CurrentUnitedHealthcarePolicy IEXD0063.08

Trogarzo (ibalizumab-uiyk) medical benefit drug policy

Defines UnitedHealthcare medical-benefit coverage criteria for Trogarzo (ibalizumab-uiyk) for treatment of multi-drug resistant HIV-1, including initial and continuation therapy criteria, applicable codes, dosing must follow FDA prescribing information, and authorization duration limits.

Policy Summary

PayerUnitedHealthcare

PolicyTrogarzo (ibalizumab-uiyk) medical benefit drug policy

Policy CodePolicy IEXD0063.08

Change TypeUpdated references / supporting information

Effective DateJun 1, 2025

Next Review Date

Key ActionProvider must attest that the patient has multi-drug resistant HIV-1 infection and confirm an optimized background antiretroviral regimen per the policy when requesting authorization.

SourceLink

POLICY UPDATE CHANGES

Updated References section to reflect the most current information and archived previous policy version IEXD0063.07.

1HCPCS drug code listed

3ICD-10 diagnosis codes referenced

12 monthsMaximum authorization duration

Coverage Summary

Coverage stance: Covered with criteria. Scope: Defines UnitedHealthcare medical-benefit coverage criteria for Trogarzo (ibalizumab-uiyk) for treatment of multi-drug resistant HIV-1, including initial and continuation therapy criteria, applicable codes, dosing per FDA prescribing information, and authorization duration limits. Trogarzo is a CD4-directed post-attachment HIV-1 inhibitor indicated, in combination with other antiretrovirals, for the treatment of HIV-1 infection in heavily treatment-experienced adults with multi-drug resistant HIV-1. Effective date: 2025-06-01. Policy number: IEXD0063.08.

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Initial Therapy (Medically Necessary)

Covered when ALL of the following are met:

ALL of the following

Both of the following
- 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
Trogarzo (ibalizumab-uiyk) initial and maintenance dosing is in accordance with the U.S. Food and Drug Administration prescribing information
Initial authorization is for no more than 12 months
Authorization duration limit

Documentation Required

Initial therapy — provider actions

Documentation: Provider must attest that the patient has multi-drug resistant HIV-1 and must confirm that the patient has been prescribed an optimized background antiretroviral regimen containing at least one agent with full viral sensitivity/susceptibility. Prior_auth: Initial authorization is limited to no more than 12 months. Billing_rule: Initial and maintenance dosing must follow the U.S. FDA prescribing information.

J1746
Authorization duration: 12 months

Continuation Therapy (Medically Necessary)

Covered when ALL of the following are met:

ALL of the following

Patient has previously received treatment with Trogarzo (ibalizumab-uiyk)
Provider confirms that the patient has achieved a clinically significant viral response to Trogarzo (ibalizumab-uiyk) therapy
Provider confirms that the patient will continue to take an optimized background antiretroviral regimen, in combination with Trogarzo (ibalizumab-uiyk)
Trogarzo (ibalizumab-uiyk) maintenance dosing is in accordance with the U.S. Food and Drug Administration prescribing information
Maintenance dosing requirement
Authorization is for no more than 12 months
Authorization duration limit

Documentation Required

Continuation therapy — provider actions

Documentation: Provider must confirm the patient has achieved a clinically significant viral response to Trogarzo and must confirm the patient will continue an optimized background antiretroviral regimen containing at least one agent with full viral sensitivity/susceptibility. Prior_auth: Continuation authorization is limited to no more than 12 months. Billing_rule: Maintenance dosing must follow the U.S. FDA prescribing information.

J1746
Authorization duration: 12 months

Provider Actions & Documentation Requirements

Note

Other provider actions (documentation, prior authorization, billing)

Documentation callouts: Provider attestation of multi-drug resistant HIV-1; Optimized background regimen confirmation (initial and continuation); Clinically significant viral response confirmation for continuation. Prior_auth callout: Authorization duration limit — initial and continuation authorizations are for no more than 12 months. Billing_rule callout: Dosing must be in accordance with the U.S. Food and Drug Administration prescribing information for initial and maintenance therapy.

Affected code: J1746

Clinical Evidence & Guidelines

Key evidence sources include: the Phase 3 NEJM 2018 study of ibalizumab for multidrug-resistant HIV-1 (Emu et al.), the Trogarzo package insert (December 2023), and the HHS guidelines update (September 12, 2024).

How evidence informs the policy: the Phase 3 clinical data and package insert support use of ibalizumab in heavily treatment-experienced, multidrug-resistant patients when combined with other antiretrovirals; the HHS guideline position — that ibalizumab is 'not recommended as initial therapy' except for patients lacking sufficient options — is reflected in policy by requiring provider attestation of multi-drug resistant HIV-1 and confirmation of an optimized background regimen before authorization, and by limiting use to specified initial and continuation criteria.

Background & Definitions

Trogarzo (ibalizumab-uiyk) is a humanized monoclonal antibody that binds primarily to the second extracellular domain of the CD4+ T-cell receptor, away from MHC II binding sites, acting as a CD4-directed post-attachment HIV-1 inhibitor. It prevents HIV from infecting CD4+ immune cells while preserving normal immunological function and is active against HIV-1 resistant to all approved antiretroviral agents. The FDA indication is for use in combination with other antiretrovirals for the treatment of HIV-1 infection in heavily treatment-experienced adults with multi-drug resistant HIV-1 who are failing their current antiretroviral regimen.

Optimized background antiretroviral regimen: a regimen containing at least one antiretroviral agent that demonstrates full viral sensitivity/susceptibility (as confirmed by provider).