CurrentColorado Rocky Mountain Health PlansPolicy CS2026D0063R

Trogarzo (ibalizumab-uiyk) — Medical Benefit Drug Coverage Criteria

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Defines medical necessity criteria, dosing expectations, and coding for Trogarzo (ibalizumab-uiyk) for treatment of multi-drug‑resistant HIV-1 in affected members; applies to Colorado Rocky Mountain Health Plans under UnitedHealthcare Community Plan framework (excludes certain states listed).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyTrogarzo (ibalizumab-uiyk) — Medical Benefit Drug Coverage Criteria

Policy CodePolicy CS2026D0063R

Change TypeNo material change

Effective DateJun 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document provider attestation of multi‑drug‑resistant HIV‑1 infection and an optimized background antiretroviral regimen with at least one fully susceptible agent.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsMax auth period

J1746HCPCS

43%VL <50 at EOT

83%≥0.5 log10 ↓ at day 7

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 therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial therapy criteria: Diagnosis of HIV-1 infection; provider attestation that the patient has multi-drug-resistant (MDR) 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. FDA prescribing information; initial authorization is for no more than 12 months.

Continuation of therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

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

This Medical Benefit Drug Policy does not apply to the following states: Kansas, New Jersey, North Carolina, Ohio, Pennsylvania, and Texas. For those states, refer to the state-specific policy or guideline where noted (for example, Kansas and Pennsylvania refer to the state’s Medicaid clinical policy; Texas refers to drug-specific criteria in the Texas Medicaid Provider Procedures Manual).

Applicability: The policy’s coverage criteria, prior authorization requirements, and coding guidance apply to Colorado Rocky Mountain Health Plans members except where one of the listed state-specific policies/guidelines supersedes this Medical Benefit Drug Policy.

Applicable Coding

Applicable HCPCS/CodesHCPCS

J1746

Injection, ibalizumab-uiyk, 10 mg

Applicable ICD-10 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 and Authorization Requirements

Prior Authorization

Prior authorization required; authorization ≤ 12 months

Prior authorization is required for Trogarzo (ibalizumab-uiyk). Initial authorization is limited to no more than 12 months; maintenance dosing must follow the U.S. FDA prescribing information.

Prior authorization required for initial and continuation therapy.
Initial and renewal authorizations each limited to a maximum of 12 months.
Maintenance dosing must be consistent with FDA prescribing information.

Step Therapy

Use only with optimized background antiretroviral regimen

Trogarzo must be used in combination with an optimized background antiretroviral regimen that includes at least one antiretroviral agent demonstrating full viral sensitivity/susceptibility.

Provider must confirm the patient has been prescribed an optimized background antiretroviral regimen.

Background on Ibalizumab (Trogarzo)

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 (specifically the second extracellular domain) and blocks HIV-1 entry into host cells without compromising CD4-mediated immune function.

Indication: Trogarzo is indicated for heavily treatment-experienced adults with multidrug-resistant (MDR) HIV-1 who are failing their current antiretroviral regimens. Use is intended in combination with an optimized background antiretroviral regimen and dosing must follow the U.S. FDA prescribing information.

Clinical context: Trogarzo retains activity against HIV-1 strains resistant to approved antiretrovirals and is used when patients have evidence of multi-drug resistance and require a therapeutic option to achieve viral suppression.

Definitions

MDR HIV-1 infection — definition and key features

DefinitionMulti-drug-resistant (MDR) HIV-1 infection: HIV-1 infection in heavily treatment-experienced adults failing current antiretroviral regimens with resistance to multiple approved antiretroviral agents.

Clinical contextOccurs in heavily treatment-experienced patients whose virus remains detectable despite prior antiretroviral therapies and who have limited remaining fully active agents.

Mechanism relevant to TrogarzoTrogarzo (ibalizumab-uiyk) is a CD4-directed post-attachment HIV-1 inhibitor that binds the second extracellular domain of CD4, preventing HIV entry while preserving immune function; it is active against HIV-1 resistant to all approved antiretroviral agents.

Treatment implicationPatients with MDR HIV-1 should receive Trogarzo only in combination with an optimized background antiretroviral regimen, per product labeling and policy criteria.

Indication per FDATrogarzo, in combination with other antiretroviral(s), is indicated for treatment of HIV-1 infection in heavily treatment-experienced adults with multi-drug-resistant HIV-1 failing their current antiretroviral regimen.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyTrogarzo (ibalizumab-uiyk) — Medical Benefit Drug Coverage Criteria

Policy CodePolicy CS2026D0063R

Change TypeNo material change

Effective DateJun 1, 2026

Next Review DateN/A

SourceLink

On This Page

Optimized regimen must contain at least one agent with documented full susceptibility.

Documentation Required

Required documentation and attestation

Documentation required includes provider attestation of multi‑drug‑resistant (MDR) HIV‑1 infection, confirmation of an optimized background antiretroviral regimen (including at least one fully susceptible agent), and dosing consistent with FDA labeling; for continuation, document prior Trogarzo receipt and clinically significant viral response.

Provider attestation that the patient has multi‑drug‑resistant HIV‑1 infection.
Confirmation that an optimized background antiretroviral regimen has been prescribed with ≥1 agent demonstrating full viral sensitivity/susceptibility.
For continuation: documentation of prior Trogarzo treatment and clinically significant viral response.
Documentation that initial and maintenance dosing follows the U.S. FDA prescribing information.

Denial Risk

Denial triggers — missing attestation, regimen, dosing, or criteria

Claims may be denied if required attestations or documentation are missing, if an optimized background regimen with at least one fully susceptible agent is not present, or if dosing is not consistent with FDA prescribing information or the policy's initial/continuation criteria.

Missing provider attestation of multi‑drug‑resistant HIV‑1 infection.
Absence of an optimized background antiretroviral regimen containing at least one agent demonstrating full susceptibility.
Dosing not consistent with U.S. FDA prescribing information.
Failure to meet the policy's initial or continuation therapy criteria (including authorization period limits).

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