CurrentUnitedHealthcarePolicy IEXD0103.16

Long-Acting Injectable Antiretroviral Agents for HIV – Individual Exchange Medical Benefit Drug Policy

Defines medical-benefit coverage criteria, initial and continuation authorization requirements, exclusions, and applicable procedure/diagnosis codes for long-acting injectable antiretroviral products (Apretude, Cabenuva, Sunlenca injection, Yeztugo injection) for Individual Exchange plans (excludes MA, NV, NY).

Policy Summary

PayerUnitedHealthcare

PolicyLong-Acting Injectable Antiretroviral Agents for HIV – Individual Exchange Medical Benefit Drug Policy

Policy CodePolicy IEXD0103.16

Change TypeRevised/additions (added Yeztugoupdated coverage language)

Effective DateNov 1, 2025

Next Review Date

Key ActionRequest initial and continuation authorizations (limited to no more than 12 months) per plan processes and document required clinical criteria (e.g., negative HIV-1 test for PrEP agents; virologic suppression for Cabenuva; multidrug resistance and optimized background regimen for Sunlenca).

SourceLink

POLICY UPDATE CHANGES

Revised list of applicable long-acting injectable antiretroviral products; added Yeztugo (lenacapavir).

Added language that policy refers to Sunlenca injection and Yeztugo injection for administration by a healthcare professional; oral tablets obtained under the pharmacy benefit.

Added Yeztugo medical necessity criteria for initial and continuation therapy mirroring PrEP requirements and authorization limits.

Updated Background, Clinical Evidence, FDA, and References sections to reflect current information.

4Long-acting products referenced

12 monthsMax authorization duration

>=35 kg

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Minimum weight for PrEP agents

<50 copies/mLVirologic suppression threshold for Cabenuva

Coverage Summary

This policy defines medical‑benefit coverage criteria for specified long‑acting injectable antiretroviral products—Apretude (cabotegravir), Cabenuva (cabotegravir/rilpivirine), Sunlenca injection (lenacapavir), and Yeztugo injection (lenacapavir)—for UnitedHealthcare Individual Exchange plans (excludes MA, NV, NY). It distinguishes that intramuscular/injectable formulations are administered under the medical benefit (Sunlenca and Yeztugo injections specifically noted for administration by a healthcare professional) while oral formulations (Sunlenca and Yeztugo tablets) are obtained under the pharmacy benefit. The policy separates clinical roles: Apretude and Yeztugo injections are covered for PrEP (pre‑exposure prophylaxis) in eligible, HIV‑negative, at‑risk patients meeting criteria, Cabenuva is covered as a maintenance treatment option for patients who are virologically suppressed with required documentation, and Sunlenca injection is covered for treatment of multidrug‑resistant HIV‑1 when used with an optimized background regimen. Initial and continuation authorizations for covered medical‑benefit injections are limited to no more than 12 months per authorization and excluded uses (for example PrEP vs treatment mismatches or treatment in non‑suppressed patients) are specified.

Key thresholds & stats

Virologic suppressionHIV-1 RNA < 50 copies/mL

Weight for PrEP products>= 35 kg

Viral suppression prior to Cabenuva>= 3 months of HIV-1 RNA < 50 copies/mL

Authorization durationInitial and continuation authorizations limited to no more than 12 months

Long-acting products referencedApretude, Cabenuva, Sunlenca, Yeztugo

Max authorization (stats)12 months

Apretude (cabotegravir) — PrEP Criteria

Apretude (cabotegravir) - PrEP

Apretude is proven and medically necessary to reduce the risk of sexually acquired HIV-1 infection when criteria below are met.

ALL of the following

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

Yeztugo (lenacapavir) — PrEP Criteria

Yeztugo (lenacapavir) - PrEP

Yeztugo is proven and medically necessary to reduce the risk of sexually acquired HIV-1 infection in at-risk adults and adolescents (>=35 kg) when criteria below are met.

ALL of the following

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

Cabenuva (cabotegravir/rilpivirine) — Treatment Criteria

Cabenuva (cabotegravir/rilpivirine) - Treatment

Cabenuva is proven and medically necessary for treatment of HIV-1 in patients who are virologically suppressed (HIV-1 RNA < 50 copies/mL) when criteria below are met.

