CurrentAnthemPolicy CC-0194

Cabenuva (cabotegravir extended-release; rilpivirine extended-release) Injection

Medical necessity criteria, coding, and quantity limits governing use of Cabenuva as a complete regimen for treatment of HIV-1 in adults and adolescents ≥12 years and ≥35 kg, including initial and continuation prior authorization requirements.

Policy Summary

PayerAnthem

PolicyCabenuva (cabotegravir extended-release; rilpivirine extended-release) Injection

Policy CodePolicy CC-0194

Change TypeClarified treatment failureadded continuation criteria

Effective Date10/01/2025

Next Review Date

Key ActionObtain prior authorization and document HIV-1 RNA <50 copies/mL for ≥3 months and no history of antiretroviral treatment failure.

SourceLink

POLICY UPDATE CHANGES

Clarify treatment failure criteria.

Added continuation criteria for Cabenuva.

3 monthsminimum viral suppression required for initial approval

HIV RNA <50virologic suppression threshold

1 per 2 moq limit 600/900 kit

1 per moq limit 400/600 kit

J0741HCPCS code

Coverage Criteria for Cabenuva

Initial Therapy

Initial requests may be approved when ALL of the following are met:

Initial approval criteria: 1) Individual is using Cabenuva to treat human immunodeficiency virus (HIV) infection;

Initial approval criteria: 2) Individual is antiretroviral treatment-experienced and has been virologically suppressed (HIV RNA <50 copies/mL) for at least three months (DHHS);HIV RNA <50 copies/mL; ≥ 3 months

Follow DHHS recommendations for candidate selection.

Initial approval criteria: 3) Individual has no history of antiretroviral treatment failure.

Policy Summary

PayerAnthem

PolicyCabenuva (cabotegravir extended-release; rilpivirine extended-release) Injection

Policy CodePolicy CC-0194

Change TypeClarified treatment failureadded continuation criteria

Effective Date10/01/2025

Next Review Date

Key ActionObtain prior authorization and document HIV-1 RNA <50 copies/mL for ≥3 months and no history of antiretroviral treatment failure.

SourceLink

On This Page

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Coding and Diagnostic Codes

HCPCSHCPCSCovered

J0741

Injection, cabotegravir and rilpivirine 2mg/3mg [Cabenuva]

ICD-10 DiagnosisICD-10

B20	Human immunodeficiency virus [HIV] disease

inv-08: Virologic suppression threshold

Virologic suppression thresholdHIV RNA < 50 copies/mL

PurposeRequired level of viral suppression for eligibility for Cabenuva initiation and continuation

Source guidanceDHHS and policy specify threshold as HIV-1 RNA less than 50 copies/mL

inv-09: Minimum duration of suppression prior to initiation

Minimum duration of suppression≥ 3 months

Applies toInitial approval for Cabenuva in antiretroviral-experienced individuals

DocumentationProvider must document HIV-1 RNA demonstrating suppression for at least three months prior to initial approval

Provider Actions, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for Cabenuva (cabotegravir extended‑release; rilpivirine extended‑release) injections. Approvals are contingent on meeting the clinical criteria in this policy (e.g., documented HIV‑1 RNA suppression, treatment‑experienced status, no history of treatment failure).

Submit clinical documentation supporting virologic suppression and prior antiretroviral history.
PA approvals depend on meeting all applicable initial or continuation criteria in the policy.

Note

Oral Lead‑In (Optional)

An oral lead‑in with cabotegravir 30 mg plus rilpivirine 25 mg daily for one month may be used to assess tolerability prior to initiating intramuscular Cabenuva injections. If used, Cabenuva injections should begin on the last day of the oral lead‑in. Use of an oral lead‑in is optional and not required for approval.

Recommended oral lead‑in regimen: Vocabria (cabotegravir) 30 mg + Edurant (rilpivirine) 25 mg daily for 1 month.
Initiate Cabenuva injections on the last day of the oral lead‑in if tolerated.

Documentation Required

Required Clinical Documentation

Providers must include documentation demonstrating eligibility when requesting authorization. Necessary evidence includes laboratory results and treatment history to confirm suppression and prior regimen details.

Recent HIV‑1 RNA demonstrating < 50 copies/mL (document dates; initial requests: ≥3 months of suppression per DHHS guidance).
Documentation of antiretroviral treatment‑experienced status and no history of treatment failure.
Medication history showing no known or suspected resistance to cabotegravir or rilpivirine.
Plan for injection schedule (monthly vs every‑2‑months) and any oral lead‑in used.

Denial Risk

Denial Triggers (Common Reasons for Non‑Approval)

Requests may be denied when key policy conditions are not met. Review common denial triggers before submission to avoid delays.

Use for HIV pre‑exposure prophylaxis (PrEP) — not approved under this policy.
Insufficient documentation of virologic suppression (HIV‑1 RNA ≥ 50 copies/mL or lack of documented suppression period).
History of antiretroviral treatment failure or documented resistance to cabotegravir or rilpivirine.
Missing medication history or failure to document treatment‑experienced status.
No plan or documentation for administration by a qualified healthcare professional (IM gluteal injection) or inappropriate dosing schedule.

Definitions

inv-15: Virologically suppressed

DefinitionVirologically suppressed = HIV-1 RNA <50 copies/mL

ContextRequired for replacement of a stable antiretroviral regimen with Cabenuva and for continuation while on therapy

Clinical noteMaintaining this threshold on therapy is required for continuation approvals

inv-16: Oral lead-in

Regimen and dosingOne-month oral lead-in: Vocabria (cabotegravir) 30 mg plus Edurant (rilpivirine) 25 mg daily; Cabenuva injections initiated on the last day of oral lead-in

PurposeUsed to assess tolerability of cabotegravir and rilpivirine prior to injectable initiation

RequirementOptional — may be considered but is not strictly required by the policy criteria

OpenPayer

Cabenuva (cabotegravir extended-release; rilpivirine extended-release) Injection

Coverage Criteria for Cabenuva

Coding and Diagnostic Codes

Provider Actions, Documentation, and Denial Triggers

Background

Definitions