RXMP-04 Iron Preparations Form

Iron Preparations

Updated on: 12/23/2025

Page 1 of 6 Policy Number RXMP-04 Line of Business Medicaid & Medicare Effective Date 1/12/2015 Revision Date 12/23/2025

Products: Monoferric, Injectafer, Triferic, Infed, Venofer, Ferrlecit, Ferahme

Override(s)
Approval Duration
Prior Authorization
Initial: 3 months; COC: 1 year

Table 1: Drugs that may be used in ESRD Dialysis (not all inclusive)
HCPCS Code
Description J1437 Injection, ferric derisomaltose, 10 mg (Monoferric) J1439 Injection, ferric carboxymaltose, 1 mg (Injectafer) J1443 Injection, ferric pyrophosphate citrate solution (Triferic), 0.1mg of iron J1750 Injection, iron dextran, 50 mg (Infed) J1756 Injection, iron sucrose, 1 mg (Venofer) (Preferred) J2916 Injection, sodium ferric gluconate complex in sucrose injection, 12.5 mg (Ferrlecit) (Preferred)
Q0138 Injection, ferumoxytol, for treatment of iron deficiency anemia, 1 mg (non-esrd use) (Feraheme) Medicare (new starts only)/Medicaid preferred agents: Venofer or Ferrlecit

Medicare Part B Coverage Criteria
Review using the most current Local Coverage Determination (LCD), National Coverage Determination (NCD), or Local Coverage Article (LCA) that applies to the Hawaii region. The LCD, NCD, or LCA can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. • No LCD/NCD/LCA found as of 8/28/2025. Review using [drug name] criteria below Medicare Part B 90-Day Transition Period For new Medicare members, a 90-day transition period applies. During this time, if a member is currently on an active course of the requested treatment, including when furnished by an out-of-network provider, Coverage and Step Therapy do not apply. After the first 90 days of enrollment, Coverage and Step Therapy Criteria must be met for continued coverage. Medicare Part B Step Therapy Criteria The member has had a trial of, an inadequate response, or intolerance to two (2) both Ferrlecit (Injection, sodium ferric gluconate complex in sucrose injection, 12.5 mg) and Venofer (Injection, iron sucrose, 1 mg).

Approval Criteria Products FERAHEME [Q1038, Injection, ferumoxytol, for treatment of iron deficiency anemia, 1 mg (non- esrd use)] FERRLECIT [J2916, Injection, sodium ferric gluconate complex in sucrose injection, 12.5 mg [Ferrlecit]] (Preferred) INFED [J1750, Injection, iron dextran, 50 mg] INJECTAFER [J1439, Injection, ferric carboxymaltose, 1 mg] VENOFER [J1756, Injection, iron sucrose, 1 mg] (Preferred) Approval Length Initial 6 months, Renewal 1 year Override Type PA, QL Diagnosis: Iron Deficiency Anemia Due to Chronic Kidney Disease (CKD) or Inflammatory Condition

1. Diagnosis of iron deficiency anemia due to chronic kidney disease (CKD) or an inflammatory condition (such as inflammatory bowel disease [IBD], heart failure) AND
2. Anemia is confirmed by one of the following are met, labs are within the last four (4) weeks:
   a. Serum ferritin levels less than 100 ng/mL
   b. TSAT levels less than 20%
   c. Serum ferritin is less than or equal to 500 ng/mL and TSAT is less than or equal to 30%

