CurrentColorado Rocky Mountain Health PlansPolicy 2026D0063K

Trogarzo (ibalizumab-uiyk) — Coverage Criteria for Multi‑drug Resistant HIV-1

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Defines medical necessity criteria, coding, and coverage considerations for Trogarzo (ibalizumab-uiyk) in treatment-experienced patients with multi-drug resistant HIV-1 for UnitedHealthcare Commercial and Individual Exchange benefit plans.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyTrogarzo (ibalizumab-uiyk) — Coverage Criteria for Multi‑drug Resistant HIV-1

Policy CodePolicy 2026D0063K

Change TypeNo material change

Effective DateJun 1, 2026

Next Review Date

Key ActionObtain prior authorization with provider attestation of multi‑drug resistant HIV-1 and documentation that the patient is on 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 monthsAuthorization period

J1746HCPCS

B20, Z16.33, Z21Diagnosis codes

Not initialHHS placement

Related Billing Codes

HCPCS-J1746-IBALIZUMAB-INJECTION-10MG

HCPCS J1746: Ibalizumab-uiyk Injection, 10 mg

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Coverage Criteria for Trogarzo (ibalizumab-uiyk)

Initial and Continuation Therapy Criteria

Trogarzo is proven and medically necessary when ALL of the following criteria are met for initial therapy and continuation therapy respectively.

Initial therapy

Diagnosis and attestation: Diagnosis of HIV-1 infection AND provider attestation that the patient has multi-drug resistant HIV-1 infection
Refer to provider attestation requirement.
Optimized background regimen: 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
Optimized background regimen required.
Dosing: Trogarzo (ibalizumab-uiyk) initial and maintenance dosing is in accordance with the U.S. Food and Drug Administration prescribing information
Follow FDA prescribing information.
Authorization duration: Initial authorization is for no more than 12 months<=12 months
Authorization duration limit.

Continuation therapy

Prior Trogarzo exposure: Patient has previously received treatment with Trogarzo (ibalizumab-uiyk)
Prior exposure required.
Clinical response: Provider confirms the patient has achieved a clinically significant viral response to Trogarzo (ibalizumab-uiyk) therapy
Clinical response must be documented.
Ongoing background regimen: Provider confirms the patient will continue to take an optimized background antiretroviral regimen in combination with Trogarzo (ibalizumab-uiyk)
Ongoing optimized background regimen required.
Maintenance dosing and authorization: Trogarzo (ibalizumab-uiyk) maintenance dosing is in accordance with the U.S. Food and Drug Administration prescribing information and authorization is for no more than 12 months

Coverage decisions for Trogarzo (ibalizumab-uiyk) may be affected by member-specific documents and applicable state mandates. Member benefit plan documents should be consulted because some Certificates of Coverage allow experimental/investigational or off-label treatment coverage for life‑threatening illnesses under specific conditions. Where a state mandate applies for off‑label use, that mandate supersedes policy language in the benefit document or medical policy. Experimental/investigational exclusions in this policy do not replace review of the member’s certificate of coverage and applicable laws.

Per the U.S. Department of Health and Human Services antiretroviral guidelines, ibalizumab is not recommended as initial therapy. The guidance cites limited efficacy and safety data (studied in a small number of patients), the need for intravenous administration, and high cost as reasons for this placement. Ibalizumab is intended for patients with ongoing detectable viremia who do not have sufficient treatment options for a fully suppressive regimen and therefore may be candidates for this therapy.

Coding References

Covered HCPCS Codes (reference)HCPCS

J1746

Injection, ibalizumab-uiyk, 10 mg.

Diagnosis Codes (reference)ICD-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 & Documentation

Prior Authorization

Prior authorization and dosing compliance

Prior authorization is required for Trogarzo (ibalizumab-uiyk). The request must document provider attestation that the patient has multi‑drug resistant HIV‑1 and confirm that initial and maintenance dosing follow the FDA prescribing information. Initial and maintenance authorizations may be granted for up to 12 months.

HCPCS code J1746 applies for billing (see coding).
Initial authorization not to exceed 12 months; maintenance authorizations also limited to 12 months.

Note

Place in therapy per HHS guidance

Ibalizumab is listed in HHS antiretroviral guidelines as “not recommended as initial therapy” and is intended for patients with ongoing detectable viremia who lack sufficient options for a fully suppressive regimen.

Definitions

Multi-drug resistant HIV-1 — definition and operational note referencing provider attestation requirements

DefinitionMulti-drug resistant HIV-1: HIV-1 infection with resistance to multiple antiretroviral agents as attested by the provider.

Operational attestation requirementProvider must attest that the patient has multi-drug resistant HIV-1 as part of the initial therapy criteria.

Associated diagnosisPatient must have a diagnosis of HIV-1 infection documented alongside the provider attestation.

Use contextIbalizumab (Trogarzo) is indicated for treatment of multi-drug resistant HIV-1 when all policy criteria are met.

Documentation noteAttestation is required for prior authorization and is part of the medical necessity determination for coverage.

Background

Trogarzo (ibalizumab-uiyk) is a humanized monoclonal antibody that binds to the CD4 receptor and blocks HIV‑1 entry into host cells, providing activity against viruses resistant to other antiretrovirals. It is indicated for use in combination with other antiretroviral agents for heavily treatment‑experienced adults with multi‑drug resistant HIV‑1 who are failing their current regimen. Clinical data demonstrate rapid declines in viral load following the approved 2,000 mg loading infusion and subsequent maintenance dosing, and clinically meaningful proportions of patients achieved viral suppression over 24 weeks. Adverse events were generally mild to moderate and no anti‑ibalizumab antibodies were detected in studied patients.

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