CurrentmhnPolicy CP.PHAR.378

Ibalizumab-uiyk (Trogarzo)

Defines medical necessity criteria, dosing limits, and authorization duration for Trogarzo (ibalizumab-uiyk) for treatment-experienced adults with multidrug-resistant HIV-1 across commercial, HIM/ICHRA, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyIbalizumab-uiyk (Trogarzo)

Policy CodePolicy CP.PHAR.378

Change TypeNo material change

Effective DateJun 1, 2018

Next Review DateN/A

Key ActionSubmit prior authorization with supporting chart notes, resistance testing, and recent HIV RNA viral load showing ≥200 copies/mL.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

>= 3antiretroviral classes with documented resistance required

>=200required HIV RNA viral load

2,000 / 800 mgdose limits (load/maint)

6 monthsapproval duration (Commercial)

12 monthsapproval duration (Medicaid/HIM)

J1746

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Coverage Criteria for Trogarzo (ibalizumab-uiyk)

inv-01: Initial Therapy

Covered when ALL of the following are met:

Initial Approval - HIV-1 Infection: 1. Diagnosis of multidrug resistant HIV-1 infection; 2. Prescribed by or in consultation with an infectious disease or HIV specialist; 3. Age >= 18 years; 4. Documentation of resistance to at least 1 antiretroviral agent from each of 3 classes (NRTI, NNRTI, PI), unless clinically significant adverse effects are experienced or all are contraindicated; 5. If CCR5 tropic, failure of maraviroc unless contraindicated, intolerant, or member is resistant; 6. Current (within the past 30 days) HIV RNA >= 200 copies/mL; 7. Prescribed concurrently with additional antiretroviral agents to which member is susceptible, if available; 8. Dose does not exceed 2,000 mg IV loading dose and/or 800 mg IV every 14 days.

inv-02: Continuation Therapy

Covered when ALL of the following are met:

Continued Therapy - HIV-1 Infection: 1. Currently receiving medication via Centene benefit, or documentation supports that member has received Trogarzo for multidrug resistant HIV-1 infection for at least 30 days; 2. Member is responding positively to therapy; 3. If request is for a dose increase, new dose does not exceed 2,000 mg IV loading dose and/or 800 mg IV every 14 days.

inv-03: Other Indications / Off-label

Other/Off-label use handling (must meet one):

Other Indications: 1. If the drug has undergone a recent label change (within the last 6 months) not yet reflected in this policy, follow the appropriate no-coverage or non-formulary policy for the relevant line of business per formulary status (see policy references); OR 2. If the requested use is not specifically listed under 'Diagnoses/Indications for which coverage is NOT authorized' and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (commercial, HIM/ICHRA, or Medicaid).

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the request includes sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policy. For Commercial lines follow CP.CPA.09, for Health Insurance Marketplace/ICHRA follow HIM.PA.154, and for Medicaid follow CP.PMN.53, or provide evidence of coverage documents that support the requested use.

When state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid provisions take precedence. Refer to the applicable state Medicaid manual for specific coverage rules and any state‑level deviations from this policy.

Uses for non‑FDA approved indications that lack sufficient documentation of efficacy and safety per the referenced off‑label use policies are considered not authorized and may be denied.

Coding and Test Thresholds

HCPCS CodesHCPCS

J1746

Injection, ibalizumab, 200 mg

HCPCS CodesHCPCS

J1746

Injection, ibalizumab, 200 mg

inv-09: HIV RNA viral load — >= 200 copies/mL (within past 30 days)

HIV RNA viral load threshold>= 200 copies/mL (measured within the past 30 days)

PurposeRequired as part of initial approval criteria for multidrug‑resistant HIV-1 to document current viremia level

Documentation sourceLaboratory result (HIV ribonucleic acid) dated within 30 days of request

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria. Approval durations: Medicaid/HIM/ICHRA — 12 months; Commercial — 6 months or to the member's renewal date, whichever is longer.

Prior authorization required with supporting clinical documentation.
Approval duration: Medicaid/HIM/ICHRA = 12 months; Commercial = 6 months or to member renewal date, whichever is longer.

Denial Risk

Insufficient Documentation / Non‑Covered Indications

Requests that lack sufficient documentation showing the member meets all approval criteria (for example: diagnosis of multidrug resistant HIV-1, documentation of resistance to required antiretroviral classes, viral load, specialist prescribing or consultation, concurrent antiretrovirals, and dosing limits) may be denied. Non‑FDA approved indications are not authorized unless supported per applicable off‑label policies and evidence of coverage.

Background

Ibalizumab‑uiyk (Trogarzo) is a CD4‑directed, post‑attachment HIV‑1 inhibitor approved for use in combination with other antiretroviral agents for heavily treatment‑experienced adults with multidrug‑resistant HIV‑1. The prescribing information describes the approved indication and provides dosing guidance and safety information; the full label and product literature should be consulted when considering therapy.

