Health Net Monoferric Coverage & Prior Auth

Coverage Criteria

A. Iron Deficiency Anemia with Chronic Kidney Disease (Initial therapy)

Covered when ALL of the following are met:

A.1 Diagnosis: Diagnosis of iron deficiency anemia (IDA) and chronic kidney disease (CKD)

A.2 Iron status confirmation: IDA is confirmed by either: a) Transferrin saturation (TSAT) ≤ 30% OR b) Serum ferritin ≤ 500 ng/mLTSAT ≤ 30% OR ferritin ≤ 500 ng/mL

A.3 Oral iron not optimal: If CKD does not require hemodialysis or peritoneal dialysis, oral iron therapy is not optimal due to any of: TSAT < 12%; Hgb < 7 g/dL; symptomatic anemia; severe or ongoing blood loss; oral iron intolerance; unable to achieve therapeutic targets with oral iron; co-existing refractory condition

A.4 Step therapy prior IV agents: Member meets both: a) failure of one of the following unless clinically significant adverse effects are experienced or both are contraindicated: Ferrlecit or Venofer; AND b) if criterion 4a is met, failure of generic Feraheme unless contraindicated or clinically significant adverse effects are experienced

A.5 Dose limit: Dose does not exceed 1000 mg elemental iron (10 mL) per infusion/injection≤1000 mg per infusion

Approval duration: 3 months

B. Iron Deficiency Anemia without Chronic Kidney Disease (Initial therapy)

Covered when ALL of the following are met:

B.1 Iron deficiency confirmation: Diagnosis of IDA confirmed by any of: 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 transferrin receptor (sTfR) or sTfR-ferritin index; f) increased erythrocyte protoporphyrin levelvarious ferritin/TSAT/Hgb thresholds

B.2 Oral iron not optimal: Oral iron therapy is not optimal due to any of: TSAT < 12%; Hgb < 7 g/dL; symptomatic anemia; severe or ongoing blood loss; oral iron intolerance; unable to achieve therapeutic targets with oral iron; co-existing condition that may be refractory to oral iron therapy

B.3 No CKD: At the time of the request, member does not have CKD

C. Management of Cancer- and Chemotherapy-Induced Anemia (off-label)

Covered when ALL of the following are met (off‑label):

C.1 Iron status: One of the following iron statuses: a) Absolute iron deficiency: ferritin < 30 ng/mL AND TSAT < 20%; b) Possible functional iron deficiency: ferritin 500-800 ng/mL AND TSAT < 50%; c) Functional iron deficiency: ferritin 30-500 ng/mL AND TSAT < 50% AND an erythropoietin‑stimulating agent prescribed in combinationspecific ferritin/TSAT ranges per subcategory

C.2 Oncologist involvement: Prescribed by or in consultation with an oncologist

C.3 Active chemotherapy: Member is prescribed chemotherapy for cancer

C.4 Step therapy prior IV agents: Member meets both: a) failure of one of the following unless clinically significant adverse effects are experienced or all are contraindicated: Ferrlecit, Infed, or Venofer; AND b) if criterion 4a is met, failure of generic Feraheme unless contraindicated or clinically significant adverse effects are experienced

Continuation/renewal criteria

Covered for continuation when ALL of the following are met:

Continuation A/B: Member is currently receiving medication via Centene benefit or previously met initial approval criteria OR member is under continuity of care regulations for state/product

Recent labs: Documentation of one of the following laboratory results measured since the last IV iron administration as applicable: TSAT ≤ 30% OR serum ferritin ≤ 500 ng/mL (CKD) OR other lab thresholds appropriate for non‑CKD indications (e.g., ferritin <15 ng/mL, ferritin ≤41 ng/mL with low Hgb, TSAT <20%)lab documentation since last IV iron

Response requirement (cancer): For cancer indication: member is currently receiving medication via Centene benefit or has received Monoferric for at least 30 days and is responding positively to therapy

Dose limit on increase:

Initial Therapy / Step Requirements

Coverage contingent on meeting prior authorization and step requirements

Initial coverage logic: Member must meet indication for IV iron and prior authorization; for IDA with CKD must have failed Ferrlecit AND Venofer; for IDA without CKD must have failed two of Ferrlecit, Infed, or Venofer; if intolerant or contraindicated to preferred agents, redirection to Feraheme (generic when available) may be allowed.

