Ferric Pyrophosphate (Triferic, Triferic Avnu) Form

Ferric pyrophosphate (Triferic®, Triferic Avnu®) is an iron replacement product. FDA Approved Indication(s) Triferic/Triferic Avnu is indicated for the replacement of iron to maintain the hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD). Limitation(s) of use:
• Triferic/Triferic Avnu is not intended for use in patients receiving peritoneal dialysis. • Triferic/Triferic Avnu has not been studied in patients receiving home hemodialysis. 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 Triferic/Triferic Avnu is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Iron Replacement Therapy with Hemodialysis-Dependent Chronic Kidney Disease (must meet all):

1. Diagnosis of iron replacement therapy with HDD-CKD;
2. Transferrin saturation (TSAT) ≤ 30%;
3. Serum ferritin ≤ 500 ng/mL;

4. Documentation that Triferic/Triferic Avnu is not used for peritoneal dialysis or home hemodialysis;

   5. Failure of Ferrlecit® and Venofer®, unless clinically significant adverse effects are experienced or both are contraindicated;
   6. Dose does not exceed 6.75 mg elemental iron per infusion/injection.
      Approval duration: 3 months B. Other diagnoses/indications (must meet 1 or 2):
   7. 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: Page 1 of 6

   CLINICAL POLICY Ferric Pyrophosphate Citrate 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. Iron Replacement Therapy with Hemodialysis-Dependent Chronic Kidney Disease
      (must meet all):

5. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);

   2. Member is responding positively to therapy as evidenced by, including but not limited to, improvement in any of the following parameters (a, b, or c): a. Hgb; b. TSAT; c. Serum ferritin;
   3. If request is for a dose increase, new dose does not exceed 6.75 mg elemental iron per infusion/injection.
      Approval duration: 3 months B. Other diagnoses/indications (must meet 1 or 2):
   4. 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
   5. 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 Page 2 of 6

   CLINICAL POLICY Ferric Pyrophosphate Citrate 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 – 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 CKD: chronic kidney disease HDD-CKD: hemodialysis-dependent chronic kidney disease Hgb: hemoglobin TSAT: transferrin saturation 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 125 mg of elemental iron per dose Sodium ferric gluconate complex in sucrose (Ferrlecit®) Adults: 125 mg by IV infusion or injection per dialysis session.

   • May require a cumulative dose of 1000 mg over 8 dialysis sessions. Children age ≥ 6 years: 1.5 mg/kg administered by IV infusion per dialysis session. 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. Appendix C: Contraindications/Boxed Warnings None reported
     V. Dosage and Administration
     Indication Iron replacement to maintain hemoglobin in patients with hemodialysis-dependent chronic kidney disease Dosing Regimen 6.75 mg IV administered by slow IV infusion over 3 to 4 hours at each hemodialysis session Maximum Dose Varies Maximum dosage is not defined for hemodialysate use; dose is dependent on dialysate volume used during hemodialysis session.
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   CLINICAL POLICY Ferric Pyrophosphate Citrate VI. Product Availability
   Drug Name Triferic (ferric pyrophosphate solution) Triferic (ferric pyrophosphate citrate powder) Triferic Avnu (ferric pyrophosphate injection) Availability Single dose ampule: 5.44 mg/mL (5 mL) Powder packets for injection: 272 mg
   Injection in single-dose luer lock ampule: 6.75 mg iron (III) per 4.5 mL solution (1.5 mg iron (III) per mL)
   VII.