Ferric Derisomaltose (Monoferric) Form

Ferric derisomaltose (Monoferric™) injection is an iron replacement product. FDA Approved Indication(s) Monoferric is indicated for treatment of iron deficiency anemia (IDA) in adult patients: • Who have intolerance to oral iron or have had unsatisfactory response to oral iron • Who have non-hemodialysis dependent chronic kidney disease (NDD-CKD).
Policy/Criteria Provider must submit documentation (including 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 Monoferric is medically necessary when the following criteria are met:
I. Initial Approval Criteria A. Iron Deficiency Anemia with Chronic Kidney Disease (must meet all):

1. Diagnosis of IDA and CKD;
   2. IDA is confirmed by either of the following: a. Transferrin saturation (TSAT) ≤ 30%; b. Serum ferritin ≤ 500 ng/mL;
2. If CKD does not require hemodialysis or peritoneal dialysis, oral iron therapy is not optimal due to any of the following: a. TSAT < 12%; b. Hgb < 7 g/dL; c. Symptomatic anemia; d. Severe or ongoing blood loss; e. Oral iron intolerance; f. Unable to achieve therapeutic targets with oral iron; g. Co-existing condition that may be refractory to oral iron therapy;
3. Member meets one of the following (a or b): a. Failure of both of the following: Ferrlecit® and Venofer®; b. Member has intolerance or contraindication to both Ferrlecit and Venofer, and failure of Feraheme®;

4. Dose does not exceed 1000 mg elemental iron (10 mL) per infusion/injection. Approval duration: 3 months Page 1 of 7

   CLINICAL POLICY Ferric Derisomaltose B. Iron Deficiency Anemia without Chronic Kidney Disease (must meet all):

5. Diagnosis of IDA confirmed by any of the following: a. Serum ferritin < 15 ng/mL or < 30 ng/mL if pregnant; b. Serum ferritin ≤ 41 ng/mL and Hgb < 12 g/dL (women)/< 13 g/dL (men); c. TSAT < 20%; d. Absence of stainable iron in bone marrow; e. Increased soluble transferring receptor (sTfR) or sTfR-ferritin index; f. Increased erythrocyte protoporphyrin level;
6. Oral iron therapy is not optimal due to any of the following: a. TSAT < 12%; b. Hgb < 7 g/dL; c. Symptomatic anemia; d. Severe or ongoing blood loss; e. Oral iron intolerance; f. Unable to achieve therapeutic targets with oral iron; g. Co-existing condition that may be refractory to oral iron therapy;
7. At the time of the request, member does not have CKD;
   4. Member meets one of the following (a or b): a. Failure of two of the following: Ferrlecit, Infed, or Venofer; b. Member has intolerance or contraindication to all preferred injectable agents (e.g. Ferrlecit, Infed, or Venofer), and failure of Feraheme;
8. Dose does not exceed 1000 mg elemental iron (10 mL) per infusion/injection. Approval duration 3 months C. 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.
    II. Continued Approval Criteria A. Iron Deficiency Anemia with Chronic Kidney Disease (must meet all):

11. Member meets one of the following (a or b): Page 2 of 7

    CLINICAL POLICY Ferric Derisomaltose 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);

12. Documentation of one of the following laboratory results measured since the last IV iron administration: a. TSAT ≤ 30%; b. Serum ferritin ≤ 500 ng/mL;
13. If request is for a dose increase, new dose not exceed 1000 mg elemental iron (10 mL) per infusion/injection. Approval duration 3 months B. Iron Deficiency Anemia without Chronic Kidney Disease (must meet all):
14. 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);
15. Documentation of one of the following laboratory results measured since the last IV iron administration: a. Serum ferritin < 15 ng/mL or < 30 ng/mL if pregnant; b. Serum ferritin ≤ 41 ng/mL and Hb < 12 g/dL (women)/< 13 g/dL (men); c. TSAT < 20%; d. Absence of stainable iron in bone marrow; e. Increased sTfR or sTfR-ferritin index; f. Increased erythrocyte protoporphyrin level;
16. At the time of the request, member does not have CKD;
    4. If request is for a dose increase, new dose does not exceed 1000 mg elemental iron (10 mL) per infusion/injection. Approval duration 3 months C. Other diagnoses/indications (must meet 1 or 2):

17. 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 Page 3 of 7

    CLINICAL POLICY Ferric Derisomaltose

18. 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 policy – 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 Hgb: hemoglobin IDA: iron deficiency anemia NDD-CKD: non-hemodialysis-dependent chronic kidney disease TSAT: transferrin saturation sTfR: soluble transferring receptor 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 and may require prior authorization. Drug Name Dosing Regimen Dose Limit/ Maximum Dose Examples of OTC Oral Iron Formulations Ferrous fumarate (Ferretts, Ferrimin 150) Ferrous gluconate (Ferate) Ferrous sulfate (BProtected Pedia Iron, Fer-In-Sol, FeroSul, Iron Supplement, Iron Supplement Childrens, Slow Fe, Slow Iron) Polysaccharide-iron complex (EZFE 200, Ferrex 150, Ferrix x- 150, IFerex 150, NovaFerrum 125, NovaFerrum, NovaFerrum Pediatric Drops, Nu-Iron, Poly-Iron 150) Injectable iron agents Sodium ferric gluconate (Ferrlecit) Infed (iron dextran) Venofer (iron sucrose) Feraheme (ferumoxytol)
    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. Oral formulations include elixirs, liquids, solutions, syrups, capsules, and tablets - including delayed/extended-release tablets.
    Varies Varies Page 4 of 7

    CLINICAL POLICY Ferric Derisomaltose Appendix C: Contraindications/Boxed Warnings • Contraindication(s): Serious hypersensitivity to Monoferric or any of its components. • Boxed warning(s): None reported. V. Dosage and Administration
    Indication IDA Dosing Regimen ≥ 50 kg: 1,000 mg IV as a single dose. Repeat dose if IDA reoccurs.
    < 50 kg: 20 mg/kg actual body weight by IV infusion as a single dose. Repeat dose if IDA reoccurs. Maximum Dose 1,000 mg per dose (treatment may be repeated)
    VI. Product Availability
    Single-dose vials: 1,000 mg/10 mL, 500 mg/5 mL, 100 mg/mL VII.