Criteria added/updated in 2Q2023 and 2Q2024 reviews

Dosage and Administration

Dosing when covered

Dosing: For IDA: adults ≥ 50 kg: 1,000 mg IV as a single dose (may repeat if IDA reoccurs); < 50 kg: 20 mg/kg actual body weight IV infusion as a single dose (may repeat if IDA reoccurs). Maximum per dose 1,000 mg.max 1,000 mg

From product dosing section

Cancer/chemotherapy-induced anemia

Cancer- and chemotherapy-induced anemia

Approval duration: Coverage for NCCN-supported cancer- and chemotherapy-induced anemia indication; approval duration modified to 3 months to align with other indications.3 months

Added 2Q2024 and modified 07.24.24

Requests for indications that are non‑FDA approved and are not specifically addressed in this policy will not be authorized unless the provider submits sufficient documentation of efficacy and safety consistent with the applicable off‑label use policy (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage documentation.

Monoferric (ferric derisomaltose) is contraindicated in patients with a history of serious hypersensitivity to Monoferric or any of its components. Providers must not initiate therapy in members with documented serious hypersensitivity to the product or its ingredients.

Uses that are non‑FDA approved and are not supported by the applicable off‑label use policy or by sufficient clinical evidence are considered not authorized for coverage under this policy.

Coding listed in this policy is provided for informational purposes only; inclusion or exclusion of codes does not guarantee coverage. Coverage is contingent on meeting all applicable prior authorization and step‑therapy requirements described in the policy; failure to satisfy those requirements may render a requested service or claim not covered.

Coding and Clinical Thresholds

HCPCS Codes referencedHCPCS

J1437

Injection, ferric derisomaltose, 10 mg

Transferrin saturation (TSAT) — thresholds

TSAT ≤ 30%Diagnostic threshold for IDA in CKD patients (meets iron deficiency criteria)

TSAT < 12%Criteria indicating oral iron is not optimal (CKD or non‑CKD contexts)

TSAT < 20%Diagnostic threshold for IDA in non‑CKD and cancer/chemotherapy contexts (absolute iron deficiency)

Serum ferritin — thresholds

Serum ferritin ≤ 500 ng/mLDiagnostic threshold for IDA in CKD patients

Serum ferritin < 15 ng/mL (or < 30 ng/mL if pregnant)Diagnostic threshold for IDA in non‑CKD patients

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation (e.g., office chart notes, laboratory results, and other clinical information) demonstrating that the member meets all applicable medical necessity criteria for use of ferric derisomaltose (Monoferric) for the requested indication.

Approval duration: generally 3 months (per indication-specific criteria).
Submit supporting documentation with the PA request: relevant labs (TSAT, ferritin, Hgb), prior therapy history, and rationale for IV iron.

Step Therapy

Step Therapy and Preferred Agent Failure Requirements

Step therapy / preferred agent failure requirements apply. For Iron Deficiency Anemia (IDA) with CKD, the member must have failed Ferrlecit or Venofer unless clinically significant adverse effects or contraindications exist, and if that criterion is met, must also have failed generic Feraheme unless contraindicated or significant adverse effects occurred. For IDA without CKD, the member must have failed two of the following: Ferrlecit, Infed, or Venofer, and if that criterion is met, must also have failed generic Feraheme unless contraindicated or significant adverse effects occurred.

Background

Ferric derisomaltose (Monoferric) is an intravenous iron replacement indicated for treatment of iron deficiency anemia (IDA) in adults intolerant of or unresponsive to oral iron and for use in non‑hemodialysis‑dependent chronic kidney disease (NDD‑CKD). Product dosing supports a maximum single administration of 1,000 mg elemental iron for adult patients (with weight‑based dosing of 20 mg/kg for patients <50 kg), and single‑dose vial presentations include 1,000 mg/10 mL and 500 mg/5 mL formulations.

