CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Trogarzo (ibalizumab-uiyk) therapy for multidrug-resistant HIV-1

Defines medical benefit coverage, dosing, authorization length, initial and renewal clinical criteria, billing codes, and NDC for Trogarzo (ibalizumab-uiyk) for Medicaid and Commercial lines (Neighborhood Health Plan of Rhode Island). Applies to adults with heavily treatment-experienced, multidrug-resistant HIV-1.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTrogarzo (ibalizumab-uiyk) therapy for multidrug-resistant HIV-1

Policy CodePolicy N/A

Change Typeclarified

Effective Date

Next Review Date

Key ActionPrescriber must submit documentation of resistance testing and baseline viral load and confirm patient meets initial criteria (age ≥18, resistance to ≥1 drug in ≥3 classes, baseline viral load ≥1,000 copies/mL, current HAART background regimen and susceptibility).

POLICY UPDATE CHANGES

Reviewed dates listed through 05/2025; medical scope includes Medicaid and Commercial.

18+Minimum age (years)

>=1,000Baseline viral load threshold (copies/mL)

200Loading dose (billable units)

80Maintenance dose per 14 days (billable units)

Coverage stance: covered_with_criteria for Trogarzo (ibalizumab-uiyk). Scope: Medicaid and Commercial lines for adults with heavily treatment-experienced, multidrug-resistant HIV-1. Effective/last review: Last review: 2025-05.

Quick facts and thresholds

Minimum age18+ years

Baseline viral load threshold>= 1,000 copies/mL

Loading dose (billable units)200 units (2000 mg)

Maintenance dose per 14 days (billable units)80 units (800 mg) every 14 days

Initial Therapy Criteria

Initial Approval Criteria

Coverage is provided when ALL of the following conditions are met:

Age: Patient is at least 18 years old
Multidrug resistance: Patient has heavily treated multi-drug resistant disease; confirmed by resistance to at least one drug in at least three classes
Classes enumerated in policy (NRTI, NNRTI, PI, etc.)
Baseline viral load is >= 1,000 copies/mL>= 1,000 copies/mL
Current regimen: Patient is on their current antiretroviral regimen
Background regimen susceptibility: Trogarzo will be used in combination with a highly active antiretroviral therapy (HAART) background regimen to which the patient's virus is known or expected to be susceptible
Requires susceptibility/resistance testing and optimization of background regimen

Continuation / Renewal Criteria

Renewal Criteria

Coverage may be renewed when ALL of the following are met:

Continued eligibility: Patient continues to meet the initial criteria
Toxicity: Absence of unacceptable toxicity
Examples include immune reconstitution inflammatory syndrome (IRIS) and other significant adverse events
Disease response: Documented disease response as indicated by a decrease in viral load from pretreatment baseline
Increases from nadir or less-than-expected reduction should prompt resistance/susceptibility testing and optimization of the background regimen

Unproven / Exclusions

Safety warnings: Trogarzo carries FDA warnings for hypersensitivity reactions, immune reconstitution inflammatory syndrome (IRIS), and embryofetal toxicity. Situations that may lead to denial or are not supported: renewal or continued coverage may be denied for unacceptable toxicity (e.g., IRIS) or lack of disease response (no decrease in viral load from pretreatment baseline) per provider documentation requirements.

Applicable Codes

HCPCS / J-code for drug administrationHCPCSCovered

J1746

Injection, ibalizumab-uiyk, 10 mg; 1 billable unit = 10 mg

Covered ICD-10 Diagnosis CodesICD-10Covered

B20	Human immunodeficiency virus [HIV] disease

NDCsNDCCovered

62064-0122-xx

Trogarzo 200 mg/1.33 mL single-dose vial

Provider Actions & Billing

Prior Authorization

Prior authorization required

Coverage requires prior authorization. To support approval submit documentation that the patient is ≥18 years old, has resistance to at least one drug in at least three drug classes, a baseline viral load ≥1,000 copies/mL, and is on a current HAART background regimen to which the virus is known or expected to be susceptible. Include resistance testing results and the pretreatment baseline viral load with the request.

Affected codes: J1746, B20
Submit: resistance testing and baseline viral load

Documentation Required

Document resistance and regimen details

The prescriber must document resistance to at least one drug in at least three classes and provide the patient’s current antiretroviral (HAART) regimen along with evidence that the background regimen is known or expected to be susceptible (e.g., susceptibility/resistance testing).

Denial Risk

Denial risk for inadequate response or toxicity

Renewal may be denied for unacceptable toxicity (examples include immune reconstitution inflammatory syndrome, IRIS) or for lack of disease response. Renewal requires a decrease in viral load from the pretreatment baseline; increases from nadir or less-than-expected reductions should prompt reassessment with resistance/susceptibility testing and optimization of the background regimen and may lead to denial if response is inadequate.

Billing Rule

Dose units and billing

Bill J1746 units corresponding to the milligrams administered (1 billable unit = 10 mg). For example, the one-time loading dose of 2000 mg should be billed as 200 units; maintenance dosing of 800 mg every 14 days should be billed as 80 units per maintenance dose.

Code: J1746
Conversion: 1 unit = 10 mg
Examples: 2000 mg = 200 units (load); 800 mg = 80 units (maintenance every 14 days)

Documentation Required

Administration route and missed dose handling

The 2000 mg loading dose must be given as an IV infusion. Maintenance doses (800 mg every 14 days) may be given as an IV infusion or as undiluted IV push. If a maintenance dose is missed by 3 days or more beyond the scheduled day, give a loading dose (2000 mg) as soon as possible and then resume the maintenance schedule.

Clinical Evidence

RefKey reference: Trogarzo package insert (Dec 2024; accessed May 2025) and N Engl J Med 2018 study

Evidence summary: Efficacy of Trogarzo was established in a single-arm, multicenter clinical trial in heavily treatment-experienced adults with multidrug-resistant HIV-1, with primary evidence reported in the package insert (Theratechnologies, Dec 2024) and the N Engl J Med 2018 study. Main safety warnings include hypersensitivity, IRIS, and embryofetal toxicity.

Background & Definitions

Background: Trogarzo (ibalizumab-uiyk) is a CD4-directed post-attachment HIV-1 inhibitor indicated in combination with other antiretrovirals for heavily treatment-experienced adults with multidrug-resistant HIV-1. In the pivotal single-arm trial, 83% of subjects achieved ≥0.5 log10 decrease in viral load during the functional monotherapy period; at week 25, 43% achieved <50 copies/mL and 50% achieved <200 copies/mL. Key warnings include hypersensitivity reactions, immune reconstitution inflammatory syndrome (IRIS), and embryofetal toxicity.

Term	Definition
HAART
Highly active antiretroviral therapy; background antiretroviral regimen to be used in combination with Trogarzo.
Loading dose
A single 2000 mg IV infusion administered one time.
Maintenance dose
800 mg administered every 14 days by IV infusion or undiluted IV push.

Revision History

2025-05reviewLatest

Reviewed dates listed through 05/2025; medical scope includes Medicaid and Commercial

2019-09review

Reviewed: 9/2019

2020-08review

Reviewed: 8/2020

2021-04review

Reviewed: 4/2021

2022-02review

Reviewed: 2/2022

2023-03review

Reviewed: 3/2023

2023-12review

Reviewed: 12/2023

2024-01review

Reviewed: 01/2024

change_flagLatest

Non-material change: Document notes multiple review dates and scope but contains no explicit material clinical change