Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Trogarzo (ibalizumab) requires prior authorization.

2)    Trogarzo is used to treat multi-drug resistant HIV infection.

3)    Trogarzo is covered under the medical benefit.

Trogarzo (ibalizumab) is considered medically necessary in members meeting the following criteria:

I.             Initial Approval Criteria

a.    HIV-1 Infection (must meet all)

                                         i.    Diagnosis of multidrug resistant HIV-1 infectoin;

                                        ii.    Prescribed by or in consultation with an infectious disease or HIV specialist;

                                       iii.    Age ≥ 18 years;

                                       iv.    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;

                                        v.    Failure of one of the following, unless clinically significant adverse effects are experienced, both are contraindicated, or member is resistant to both: Fuzeon®, Selzentry® if CCR5 tropic;

                                       vi.    Current (within the past 30 days) HIV ribonucleic acid viral load of ≥ 200 copies/mL;

                                      vii.    Prescribed concurrently with additional antiretroviral agents to which member is susceptible, if available;

                                   viii.    Dose does not exceed 2,000 mg (10 vials) IV loading dose* and/or 800 mg (4 vials) IV every 14 days.

   *A loading dose may be repeated if the member misses scheduled maintenance dose by 3 days or more

                        Approval Duration: 6 months

II.            Continued Therapy

a.    Member is responding positively to therapy

b.    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.

Approval Duration: 12 months

Codes Used In This BI:

1)    J1746 – Injection, ibalizumab, 200mg

1)    Trogarzo Prescribing Information. Irvine, CA: TaiMEd Biologics USA Corp.; October 2022. Available at: https://www.trogarzo.com. Accessed January 4, 2023

2)    Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV. US Department of Health and Human Services. Last updated September 21, 2022. Available at: https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescentarv/whats-new-guidelines. Accessed January 23, 2023.