ALL of the following

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
- Treatment readiness (both required)

Sunlenca (lenacapavir) — Treatment for Multidrug-Resistant HIV-1

Sunlenca (lenacapavir) - Treatment for multidrug-resistant HIV-1

Sunlenca injection is proven and medically necessary for treatment of multi-drug resistant HIV-1 when all criteria below are met.

ALL of the following

Initial therapy
- Diagnostic requirement (both required)
  - Diagnosis of HIV-1 infection
  - Provider attestation that the patient has multi-drug 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/susceptibility

Unproven / Not Medically Necessary

Denial Risk

Not medically necessary exclusions

Claims outside the specified indications for long-acting injectable antiretrovirals may be denied. Examples include Cabenuva (J0741) for patients not virally suppressed, Sunlenca (J1961) for virologically suppressed or ARV‑naïve patients or for PrEP, and Apretude/Yeztugo (J0738, J0739) when used for HIV treatment rather than PrEP.

J0741: Cabenuva claims may be denied if patient not virally suppressed (HIV-1 RNA >= 50 copies/mL)
J1961: Sunlenca claims may be denied for virologically suppressed, ARV‑naïve, or PrEP use
J0738, J0739: Apretude/Yeztugo claims may be denied if used for HIV treatment rather than PrEP

Applicable Codes

Injection J-codes (long-acting antiretrovirals)HCPCS

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

Relevant diagnosis 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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Provider Actions & Documentation Requirements

Prior Authorization

Authorization required with 12-month limit

Initial and continuation authorizations for long-acting injectable antiretroviral products are limited to no more than 12 months. Affected procedure codes include J0738, J0739, J0741, and J1961. Providers must request authorization per the member's plan processes.

Authorization duration: no more than 12 months (initial and continuation)
Affected codes: J0738, J0739, J0741, J1961
Providers must request authorization per plan processes

Documentation Required

HIV testing documentation for PrEP products

For Apretude and Yeztugo (PrEP agents), providers must document a negative HIV-1 test prior to initiation and confirm testing with each subsequent injection. Both agents are indicated for patients weighing at least 35 kg. Applicable codes include J0738 and J0739.

Clinical Evidence Highlights

66-69%Apretude HPTN 083: 66–69% reduction in HIV-1 incidence vs Truvada

88-90%Apretude HPTN 084: 88–90% reduction in HIV-1 incidence vs Truvada

87.5%Sunlenca CAPELLA: 87.5% achieved ≥0.5 log10 HIV‑1 RNA decrease vs 16.7% placebo

100% / 89%Yeztugo PURPOSE trials: PURPOSE1 100% reduction; PURPOSE2 89% reduction vs Truvada

Clinical evidence shows long‑acting injectable cabotegravir demonstrated superiority to oral Truvada for PrEP in the HPTN 083 and HPTN 084 trials, long‑acting cabotegravir plus rilpivirine maintained virologic suppression in the FLAIR, ATLAS and ATLAS‑2M trials as a maintenance therapy, and lenacapavir (Sunlenca/Yeztugo) showed efficacy in heavily treatment‑experienced, multidrug‑resistant cohorts (CAPELLA) and Yeztugo demonstrated PrEP efficacy in the PURPOSE 1 and PURPOSE 2 trials.

Background

Cabotegravir (available as Apretude for PrEP and as part of Cabenuva for treatment) is an HIV‑1 integrase strand transfer inhibitor that blocks the strand transfer step of viral DNA integration; Apretude (injectable) is indicated for HIV‑1 PrEP in at‑risk individuals ≥ 35 kg with a documented negative HIV‑1 test, while Cabenuva (co‑packaged cabotegravir plus rilpivirine injectable) is a complete two‑drug regimen for treatment to replace a current antiretroviral regimen in adults who are virologically suppressed (HIV‑1 RNA less than 50 copies/mL) with no known or suspected resistance to cabotegravir or rilpivirine. Rilpivirine (the non‑nucleoside reverse transcriptase inhibitor component of Cabenuva) non‑competitively inhibits HIV‑1 reverse transcriptase. Lenacapavir (Sunlenca, Yeztugo) is a multistage selective inhibitor of HIV‑1 capsid function that interferes with multiple steps of the viral lifecycle; Sunlenca injection is indicated for treatment of heavily treatment‑experienced adults with multidrug‑resistant HIV‑1 (in combination with other antiretrovirals) and Yeztugo injection is indicated for PrEP in at‑risk adults and adolescents ≥ 35 kg. The policy notes the route distinction: injectable formulations intended for administration by a healthcare professional are under the medical benefit, whereas oral tablets are obtained under the pharmacy benefit. An Optimized background regimen (OBR) is defined as an antiretroviral regimen including at least one agent that demonstrates full viral sensitivity/susceptibility to be used in combination with Sunlenca for multidrug‑resistant HIV, and Virologic suppression is defined as HIV‑1 RNA less than 50 copies per mL.

