CurrentUnitedHealthcarePolicy 202500063J

Trogarzo (Ibalizumab-Uiyk) — Medical Benefit Drug Policy

Defines UnitedHealthcare medical benefit drug policy coverage criteria for Trogarzo (ibalizumab-uiyk) for treatment of heavily treatment-experienced patients with multidrug-resistant HIV-1 and describes dosing alignment with FDA labeling and benefit considerations affecting coverage.

Policy Summary

PayerUnitedHealthcare

PolicyTrogarzo (Ibalizumab-Uiyk) — Medical Benefit Drug Policy

Policy CodePolicy 202500063J

Change TypeSupporting information updated

Effective DateJun 1, 2025

Next Review Date

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

SourceLink

POLICY UPDATE CHANGES

Supporting Information Updated References section to reflect the most current information; Archived previous policy version 2024000631.

12 monthsmaximum initial authorization period

J1746HCPCS code for ibalizumab-uiyk

43%undetectable at 24 weeks

83%≥0.5 log10 decrease day 7

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Initial Therapy

Covered when ALL of the following are met:

Initial therapy coverage: Provider attestation that the patient has multi-drug resistant HIV-1 infection

Initial therapy coverage: Diagnosis of HIV-1 infection

Initial therapy coverage: Ibalizumab initial and maintenance dosing is in accordance with the US Food and Drug Administration prescribing information

Initial therapy coverage: 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

Initial therapy coverage: Initial authorization is for no more than 12 months

Continuation Therapy

Covered for continuation when ALL of the following are met:

Continuation therapy coverage: Patient has previously received treatment with Trogarzo (ibalizumab-uiyk)

Continuation therapy coverage: Provider confirms that the patient has achieved a clinically significant viral response to Trogarzo (ibalizumab-uiyk)

Continuation therapy coverage: Provider confirms that the patient will continue to take an optimized background antiretroviral regimen in combination with Trogarzo (ibalizumab-uiyk)

Continuation therapy coverage: Trogarzo (ibalizumab-uiyk) maintenance dosing is in accordance with the US Food and Drug Administration prescribing information

Coverage for experimental, investigational, or unproven treatments may be allowed only as specified by the member's specific benefit plan document or applicable state mandates. Consult the member's benefit plan to determine whether such coverage is permitted under the Certificate of Coverage or other plan documents. Where state mandates require coverage for off‑label or investigational uses, those mandates supersede the benefit document and the medical or drug policy.

Per DHHS guidance, ibalizumab is not recommended as initial therapy because its efficacy and safety have been evaluated in a small number of patients, it requires intravenous administration, and it has high cost. The guideline indicates ibalizumab is intended for adults with ongoing detectable viremia who do not have sufficient treatment options for a fully suppressive regimen, and therefore may be considered only for patients lacking other viable antiretroviral options.

Coding and Clinical Definitions

Applicable HCPCS Procedure CodesHCPCS

J1746

Injection, ibalizumab-uiyk; 10 mg.

Diagnosis Codes (examples listed)ICD-10

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

Virologic response definitions referenced in clinical evidence

Primary virologic endpoint (day 7)≥0.5 log10 decrease in HIV-1 RNA seven days after the first dose (primary endpoint)

Undetectable viral load (24 weeks)Undetectable defined as <50 copies/mL; 43% of study participants achieved this at 24 weeks

Proportion achieving ≥0.5 log10 at day 783% of patients achieved a ≥0.5 log10 decrease in viral load at day 7 after the 2000 mg loading dose

Viral load thresholds reportedOutcomes also reported at 200 copies/mL (50% of patients <200 copies/mL) and mean reductions (mean 3.1 log10 at end of treatment)

Provider Actions, Documentation, and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required. Initial and continuation therapy both require prior authorization. Initial authorization is for up to 12 months; continuation (maintenance) authorization is also for up to 12 months. Documentation must show dosing per FDA prescribing information and that the patient is on an optimized background antiretroviral regimen.

Initial and continuation authorizations each limited to no more than 12 months.
Dosing must follow US FDA prescribing information for ibalizumab (Trogarzo).
Provider must document an optimized background antiretroviral regimen with at least one agent demonstrating full viral susceptibility.

Note

Clinical Guidance Note

Guideline positioning and intended use. Ibalizumab (Trogarzo) is not recommended as initial antiretroviral therapy per DHHS guidelines; it is intended for patients with multi-drug resistant (MDR) HIV-1 who have limited treatment options and ongoing detectable viremia despite prior regimens.

DHHS: not recommended as initial therapy due to limited evidence, IV administration, and cost.
Appropriate for patients who lack sufficient options for a fully suppressive regimen.

Documentation Required

Provider Attestation and Documentation Required

Provider attestation and required documentation. Provider must attest that the patient has multi-drug resistant HIV-1 and supply documentation to support the attestation, including prior and current antiretroviral regimen history, resistance testing/results, HIV-1 diagnosis, and confirmation the patient has previously received ibalizumab if requesting continuation.

Signed provider attestation that the patient has multi-drug resistant (MDR) HIV-1 infection.
Documented HIV-1 diagnosis (ICD-10 Z21 or equivalent where applicable).
History of prior and current antiretroviral regimens, including dates and responses.
Resistance testing results demonstrating multi-drug resistance (e.g., genotype/phenotype reports).
Evidence that the patient has been prescribed and is receiving an optimized background regimen with at least one fully susceptible agent.
For continuation requests: documentation of prior treatment with ibalizumab and evidence of a clinically significant viral response to therapy.

Denial Risk

Denial Risk / Documentation Shortfalls

Denial-risk conditions. Requests lacking the required attestation or supporting documentation, missing an HIV-1 diagnosis, or failing to confirm an optimized background regimen are at high risk for denial.

No provider attestation of multi-drug resistant HIV-1.
Absent or undocumented HIV-1 diagnosis.
No documentation of resistance testing/results demonstrating MDR.
Failure to confirm an optimized background antiretroviral regimen containing at least one fully susceptible agent.
Requests for use as initial antiretroviral therapy without documented rationale consistent with guidelines.

Key Definitions

Multidrug-resistant (MDR) HIV-1

DefinitionMultidrug-resistant (MDR) HIV-1: HIV-1 infection resistant to multiple approved antiretroviral agents, as noted by provider attestation and diagnostic/resistance documentation

Indication relationIbalizumab (Trogarzo) is indicated for heavily treatment-experienced adults with MDR HIV-1 failing their current antiretroviral regimen (FDA indication)

Provider attestationCoverage requires provider attestation that the patient has multi-drug resistant HIV-1 infection and documentation supporting resistance and treatment history

Relation to resistance testing and therapyPolicy requires documentation of an optimized background antiretroviral regimen with at least one agent demonstrating full viral susceptibility in addition to resistance information

OpenPayer

Trogarzo (Ibalizumab-Uiyk) — Medical Benefit Drug Policy

Coverage Criteria for Trogarzo (ibalizumab-uiyk)

Coding and Clinical Definitions

Provider Actions, Documentation, and Authorization

Key Definitions

Background

Revision History