Ferumoxytol (Feraheme) Form

Ferumoxytol (Feraheme®) injection is an iron replacement product. FDA Approved Indication(s) Feraheme is indicated for the 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 chronic kidney disease (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 Feraheme is medically necessary when the following criteria are met:
I. Initial Approval Criteria A. Iron Deficiency Anemia associated 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. Failure of both of the following agents: Ferrlecit® and Venofer®, unless clinically significant adverse effects are experienced or both are contraindicated;
   5. If request is for Feraheme, member must use generic ferumoxytol, unless contraindicated or clinically significant adverse effects are experienced;

4. Dose does not exceed 510 mg elemental iron per infusion/injection. Approval duration: 3 months Page 1 of 8

   CLINICAL POLICY Ferumoxytol 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. Failure of two of the following agents, unless clinically significant adverse effects are experienced or all are contraindicated: Ferrlecit®, Infed®, or Venofer®;
   5. If request is for Feraheme, member must use generic ferumoxytol, unless contraindicated or clinically significant adverse effects are experienced;
8. Dose does not exceed 510 mg elemental iron 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 Therapy A. Iron Deficiency Anemia with Chronic Kidney Disease (must meet all):

11. Member meets one of the following (a or b): Page 2 of 8

    CLINICAL POLICY Ferumoxytol 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. Failure of both of the following agents: Ferrlecit and Venofer, unless clinically significant adverse effects are experienced or both are contraindicated;
    4. If request is for Feraheme, member must use generic ferumoxytol, unless contraindicated or clinically significant adverse effects are experienced;
14. If request is for a dose increase, new dose does not exceed 510 mg elemental iron per infusion/injection. Approval duration 3 months B. Iron Deficiency Anemia without Chronic Kidney Disease (must meet all):
15. 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);
16. 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;
17. At the time of the request, member does not have CKD;
    4. Failure of two of the following agents, unless clinically significant adverse effects are experienced or all are contraindicated: Ferrlecit, Infed, or Venofer;
18. If request is for Feraheme, member must use generic ferumoxytol, unless contraindicated or clinically significant adverse effects are experienced;
19. If request is for a dose increase, new dose does not exceed 510 mg elemental iron per infusion/injection. Approval duration 3 months C. Other diagnoses/indications (must meet 1 or 2):

20. 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 3 of 8

    CLINICAL POLICY Ferumoxytol 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

21. 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 ESA: erythropoiesis stimulating agent Hb: hemoglobin IDA: iron deficiency anemia 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) Varies Varies Page 4 of 8

    CLINICAL POLICY Ferumoxytol Drug Name Dosing Regimen Dose Limit/ Maximum Dose Venofer (iron sucrose) 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.
    Appendix C: Contraindications/Boxed Warnings • Contraindication(s): Known hypersensitivity to Feraheme or any of its components; history of allergic reaction to any intravenous iron product. • Boxed warning(s): Serious hypersensitivity/anaphylaxis reactions. V. Dosage and Administration
    Indication Dosing Regimen IDA with or without CKD (adults) 510 mg IV infusion followed by a second 510 mg IV infusion 3 to 8 days later.
    For patients receiving hemodialysis, administer after at least one hour of hemodialysis. Maximum Dose 510 mg per dose -Treatment course: 1020 mg
    -Treatment may be repeated VI. Product Availability
    Intravenous solution single-dose vial: 510 mg/17 mL (17 mL) VII.