Colorado Rocky Mountain Health Plans long-acting ARV Coverage

Coverage Criteria for Long-Acting Injectable Antiretrovirals

Apretude (cabotegravir) — PrEP

Proven and medically necessary to reduce the risk of sexually acquired HIV-1 infection when ALL criteria are met

Apretude 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 the United States Food and Drug Administration approved labeling; initial authorization is for no more than 12 monthsweight >= 35 kg

Apretude — Continuation

Covered when ALL criteria are met for continuation

Apretude continuation: 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 the United States Food and Drug Administration approved labeling; authorization is for no more than 12 monthsweight >= 35 kg

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

Cabenuva (cabotegravir/rilpivirine) — Treatment

Proven and medically necessary for treatment of HIV-1 when ALL criteria are met

Cabenuva initial therapy: 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 patient has achieved viral suppression (HIV-1 RNA less than 50 copies per mL) for at least 3 months prior to initiation; provider attests the patient demonstrates treatment readiness (understands the risks of missed doses and has ability to adhere to required monthly or every-2-month injection appointments); dosing is in accordance with the United States Food and Drug Administration approved labeling; initial authorization is for no more than 12 monthsHIV-1 RNA < 50 copies/mL for >=3 months

Oral lead-in is optional per labeling; document prior suppression and absence of resistance.

Cabenuva — Continuation

Covered when ALL continuation criteria are met

Cabenuva continuation: Patient has previously received treatment with Cabenuva; provider confirms the patient has achieved and maintained viral suppression (HIV-1 RNA less than 50 copies per mL) while on Cabenuva therapy; dosing is in accordance with the United States Food and Drug Administration approved labeling; authorization is for no more than 12 monthsHIV-1 RNA < 50 copies/mL

Cabenuva is not medically necessary for patients who are not currently virally suppressed.

Sunlenca (lenacapavir) — Treatment for multi-drug resistant HIV

Proven and medically necessary when ALL criteria are met

Sunlenca initial therapy: Diagnosis of HIV-1 infection; provider attests that the patient has multi-drug resistant HIV-1 infection; provider confirms the patient has been prescribed an optimized background antiretroviral regimen containing at least one agent with full viral susceptibility; Sunlenca initial and maintenance dosing is in accordance with the United States Food and Drug Administration approved labeling; initial authorization is for no more than 12 months

Use limited to heavily treatment-experienced patients with documented multiclass resistance.

Sunlenca — Continuation

Covered when ALL continuation criteria are met

Sunlenca continuation: Patient has previously received treatment with Sunlenca; provider confirms that the patient has achieved a clinically significant viral response to Sunlenca therapy; provider confirms continued use of an optimized background antiretroviral regimen in combination with Sunlenca; Sunlenca maintenance dosing is in accordance with the United States Food and Drug Administration approved labeling; authorization is for no more than 12 months

Sunlenca is not medically necessary for virologically suppressed patients, ARV-naïve patients, or for PrEP.

Yeztugo (lenacapavir) — PrEP

Proven and medically necessary to reduce the risk of sexually acquired HIV-1 infection when ALL criteria are met

Yeztugo 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 the United States Food and Drug Administration approved labeling; initial authorization is for no more than 12 monthsweight >= 35 kg

Yeztugo is contraindicated in unknown or positive HIV-1 status and carries boxed warning for resistance risk if used in undiagnosed infection.

Yeztugo — Continuation

Covered when ALL continuation criteria are met

Yeztugo continuation: Patient has previously received 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 the United States Food and Drug Administration approved labeling; authorization is for no more than 12 monthsweight >= 35 kg

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

Yeztugo (lenacapavir) — Initial and Continuation Therapy (PrEP) combined

Yeztugo (lenacapavir) for HIV-1 pre-exposure prophylaxis is medically necessary when the following criteria are met.

Initial Therapy: Used for HIV-1 pre-exposure prophylaxis (PrEP); patient has a negative HIV-1 test prior to initiation; provider confirms the patient will be tested for HIV-1 infection with each subsequent injection; dosing is in accordance with the U.S. FDA approved labeling; initial authorization is for no more than 12 months.weight >= 35 kg

Documentation must confirm negative HIV-1 test prior to initiation and planned HIV testing at each subsequent injection.

Continuation of Therapy: Patient has previously received treatment with Yeztugo; patient has a negative HIV-1 test; provider confirms patient will be tested for HIV-1 infection with each subsequent injection; dosing is in accordance with the U.S. FDA approved labeling; authorization is for no more than 12 months.weight >= 35 kg

Authorizations for Yeztugo (PrEP) are limited to no more than 12 months.

