UnitedHealthcare long-acting injectable ARVs Coverage Update

Coverage Criteria for Long-Acting Injectable Antiretrovirals

Apretude (cabotegravir) - PrEP

Apretude is medically necessary when ALL of the following are met:

Apretude initial therapy: Used for HIV-1 pre-exposure prophylaxis (PrEP); and Patient has a negative HIV-1 test; and Provider confirms that the patient will be tested for HIV-1 infection with each subsequent injection; and Dosing is in accordance with the United States Food and Drug Administration approved labeling; and Initial authorization is for no more than 12 months

Apretude continuation therapy: Patient has previously received treatment with Apretude; and Patient has a negative HIV-1 test; and Provider confirms that the patient will be tested for HIV-1 infection with each subsequent injection; and Dosing is in accordance with the United States Food and Drug Administration approved labeling; and Authorization is for no more than 12 months

Cabenuva (cabotegravir/rilpivirine) - Treatment in virologically suppressed patients

Cabenuva is medically necessary when ALL of the following are met for initial therapy:

Cabenuva initial therapy clinical requirements: Diagnosis of HIV-1 infection; and Patient has no prior virologic failures or baseline resistance to either cabotegravir or rilpivirine; and Patient is currently on a stable antiretroviral regimen; and Provider attests that patient has achieved viral suppression (HIV-1 RNA less than 50 copies per mL) for at least 3 months prior to initiation; and Provider attests that patient demonstrates treatment readiness (understands risks of missed doses and can adhere to required injection appointments); and Dosing is in accordance with the United States Food and Drug Administration approved labeling; and Initial authorization is for no more than 12 monthsHIV-1 RNA < 50 copies/mL for ≥3 months

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

Sunlenca (lenacapavir) - Multi-drug resistant HIV

Sunlenca is proven and medically necessary for treatment when ALL of the following are met for initial therapy:

Sunlenca initial therapy clinical requirements: Diagnosis of HIV-1 infection; and Provider attestation that the patient has multi-drug resistant HIV-1 infection; and Provider confirms that the patient has been prescribed an optimized background antiretroviral regimen, containing at least one antiretroviral agent that demonstrates full viral sensitivity/susceptibility; and Sunlenca initial and maintenance dosing is in accordance with the US Food and Drug Administration prescribing information; and Initial authorization is for no more than 12 months

Sunlenca continuation therapy: Patient has previously received treatment with Sunlenca; and Provider confirms that the patient has achieved a clinically significant viral response to Sunlenca therapy; and Provider confirms continuation of an optimized background antiretroviral regimen in combination with Sunlenca; and Sunlenca maintenance dosing is in accordance with US Food and Drug Administration prescribing information; and Authorization is for no more than 12 months

Sunlenca clinical evidence (informational)

Evidence and pivotal study attributes for Sunlenca (CAPELLA):

CAPELLA entry requirements: Subjects required viral load >= 400 copies/mL; documented resistance to at least two antiretroviral medications from each of at least 3 of the 4 classes (NRTI, NNRTI, PI, INSTI); and ≤ 2 fully active antiretroviral medications remaining at baselineas stated

supports definition of heavily treatment-experienced

Primary efficacy endpoint: Proportion achieving ≥ 0.5 log10 reduction in HIV-1 RNA at end of functional monotherapy period>=0.5 log10

Sunlenca 87.5% vs placebo 16.7% in cohort 1

Longer-term virologic outcomes: In cohort 2, proportion achieving HIV-1 RNA <50 copies/mL at Weeks 26 and 52 were 81% and 72%, respectively; CD4 count increases reported

Apretude, Cabenuva, and Sunlenca have distinct, product-specific coverage positions in this policy. Apretude (cabotegravir) is considered proven and medically necessary only for HIV-1 pre-exposure prophylaxis (PrEP) when the specific PrEP criteria are met; it is not medically necessary for the treatment of HIV-1. Cabenuva (cabotegravir/rilpivirine) is covered as a complete regimen only for patients who meet the treatment criteria, including documentation of viral suppression; it is not medically necessary for patients who are not currently virally suppressed. Sunlenca (lenacapavir) is covered for its approved indication in heavily treatment-experienced, multi-drug resistant HIV-1 when the stated criteria are met; it is not medically necessary for virologically suppressed patients, for ARV‑naïve patients, or for PrEP.

