FUZEON, Enfuvirtide Form

Enfuvirtide (Fuzeon®) is a human immunodeficiency virus-1 (HIV-1) fusion inhibitor. FDA Approved Indication(s) Fuzeon is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment experienced patients with HIV-1 replication despite ongoing antiretroviral therapy. 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 Fuzeon is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. HIV-1 Infection (must meet all):

1. Diagnosis of HIV-1 infection;
2. Prescribed by or in consultation with an infectious disease or HIV specialist;
3. Age ≥ 6 years;
4. Failure of ≥ 12 weeks of antiretroviral therapy which includes 2 nucleoside analogue reverse transcriptase inhibitors and 1 drug from one of the following classes: an integrase strand transfer inhibitor, a nonnucleoside analogue reverse transcriptase inhibitor, or a pharmacokinetic enhanced protease inhibitor;
   
   5. Current (within the past 30 days) HIV ribonucleic acid viral load ≥ 200 copies/mL;

5. Fuzeon is prescribed concurrently with additional antiretroviral agents to which the member is susceptible;

   7. Dose does not exceed 180 mg per day. Approval duration:
      Medicaid/HIM – 6 months Commercial – 6 months or to the member’s renewal date, whichever is longer B. Other diagnoses/indications (must meet 1 or 2):
   8. 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 Enfuvirtide 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

   2. 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):
   3. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Fuzeon for HIV-1 infection and has received this medication for at least 30 days;
   4. Member is responding positively to therapy;

6. If request is for a dose increase, new dose does not exceed 180 mg per day. Approval duration:
   Medicaid/HIM – 12 months
   Commercial – 6 months or to the member’s renewal date, whichever is longer
   B. Other diagnoses/indications (must meet 1 or 2):

   1. 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
   2. 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 Enfuvirtide 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-1 RNA: ribonucleic acid 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 Refer to prescribing information Nucleos(t)ide reverse transcriptase inhibitors (NRTIs) (e.g., abacavir, tenofovir disoproxil fumarate, Emtriva®, etc.) Non-nucleoside reverse transcriptase inhibitors (NNRTIs) (e.g., efavirenz, nevirapine, Edurant®, etc.) Integrase strand transfer inhibitors (INSTIs) (e.g., Tivicay®, Isentress®) Protease inhibitors (PIs) (e.g., atazanavir, fosamprenavir, Invirase®, Viracept®, etc.) Fixed-dose combinations (e.g., Genvoya®, Stribild®, Odefsey®, Descovy®, Truvada®, etc.) 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 Refer to prescribing information Refer to prescribing information Refer to prescribing information Refer to prescribing information Refer to prescribing information Appendix C: Contraindications/Boxed Warnings • Contraindication(s): hypersensitivity to Fuzeon or any of its components • Boxed warning(s): none reported
   Appendix D: General Information Per the Department of Health and Human Services Antiretroviral Guidelines: • Evaluation of virologic failure should include as assessment of adherence, drug-drug and drug-food interactions, drug tolerability, HIV ribonucleic acid (RNA), and CD4 T lymphocyte (CD4) cell count trends over time, treatment history, and prior and current drug-resistance testing results. Page 3 of 6

   CLINICAL POLICY Enfuvirtide • Virologic failure is defined as the inability to achieve or maintain suppression of viral replication to an HIV RNA level < 200 copies/mL. Patients with levels persistently above 200 copies/mL, especially > 500 copies/mL, often develop drug resistance. • Virologic suppression is defined as a confirmed HIV RNA level below the lower limit of assay detection (LLOD). • There is no consensus regarding how to manage patients with HIV RNA above LLOD and < 200 copies/mL. The risk of emerging resistance is believed to be relatively low. HIV RNA levels should be monitored at least every 3 months to assess the need for changes in antiretroviral therapy in the future.
   V. Dosage and Administration
   Indication HIV-1 infection Adults: 90 mg SC BID Dosing Regimen Maximum Dose 180 mg/day Pediatric patients weighing at least 11 kg: 2 mg/kg SC BID up to 90 mg SC BID VI. Product Availability
   Lyophilized powder in vial: 108 mg (90 mg/mL when reconstituted) VII.