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    v1.0.28
    OpenPayerPolicy UpdatesInfectious DiseaseColorado Rocky Mountain Health Plans HIV PA | Open…
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    CurrentColorado Rocky Mountain Health PlansPolicy 2026D0103O

    Long-Acting Injectable Antiretroviral Agents for HIV

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    Coverage and prior authorization criteria for Apretude, Cabenuva, Sunlenca, and Yeztugo administered by a healthcare professional for HIV pre-exposure prophylaxis or treatment.

    Policy Summary
    PayerColorado Rocky Mountain Health Plans
    PolicyLong-Acting Injectable Antiretroviral Agents for HIV
    Policy CodePolicy 2026D0103O
    Change TypeAdministrative template and supporting-information update
    Effective DateOctober 1, 2026
    Next Review DateN/A
    Key ActionObtain prior authorization and document a negative HIV-1 test before initiating Apretude or Yeztugo PrEP.
    SourceLink
    POLICY UPDATE CHANGES

    The policy history documents transfer of content to a shared policy template and updates to the application, FDA, and references sections.

    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.

    4
    Long-acting injectable products addressed
    12 monthsMaximum authorization period
    RNA <50 copies/mLCabenuva viral suppression threshold
    35 kgMinimum weight for Apretude and Yeztugo PrEP

    Coverage Criteria

    Apretude HIV PrEP

    Covered when all applicable criteria are met.

    Apretude initial or continuation therapy

    • Initial therapy

      • Required criteria

        • Used for HIV-exposure prophylaxis (PrEP).
        • Patient has a negative HIV-1 test.
        • Provider confirms that the patient will be tested for HIV-1 infection with each subsequent injection.
        • Dosing is in accordance with FDA-approved labeling.
        • Initial authorization is for no more than 12 months.12 months maximum

    • Continuation therapy

      • Patient has previously received treatment with Apretude.
      • Patient has a negative HIV-1 test.
      • Provider confirms that the patient will be tested for HIV-1 infection with each subsequent injection.
      • Dosing is in accordance with FDA-approved labeling.
      • Authorization is for no more than 12 months.12 months maximum

    Cabenuva HIV-1 treatment

    Covered when all criteria within the applicable initial or continuation pathway are met.

    Cabenuva initial or continuation therapy

    • Initial therapy

      • Patient has a diagnosis of HIV-1 infection.
      • Patient has no prior virologic failures or baseline resistance to either cabotegravir or rilpivirine.
      • Patient is currently on a stable antiretroviral regimen.
      • Provider attests that the patient has achieved viral suppression, defined as HIV-1 RNA less than 50 copies per mL, for at least 3 months before initiation of Cabenuva.HIV-1 RNA <50 copies/mL for at least 3 months

      • Treatment readiness

    Sunlenca multidrug-resistant HIV-1 treatment

    Covered when all criteria within the applicable initial or continuation pathway are met.

    Sunlenca initial or continuation therapy

    • Initial therapy

      • HIV-1 diagnosis and multidrug resistance

        • Patient has a diagnosis of HIV-1 infection.
        • Provider attests that the patient has multidrug-resistant HIV-1 infection.
      • Provider confirms that the patient has been prescribed an optimized background antiretroviral regimen containing at least one antiretroviral agent that demonstrates full viral sensitivity or susceptibility.
      • Sunlenca initial and maintenance dosing is in accordance with FDA-approved labeling.

    Yeztugo HIV PrEP

    Covered when all applicable criteria are met.

    Yeztugo initial or continuation therapy

    • Initial therapy

      • Used for HIV-1 pre-exposure prophylaxis (PrEP).
      • Patient has a negative HIV-1 test.
      • Provider confirms that the patient will be tested for HIV-1 infection with each subsequent injection.
      • Dosing is in accordance with FDA-approved labeling.
      • Initial authorization is for no more than 12 months.12 months maximum

    Apretude is excluded as medically necessary treatment for HIV-1. It is intended for HIV-1 pre-exposure prophylaxis, not HIV-1 treatment.

    Cabenuva is excluded as medically necessary treatment for HIV-1 when the patient is not currently virologically suppressed, defined as HIV-1 RNA less than 50 copies per mL.

