Last Review Date: 12/01/2022

Date of Origin: 04/03/2018

Dates Reviewed: 04/2018, 08/2018, 08/2019, 08/2020, 12/2021, 12/2022

1. Length of Authorization

Coverage is provided for six months and may be renewed.

2. Dosing Limits

A. Quantity Limit (max daily dose) [NDC Unit]:

Trogarzo 200 mg single-dose vial: 10 vials initially followed by 4 vials every 14 days thereafter.

B. 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 old; 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 ^1-3

• 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 > 1,000 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 ^1,2

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 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

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.; October 2022. Accessed November 2022.
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 9/21/2022. Accessed 11/16/2022

Appendix 1 – Covered Diagnosis Codes

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

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 Determination (NCD), Local Coverage Articles (LCAs) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.

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