Definitions

Optimized background regimen (OBR)An antiretroviral regimen including at least one agent that demonstrates full viral sensitivity/susceptibility, used in combination with Sunlenca for multidrug-resistant HIV

Virologic suppressionHIV-1 RNA less than 50 copies per mL

Revision History

11/01/2025revisedLatest

Revised list of applicable long-acting injectable antiretroviral products; added Yeztugo (lenacapavir). This policy now references Apretude, Cabenuva, Sunlenca, and Yeztugo as long-acting injectable antiretroviral products (policy IEXD0103.16).

11/01/2025addedLatest

Added language clarifying administration routes: the policy refers to Sunlenca injection and Yeztugo injection for administration by a healthcare professional; Sunlenca oral tablets and Yeztugo oral tablets are obtained under the pharmacy benefit.

Policy Summary

PayerUnitedHealthcare

PolicyLong-Acting Injectable Antiretroviral Agents for HIV – Individual Exchange Medical Benefit Drug Policy

Policy CodePolicy IEXD0103.16

Change TypeRevised/additions (added Yeztugoupdated coverage language)

Effective DateNov 1, 2025

Next Review Date

SourceLink

On This Page

Initial authorization is for no more than 12 months

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 the United States Food and Drug Administration approved labeling
Authorization is for no more than 12 months

Documentation Required

HIV testing documentation for PrEP products

Provider must document a negative HIV-1 test prior to initiating PrEP with Apretude or Yeztugo and must confirm testing with each subsequent injection. Applicable procedure codes: J0738 (lenacapavir injection) and J0739 (cabotegravir injection).

Document negative HIV-1 test prior to initiation
Confirm HIV-1 testing with each subsequent injection
Applicable codes: J0738, J0739

Prior Authorization

Authorization required with 12-month limit

Initial and continuation authorizations for Apretude and Yeztugo (and other long-acting injectable antiretrovirals) are limited to no more than 12 months. Providers must request authorization per the member's plan processes. Applicable J-codes include J0738 and J0739 (Apretude/Yeztugo PrEP injections) as relevant to these products.

Initial and continuation authorizations limited to no more than 12 months
Providers must request authorization per plan processes
Applicable codes for PrEP agents: J0738, J0739

Initial authorization is for no more than 12 months

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 the United States Food and Drug Administration approved labeling
Authorization is for no more than 12 months

Not covered: Yeztugo is unproven and not medically necessary for treatment of HIV-1

Prior Authorization

Authorization required with 12-month limit

Yeztugo (lenacapavir injection) requires documentation of PrEP-specific testing and has an authorization limit of no more than 12 months. Yeztugo is indicated for patients weighing at least 35 kg. Providers must document a negative HIV-1 test prior to initiation and confirm HIV testing with each subsequent injection; authorizations (initial and continuation) are limited to 12 months.

Indication: PrEP in patients >= 35 kg
Document negative HIV-1 test prior to initiation
Confirm HIV-1 testing with each subsequent injection
Initial and continuation authorizations limited to no more than 12 months

Patient understands the risks of missed doses of Cabenuva

Patient has the ability to adhere to the required monthly or every 2 months injection appointments

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 of Cabenuva

Dosing is in accordance with the United States Food and Drug Administration approved labeling

Initial authorization is for no more than 12 months

Continuation therapy

Patient has previously received treatment with Cabenuva
Provider confirms that 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 months

Documentation Required

Virologic suppression documentation for Cabenuva

Providers must attest that patients starting Cabenuva meet virologic suppression criteria and other readiness requirements: HIV-1 RNA less than 50 copies/mL for at least 3 months prior to initiation, no prior virologic failures or baseline resistance to cabotegravir or rilpivirine, and current viral suppression at initiation. Also note that initial and continuation authorizations are limited to no more than 12 months.

