CurrentCignaPolicy IP0123

Cabenuva (cabotegravir + rilpivirine) long-acting injections for HIV-1 — Coverage Criteria

This policy governs prior authorization and medical necessity criteria for Cigna-administered coverage of Cabenuva (cabotegravir extended-release and rilpivirine extended-release intramuscular injection) as a complete regimen for treatment of HIV-1 in eligible patients.

Policy Summary

PayerCigna

PolicyCabenuva (cabotegravir + rilpivirine) long-acting injections for HIV-1 — Coverage Criteria

Policy CodePolicy IP0123

Change TypeMaterial clinical updates

Effective Date

Next Review Date

Key ActionObtain prior authorization and document virologic suppression, age/weight criteria, and prescriber specialty when requesting coverage.

SourceLink

POLICY UPDATE CHANGES

Added criterion for minimum weight.

Added criterion for screening individual treated with a stable regimen for at least 3 months.

Updated criterion for continuation of treatment.

Added documentation requirements to medical necessity criteria.

≥12minimum age for coverage

≥35 kgminimum weight for coverage

<50viral suppression requirement

1 yearauthorization duration

28+ days

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Coverage Criteria for Cabenuva (cabotegravir + rilpivirine)

Initial and Continuing Therapy

Approve for treatment of HIV-1 for 1 year if ONE of the following is met:

Overall approval pathways

A) Initial Therapy
- Age: Patient is >= 12 years of age>= 12 years
- Weight: Patient weighs >= 35 kg>= 35 kg
  Added minimum weight requirement per revision
- Viral suppression: Documentation that HIV-1 RNA < 50 copies/mL (viral suppression)< 50 copies/mL
- Prior stable regimen: Documentation that prior to initiating Cabenuva or a 1-month lead-in with Vocabria, the patient was treated with a stable antiretroviral regimen for >= 3 months>= 3 months on stable regimen
  Patient should be virologically suppressed on a stable regimen prior to switch
- Prescriber: Medication is prescribed by or in consultation with a physician who specializes in HIV treatment
  Documentation may be required
B) Currently Receiving Cabenuva: Approve if documentation provided that the patient has HIV-1 RNA < 50 copies/mL (viral suppression)< 50 copies/mL

Dosing authorization (select one): Dosing approved per FDA‑approved schedules: once‑monthly or once every 2 months (specific intramuscular dosing per policy)

Provider must select and document one approved dosing regimen

Cabenuva is not indicated for pre-exposure prophylaxis (PrEP) and should not be used for prevention of HIV infection. Additionally, because Cabenuva is provided as a complete antiretroviral regimen, co‑administration with other antiretroviral medications for HIV treatment is not recommended.

Use of Cabenuva for indications outside the FDA‑approved treatment of HIV‑1 is considered not medically necessary. Examples of non‑covered indications include prevention of HIV infection (PrEP), co‑administration with other antiretrovirals (since Cabenuva is a complete regimen), and treatment of HIV‑2 infection.

Coding and Clinical Requirements

Covered/administration billing (example)HCPCS

J3453

Cabotegravir and rilpivirine injection (example combined HCPCS) - provider should verify current billing codes as of date of service

inv-05: Viral suppression requirement — key clinical threshold < 50 copies/mL required for initiation/continuation.

Viral suppression thresholdHIV-1 RNA < 50 copies/mL required for initiation and continuation of Cabenuva

Role in approvalDocumentation of HIV-1 RNA < 50 copies/mL is required for both: A) Initial Therapy pathway (item iii) and B) Patients currently receiving Cabenuva

Timeframe relevanceViral load must reflect current virologic suppression at time of authorization request

inv-06: Age and weight requirements — minimum age >= 12 years and minimum weight >= 35 kg for coverage.

Minimum agePatient must be ≥ 12 years of age

Minimum weight

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization Required — Cabenuva requires prior authorization. Approvals are issued for the duration stated in the policy (e.g., up to 1 year for FDA‑approved indication). When approvals are given in months, 1 month = 30 days.

Prior authorization is recommended for prescription benefit coverage of Cabenuva.
Approvals provided for duration noted in policy; 1 month = 30 days.