Iron Preparations

Updated on: 12/23/2025

Page 2 of 6 d. Bone marrow demonstrates inadequate iron stores
AND

3. The member has had a four (4) week trial of, an inadequate response, or intolerance to oral iron supplementation AND
4. Request for Feraheme, Injectafer, or Infed: The member has had a trial of, an inadequate response, or intolerance to both Ferrlecit (Injection, sodium ferric gluconate complex in sucrose injection, 12.5 mg) and Venofer (Injection, iron sucrose, 1 mg)
5. Note: For Medicare: Step Therapy Criteria applies to new start only. Diagnosis: Iron Deficiency Anemia Due to Cancer/Chemotherapy or Non-Inflammatory Conditions
6. Diagnosis of iron deficiency anemia due to cancer/chemotherapy or non-inflammatory conditions (such as blood loss, malabsorption, malnutrition) AND
7. Anemia is confirmed by one of the following are met, labs are within the last four (4) weeks:
   a. Serum ferritin levels less than 30 ng/mL
   b. TSAT levels less than 20%
   c. Bone marrow demonstrates inadequate iron stores AND
8. The member has had a four (4) week trial of, an inadequate response, or intolerance to oral iron supplementation AND
9. Request for Feraheme, Injectafer, or Infed: The member has had a trial of, an inadequate response, or intolerance to both Ferrlecit (Injection, sodium ferric gluconate complex in sucrose injection, 12.5 mg) and Venofer (Injection, iron sucrose, 1 mg) AND
10. For Infed: The member requires intramuscular (IM) administration due to difficult vein access that precludes use of an intravenous iron deficiency agent.
11. Note: For Medicare: Step Therapy Criteria applies to new start only. Diagnosis: Iron Deficiency Anemia in Pregnancy
12. Diagnosis of iron deficiency anemia in pregnancy AND
13. Anemia is confirmed by one of the following (a, b, or c) a. Serum ferritin levels less than 30 ng/mL b. TSAT levels less than 20% c. Bone marrow demonstrates inadequate iron stores AND
14. ONE of the following: a. Member is past 14 weeks of pregnancy and has had a four (4) week trial of and inadequate response, or intolerance to oral iron supplementation b. Member is past 14 weeks of pregnancy and diagnosed with severe iron deficiency anemia, defined as Hemoglobin (HGB) less than 8 g/dL OR c. Member is past 34 weeks of pregnancy AND
15. Request for Feraheme, Injectafer, or Infed: The member has had a trial of, an inadequate response, or intolerance to two (2) both Ferrlecit (Injection, sodium ferric gluconate complex in sucrose injection, 12.5 mg) and Venofer (Injection, iron sucrose, 1 mg) AND
16. For Infed: The member requires intramuscular (IM) administration due to difficult vein access that precludes use of an intravenous iron deficiency agent.

17. Note: For Medicare: Step Therapy Criteria applies to new start only.

    Products Monoferric [J1437, Injection, ferric derisomaltose, 10 mg] Approval Length Initial 6 months, Renewal 1 year Override Type PA, QL Diagnosis: Iron Deficiency Anemia Due to Chronic Kidney Disease (CKD) or Inflammatory Condition

Iron Preparations

Updated on: 12/23/2025

Page 3 of 6

1. Diagnosis of iron deficiency anemia due to chronic kidney disease (CKD) not on dialysis or an inflammatory condition (such as inflammatory bowel disease [IBD], heart failure) AND
2. Anemia is confirmed by one of the following are met, labs are within the last four (4) weeks:
   a. Serum ferritin levels less than 100 ng/mL
   b. TSAT levels less than 20%
   c. Serum ferritin is less than or equal to 500 ng/mL and TSAT is less than or equal to 30%
   d. Bone marrow demonstrates inadequate iron stores
   AND
3. The member has had a four (4) week trial of, an inadequate response, or intolerance to oral iron supplementation AND
4. The member has had a trial of, an inadequate response, or intolerance to all of the following agents: Ferrlecit (Injection, sodium ferric gluconate complex in sucrose injection, 12.5 mg), Venofer (Injection, iron sucrose, 1 mg), AND Feraheme [Injection, ferumoxytol, for treatment of iron deficiency anemia, 1 mg (non-esrd use)]
5. Note: For Medicare: Step Therapy Criteria applies to new start only. Diagnosis: Iron Deficiency Anemia Due to Cancer/Chemotherapy or Non-Inflammatory Conditions
6. Diagnosis of iron deficiency anemia due to cancer/chemotherapy or non-inflammatory conditions (such as blood loss, malabsorption, malnutrition) AND
7. Anemia is confirmed by one of the following are met, labs are within the last four (4) weeks:
   a. Serum ferritin levels less than 30 ng/mL
   b. TSAT levels less than 20%
   c. Bone marrow demonstrates inadequate iron stores AND
8. The member has had a four (4) week trial of, an inadequate response, or intolerance to oral iron supplementation AND
9. The member has had a trial of, an inadequate response, or intolerance to both Ferrlecit (Injection, sodium ferric gluconate complex in sucrose injection, 12.5 mg) and Venofer (Injection, iron sucrose, 1 mg)

10. Note: For Medicare: Step Therapy Criteria applies to new start only.

    Products Triferic/Triferic AVNU [J1443, Injection, ferric pyrophosphate citrate solution (triferic), 0.1mg of iron] Approval Length Initial 6 months, Renewal 1 year Override Type PA, QL Diagnosis: Iron Deficiency Anemia Due to Chronic Kidney Disease (CKD) or Inflammatory Condition

11. Diagnosis of iron deficiency anemia due to chronic kidney disease (CKD) AND
12. Member is hemodialysis dependent; AND
13. The member has had a trial of, an inadequate response, or intolerance to both Ferrlecit (Injection, sodium ferric gluconate complex in sucrose injection, 12.5 mg) and Venofer (Injection, iron sucrose, 1 mg)

14. Note: For Medicare: Step Therapy Criteria applies to new start only.

    Exclusion

15. Venofer when used for restless legs syndrome
16. Triferic/Triferic AVNU (ferric pyrophosphate citrate) may not be approved for peritoneal dialysis