Definitions

TSAT — definition

TSATTransferrin saturation

ContextUsed throughout policy as laboratory measure to confirm iron deficiency and to determine oral iron optimization

Abbreviation sourceDefined in Appendix A: TSAT = transferrin saturation

IDA — definition and context

IDAIron deficiency anemia

UsagePrimary diagnosis for which ferric derisomaltose (Monoferric) is authorized when criteria met

Diagnostic confirmation

Initial Therapy Criteria

Initial therapy

Initial CKD: For initial authorization, member must meet diagnostic and iron status criteria for IDA with CKD; oral iron not optimal; step therapy failures of specified IV agents (Ferrlecit and Venofer) then failure of generic Feraheme if applicable; dose ≤1000 mg per infusion. Approval duration: 3 months.

Initial non‑CKD: For initial authorization, member must meet diagnostic iron criteria for IDA without CKD; oral iron not optimal; no CKD at time of request; step therapy failures of specified IV agents (failure of one of Ferrlecit, Infed, or Venofer) then failure of generic Feraheme if applicable; dose ≤1000 mg per infusion. Approval duration: 3 months.

Initial therapy requirements

Initial authorization requires documented failure (or intolerance/contraindication) of preferred agents: for IDA with CKD, failure of Ferrlecit and Venofer is required; for IDA without CKD, failure of two of Ferrlecit, Infed, or Venofer is required. If intolerant/contraindicated to preferred agents, redirection to Feraheme (generic when available) may be permitted.

Continuation Criteria

Continuation therapy

Criteria for continuation or dose increase

Continuation general: Member is currently receiving medication via Centene benefit or previously met initial approval criteria OR is under continuity of care regulations

Lab documentation: Documentation of relevant labs measured since last IV iron administration (TSAT, ferritin, Hgb as applicable)

Dose increase: If request is for a dose increase, new dose must not exceed 1000 mg elemental iron per infusion/injection or must be within FDA maximum/supporting literature for off‑label uses≤1000 mg per infusion or evidence‑supported

Continuation therapy redirection

Step Therapy Requirements

Requirement	Details
Step therapy requirement
Must document failure or intolerance to the listed alternative IV iron agents prior to approval of ferric derisomaltose (Monoferric). For IDA with CKD the policy requires failure of one of Ferrlecit or Venofer; for IDA without CKD failure of one of Ferrlecit, Infed, or Venofer (see related step rows). If the member has experienced clinically significant adverse effects or the agents are contraindicated, document the intolerance/contraindication.

Requirement

Details

Step therapy requirement

Must document failure or intolerance to the listed alternative IV iron agents prior to approval of ferric derisomaltose (Monoferric). For IDA with CKD the policy requires failure of one of Ferrlecit or Venofer; for IDA without CKD failure of one of Ferrlecit, Infed, or Venofer (see related step rows). If the member has experienced clinically significant adverse effects or the agents are contraindicated, document the intolerance/contraindication.

Diagnosis context	Required preferred-agent failures before Monoferric approval
IDA with chronic kidney disease (CKD)
Failure of both Ferrlecit and Venofer is required before approval of ferric derisomaltose (Monoferric), unless clinically significant adverse effects occurred or both agents are contraindicated. If those preferred agents are failed, generic Feraheme must be tried and failed unless contraindicated or not tolerated (step redirection).

Quantity Limits

Ferric derisomaltose (Monoferric) — product dosing

Standard single doseFerric derisomaltose (Monoferric) single IV dose: 1,000 mg

Vial presentationAvailable as single‑dose vials: 1,000 mg/10 mL and 500 mg/5 mL

Coding noteHCPCS code J1437 represents Injection, ferric derisomaltose, 10 mg (refer to coding section)

Ferric derisomaltose (Monoferric) — maximum single dose

Maximum labeled single dose1,000 mg per single IV administration

Product vial sizesSingle‑dose vials: 1,000 mg/10 mL and 500 mg/5 mL

OpenPayer

Ferric Derisomaltose (Monoferric) infusion therapy