    Sunlenca is excluded as medically necessary for treatment of virologically suppressed HIV-1, treatment of antiretroviral-naive HIV-1, and HIV-1 pre-exposure prophylaxis. Virologic suppression is defined as HIV-1 RNA less than 50 copies per mL.

    Yeztugo is excluded as medically necessary treatment for HIV-1. It is covered under this policy for HIV-1 pre-exposure prophylaxis when applicable criteria are met.

    Apretude is unproven and not medically necessary for treatment of HIV-1.

    Cabenuva is unproven and not medically necessary for treatment of HIV-1 in patients who are not currently virally suppressed, defined as HIV-1 RNA less than 50 copies per mL.

    Sunlenca is unproven and not medically necessary outside the covered treatment pathway for multidrug-resistant HIV-1. This includes use in virologically suppressed patients, antiretroviral-naive patients, and patients seeking HIV-1 pre-exposure prophylaxis.

    Yeztugo is unproven and not medically necessary for treatment of HIV-1.

    Coding and Authorization Parameters

    HCPCS CodesHCPCS
    J0738Injection, lenacapavir, 1 mg, FDA-approved prescription, only for use as HIV pre-exposure prophylaxis (PrEP) (not for use as treatment for HIV)
    J0739Injection, cabotegravir, 1 mg, FDA-approved prescription, only for use as HIV pre-exposure prophylaxis (PrEP) (not for use as treatment for HIV)
    J0741Injection, cabotegravir and rilpivirine, 2 mg/3 mg
    J1961Injection, lenacapavir (only for use as HIV treatment), 1 mg
    ICD-10 Diagnosis CodesICD-10
    B20Human immunodeficiency virus [HIV] disease
    Z11.3Encounter for screening for infections with a predominantly sexual mode of transmission
    Z11.4Encounter for screening for human immunodeficiency virus [HIV]
    Z16.33Resistance to antiviral drug(s)
    Z20.2Contact with (and suspected exposure to) infections with a predominantly sexual mode of transmission
    Z20.6Contact with human immunodeficiency virus (HIV)
    Z21Asymptomatic human immunodeficiency virus [HIV] infection status
    Z29.81Encounter for HIV pre-exposure prophylaxis
    Z72.51High risk heterosexual behavior
    Z72.52High risk homosexual behavior
    1–10 of 11
    1/2
    Minimum Patient Weight
    ApretudeAt-risk adults and adolescents weighing at least 35 kg for HIV-1 PrEP.
    YeztugoAt-risk adults and adolescents weighing at least 35 kg for HIV-1 PrEP.
    ThresholdMinimum patient weight: 35 kg.
    Virologic Suppression Threshold
    DefinitionVirologically suppressed means HIV-1 RNA less than 50 copies per mL.
    Cabenuva initial therapyHIV-1 RNA must be less than 50 copies per mL for at least 3 months before initiation.

    Prior Authorization and Documentation

    Prior Authorization

    Apretude Prior Authorization Required

    Prior authorization is required for Apretude for HIV-1 pre-exposure prophylaxis (PrEP) in at-risk adults and adolescents weighing at least 35 kg. Authorization may be approved for no more than 12 months at a time, with FDA-approved dosing required.

    • Initial therapy: confirm use for HIV-1 PrEP, a negative HIV-1 test, testing with each subsequent injection, and FDA-approved dosing.
    • Continuation therapy: confirm prior Apretude treatment, a negative HIV-1 test, testing with each subsequent injection, and FDA-approved dosing.
    • Initial and continuation authorization periods may not exceed 12 months.
    Prior Authorization

    Cabenuva Prior Authorization Required

    Prior authorization is required for Cabenuva as a complete regimen for patients with HIV-1 who are virologically suppressed on a stable antiretroviral regimen. Authorization may be approved for no more than 12 months at a time.

    • Initial therapy requires HIV-1 diagnosis; no prior virologic failures or baseline resistance to cabotegravir or rilpivirine; a stable antiretroviral regimen; and viral suppression (HIV-1 RNA less than 50 copies/mL) for at least 3 months before initiation.