Attest HIV-1 RNA < 50 copies/mL for at least 3 months before initiation
Attest no prior virologic failures or baseline resistance to cabotegravir or rilpivirine
Attest patient is currently virologically suppressed at initiation
Initial and continuation authorizations limited to no more than 12 months

Denial Risk

Not medically necessary exclusions

Claims for Cabenuva (J0741) in patients who are not virologically suppressed (HIV-1 RNA greater than or equal to 50 copies/mL) are not medically necessary and may be denied.

Denial risk when HIV-1 RNA >= 50 copies/mL
Applicable code: J0741

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

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 the United States Food and Drug Administration approved labeling
Authorization is for no more than 12 months

Not covered: Sunlenca is unproven and not medically necessary for treatment of HIV-1 in patients who are virologically suppressed (HIV-1 RNA less than 50 copies per mL), for ARV-naïve patients, and for HIV-1 PrEP

Documentation Required

Multidrug resistance and optimized background regimen for Sunlenca

For Sunlenca (lenacapavir injection) initial therapy, providers must attest that the patient has multidrug-resistant HIV-1 and has been prescribed an optimized background antiretroviral regimen (OBR) that includes at least one fully active agent. For continuation, providers must document a clinically significant viral response to Sunlenca and ongoing use of an OBR. Initial and continuation authorizations are limited to no more than 12 months.

Attest multidrug-resistant HIV-1 infection
Confirm OBR with at least one fully active antiretroviral agent
For continuation: document clinically significant viral response and ongoing OBR
Initial and continuation authorizations limited to no more than 12 months

Denial Risk

Not medically necessary exclusions

Sunlenca (J1961) is not medically necessary and may be denied for patients who are virologically suppressed, for antiretroviral-naïve patients, or for use as PrEP.

Not medically necessary for virologically suppressed patients
Not medically necessary for ARV‑naïve patients
Not medically necessary for PrEP
Applicable code: J1961

Document negative HIV-1 test prior to initiation

Confirm HIV-1 testing with each subsequent injection

Minimum weight for PrEP agents: at least 35 kg

Applicable codes: J0738, J0739

Documentation Required

Virologic suppression documentation for Cabenuva

Cabenuva documentation requirements: provider must attest the patient has HIV-1 RNA less than 50 copies/mL for at least 3 months prior to initiation, has no prior virologic failures or baseline resistance to cabotegravir or rilpivirine, and the patient is ready and able to adhere to the injection schedule (understands risks of missed doses and can attend monthly or every‑2‑month appointments).

Attest HIV-1 RNA < 50 copies/mL for ≥ 3 months prior to initiation
Attest no prior virologic failures or baseline resistance to cabotegravir or rilpivirine
Attest patient readiness and ability to adhere to injection schedule

Documentation Required

Multidrug resistance and optimized background regimen for Sunlenca

Sunlenca documentation requirements: provider must attest the patient has multidrug‑resistant HIV-1 and has been prescribed an optimized background regimen with at least one fully active agent. For continuation, document a clinically significant viral response to Sunlenca and ongoing use of the optimized background regimen.

Attest multidrug-resistant HIV-1 infection
Confirm OBR contains at least one fully active agent
For continuation: document clinically significant viral response and ongoing OBR

Denial Risk

Not medically necessary exclusions

Summary of denial-risk scenarios across products: Cabenuva claims may be denied when the patient is not virally suppressed (HIV-1 RNA ≥ 50 copies/mL; J0741). Sunlenca (J1961) is not medically necessary for virologically suppressed patients, ARV‑naïve patients, or for PrEP. Apretude/Yeztugo (J0738, J0739) are PrEP agents and are not indicated for HIV treatment; claims for treatment use may be denied.

Cabenuva (J0741): denial risk if HIV-1 RNA ≥ 50 copies/mL
Sunlenca (J1961): denial risk for virologically suppressed, ARV‑naïve, or PrEP use
Apretude/Yeztugo (J0738, J0739): denial risk if used for HIV treatment rather than PrEP

11/01/2025addedLatest

Added Yeztugo (lenacapavir) medical necessity criteria for initial and continuation therapy mirroring PrEP requirements: use for HIV-1 PrEP, negative HIV-1 test prior to initiation, documentation of testing with each subsequent injection, dosing per FDA labeling, and authorization limits (initial and continuation authorizations limited to no more than 12 months).

11/01/2025revisedLatest

Updated Background, Clinical Evidence, FDA, and References sections to reflect current information (non-material background/evidence updates).