Last Review Date: 01/06/2025

Date of Origin: 04/03/2018

Dates Reviewed: 04/2018, 08/2018, 08/2019, 08/2020, 12/2021, 12/2022, 12/2023, 01/2024, 01/2025

1. Length of Authorization

Initial coverage is provided for 6 months and may be renewed annually.

2. Dosing Limits

      Max Units (per dose and over time) [HCPCS Unit]:

• Load: 200 billable units one time only
• Maintenance: 80 billable units every 14 days

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Universal Criteria ¹

• Used in combination with highly active antiretroviral therapy (HAART) for which, via resistance testing, the patient’s disease is known to be sensitive/susceptible; AND

Human Immunodeficiency Virus Type-1 (HIV-1) † ‡ Ф ^1-4

• Patient has heavily treated multi-drug resistant disease, confirmed by resistance testing, to at least one drug in at least three classes** (see table below); AND
• Patient has a baseline viral load ≥ 200 copies/mL; AND
• Patient is failing on their current anti-retroviral regimen

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ^1-3

Coverage can be renewed based upon the following criteria:

• Patient continues to meet the universal and other indication-specific relevant criteria identified in section III; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: hypersensitivity reactions including infusion-related reactions and anaphylactic reactions, immune reconstitution inflammatory syndrome (IRIS), etc.; AND
• Disease response as indicated by a decrease in viral load from pretreatment baseline
  • Note: increases in viral load from nadir and/or less than anticipated reduction from baseline should prompt resistance testing for susceptibility and optimization of the background regimen

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS code:

• J1746 - Injection, ibalizumab-uiyk, 10 mg; 1 billable unit = 10 mg

NDC:

• Trogarzo 200 mg/1.33 mL single-dose vial: 62064-0122-xx

7. References

1. Trogarzo [package insert]. Montreal, Quebec Canada; Theratechnologies, Inc.; December 2023. Accessed December 2024.
2. Emu B, Fessel J, Schrader S, et al. Phase 3 Study of Ibalizumab for Multidrug-Resistant HIV-1. N Engl J Med. 2018 Aug 16;379(7):645-654.
3. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. Department of Health and Human Services. Available at https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv. Last updated 09/12/2024. Accessed 12/02/2024.
4. HIV Overview. FDA-Approved HIV Medicines. Department of Health and Human Services. Available at https://hivinfo.nih.gov/understanding-hiv/fact-sheets/fda-approved-hiv-medicines. Last updated 07/31/2024. Accessed 12/2/2024.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCA/LCD): N/A