    Product Background

    These long-acting injectable antiretroviral products serve different clinical purposes. Apretude is a long-acting cabotegravir integrase inhibitor used for HIV prevention. Cabenuva combines cabotegravir and rilpivirine for treatment of virologically suppressed HIV-1. Sunlenca and Yeztugo contain lenacapavir; Sunlenca is used with an optimized background regimen for multidrug-resistant HIV-1 treatment, while Yeztugo is used for HIV-1 pre-exposure prophylaxis.

    Key Definitions

    PrEP
    TermPrEP means pre-exposure prophylaxis.
    PurposePrEP is intended to prevent HIV acquisition.
    Applicable populationPrEP is for people with an ongoing substantial risk of HIV exposure and acquisition.
    Virologically Suppressed
    DefinitionVirologically suppressed means HIV-1 RNA less than 50 copies per mL.
    Cabenuva eligibilityCabenuva is used to replace a stable antiretroviral regimen in patients who are virologically suppressed.
    Duration before initiation
    Policy Summary
    PayerColorado Rocky Mountain Health Plans
    PolicyLong-Acting Injectable Antiretroviral Agents for HIV
    Policy CodePolicy 2026D0103O
    Change TypeAdministrative template and supporting-information update
    Effective DateOctober 1, 2026
    Next Review DateN/A
    Key ActionObtain prior authorization and document a negative HIV-1 test before initiating Apretude or Yeztugo PrEP.
    SourceLink
    On This Page
    Coverage CriteriaCoding and Authorization ParametersPrior Authorization and DocumentationProduct BackgroundKey Definitions
    • Patient understands the risks of missed doses of Cabenuva.
    • Patient has the ability to adhere to the required monthly or every-2-month injection appointments.
  1. Dosing is in accordance with FDA-approved labeling.
  2. Initial authorization is for no more than 12 months.12 months maximum

  3. Continuation therapy

    • Patient has previously received treatment with Cabenuva.
    • Provider confirms that the patient has achieved and maintained viral suppression, defined as HIV-1 RNA less than 50 copies per mL, while on Cabenuva therapy.HIV-1 RNA <50 copies/mL
    • Dosing is in accordance with FDA-approved labeling.
    • Authorization is for no more than 12 months.12 months maximum
  4. Initial authorization is for no more than 12 months.12 months maximum

  5. Continuation therapy

    • Patient has previously received treatment with Sunlenca.
    • Provider confirms that the patient has achieved a clinically significant viral response to Sunlenca therapy.
    • Provider confirms that the patient will continue to take an optimized background antiretroviral regimen in combination with Sunlenca.
    • Sunlenca maintenance dosing is in accordance with FDA-approved labeling.
    • Authorization is for no more than 12 months.12 months maximum

  6. Continuation therapy

    • Patient has previously received treatment with Yeztugo.
    • Patient has a negative HIV-1 test.
    • Provider confirms that the patient will be tested for HIV-1 infection with each subsequent injection.
    • Dosing is in accordance with FDA-approved labeling.
    • Authorization is for no more than 12 months.12 months maximum
    7. Cabenuva continuation therapy
    The patient must have achieved and maintained HIV-1 RNA less than 50 copies per mL while receiving Cabenuva.
    Cabenuva Initiation
    Minimum durationHIV-1 RNA suppression must be maintained for at least 3 months before Cabenuva initiation.
    Current regimenThe patient must be receiving a stable antiretroviral regimen.
    Additional eligibilityThe patient must have no prior virologic failures or baseline resistance to cabotegravir or rilpivirine.
    Maximum Authorization Period
    ApretudeInitial and continuation authorization: no more than 12 months.
    CabenuvaInitial and continuation authorization: no more than 12 months.
    SunlencaInitial and continuation authorization: no more than 12 months.
    YeztugoInitial and continuation authorization: no more than 12 months.
  7. Initial therapy also requires treatment readiness, including understanding the risks of missed doses and ability to attend monthly or every-2-month injection appointments.
  8. Continuation therapy requires prior Cabenuva treatment and maintained viral suppression on therapy.
  9. Dosing must follow FDA-approved labeling; initial and continuation authorization periods may not exceed 12 months.
    10. Prior Authorization

    Sunlenca Prior Authorization Required

    Prior authorization is required for Sunlenca in heavily treatment-experienced patients with multidrug-resistant HIV-1. Sunlenca must be used with an optimized background antiretroviral regimen and FDA-approved dosing.