FDA-indicated uses for referenced long-acting injectables (grouped)

Long-acting injectables for HIV-1 treatment are referenced with their FDA indications.

Sunlenca indication: Sunlenca (capsid inhibitor), in combination with other antiretroviral(s), is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.

Clinical trial evidence: proportion achieving >=0.5 log10 decrease in viral load reported.

Cabenuva indication: Cabenuva (cabotegravir + rilpivirine) is indicated as a complete regimen for treatment of HIV-1 in adults to replace a current antiretroviral regimen in those virologically suppressed (HIV-1 RNA less than 50 copies per mL) with no history of treatment failure and no known or suspected resistance to cabotegravir or rilpivirine.HIV-1 RNA <50 copies/mL

Apretude indication: Apretude (cabotegravir) is indicated for HIV-1 PrEP in at-risk adults and adolescents weighing at least 35 kg; individuals must have a negative HIV-1 test prior to initiating Apretude.

Apretude, Sunlenca, and Yeztugo are each addressed with specific, limited indications in this policy. Apretude and Yeztugo are authorized only for HIV-1 pre-exposure prophylaxis (PrEP) in qualifying at-risk, HIV‑negative individuals (weight threshold applies) when all product-specific criteria are met, including a documented negative HIV-1 test prior to initiation and planned HIV-1 testing with each subsequent injection. Sunlenca is limited to treatment of multi-drug resistant HIV-1 in heavily treatment-experienced patients who meet the policy’s documented resistance and optimized-background-regimen requirements. These agents are not covered for general treatment of HIV-1 outside their explicit policy indications.

Cabenuva (cabotegravir/rilpivirine) is only covered for use as a replacement maintenance regimen in patients who are virologically suppressed. The policy requires documentation that the member has had HIV-1 RNA < 50 copies/mL for at least three months prior to initiation and that there is no history of virologic failure or known/suspected resistance to cabotegravir or rilpivirine. Use of Cabenuva in patients who are not currently virally suppressed is not medically necessary and will be denied.

Yeztugo (lenacapavir) is covered under this policy only for HIV-1 pre-exposure prophylaxis (PrEP) when all PrEP-specific criteria are met. The policy explicitly states that Yeztugo is not medically necessary for the treatment of HIV-1 infection (treatment indication), and therefore use of Yeztugo to treat established HIV-1 infection is considered unproven and excluded.

Apretude (cabotegravir) is approved and covered only for PrEP in eligible at-risk adults and adolescents; the policy designates Apretude as unproven and not medically necessary for treatment of established HIV-1 infection and therefore excludes its use for treatment indications.

Sunlenca (lenacapavir) is limited to use in heavily treatment-experienced patients with documented multi-drug resistant HIV-1 and only when an optimized background antiretroviral regimen with at least one fully susceptible agent is in place. The policy specifies that Sunlenca is not medically necessary for patients who are virologically suppressed, for antiretroviral‑naïve patients, and for PrEP.

Yeztugo carries a boxed warning concerning the risk of drug resistance if used in undiagnosed HIV‑1 infection and is contraindicated in individuals with unknown or positive HIV‑1 status. Consistent with this safety profile and the policy update, Yeztugo is considered not medically necessary for treatment of established HIV‑1 infection and is authorized only for PrEP when the required testing and monitoring conditions are met.

In summary, the policy considers the use of Yeztugo for HIV‑1 treatment to be unproven and not medically necessary. Yeztugo coverage is restricted to its FDA‑approved role in PrEP, with mandatory documentation of a negative HIV‑1 test prior to initiation, confirmation that HIV‑1 testing will occur with each subsequent injection, dosing per FDA labeling, and authorization periods limited to no more than 12 months.

Billing and Diagnosis Codes

Procedure/HCPCS CodesHCPCS

J0738	Injection, lenacapavir, 1 mg, FDA approved prescription, only for use as HIV pre-exposure prophylaxis (not for use as treatment for HIV).
J0739	Injection, cabotegravir, 1 mg, FDA-approved prescription, only for use as HIV pre-exposure prophylaxis (not for use as treatment for HIV).
J0741	Injection, cabotegravir and rilpivirine, 2mg/3mg.
J1961	Injection, lenacapavir (only for use as HIV treatment), 1 mg.

