CurrentUnitedHealthcarePolicy CS2025D0063P

Trogarzo (ibalizumab-uiyk) medical benefit drug coverage

Defines UnitedHealthcare's medical necessity criteria, coding, and authorization expectations for Trogarzo (ibalizumab-uiyk) for treatment of multi-drug-resistant HIV-1 in affected members; applies to UnitedHealthcare plans except where state-specific guidance is noted.

Policy Summary

PayerUnitedHealthcare

PolicyTrogarzo (ibalizumab-uiyk) medical benefit drug coverage

Policy CodePolicy CS2025D0063P

Change TypeNo material change

Effective DateJun 1, 2025

Next Review Date

Key ActionObtain prior authorization documenting HIV-1 diagnosis, provider attestation of multi-drug-resistant HIV-1, and use with an optimized background antiretroviral regimen including at least one fully susceptible agent.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsmaximum initial authorization duration

J1746HCPCS code listed

MDR HIV-1covered indication

43%viral load response at 24 wks

2019DHHS guidance year

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Coverage Criteria for Trogarzo (ibalizumab-uiyk)

Initial Therapy — Covered when ALL of the following are met for initial therapy

Covered when ALL of the following are met for initial therapy:

Initial therapy - all conditions: 1) Diagnosis of HIV-1 infection; 2) Provider attestation that the patient has multi-drug-resistant HIV-1 infection; 3) Patient has been prescribed an optimized background antiretroviral regimen containing at least one antiretroviral agent that demonstrates full viral sensitivity/susceptibility; 4) Trogarzo (ibalizumab-uiyk) initial and maintenance dosing is in accordance with the U.S. Food and Drug Administration prescribing information; 5) Initial authorization is for no more than 12 months.

Continuation Therapy — Covered when ALL of the following are met for continuation of therapy

Covered when ALL of the following are met for continuation of therapy:

Continuation therapy - all conditions: 1) Patient has previously received treatment with Trogarzo (ibalizumab-uiyk); 2) Provider confirms the patient has achieved a clinically significant viral response to Trogarzo therapy; 3) Patient will continue an optimized background antiretroviral regimen in combination with Trogarzo; 4) Trogarzo (ibalizumab-uiyk) maintenance dosing is in accordance with the U.S. Food and Drug Administration prescribing information; 5) Authorization is for no more than 12 months.

This policy does not apply in the states listed below; refer to the state-specific policy or guideline identified for each jurisdiction: Indiana (see Trogarzo® [Ibalizumab-uiyk] policy for Indiana), Kansas (refer to the state's Medicaid clinical policy), Louisiana (refer to state resources), New Jersey, North Carolina, Ohio, Pennsylvania (refer to the state's Medicaid clinical policy), and Texas (refer to drug-specific criteria in the Texas Medicaid Provider Procedures Manual).

The U.S. Department of Health and Human Services antiretroviral guidelines (since 2019) list ibalizumab as an antiretroviral component not recommended as initial therapy. The guidance cites limited evidence from a small number of patients with virologic failure, the requirement for intravenous administration, and the drug's high cost; it notes ibalizumab may be considered only for patients with ongoing detectable viremia who lack sufficient treatment options for a fully suppressive regimen.

Coding and Billing

HCPCS CodesHCPCSCovered

J1746

Injection, ibalizumab-uiyk, 10 mg

Relevant Diagnosis CodesICD-10

B20	Human immunodeficiency virus [HIV] disease
Z16.33	Resistance to antiviral drug(s)
Z21	Asymptomatic human immunodeficiency virus [HIV] infection status

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Providers must document clinical criteria supporting use of Trogarzo (ibalizumab-uiyk) for multi-drug-resistant HIV-1, including diagnosis, attestation of multi-drug-resistant HIV-1, and treatment context consistent with coverage criteria.

