TROGARZO, Ibalizumab-uiyk Form

Ibalizumab-uiyk (Trogarzo®) is a CD4-directed post-attachment human immunodeficiency virus type 1 (HIV-1) inhibitor. FDA Approved Indication(s) Trogarzo is indicated for the treatment of HIV-1 infection, in combination with other antiretroviral(s), in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Trogarzo is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. HIV-1 Infection (must meet all):

1. Diagnosis of multidrug resistant HIV-1 infection;
   2. Prescribed by or in consultation with an infectious disease or HIV specialist;
   3. Age ≥ 18 years;
   4. 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;
2. 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;
3. Current (within the past 30 days) HIV ribonucleic acid viral load of ≥ 200 copies/mL;
   
   7. Prescribed concurrently with additional antiretroviral agents to which member is susceptible, if available;

4. 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 Page 1 of 6

   CLINICAL POLICY Ibalizumab-uiyk B. Other diagnoses/indications (must meet 1 or 2):

5. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
6. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. HIV-1 Infection (must meet all):
7. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Trogarzo for multidrug resistant HIV-1 infection and has received this medication for at least 30 days;
8. Member is responding positively to therapy;
   3. 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. A loading dose may be repeated if the member misses scheduled maintenance dose by 3 days or more. Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):
9. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

10. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
    Page 2 of 6

    CLINICAL POLICY Ibalizumab-uiyk III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration HIV-1: human immunodeficiency virus NNRTI: non-nucleoside reverse transcriptase inhibitor type 1 NRTI: nucleos(t)ide reverse transcriptase INSTI: integrase strand transfer inhibitors inhibitor PI: protease inhibitor Appendix B: Therapeutic Alternatives
    This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
    Drug Name Dosing Regimen Refer to prescribing information Dose Limit/ Maximum Dose Refer to prescribing information Nucleos(t)ide reverse transcriptase inhibitors (NRTIs) (e.g., abacavir, tenofovir disoproxil fumarate, Emtriva®) Non-nucleoside reverse transcriptase inhibitors (NNRTIs) (e.g., efavirenz, nevirapine, Edurant®) Protease inhibitors (PIs) (e.g., atazanavir, fosamprenavir, Invirase®, Viracept®) Fuzeon® (enfurvirtide, T-20)
    Selzentry® (maraviroc, MVC) Refer to prescribing information Refer to prescribing information Refer to prescribing information Refer to prescribing information Refer to prescribing information Refer to prescribing information Adults: 180 mg/day Children 6 years and older: 4 mg/kg/day 600 mg/day; 1,200 mg/day if taking a potent CYP3A inducer Refer to prescribing information Fixed-dose combinations (e.g., Genvoya®, Stribild®, Odefsey®, Descovy®, Truvada®) Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Refer to prescribing information Page 3 of 6

    CLINICAL POLICY Ibalizumab-uiyk Appendix C: Contraindications/Boxed Warnings • Contraindication(s): prior hypersensitivity to Trogarzo or any components of the product • Boxed warning(s) none reported V. Dosage and Administration Indication HIV-1 infection Dosing Regimen A single loading dose of 2,000 mg IV, followed by a maintenance dose of 800 mg every 2 weeks. If a maintenance dose is missed by 3 days or longer beyond the scheduled dosing day, a loading dose of 2,000 mg should be administered as early as possible prior to resuming maintenance dosing of 800 mg every 2 weeks thereafter. Maximum Dose A loading dose of 2,000 mg up to every 17 days A maintenance dose of 800 mg every 14 days Frequency of every 17 days was calculated from frequency of maintenance dose (every 14 days) plus minimum number of days that the dose is missed to qualify for another loading dose (3 days). VI. Product Availability Injection in single-dose vial: 200 mg/1.33 mL (150 mg/mL) VII.