17. All agents: When the above criteria are not met and for all other indications

    FDA Indications & Dosing Drug Name Indication Dosing/Administration Venofer (Injection, iron sucrose, 1 mg)

    Chronic kidney disease - Iron deficiency anemia • (Hemodialysis-dependent) 100 mg elemental iron via IV injection undiluted over 2 to 5 minutes OR via IV infusion in a maximum of 100 mL NS over at least 15 minutes, per consecutive hemodialysis

Iron Preparations

Updated on: 12/23/2025

Page 4 of 6 Drug Name Indication Dosing/Administration Doses are expressed in terms of mg of elemental iron; iron sucrose contains 20 mg elemental iron/mL session; usual total cumulative dose, 1000 mg elemental iron; may repeat upon recurrence of iron deficiency • (Nondialysis-dependent) 200 mg elemental iron via IV injection undiluted over 2 to 5 minutes OR via IV infusion in a maximum of 100 mL NS over 15 minutes, on 5 different occasions within a 14-day period; may repeat upon recurrence of iron deficiency • (Nondialysis-dependent) Alternative regimen, 500 mg elemental iron via IV infusion in a maximum of 250 mL NS over 3.5 to 4 hours on day 1 and day 14; may repeat upon recurrence of iron deficiency • (Peritoneal dialysis-dependent) 300 mg elemental iron via IV infusion in a maximum of 250 mL NS over 1.5 hours every 14 days for 2 doses, followed by 400 mg elemental iron IV infusion in a maximum of 250 mL NS over 2.5 hours 14 days later; may repeat upon recurrence of iron deficiency Feraheme [Injection, ferumoxytol, for treatment of iron deficiency anemia, 1 mg (non-esrd use)]

Each vial contains 510 mg of elemental iron in 17 mL (30 mg/mL) Chronic kidney disease - Iron deficiency anemia

• 510 mg elemental iron IV once, followed by a second 510 mg IV dose 3 to 8 days later; may repeat for persistent or recurrent iron deficiency anemia (FDA dosage) • 1020 mg elemental iron diluted in 100 mL NS IV over 15 minutes (off- label dosage)

Iron deficiency anemia, Intolerant or unsatisfactory response to oral iron 510 mg elemental iron IV once, followed by a second 510 mg IV dose 3 to 8 days later; may repeat dose for persistent or recurrent iron deficiency anemia Ferrlecit (Injection, sodium ferric gluconate complex in sucrose injection, 12.5 mg)

Anemia due to and following chemotherapy, In combination with an erythropoiesis- stimulating agent 125 mg IV once weekly for 6 [3] or 8 [4] weeks (off-label dosage) Ferrlecit (Injection, sodium ferric gluconate complex in sucrose injection, 12.5 mg)

Doses are expressed in terms of mg of elemental iron; sodium ferric gluconate complex Hemodialysis - Iron deficiency anemia, during epoetin therapy • 10 mL IV (125 mg elemental iron) in 100 mL NS over 1 hour OR slow IV (up to 12.5 mg elemental iron/min) undiluted; usual cumulative dose 1 g elemental iron over 8 dialysis sessions; may repeat course if needed • Individual doses greater than 125 mg elemental iron may be associated with increased incidence or severity of adverse reactions

Iron Preparations

Updated on: 12/23/2025

Page 5 of 6 Drug Name Indication Dosing/Administration contains 12.5 mg elemental iron/mL
Infed (Injection, iron dextran, 50 mg) Anemia due to and following chemotherapy, In combination with an erythropoiesis- stimulating agent • (Infed(R), weekly bolus dosing) Total dose in mL= 0.0442 (desired Hb - observed Hb) x lean body weight in kg + (0.26 x lean body weight in kg); give 25 mg test dose as IV push followed by 75 mg bolus injection, weekly for 3 weeks, then 100 mg bolus repeated weekly until total dose reached (off-label dosage) • (Infed(R), total dose infusion) Total dose in mL= 0.0442 (desired Hb - observed Hb) x lean body weight in kg + (0.26 x lean body weight in kg) diluted in 500 mL of NS; give 25 mg IV push test dose followed by remaining total calculated dose at 175 mL/hr IV infusion with methylprednisolone 125 mg before and after the infusion (off-label dosage) Infed (Injection, iron dextran, 50 mg) Iron deficiency, due to blood loss Total mg of iron required = blood loss (in mL) x hematocrit; divide total mg of iron required by 50 mg elemental iron/mL to get total replacement dose in mL; MAX: 2 mL (100 mg elemental iron) per day; administer via slow IV infusion OR (INFeD(R) only) by deep IM injection into buttock Infed (Injection, iron dextran, 50 mg)