Definitions and Reference Materials

inv-19: Ibalizumab-uiyk — Trogarzo (ibalizumab-uiyk)

Generic name / brandIbalizumab-uiyk (Trogarzo)

Mechanism of actionCD4-directed post-attachment HIV-1 inhibitor

Indication (FDA)Treatment of HIV-1 infection in combination with other antiretrovirals for heavily treatment-experienced adults with multidrug-resistant HIV-1 failing current regimen

Typical dosing overviewIV loading dose 2,000 mg; maintenance 800 mg IV every 14 days (dose limits apply)

inv-20: Acronyms — Abbreviations for antiretroviral classes referenced in criteria (NRTI, NNRTI, PI, INSTI).

NRTINucleos(t)ide reverse transcriptase inhibitor (e.g., abacavir, tenofovir disoproxil fumarate, emtricitabine, lamivudine)

Revision History

2025-06-27policy update

Added step therapy bypass for IL HIM per IL HB 5395 and removed requirement for failure of Fuzeon following manufacturer discontinuation; references reviewed and updated during 2Q 2025 annual review.

2024-06-04policy update

Added disclaimer that medical management techniques, including quantity management beyond step therapy, are not allowed for members in Nevada per SB 439; references reviewed and updated during 2Q 2024 annual review.

2024-02-01review

Policy Summary

Payermhn

PolicyIbalizumab-uiyk (Trogarzo)

Policy CodePolicy CP.PHAR.378

Change TypeNo material change

Effective DateJun 1, 2018

Next Review DateN/A

Key ActionSubmit prior authorization with supporting chart notes, resistance testing, and recent HIV RNA viral load showing ≥200 copies/mL.

SourceLink

On This Page

Insufficient documentation may result in denial of the request.
Coverage not authorized for non‑FDA approved indications unless addressed by off‑label policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence of coverage.

Billing Rule

Coding Does Not Guarantee Coverage

Codes shown in this policy are for informational purposes only. Inclusion or exclusion of any code does not guarantee coverage. Providers should reference current professional coding guidance prior to claim submission.

HCPCS: J1746 — Injection, ibalizumab, 200 mg (informational).
Coding inclusion/exclusion does not guarantee coverage; verify up-to-date coding guidance before billing.

Documentation Required

Required Supporting Documentation

Provider must submit clinical supporting documentation with the prior authorization request, such as office chart notes, lab results (including current HIV RNA within 30 days showing ≥ 200 copies/mL), resistance test results demonstrating resistance per criteria, and documentation of specialist involvement.

Office chart notes and lab results (including HIV RNA within 30 days).
Resistance testing documenting resistance to required antiretroviral classes.
Documentation of prescribing clinician specialty (infectious disease or HIV specialist) or consultation.

Step Therapy

Step Therapy / Prior Failures

Step therapy applies for initial approval: member must have documented resistance to at least one agent from each of the three classes (NRTI, NNRTI, PI), unless clinically significant adverse effects or contraindications exist. If CCR5 tropic, failure of maraviroc is required unless contraindicated or not tolerated.

Document resistance to ≥1 agent from each class: NRTI, NNRTI, PI, unless contraindicated or not tolerated.
If CCR5 tropic, documented failure of maraviroc is required unless contraindicated or not tolerated.

Note

Step Therapy Updates and State‑Specific Variances

Step therapy requirements and other medical management rules have state‑specific variances: Nevada — medical management techniques, including quantity management beyond step therapy, are not allowed; Illinois (HIM) — step therapy bypass added per IL HB 5395 (effective 1/1/2026) for HIM requests. Policy updates have also adjusted approval durations and added ICHRA line of business in recent reviews.

Nevada: no medical management beyond step therapy allowed (per SB 439).
Illinois HIM: step therapy requirements do not apply per IL HB 5395 (effective 1/1/2026) — step therapy bypass for IL HIM.
Recent updates extended Medicaid/HIM initial approval duration to 12 months and added ICHRA line of business.

NNRTINon-nucleoside reverse transcriptase inhibitor (e.g., efavirenz, etravirine, nevirapine)

PIProtease inhibitor (e.g., atazanavir, darunavir, fosamprenavir)

INSTIIntegrase strand transfer inhibitor (INSTI) — referenced in policy appendices as antiretroviral class abbreviation

inv-21: Trogarzo Prescribing Information (Theratechnologies Inc., Dec 2023)

Document titleTrogarzo Prescribing Information (Theratechnologies Inc., December 2023)

AvailabilityFull prescribing information available at https://www.trogarzo.com

Reference dateSource listed in policy references (Accessed February 6, 2026)

inv-22: Panel on Antiretroviral Guidelines — US Department of Health and Human Services adult/adolescent antiretroviral guidelines last updated Sep 25, 2025

Guideline titlePanel on Antiretroviral Guidelines for Adults and Adolescents — Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV

Sponsoring bodyUS Department of Health and Human Services

Last updatedSeptember 25, 2025 (as cited in policy references; accessed February 6, 2026)

2Q 2024 annual review: no significant changes; references reviewed and updated.

2023-01-23review

2Q 2023 annual review: no significant changes; references reviewed and updated.