Fostemsavir (Rukobia) Form

Fostemsavir (Rukobia®) is a human immunodeficiency virus type 1 (HIV-1) gp120-directed attachment inhibitor. FDA Approved Indication(s) Rukobia is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations. 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 Rukobia 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 contraindicated or clinically significant adverse effects are experienced;
2. Failure of one of the following at up to maximally indicated dose, 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 ≥ 200 copies/mL;
   7. Prescribed concurrently with additional antiretroviral agents to which member is susceptible, if available;
4. Dose does not exceed 1,200 mg (2 tablets) per day. Approval duration: 6 months 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): Page 1 of 6

   CLINICAL POLICY Fostemsavir 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 Rukobia for a covered indication 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 1,200 mg (2 tablets) per day.
      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. 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 – Page 2 of 6

    CLINICAL POLICY Fostemsavir 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 CYP: cytochrome P450
    FDA: Food and Drug Administration HIV-1: human immunodeficiency virus type 1
    NNRTI: non-nucleoside reverse transcriptase inhibitor
    NRTI: nucleos(t)ide reverse transcriptase 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 Dose Limit/ Maximum Dose Refer to prescribing information Refer to prescribing information Refer to prescribing information 180 mg per day 1,200 mg per day 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® (enfuvirtide) maraviroc (Selzentry®) Refer to prescribing information
    Refer to prescribing information Refer to prescribing information 90 mg SC BID • Concomitant CYP3A inhibitors with or without potent CYP3A inducers: 150 mg PO BID • Concomitant NRTIs, tipranavir/ritonavir, nevirapine, raltegravir, and other drugs that are not potent CYP3A inhibitors or CYP3A inducers: 300 mg PO BID • Concomitant CYP3A inducers without a potent CYP3A inhibitor: 600 mg PO BID 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. Page 3 of 6

    CLINICAL POLICY Fostemsavir Appendix C: Contraindications/Boxed Warnings • Contraindication(s): hypersensitivity, co-administration with strong cytochrome P450 (CYP)3A inducers
    • Boxed warning(s): none reported V. Dosage and Administration
    Indication HIV-1 infection Dosing Regimen 600 mg PO BID with or without food Maximum Dose 1,200 mg per day VI. Product Availability
    Extended-release tablet: 600 mg VII.