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    v1.0.28
    OpenPayerPolicy UpdatesInfectious DiseaseAvMed Cabenuva Prior Auth & Coverage | OpenPayer
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    CurrentAvMedPolicy Pub. 100-2

    Cabenuva (cabotegravir/rilpivirine) prior authorization and coverage criteria

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    This document governs prior authorization and step-edit requirements for Cabenuva (cabotegravir/rilpivirine) long-acting injectable therapy for AvMed members, describing required provider actions, clinical criteria, and quantity limits.

    Policy Summary
    PayerAvMed
    PolicyCabenuva (cabotegravir/rilpivirine) prior authorization and coverage criteria
    Policy CodePolicy Pub. 100-2
    Change TypeNo material changes
    Effective Date
    Next Review Date
    Key ActionObtain prior authorization and submit prescriber-signed request with chart notes and recent HIV RNA lab results demonstrating >=3 months virologic suppression.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    1 kit/28ddispensing frequency
    >=12minimum patient age
    >=3 mo suppressed

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    stability requirement
    J0741billing code listed

    Coverage Criteria for Cabenuva

    Initial Authorization Criteria

    Covered when ALL of the following are met

    Age requirement: Member is 12 years of age or olderage >= 12

    see chunk 4

    Diagnosis: Confirmed diagnosis of human immunodeficiency virus type-1 (HIV-1)HIV-1 diagnosis

    see chunk 4

    Prescriber specialty: Medication is being prescribed by, or in consultation with, an infectious disease specialist or specialist in HIV treatmentspecialist involvement

    see chunk 4

    Virologic suppression and stability: Member has been stabilized AND virologically suppressed on current treatment for at least 3 months, defined as HIV RNA <50 copies/mL (must submit chart notes/progress notes displaying regimen from the past 3 months and laboratory documentation of measured RNA from the past 30 days)>= 3 months; RNA <50 copies/mL

    see chunk 4

    No treatment failure or resistance: Member has NOT experienced any treatment failure and is not suspected/known to have resistance to cabotegravir or rilpivirineno known resistance

    see chunk 4

    Use of samples to initiate therapy does not meet step edit or preauthorization criteria. Requests initiated with samples will not satisfy the requirement to document prior therapy and stabilization; previous therapies will be verified through pharmacy paid claims or submitted chart notes.

    Requests may be considered not medically necessary or may be denied when required clinical criteria are not met. Examples include when the member is not virologically suppressed (see definition below), the member is under 12 years of age, or the medication is not prescribed by or in consultation with an infectious disease/HIV specialist. Additionally, requests lacking documentation of stabilization and a recent HIV RNA measurement from the past 30 days, or where evidence of no treatment failure or resistance to cabotegravir or rilpivirine is absent, may be denied.

    Quantity limits also apply: the policy specifies a limit of 1 kit containing two single‑dose vials per 28 days, and insufficient or incorrect supporting documentation (including lab results and chart notes) can delay or result in denial of authorization.

    Coding and Quantity Limits

    Covered HCPCS CodesHCPCSCovered
    J0741Cabotegravir and rilpivirine, long-acting injectable
    Virologic suppression duration
    RequirementMember has been stabilized and virologically suppressed on current treatment for at least 3 months
    Definition of suppressionHIV RNA <50 copies/mL
    Documentation requiredChart notes/progress notes showing regimen from the past 3 months and laboratory documentation of HIV RNA from the past 30 days
    Quantity limit
    Quantity limit1 kit containing two single-dose vials per 28 days
    Kit configuration (example)Cabotegravir 400 mg and rilpivirine 600 mg per 2 mL per vial (4 mL)

    Required Provider Actions and Documentation

    Prior Authorization

    Prior authorization required; prescriber signature mandatory

    Prior authorization is required for Cabenuva (cabotegravir/rilpivirine) medical benefit billed with HCPCS J0741. The prescribing physician must sign and clearly print their name on the medical prior authorization/step-edit request form (preprinted stamps are not valid) before submission to AvMed.

    • Drug requested: Cabenuva (cabotegravir/rilpivirine) LAP (J0741).
    • Fax completed form to AvMed as instructed; incomplete or illegible information can delay authorization.
    Step Therapy

    Samples do not meet step-edit/preauth criteria

    Use of samples to initiate Cabenuva does not satisfy the step-edit/preauthorization requirement; AvMed will verify prior therapies through pharmacy paid claims or submitted chart notes.

    • If samples were used to start therapy, provide documentation of prior therapies (pharmacy claims or chart notes) to demonstrate step criteria are met.

    Definitions

    Virologic suppression
    Virologic suppression thresholdHIV RNA <50 copies/mL (documented within the past 30 days)
    Stability periodSuppressed on current regimen for at least 3 months
    Supporting evidenceChart notes/progress notes showing regimen from the past 3 months and lab documentation of measured RNA from the past 30 days

    Background

    Cabenuva is a long‑acting injectable combination of cabotegravir and rilpivirine used as maintenance therapy for patients with confirmed HIV‑1 infection who have been stabilized and are virologically suppressed on their current antiretroviral regimen. The policy requires members to be 12 years of age or older and to have documented virologic suppression (HIV RNA <50 copies/mL) on their current regimen for at least 3 months prior to initiating the long‑acting injectable regimen.

    Policy Summary
    PayerAvMed
    PolicyCabenuva (cabotegravir/rilpivirine) prior authorization and coverage criteria
    Policy CodePolicy Pub. 100-2
    Change TypeNo material changes
    Effective Date
    Next Review Date
    Key ActionObtain prior authorization and submit prescriber-signed request with chart notes and recent HIV RNA lab results demonstrating >=3 months virologic suppression.
    SourceLink
    On This Page
    Coverage Criteria for CabenuvaCoding and Quantity LimitsRequired Provider Actions and DocumentationDefinitionsBackground
    Kit configuration (alternate)
    Cabotegravir 600 mg and rilpivirine 900 mg per 3 mL per vial (6 mL)
    Documentation Required

    Prescriber signature and clinical documentation required

    The prescribing physician’s signature is required on the request form (preprinted stamps are not valid). Submit chart notes/progress notes documenting the member’s regimen for the past 3 months and laboratory documentation of HIV RNA from the past 30 days to support virologic suppression.

    • Signature must be hand-signed and clearly printed by the prescribing physician.
    • Chart notes/progress notes must display the regimen from the past 3 months.
    • Provide laboratory documentation showing HIV RNA <50 copies/mL from the past 30 days.
    Denial Risk

    Incomplete or missing documentation can delay or deny authorization

    Authorization may be delayed or denied if the request form information is incomplete, incorrect, or illegible, or if supporting documentation (lab results, diagnostics, chart notes) for checked clinical criteria is not provided.

    • Ensure phone and fax numbers on the form are accurate to avoid processing delays.
    • Provide all requested supporting documents for each clinical checkbox selected; missing documentation can lead to denial.