CurrentUnitedHealthcarePolicy CSIND0063.06

Trogarzo (Ibalizumab-uiyk) — Medical Benefit Drug Policy (Indiana Only)

Defines medical benefit drug coverage criteria for Trogarzo (ibalizumab-uiyk) for treatment of multi-drug resistant HIV-1 for UnitedHealthcare Community Plan members in Indiana.

Policy Summary

PayerUnitedHealthcare

PolicyTrogarzo (Ibalizumab-uiyk) — Medical Benefit Drug Policy

Policy CodePolicy CSIND0063.06

Change TypeClarified references (non-material)

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document provider attestation of multidrug-resistant HIV-1 and an optimized background antiretroviral regimen.

SourceLink

POLICY UPDATE CHANGES

Updated References section to reflect the most current information.

Indiana-onlystate application

Initial ≤12mauthorization duration

Continuation ≤12mcontinuation duration

J1746procedure code listed

MDR HIV-1indication summary

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Trogarzo (ibalizumab-uiyk)

Initial Therapy

Covered when ALL of the following are met

Initial therapy requirements: Patient has diagnosis of HIV-1 infection AND provider attestation 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 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 (FDA) prescribing information; initial authorization is for no more than 12 months.

Continuation Therapy

Covered when ALL of the following are met

Continuation therapy requirements: Patient has previously received treatment with Trogarzo (ibalizumab-uiyk); provider confirms the patient has achieved a clinically significant viral response to Trogarzo; provider confirms continued use of an optimized background antiretroviral regimen in combination with Trogarzo; Trogarzo (ibalizumab-uiyk) maintenance dosing is in accordance with the U.S. Food and Drug Administration (FDA) prescribing information; authorization is for no more than 12 months.

This coverage criteria is intended for UnitedHealthcare Community Plan members in Indiana who have multi‑drug resistant (MDR) HIV‑1 and for whom standard oral antiretroviral regimens are insufficient to achieve viral suppression. Trogarzo (ibalizumab‑uiyk) is not recommended as initial therapy for most patients; it is reserved for heavily treatment‑experienced patients with ongoing detectable viremia and limited options for a fully suppressive regimen. Prior authorization is required and initial requests should document the MDR HIV‑1 diagnosis, provider attestation that the patient has been prescribed an optimized background antiretroviral regimen (OBR) containing at least one agent with demonstrated full viral sensitivity/susceptibility, and that dosing follows FDA prescribing information. Initial authorization is limited to no more than 12 months.

Applicable Billing and Diagnosis Codes

Applicable HCPCS CodesHCPCS

J1746

Injection, ibalizumab-uiyk, 10 mg.

Diagnosis CodesICD-10

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

What Providers Must Do

Prior Authorization

Prior Authorization Required

Prior authorization is required for Trogarzo (ibalizumab-uiyk). Initial authorization will be approved for up to 12 months. Continuation (renewal) authorizations are approved for up to 12 months.

Prior Authorization Required
Initial authorization ≤ 12 months
Continuation authorization ≤ 12 months

Note

Background Regimen Requirement

Provider must confirm the patient is on an optimized background antiretroviral regimen that includes at least one agent to which the virus is fully susceptible. Trogarzo must be used in combination with this optimized background regimen.

Optimized background antiretroviral regimen required
At least one fully susceptible antiretroviral agent

Drug Background

Trogarzo (ibalizumab‑uiyk) is a humanized monoclonal antibody that acts as a CD4‑directed post‑attachment HIV‑1 inhibitor. It binds to the CD4 receptor and interferes with HIV‑1 entry after the virus has attached to the host cell. Trogarzo is administered intravenously with a loading dose followed by maintenance dosing every two weeks and has demonstrated reductions in viral load and increases in CD4+ T‑cell counts in treatment‑experienced patients. Clinical guidance notes that ibalizumab has been studied in a limited number of patients, requires IV administration, and is therefore not recommended as initial therapy for most patients; it may be considered for patients with ongoing detectable viremia who lack sufficient options for a fully suppressive regimen.

Key Definitions

Multidrug-resistant (MDR) HIV-1 — definition and explanatory points

DefinitionHIV-1 infection that is resistant to multiple approved antiretroviral agents and for which patients have limited suppressive regimen options.

Clinical contextTrogarzo (ibalizumab-uiyk) is active against HIV-1 resistant to all approved antiretroviral agents and is intended for treatment-experienced patients with multidrug-resistant HIV-1.

Typical patient populationHeavily treatment‑experienced adults with ongoing detectable viremia who lack sufficient treatment options for a fully suppressive regimen.

Evidence basisSingle‑arm multicenter study demonstrated rapid and sustained viral load reductions and CD4+ T‑cell increases when ibalizumab was added to an optimized background regimen in patients with multidrug‑resistant HIV‑1.

Optimized background regimen (OBR) — definition and required features (at least one fully susceptible agent)

Policy Summary

PayerUnitedHealthcare

PolicyTrogarzo (Ibalizumab-uiyk) — Medical Benefit Drug Policy

Policy CodePolicy CSIND0063.06

Change TypeClarified references (non-material)

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document provider attestation of multidrug-resistant HIV-1 and an optimized background antiretroviral regimen.

SourceLink

On This Page

Documentation Required

Required Documentation

Providers must submit documentation to support the request, including: provider attestation of multi‑drug resistant HIV-1 infection, confirmation of an optimized background antiretroviral regimen (including evidence of at least one fully susceptible agent), treatment history demonstrating resistance to other antiretroviral agents as applicable, and dosing consistent with FDA prescribing information.

Provider attestation of diagnosis of HIV‑1 and multi‑drug resistant HIV-1
Confirmation of optimized background regimen with at least one fully susceptible agent
Documentation of prior antiretroviral treatment/resistance history as applicable
Dosing consistent with FDA prescribing information

Denial Risk

Triggers for Denial

Requests lacking the required attestation or confirmation of an optimized background antiretroviral regimen, inadequate documentation of prior resistance/treatment history when applicable, or dosing inconsistent with FDA prescribing information will be denied.

Missing provider attestation of multi‑drug resistant HIV-1
No confirmation of optimized background regimen with a fully susceptible agent
Insufficient prior treatment/resistance documentation when applicable
Dosing not consistent with FDA prescribing information

An antiretroviral regimen selected in combination with ibalizumab that includes at least one agent demonstrating full viral sensitivity/susceptibility.

Required featureMust contain at least one fully susceptible antiretroviral agent as part of the optimized background regimen (OBR).

Clinical roleOBR is prescribed concurrently with Trogarzo to provide background antiretroviral activity while ibalizumab exerts additional antiviral effect.

DocumentationProvider must confirm that the patient has been prescribed an optimized background antiretroviral regimen containing at least one agent demonstrating full viral sensitivity/susceptibility when requesting Trogarzo coverage.