Affected code: HCPCS J1746 (Injection, ibalizumab-uiyk, 10 mg)
Required: provider attestation of multi-drug-resistant HIV-1
Required: documentation of optimized background antiretroviral regimen with at least one agent demonstrating full viral sensitivity/susceptibility
Initial and maintenance dosing must follow FDA prescribing information
Initial and continuation authorizations are for no more than 12 months

Note

Guidance on Sequencing

Ibalizumab is not recommended as initial therapy per DHHS guidance; it is intended for patients with limited treatment options and ongoing detectable viremia who do not have sufficient options for a fully suppressive regimen. Providers should sequence therapies accordingly and confirm that ibalizumab is being used after consideration of standard antiretroviral regimens.

Background

Ibalizumab (Trogarzo) is a humanized monoclonal antibody that functions as a CD4-directed post-attachment HIV-1 inhibitor. It binds the second extracellular domain of the CD4 receptor and blocks HIV-1 from entering CD4+ T cells while preserving immune function. Trogarzo is active against HIV-1 strains resistant to other antiretroviral agents and is used in heavily treatment-experienced patients with multi-drug–resistant HIV-1, administered in combination with an optimized background antiretroviral regimen.

Definitions and Key Terms

Optimized background antiretroviral regimen (OBR)

DefinitionOptimized background antiretroviral regimen (OBR): a companion antiretroviral regimen used with Trogarzo composed of agents selected based on resistance testing with at least one agent demonstrating full viral susceptibility.

PurposeProvides accompanying active agents to which the patient’s virus remains susceptible to maximize chance of virologic response when adding ibalizumab.

Use settingRequired for both initial and continuation Trogarzo therapy per coverage criteria — patient must continue an OBR in combination with Trogarzo.

Documentation requiredProvider must document the OBR and at least one antiretroviral with documented full viral sensitivity as part of prior authorization and continuation requests.

Clinical rationaleIbalizumab is active against HIV-1 strains resistant to approved antiretrovirals but is intended to be used with an optimized background regimen to achieve and maintain viral suppression.

Policy Summary

PayerUnitedHealthcare

PolicyTrogarzo (ibalizumab-uiyk) medical benefit drug coverage

Policy CodePolicy CS2025D0063P

Change TypeNo material change

Effective DateJun 1, 2025

Next Review Date

SourceLink

On This Page

Use after assessment of standard antiretroviral options and when an optimized background regimen cannot achieve full viral suppression
Ensure intent is not to initiate ibalizumab as first-line antiretroviral therapy

Documentation Required

Required Documentation

Providers must document the diagnosis of HIV-1, a provider attestation that the patient has multi-drug-resistant HIV-1, and evidence that the patient has been prescribed and will continue an optimized background antiretroviral regimen (with at least one agent demonstrating full viral sensitivity). Initial and continuation dosing must follow FDA labeling and authorization is limited to periods of up to 12 months.

Documented diagnosis: B20 (HIV disease) or appropriate ICD-10 code
Attestation: provider statement that HIV-1 is multi-drug-resistant
Optimized background regimen: list of agents and evidence of full viral sensitivity for at least one agent
Evidence of prior Trogarzo therapy and clinically significant viral response required for continuation requests
Dosing per FDA prescribing information; authorizations limited to ≤12 months

Denial Risk

Denial Triggers

Failure to provide required documentation or clinical justification may result in denial. Common denial triggers include missing diagnosis/attestation, lack of an optimized background regimen, use as initial therapy without justification, or dosing inconsistent with FDA labeling.

No provider attestation of multi-drug-resistant HIV-1
No documentation of an optimized background antiretroviral regimen with at least one fully sensitive agent
Request indicates ibalizumab as initial therapy without documented clinical rationale
Dosing or duration requests inconsistent with FDA prescribing information or exceeding 12 months without justification

Ibalizumab (Trogarzo) mechanism

Mechanism summaryCD4-directed post-attachment HIV-1 inhibitor: a humanized monoclonal antibody that binds primarily to the second extracellular domain of CD4, preventing HIV entry into CD4+ T cells.

ActivityPreserves normal immunological function while blocking viral entry and is active against HIV-1 strains resistant to approved antiretroviral agents.

Indication contextUsed in combination with other antiretroviral(s) for heavily treatment-experienced adults with multi-drug-resistant HIV-1 failing current regimens (per FDA labeling).

Route/administration noteAdministered intravenously (IV) per product labeling as part of a regimen including an optimized background antiretroviral regimen.