg once daily; rilpivirine 25 mg once daily) and intramuscular injection schedules of either an initiation dose followed by monthly maintenance injections (initial 600 mg/900 mg one‑time then 400 mg/600 mg monthly) or an every‑2‑month regimen (initiation injections at Months 1 and 2 then every 2 months thereafter).

Scope summary: This policy defines medical‑benefit coverage for Cabenuva including dosing options, eligibility criteria for initial approval and renewal, length of authorization (initially 12 months), applicable NDCs and ICD‑10 diagnosis codes, and exclusions (including PrEP, HIV‑2, and co‑administration not per labeled regimen).

Revision History

4/5/2021added

Policy originated (New Medical Policy).

4/6/2022revised

Policy transferred to new template.

9/22/2022revised

Updated to reflect FDA label: oral lead-in changed to optional (not mandatory); prior therapy duration specified as 2–4 months; age restriction clarified to include adolescents ≥12 years and weighing at least 35 kg.