ModifiedmhnPolicy CP.PHAR.378

Ibalizumab-uiyk (Trogarzo)

Defines medical necessity criteria, dosing limits, and prior authorization requirements for Trogarzo (ibalizumab-uiyk) for treatment-experienced adults with multidrug-resistant HIV-1 across Centene-affiliated lines of business.

Policy Summary

Payermhn

PolicyIbalizumab-uiyk (Trogarzo)

Policy CodePolicy CP.PHAR.378

Change TypeMaterial updates and operational state-specific notes

Effective DateJun 1, 2018

Next Review Date

Key ActionSubmit prior authorization with documentation showing multidrug-resistant HIV-1, specialist involvement, resistance to agents in required ARV classes, current HIV RNA ≥200 copies/mL, and dosing within specified limits.

SourceLink

POLICY UPDATE CHANGES

Added disclaimer that medical management techniques, including quantity management, beyond step therapy is not allowed for members in Nevada per SB 439.

Added step therapy bypass for Illinois HIM per IL HB 5395.

Updated Appendix B therapeutic alternatives and references (2Q 2025 annual review).

Removed failure of Fuzeon per manufacturer discontinuation.

>=200Required current HIV RNA viral load for initial approval

2,000 mgMaximum IV loading dose

800 mg q14dMaintenance dosing limit

6 mo

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Initial approval duration

J1746Drug billing code (200 mg vial)

NV, ILState-specific notes added

Coverage Criteria for Trogarzo (ibalizumab-uiyk)

Initial Therapy Criteria

Covered when ALL of the following are met:

Initial HIV-1 Infection Criteria: 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 (Selzentry) unless contraindicated, clinically significant adverse effects are experienced, or member is resistant; (For Illinois HIM requests, the step therapy requirements do not apply as of 1/1/2026 per IL HB 5395); 6) Current (within the past 30 days) HIV RNA viral load >= 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 (10 vials) IV loading dose and/or 800 mg (4 vials) IV every 14 days; note: a loading dose may be repeated if the member misses a scheduled maintenance dose by >= 3 days.

Continuation Therapy Criteria

Covered when ALL of the following are met:

Continued HIV-1 Infection Criteria: 1) Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Trogarzo for multidrug resistant HIV-1 infection and has received this medication 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 (10 vials) IV loading dose and/or 800 mg (4 vials) IV every 14 days; note: a loading dose may be repeated if the member misses a scheduled maintenance dose by >= 3 days.

Requests for use of ibalizumab (Trogarzo) for indications that are not FDA-approved and that are not specifically addressed in this clinical policy will not be authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid), or unless such use is supported by the member’s evidence of coverage documents.

The HCPCS and other codes listed in this policy are provided for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage; coverage determinations remain subject to the member’s benefit terms, plan exclusions, and limitations. Providers should consult current professional coding guidance before submitting claims.

Use of ibalizumab for non‑FDA indications that are not covered by this policy is considered not authorized unless the requester provides documentation meeting the referenced off‑label use criteria or the applicable evidence of coverage. Requests lacking sufficient off‑label evidence per the referenced policies may be denied.

Coding and Billing Information

HCPCS CodesHCPCSCovered

J1746

Injection, ibalizumab, 200 mg

HCPCS CodesHCPCS

J1746

Injection, ibalizumab, 200 mg

inv-08: HIV RNA viral load

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

Initial approval durationApproval: 6 months

Test timingViral load must be current within the past 30 days

Provider Requirements, Prior Authorization, and Billing

Prior Authorization

Prior Authorization and Billing Code

Prior authorization is required for Trogarzo (ibalizumab). Providers must obtain prior authorization before dispensing. Billing should reference HCPCS code J1746 (Injection, ibalizumab, 200 mg).

Prior authorization required prior to benefit payment
HCPCS: J1746

Documentation Required

Required Documentation and Denial Risk for Missing Information

Providers must submit supporting clinical documentation with the prior authorization request. Typical documentation includes recent office/clinic notes, HIV resistance testing results, HIV viral load (within past 30 days), and records of concomitant antiretroviral therapy. Missing or incomplete documentation may result in denial or delay of the request.

Office chart notes documenting diagnosis and specialty consult
Lab results: resistance testing and HIV RNA viral load (≤30 days)

Background on Ibalizumab-uiyk (Trogarzo)

Ibalizumab‑uiyk (Trogarzo) is a CD4‑directed post‑attachment HIV‑1 inhibitor indicated as part of combination antiretroviral therapy for heavily treatment‑experienced adults with multidrug‑resistant HIV‑1 who are failing their current regimen. The labelled dosing regimen is a 2,000 mg IV loading dose followed by 800 mg IV every 14 days; a loading dose may be repeated if a maintenance dose is missed by ≥3 days.

Definitions and Abbreviations

inv-19: multidrug resistant HIV-1

DefinitionMultidrug resistant HIV-1: diagnosis required for therapy with ibalizumab in treatment-experienced adults per policy criteria

Specialist involvementMust be prescribed by or in consultation with an infectious disease or HIV specialist

Resistance requirementDocumentation of resistance to at least 1 agent from each of 3 ARV classes (NRTI, NNRTI, PI) unless contraindicated

inv-20: ARV classes

NRTINucleos(t)ide reverse transcriptase inhibitor (referenced for resistance requirement)

NNRTINon-nucleoside reverse transcriptase inhibitor (referenced for resistance requirement)

Policy Summary

Payermhn

PolicyIbalizumab-uiyk (Trogarzo)

Policy CodePolicy CP.PHAR.378

Change TypeMaterial updates and operational state-specific notes

Effective DateJun 1, 2018

Next Review Date

SourceLink

On This Page

Records showing concurrent antiretroviral regimen

Denial Risk

Non‑FDA Indication Risk

Requests for non‑FDA labeled uses of Trogarzo will be evaluated against off‑label coverage policies. If sufficient evidence of safety and efficacy per CP.CPA.09 (Commercial), HIM.PA.154 (Marketplace), or CP.PMN.53 (Medicaid) is not provided, coverage may be denied.

Non‑FDA indications require evidence per off‑label policies
Insufficient evidence may lead to denial

Step Therapy

Step Therapy Policy Notes

Step therapy requirements: For members with CCR5‑tropic virus, step therapy requires prior failure of maraviroc (Selzentry) unless contraindicated, there are clinically significant adverse effects, or resistance is documented. Note: Illinois HIM requests are exempt from the step therapy requirement per IL HB 5395 (effective 1/1/2026). The policy previously required failure of enfuvirtide (Fuzeon) but this requirement has been removed.

Step therapy: failure of maraviroc (Selzentry) required for CCR5‑tropic virus unless contraindicated or resistant
Illinois HIM: step therapy bypass per IL HB 5395 effective 01/01/2026
Removed: Fuzeon (enfuvirtide) failure no longer required

Billing Rule

Coding Guidance Reminder and Coverage Disclaimer

Codes listed in this policy (e.g., HCPCS J1746) are for informational purposes only. Inclusion does not guarantee coverage. Providers should verify current coding guidance and payer-specific billing instructions prior to claim submission to avoid denials or miscoding.

Verify most up-to-date coding guidance before claims submission
Code inclusion is informational and not a coverage guarantee

PIProtease inhibitor (referenced for resistance requirement)

inv-21: Health Plan

Health Plan definitionA health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan's affiliates

Policy purposeProvides guidance on medical necessity to assist coverage decisions and administer benefits; not a contract or guarantee of payment

Scope noteCoverage decisions subject to terms, exclusions, limitations of coverage documents and applicable law/regulation