Diagnosis/Encounter CodesICD-10

B20	Human immunodeficiency virus (HIV) disease.
Z11.3	Encounter for screening for infections with a predominantly sexual mode of transmission.
Z11.4	Encounter for screening for human immunodeficiency virus (HIV).
Z16.33	Resistance to antiviral drug(s).
Z20.2	Contact with and (suspected) exposure to infections with a predominantly sexual mode of transmission.
Z20.6	Contact with and (suspected) exposure to human immunodeficiency virus (HIV).
Z21	Asymptomatic human immunodeficiency virus (HIV) infection status.
Z29.81	Encounter for HIV pre-exposure prophylaxis.
Z72.51	High risk heterosexual behavior.
Z72.52	High risk homosexual behavior.

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Covered/Referenced products (medical benefit injections)mixed

No codes listed

inv-21: Virologic suppression — HIV-1 RNA < 50 copies/mL

CriterionVirologic suppression defined as HIV-1 RNA less than 50 copies per mL

Required duration for initiation of CabenuvaProvider must attest patient has achieved viral suppression (HIV-1 RNA <50 copies/mL) for at least 3 months prior to initiation

Continuation requirementProvider must confirm patient has achieved and maintained viral suppression (HIV-1 RNA <50 copies/mL) while on Cabenuva for continuation authorization

inv-22: Minimum weight for PrEP injectables — at-risk adults/adolescents >= 35 kg

Minimum weightAt-risk adults and adolescents weighing at least 35 kg

Use case

Prior Authorization, Documentation, and Operational Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required. Long-acting injectable antiretroviral products (including Apretude, Cabenuva, Sunlenca, and Yeztugo) require prior authorization. Initial and continuation authorizations are limited to no more than 12 months for injectable PrEP agents (Apretude, Yeztugo) and treatment agents per policy labeling.

Applies to Sunlenca injection and Yeztugo injection when administered by a healthcare professional; oral formulations are covered under the pharmacy benefit.
Initial and continuation authorizations generally limited to <= 12 months.

Documentation Required

Required Documentation

Providers must document the diagnosis, relevant baseline HIV-1 test results, viral load status, prior treatment history, and adherence/monitoring plans when requesting authorization.

Include documentation of diagnosis of HIV-1 when applicable and evidence of prior virologic suppression (e.g., HIV-1 RNA <50 copies/mL) when required (Cabenuva).

Background and Context

This policy addresses long‑acting injectable antiretrovirals used either for HIV‑1 pre‑exposure prophylaxis (PrEP) or for treatment in narrowly defined populations. The products covered include: Apretude (cabotegravir) and Yeztugo (lenacapavir) for PrEP in at‑risk, HIV‑negative adults and adolescents meeting weight and testing requirements; Cabenuva (cabotegravir + rilpivirine) as a complete maintenance regimen replacement only for patients who are virologically suppressed (HIV‑1 RNA < 50 copies/mL) with no prior treatment failure or resistance; and Sunlenca (lenacapavir) for treatment of multi‑drug resistant HIV‑1 in heavily treatment‑experienced patients with an optimized background regimen. The policy emphasizes product‑specific prerequisites (negative baseline HIV‑1 test for PrEP agents; documented viral suppression and absence of resistance for Cabenuva; documented multiclass resistance and optimized background therapy for Sunlenca), dosing per FDA labeling, and prior authorization with documentation and limited authorization durations (generally ≤ 12 months for initial and continuation approvals).

Definitions and Key Terms

inv-35: Lenacapavir — mechanism summary

Mechanism classMultistage selective inhibitor of HIV-1 capsid function

Binding targetBinds interface between capsid protein (p24) subunits in hexamers

Functional effectsInterferes with capsid-mediated nuclear import, virus assembly/release, and capsid core formation

inv-36: Cabotegravir — mechanism summary

Mechanism classIntegrase strand transfer inhibitor (INSTI)

ActionBinds the integrase active site and blocks the strand transfer step of retroviral DNA integration

Clinical role

Policy Revision History

2025-11-01policy_updateLatest

Revised list of applicable long-acting injectable antiretroviral products and added Yeztugo (lenacapavir); specified that Sunlenca and Yeztugo injections are medical-benefit administration and oral formulations are pharmacy benefit; added detailed initial and continuation PrEP criteria for Yeztugo including negative HIV-1 test prior to initiation, required HIV-1 testing at each subsequent injection, dosing per FDA labeling, and authorization limits of no more than 12 months; stated Yeztugo is not medically necessary for treatment of HIV-1.

OpenPayer

Long-Acting Injectable Antiretroviral Agents for HIV

Coverage Criteria for Long-Acting Injectable Antiretrovirals

Billing and Diagnosis Codes

Prior Authorization, Documentation, and Operational Requirements

Background and Context

Definitions and Key Terms

Policy Revision History