Billing Rule

Dosing Authorization / Billing Note

Dosing must match one of the approved regimens below and billing should align with the approved schedule. Document the selected regimen in the prior authorization request.

Definitions and Key Terms

inv-13: Oral lead-in — definition and typical duration (approximately 1 month, at least 28 days) for oral cabotegravir + rilpivirine prior to injection.

DefinitionOral lead-in = approximately 1 month (at least 28 days) of oral cabotegravir (Vocabria) + rilpivirine (Edurant) used prior to intramuscular injection initiation to assess tolerability

Typical durationApproximately 1 month; policy specifies at least 28 days

PurposeUsed to assess tolerability of cabotegravir and rilpivirine before starting long-acting injections

inv-14: Virologic suppression definition — HIV-1 RNA < 50 copies/mL required for initiation and continuation.

Operational definitionVirologic suppression defined as HIV-1 RNA < 50 copies/mL

Use in initiation criteria

Background

Cabenuva is a co‑packaged long‑acting injectable regimen containing cabotegravir and rilpivirine, indicated as a complete regimen for the treatment of HIV‑1. It is intended for patients who are ≥ 12 years of age and weigh ≥ 35 kg, and who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and no known or suspected resistance to either agent. An oral lead‑in of at least 28 days with cabotegravir and rilpivirine may be used to assess tolerability, and maintenance dosing options include once‑monthly or once every two months injections per the FDA‑approved schedule.

Policy Summary

PayerCigna

PolicyCabenuva (cabotegravir + rilpivirine) long-acting injections for HIV-1 — Coverage Criteria

Policy CodePolicy IP0123

Change TypeMaterial clinical updates

Effective Date

Next Review Date

Key ActionObtain prior authorization and document virologic suppression, age/weight criteria, and prescriber specialty when requesting coverage.

SourceLink

On This Page

Patient must weigh ≥ 35 kg

Indication contextCabenuva is indicated as a complete regimen for treatment of HIV-1 infection in patients ≥ 12 years and ≥ 35 kg

Once-monthly regimen: initial 600 mg/900 mg IM then 400 mg/600 mg IM every 4 weeks.
Every-2-months regimen: initial two 600 mg/900 mg IM doses 1 month apart, then 600 mg/900 mg IM every 8 weeks.
Ensure claims/billing reflect monthly vs every-2-months administration and corresponding units/dates.

Prior Authorization

Requirement: Prior Stable Oral Regimen / Virologic Suppression

Prior to initiating Cabenuva, the patient must be virologically suppressed on a stable oral antiretroviral regimen for at least 3 months (oral lead‑in with Vocabria as applicable). Documentation of HIV‑1 RNA < 50 copies/mL and evidence of the prior stable regimen must be provided.

Patient must have HIV‑1 RNA < 50 copies/mL (viral suppression) documented.
Documentation that patient was treated with a stable antiretroviral regimen ≥ 3 months prior to initiating Cabenuva or 1‑month lead‑in with Vocabria when applicable.

Documentation Required

Documentation & Prescriber Specialization

Provide supporting documentation with the prior authorization request. Because specialized clinical evaluation and monitoring are required, Cabenuva must be prescribed by or in consultation with a physician who specializes in the treatment of HIV.

Documentation may include chart notes, laboratory test results (e.g., HIV‑1 RNA), and claims records.
Prescriber requirement: prescribed by or in consultation with a physician who specializes in HIV treatment.
Include documentation of weight (≥ 35 kg) and age (≥ 12 years) where applicable, and any notes on prior lead‑in with Vocabria.

Denial Risk

Coding / Claims Denial Risk

Claims submitted without covered diagnosis or procedure codes that support Cabenuva use will be denied. Ensure the PA request and claims include the appropriate diagnosis (HIV‑1) and administration/procedure codes matching the dosing schedule.

Missing or incorrect codes/diagnosis on claims or prior authorization submissions may result in denial.
Confirm coding aligns with the approved dosing regimen and service dates.

Required documentation of HIV-1 RNA < 50 copies/mL for Initial Therapy pathway (item iii)

Use in continuation criteriaRequired documentation of HIV-1 RNA < 50 copies/mL for patients currently receiving Cabenuva (continuation)