CurrentCignaPolicy IP0171

Trogarzo

Cigna drug coverage policy for Trogarzo (ibalizumab-uiyk) for treatment of HIV-1 in heavily treatment-experienced adults with multidrug-resistant infection, defining medical necessity criteria for initial and continuation therapy, dosing, coding, and prior authorization expectations.

Policy Summary

PayerCigna

PolicyTrogarzo

Policy CodePolicy IP0171

Change TypeAnnual review; material revisions

Effective DateJun 1, 2025

Next Review Date

Key ActionDocument specialist involvement and evidence of multiclass antiretroviral resistance when requesting prior authorization for Trogarzo; approvals: 6 months initial, 1 year continuation.

POLICY UPDATE CHANGES

Updated documentation language to 'Patient has multiple antiretroviral drug resistance as demonstrated by' and specified 'resistance to at least one antiretroviral from at least THREE of the following antiviral classes'.

Removed 'Human Immunodeficiency Virus (HIV)-2' from Condition Not Covered.

Modified the continuation criterion examples of response by adding HIV RNA < 50 cells/mm3 and improvement or stabilization in CD4 T-cell count.

2Approval Durations (initial, continuation)

>=3Required antiviral classes with resistance

J1746Primary billing code

Coverage Summary

Trogarzo (ibalizumab-uiyk) is an intravenous monoclonal antibody indicated in combination with other antiretrovirals for heavily treatment-experienced adults (age ≥18) with multidrug‑resistant HIV‑1 who are failing their current antiretroviral regimen. The policy defines medical necessity criteria for both initial therapy (approved for 6 months) and continuation when the patient is currently receiving Trogarzo (approved for 1 year), requires prescription by or consultation with an HIV specialist, and requires use with an optimized antiviral background regimen.

Dosing Criteria

Approve the following dosing regimens:

Dosing

Loading dose of 2,000 mg as an intravenous infusion or intravenous push, given one time
Maintenance dose of 800 mg as an intravenous infusion or intravenous push given every 2 weeks
Missed-dose handling: If an 800-mg maintenance dose is missed by ≥ 3 days of the scheduled dosing day, approve an additional 2,000 mg loading dose and resume maintenance dosing thereafter

Applicable Codes

HCPCS - Drug J-codeHCPCSCovered

J1746

Injection, ibalizumab-uiyk, 10 mg

The policy identifies HCPCS code J1746 as the primary billing code for Trogarzo, where J1746 = Injection, ibalizumab-uiyk, 10 mg. Dosing per policy is a 2,000 mg IV loading dose once, then 800 mg IV every 2 weeks for maintenance; translate these into billing units by dividing the milligram dose by the code unit of 10 mg (for example, the 2,000 mg loading dose = 200 units of J1746, and the 800 mg maintenance dose = 80 units of J1746). The policy also allows an additional 2,000 mg loading dose if a maintenance dose is missed by ≥ 3 days, with maintenance dosing resumed thereafter.

Prior Authorization & Documentation

Prior Authorization

Prior Authorization Recommended

Prior Authorization is recommended for prescription benefit coverage of Trogarzo; approvals are provided for specified durations: 6 months for initial therapy and 1 year for continuation. Affected billing code: J1746 (Injection, ibalizumab-uiyk, 10 mg).

Initial approval duration: 6 months
Continuation approval duration: 1 year
Affected code: J1746 (10 mg units)

Documentation Required

Specialist Prescriber Requirement

Trogarzo must be prescribed by or in consultation with a physician who specializes in the treatment of HIV infection; documentation of specialist involvement is required for approval.

Documentation Required

Resistance Documentation

Document evidence of resistance to at least one antiretroviral from at least THREE antiviral classes and that Trogarzo will be used in combination with an optimized antiviral background regimen (one or more other antiretroviral agents).

Billing Rule

Dosing and Missed Dose Handling

Loading dose: 2,000 mg IV (infusion or IV push) given one time; Maintenance dose: 800 mg IV (infusion or IV push) every 2 weeks. If an 800-mg maintenance dose is missed by ≥ 3 days of the scheduled dosing day, approve an additional 2,000 mg loading dose and resume maintenance dosing thereafter.

Affected code: J1746
Unit conversion: J1746 = 10 mg

Clinical Evidence & Definitions

Selected references supporting this policy include the FDA Prescribing Information and HHS treatment guidelines:

• FDA Prescribing Information: Trogarzo injection, Theratechnologies; December 2023.

• HHS Guidelines: Guidelines for the use of antiretroviral agents in adults and adolescents with HIV; Last Updated September 23, 2024.

Optimized antiviral background regimen: A combination of one or more other antiretroviral agents selected to provide the best possible activity alongside Trogarzo, including at least one fully active agent when possible and continued in combination with Trogarzo as required by the policy.

Multiclass or three-class drug resistant HIV-1 infection: Presence of phenotypic or genotypic resistance to at least one drug in each of three antiretroviral classes (commonly nucleoside RTIs, non-nucleoside RTIs, and protease inhibitors) as described in the policy.

Surface thresholds

Age>= 18 years

Resistance classes requiredResistance to at least one antiretroviral from at least THREE antiviral classes

Continuation response examplesHIV RNA < 50 cells/mm3 or >= 0.5 log10 reduction from baseline or improvement/stabilization of CD4 T-cell count

Background

Trogarzo blocks HIV‑1 entry by binding to CD4 domain 2, interfering with post‑attachment steps required for viral entry and preventing cell‑cell fusion; this mechanism allows viral entry blockade without causing immunosuppression. It is indicated for heavily treatment‑experienced adults with multidrug‑resistant HIV‑1 who are failing current regimens and is intended to be used in combination with an optimized background antiretroviral regimen.

Revision History

8/1/2024revised

Annual review: Updated documentation language to 'Patient has multiple antiretroviral drug resistance as demonstrated by' and specified 'resistance to at least one antiretroviral from at least THREE of the following antiviral classes'. (material change)

9/15/2024revised

Selected revision: Modified continuation criterion examples of treatment response to add 'HIV RNA < 50 cells/mm3' and 'improvement or stabilization of CD4 T-cell count'; retained 'HIV-1 RNA ≥ 0.5 log10 reduction' as an example. (material change)

8/1/2024revised

Annual review: Added age requirement (Patient is ≥ 18 years of age) and specialist prescriber requirement (must be prescribed by or in consultation with a physician who specializes in HIV). (material change)

8/1/2024removed

Condition Not Covered: Removed 'Human Immunodeficiency Virus (HIV)-2' from conditions not covered. (non-material change)

6/1/2025effective_dateLatest

Policy effective date updated to 6/1/2025 reflecting current document; includes dosing and approval durations (no clinical policy statement changes beyond those above).