Discontinue oral iron therapy prior to use Iron deficiency anemia Dose in mL (50 mg elemental iron/mL) = 0.0442 (desired Hb - observed Hb) x lean body weight in kg + (0.26 x lean body weight in kg); MAX: 2 mL (100 mg elemental iron) per day until total dose reached; administer via slow IV infusion OR (INFeD(R) only) by deep IM injection into buttock
Injectafer (Injection, ferric carboxymaltose, 1 mg) Chronic kidney disease, Nondialysis- dependent - Iron deficiency anemia • (50 kg or greater) 750 mg elemental iron IV followed by 750 mg IV 7 days later; total cumulative dose of 1500 mg of elemental iron per course OR 15 mg/kg elemental iron IV up to a MAX of 1000 mg as a single dose; treatment may be repeated if iron deficiency anemia recurs • (Less than 50 kg) 15 mg/kg elemental iron IV followed by 15 mg/kg IV 7 days later; treatment may be repeated if iron deficiency anemia recurs Injectafer (Injection, ferric carboxymaltose, 1 mg) Heart failure with reduced ejection fraction - Iron deficiency anemia 1 or 2 doses of 500 to 1000 mg of elemental iron IV each; reassess iron levels in 4 months (guideline dosage) Injectafer (Injection, ferric carboxymaltose, 1 mg)

Each mL of ferric carboxymaltose contains 50 mg elemental iron; the 15 mL single-use vial contains 750 mg elemental iron and the 20 mL single-use Iron deficiency anemia, with intolerance or inadequate response to oral iron • (50 kg or greater) 750 mg elemental iron IV followed by 750 mg IV 7 days later; total cumulative dose of 1500 mg elemental iron per course OR 15 mg/kg elemental iron IV up to a MAX of 1000 mg as a single dose; treatment may be repeated if iron deficiency anemia recurs • (Less than 50 kg) 15 mg/kg elemental iron IV followed by 15 mg/kg IV 7 days later; treatment may be repeated if iron deficiency anemia recurs

Iron Preparations

Updated on: 12/23/2025

Page 6 of 6 Drug Name Indication Dosing/Administration vial contains 1000 mg elemental iron Monoferric (Injection, ferric derisomaltose, 10 mg) Chronic kidney disease, nondialysis- dependent - Iron deficiency anemia • (50 kg or greater) 1000 mg IV over at least 20 minutes as a single dose; repeat dose if iron deficiency anemia reoccurs. (Less than 50 kg) 20 mg/kg actual body weight IV over at least 20 minutes as a single dose; repeat dose if iron deficiency anemia reoccurs Monoferric (Injection, ferric derisomaltose, 10 mg) Iron deficiency anemia, with intolerance or inadequate response to oral iron • (50 kg or greater) 1000 mg IV over at least 20 minutes as a single dose; repeat dose if iron deficiency anemia reoccurs. (Less than 50 kg) 20 mg/kg actual body weight IV over at least 20 minutes as a single dose; repeat dose if iron deficiency anemia reoccurs Triferic Triferic AVNU [Injection, ferric pyrophosphate citrate solution (triferic), 0.1mg of iron] Dependence on hemodialysis due to end stage renal disease - Iron deficiency anemia • (Triferic(R), solution, 5-mL ampule) 1 ampule (27.2 mg iron [III]) per 2.5 gallons (9.46 L) of bicarbonate concentrate; administer at each hemodialysis session. May also add to dialysis center's master bicarbonate mix at a ratio of 1 ampule per 2.5 gallons (9.46 L) of bicarbonate concentrate • (Triferic(R), solution, 50-mL ampule) 1 ampule (272 mg iron [III]) per 25 gallons (94.6 L) of bicarbonate concentrate; administer at each hemodialysis session. May also add to dialysis center's master bicarbonate mix at a ratio of 1 ampule per 25 gallons (94.6 L) of bicarbonate concentrate • (Triferic(R), powder for solution) 1 packet (272 mg iron [III]) per 25 gallons (94.6 L) of bicarbonate concentrate; administer at each hemodialysis session. May also add to dialysis center's master bicarbonate mix at a ratio of 1 packet per 25 gallons (94.6 L) of bicarbonate concentrate • (Triferic AVNU(R), solution) 4.5 mL IV (1 ampule; 6.75 mg iron [III]); administer at each hemodialysis session for as long as patient is receiving maintenance hemodialysis therapy

References

1. Iron Preparations – AlohaCare/Carelon Rx, PA criteria, accessed May 2023.
2. CodeSource, accessed May 2023.

3. Micromedix, accessed May 2023.

   Review History:

4. Iron Preparations, supersedes prior version, 5/23/2023 HB.