    • Initial therapy requires HIV-1 diagnosis, provider attestation of multidrug-resistant HIV-1 infection, and an optimized background regimen containing at least one fully active antiretroviral agent.
    • Continuation therapy requires prior Sunlenca treatment, a clinically significant viral response, and continued use of an optimized background antiretroviral regimen.
    • Initial and continuation authorization periods may not exceed 12 months.
    Prior Authorization

    Yeztugo Prior Authorization Required

    Prior authorization is required for Yeztugo for HIV-1 pre-exposure prophylaxis (PrEP) in at-risk adults and adolescents weighing at least 35 kg. Authorization may be approved for no more than 12 months at a time, with FDA-approved dosing required.

    • Initial therapy: confirm use for HIV-1 PrEP, a negative HIV-1 test, testing with each subsequent injection, and FDA-approved dosing.
    • Continuation therapy: confirm prior Yeztugo treatment, a negative HIV-1 test, testing with each subsequent injection, and FDA-approved dosing.
    • Initial and continuation authorization periods may not exceed 12 months.
    Documentation Required

    Apretude HIV Testing Documentation

    Document a negative HIV-1 test before initiating Apretude and confirm that the patient will be tested for HIV-1 infection with each subsequent injection.

    • Applies to both initial and continuation Apretude therapy.
    • Apretude is for HIV-1 PrEP, not treatment of established HIV-1 infection.

    Unsupported block type: documentation

    Unsupported block type: documentation

    Unsupported block type: documentation

    Documentation Required

    Document HIV Status and Treatment Eligibility

    Document HIV status and treatment eligibility before requesting a long-acting injectable antiretroviral agent. PrEP products require a negative HIV-1 test, while Cabenuva requires HIV-1 infection with virologic suppression.

    • Apretude and Yeztugo: document a negative HIV-1 test before initiation.
    • Cabenuva: document HIV-1 diagnosis and HIV-1 RNA less than 50 copies/mL on a stable antiretroviral regimen.
    • FDA approval alone does not establish coverage.
    Denial Risk

    Apretude Treatment Use Not Covered

    Apretude is not medically necessary for treatment of HIV-1. Use Apretude only for HIV-1 pre-exposure prophylaxis in eligible patients without HIV-1 infection.

    • Do not submit Apretude as treatment for established HIV-1 infection.
    Denial Risk

    Cabenuva Requires Viral Suppression

    Cabenuva is not medically necessary when the patient is not currently virologically suppressed, defined as HIV-1 RNA less than 50 copies/mL.

    • Do not initiate or continue Cabenuva without documentation of the required viral suppression.
    Denial Risk

    Sunlenca Use Restrictions

    Sunlenca is not medically necessary outside treatment of multidrug-resistant HIV-1 with an optimized background antiretroviral regimen.

    • Not medically necessary for patients who are virologically suppressed (HIV-1 RNA less than 50 copies/mL).
    • Not medically necessary for antiretroviral-naive patients.
    • Not medically necessary for HIV-1 PrEP.
    Denial Risk

    Yeztugo Treatment Use Not Covered

    Yeztugo is not medically necessary for treatment of HIV-1. Use Yeztugo only for HIV-1 pre-exposure prophylaxis in eligible patients without HIV-1 infection.

    • Do not submit Yeztugo as treatment for established HIV-1 infection.
    For initial Cabenuva therapy, suppression must be maintained for at least 3 months before initiation.
    Multidrug-Resistant HIV-1
    DefinitionMultidrug-resistant HIV-1 is HIV-1 infection resistant to multiple antiretroviral drug classes.
    Treatment contextSunlenca is used for heavily treatment-experienced adults with multidrug-resistant HIV-1 infection.
    Regimen requirementSunlenca must be used with an optimized background antiretroviral regimen containing at least one agent with full viral sensitivity or susceptibility.