CurrentColorado Rocky Mountain Health PlansPolicy CS2026D0063R

Trogarzo (Ibalizumab-Uiyk) — Coverage Criteria

Defines medical necessity criteria, dosing alignment with FDA labeling, and authorization durations for Trogarzo (ibalizumab-uiyk) when used to treat heavily treatment-experienced patients with multidrug-resistant HIV-1; applies to UnitedHealthcare Community Plan membership except specified states with separate guidance.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyTrogarzo (Ibalizumab-Uiyk) — Coverage Criteria

Policy CodePolicy CS2026D0063R

Change TypeRoutine review — no material changes

Effective DateJun 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document an optimized background antiretroviral regimen with at least one fully susceptible agent.

SourceLink

POLICY UPDATE CHANGES

Routine review; no content changes

12 monthsmaximum initial or renewal authorization period

43%proportion with HIV-1 <50 copies/mL

83%≥0.5 log10 viral decrease at day 7

Coverage and Medical Necessity Criteria

Medical necessity criteria

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Initial therapy

Diagnosis and resistance: Diagnosis of HIV-1 infection; and provider attestation that the patient has multi-drug-resistant HIV-1 infection.
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.
Dosing: Trogarzo (ibalizumab-uiyk) initial and maintenance dosing is in accordance with the U.S. Food and Drug Administration prescribing information.
Authorization duration: Initial authorization is for no more than 12 months.

Continuation therapy

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

Prior Authorization, Documentation, and Authorization Durations

Prior Authorization

Prior Authorization Required

Prior authorization required. Initial and renewal authorizations are limited to a maximum of 12 months.

Initial authorization: up to 12 months
Renewal/continuation authorization: up to 12 months

Documentation Required

Required Documentation

Provider must document and attest to the member's clinical status and treatment background to support medical necessity.

Provider attestation of multi-drug‑resistant HIV‑1 infection is required
Documentation that the patient has been prescribed an optimized background antiretroviral regimen that includes at least one agent with documented full viral susceptibility
Confirmation that Trogarzo (ibalizumab‑uiyk) dosing (initial and maintenance) follows FDA‑approved prescribing information

Note

Optimized Background Regimen Required

An optimized background antiretroviral regimen must be continued in combination with Trogarzo. The regimen must contain at least one fully susceptible antiretroviral agent as confirmed by the provider.

Provider confirmation that an optimized background regimen is prescribed and will be continued with Trogarzo
Optimized regimen must include ≥1 agent demonstrating full viral sensitivity/susceptibility

Drug Background and Clinical Evidence

Trogarzo (ibalizumab-uiyk) is a CD4-directed, post-attachment monoclonal antibody HIV-1 inhibitor indicated, in combination with other antiretroviral(s), for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant (MDR) HIV-1 who are failing their current antiretroviral regimen. It binds the CD4 receptor to prevent HIV entry and is intended for use when viruses are resistant to multiple antiretroviral classes and a fully suppressive regimen is not available or has failed.

Key Definitions

Multidrug-resistant (MDR) HIV-1 definition

DefinitionHIV-1 infection with resistance to multiple approved antiretroviral agents such that a fully suppressive regimen is not available or has failed; provider attestation is required per policy.

Clinical implicationVirus remains susceptible to neither single nor combination regimens across approved antiretroviral classes, necessitating alternative therapies such as ibalizumab (Trogarzo).

Mechanism relevanceTrogarzo is active against HIV-1 resistant to all approved antiretroviral agents, making it an option for patients with MDR HIV-1.

Provider requirementProvider attestation of multidrug-resistant HIV-1 infection is required for authorization under this policy.

Treatment contextApplies to heavily treatment-experienced adults failing their current regimen where a fully suppressive regimen is not available or has failed.