Apretude is indicated by the FDA for HIV-1 PrEP in at-risk adults and adolescents weighing at least 35 kg, and individuals must have a negative HIV-1 test prior to initiating therapy. This FDA approval is provided here for informational context only; FDA approval alone is not the sole basis for coverage — members must meet the specific medical necessity criteria described in this policy for prior authorization and coverage.

Consistent with the coverage criteria, Apretude (cabotegravir) is unproven and not medically necessary for the treatment of HIV-1. Coverage for Apretude is limited to PrEP when all PrEP-specific requirements (including a documented negative HIV-1 test and FDA‑label dosing) are met.

Cabenuva is only medically necessary when the patient meets the treatment criteria for switching to the co‑packaged regimen, including documentation of current viral suppression. Cabenuva is not medically necessary for patients who are not currently virally suppressed (HIV-1 RNA ≥ 50 copies/mL).

Sunlenca (lenacapavir) is indicated and covered for heavily treatment‑experienced adults with multidrug‑resistant HIV-1 when used in combination with an optimized background regimen per the policy criteria. Sunlenca is not medically necessary for patients who are virologically suppressed (HIV-1 RNA < 50 copies/mL), for antiretroviral‑naïve patients, or for HIV‑1 pre‑exposure prophylaxis (PrEP).

Billing and Diagnosis Codes

HCPCS codesHCPCS

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, 2 mg/3 mg
J1961	Injection, lenacapavir, 1 mg.

ICD-10 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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inv-12: Viral suppression threshold required for Cabenuva (HIV-1 RNA < 50 copies/mL)

Viral suppression thresholdHIV-1 RNA < 50 copies/mL (required; provider must attest viral suppression for at least 3 months prior to Cabenuva initiation)

Duration of documented suppressionAt least 3 months prior to initiation for initial Cabenuva therapy

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

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required — documentation & codes

Prior authorization is required. Provider must submit documentation supporting the clinical criteria and applicable HCPCS/NDC/ICD-10 codes at time of request. Initial and continuation authorizations are generally limited to no more than 12 months.

Prior authorization required for Apretude, Cabenuva, Sunlenca and other long-acting injectable antiretrovirals
Include applicable procedure (HCPCS) and diagnosis (ICD-10) codes with request

Documentation Required

Supporting clinical documentation

Providers must supply supporting clinical documentation to demonstrate that the patient meets the drug‑specific medical necessity criteria. Documentation should clearly show diagnosis, baseline and/or recent viral load(s), HIV‑1 resistance testing when applicable, prior antiretroviral therapy history, and treatment response to support initiation or continuation.

For Apretude (PrEP): negative HIV‑1 test prior to each injection and documentation of dosing per FDA labeling

Background and Mechanism of Action

Background: Apretude (cabotegravir) is a long‑acting injectable integrase strand transfer inhibitor formulated for HIV‑1 pre‑exposure prophylaxis; it reduces the risk of sexually acquired HIV‑1 infection when used per labeling. Cabenuva is a co‑packaged, extended‑release injectable regimen combining cabotegravir (an INSTI) and rilpivirine (an NNRTI) intended as a complete regimen for virologically suppressed patients. Sunlenca (lenacapavir) is a long‑acting capsid inhibitor with activity against multi‑drug resistant HIV‑1 that interferes with multiple stages of the viral lifecycle and is indicated, in combination with other antiretrovirals, for heavily treatment‑experienced adults with multidrug‑resistant HIV‑1 failing their current regimen.

Product Definitions and Indications

inv-23: Apretude (cabotegravir) — definition and indication for PrEP

AgentApretude (cabotegravir)

MechanismIntegrase strand transfer inhibitor — binds integrase active site and blocks strand transfer step of retroviral DNA integration

Indication (PrEP)Indicated for HIV-1 pre-exposure prophylaxis (PrEP) in at-risk adults and adolescents ≥35 kg with a negative HIV-1 test prior to initiation

inv-24: Cabenuva (cabotegravir/rilpivirine) — definition and indication for treatment of virologically suppressed adults

AgentCabenuva (cabotegravir/rilpivirine)

CompositionCo-packaged long-acting injectable cabotegravir (INSTI) and rilpivirine (NNRTI)

Policy Revisions and Effective Dates

2025-01-01material_revision

Revised coverage criteria for Apretude initial therapy to remove the requirement that the provider determine Apretude is preferred over lower-cost alternatives and to remove the provider attestation of patient treatment readiness.

2025-07-01template_updateLatest

Template update to the policy that updated the Benefit Considerations section.

OpenPayer

Long-Acting Injectable Antiretroviral Agents for HIV