Centene Monoferric Coverage Update

Coverage and Medical Necessity Criteria

Initial Therapy — IDA with CKD

Initial Approval Criteria — Iron Deficiency Anemia with Chronic Kidney Disease (must meet all):

IDA with CKD initial: 1. Diagnosis of iron deficiency anemia (IDA) with chronic kidney disease (CKD). 2. IDA confirmed by one of the following: serum ferritin < 500 ng/mL OR transferrin saturation (TSAT) < 30%. 3. Oral iron therapy is not optimal because of any of the following: symptomatic anemia (e.g., Hgb < 7 g/dL), severe or ongoing blood loss, oral iron intolerance, inability to achieve therapeutic targets with oral iron, or co-existing condition refractory to oral iron. 4. Failure of both Ferrlecit (sodium ferric gluconate) and iron sucrose (generic Venofer), unless clinically significant adverse effects or contraindications to these agents. 5. If criterion 4 is satisfied, failure of generic Feraheme (ferumoxytol) unless contraindicated or clinically significant adverse effects are experienced. 6. Requested dose does not exceed 1000 mg elemental iron (10 mL) per infusion/injection. Approval duration: 3 months.serum ferritin < 500 ng/mL; TSAT < 30%

Initial Therapy — IDA without CKD

Initial Approval Criteria — Iron Deficiency Anemia without Chronic Kidney Disease (must meet all):

IDA without CKD initial: 1. Diagnosis of iron deficiency anemia (IDA) confirmed by one or more of the following laboratory findings: serum ferritin ≤ 15 ng/mL (or ≤ 30 ng/mL if pregnant), serum ferritin < 41 ng/mL with low hemoglobin (Hgb <12 g/dL for women or <13 g/dL for men), TSAT < 20%, absence of stainable iron in bone marrow, increased soluble transferrin receptor (sTfR) or sTfR-ferritin index, or increased erythrocyte protoporphyrin. 2. Oral iron therapy is not optimal due to any of the following: TSAT < 12%, Hgb < 7 g/dL, symptomatic anemia, oral iron intolerance, severe or ongoing blood loss, inability to achieve therapeutic targets with oral iron, or co-existing condition refractory to oral iron. 3. Member does not have CKD at the time of request. 4. Failure of two of the following, unless clinically significant adverse effects or contraindications: Ferrlecit, Infed, or iron sucrose (generic Venofer). 5. If criterion 4 is satisfied, failure of generic Feraheme unless contraindicated or clinically significant adverse effects are experienced. 6. Requested dose does not exceed 1000 mg elemental iron (10 mL) per infusion/injection.ferritin thresholds per lab criteria; TSAT < 20%

Initial Therapy — Cancer/chemotherapy-induced anemia (off-label)

Management of Cancer- and Chemotherapy-Induced Anemia (off-label) — must meet all:

Oncology off-label initial: 1. Diagnosis of iron deficiency in the setting of cancer and chemotherapy with iron status documented as one of the defined patterns (e.g., absolute iron deficiency: ferritin < 30 ng/mL and TSAT < 20%; possible or functional deficiency as specified by ferritin and TSAT ranges, including ferritin 500–800 ng/mL with TSAT criteria, or functional deficiency when used with an erythropoietin-stimulating agent). 2. Prescribed by or in consultation with an oncologist and member is prescribed chemotherapy. 3. Failure of two of the following, unless clinically significant adverse effects or contraindications: Ferrlecit, Infed, or iron sucrose (generic Venofer). 4. If criterion 3 is satisfied, failure of generic Feraheme unless contraindicated or clinically significant adverse effects are experienced. 5. Dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Approval duration: 6 months.see specified ferritin/TSAT definitions

Continuation Therapy

Continued Therapy criteria (by indication):

Continued — IDA with CKD: Member is currently receiving medication via the Centene benefit or has previously met initial approval criteria AND documentation since the last IV iron administration demonstrates one of the following: TSAT < 30% OR serum ferritin < 500 ng/mL. Continuation requires the step therapy failures described in the policy; if request is for a dose increase the new dose must not exceed 1000 mg elemental iron per infusion. Approval duration: 3 months.

Continued — IDA without CKD: Member is currently receiving medication via the Centene benefit or has previously met initial approval criteria AND documentation since the last IV iron administration demonstrates one of the following: serum ferritin per initial thresholds (e.g., ≤15 ng/mL or ≤30 ng/mL if pregnant) or ferritin <41 ng/mL with low Hgb, TSAT < 20%, absence of stainable bone marrow iron, increased sTfR or related indices, or increased erythrocyte protoporphyrin. Continuation requires the step therapy failures described in the policy; dose increases must not exceed 1000 mg elemental iron per infusion. Approval duration: 3 months.

Continued — Oncology off-label: Member is currently receiving medication via the Centene benefit or has received Monoferric for at least 30 days with evidence of a positive response; meets step therapy failures as required for the indication; if request is for a dose increase the new dose must be within FDA maximum limits or supported by guidelines/peer-reviewed literature with submitted evidence. Approval duration: 6 months.

Other indications / Off-label routing

Other/Non-standard indications and exclusions:

Other diagnoses/indications: 1. For requests for other indications: follow the applicable formulary/no coverage or non‑formulary policies for the relevant line of business (e.g., CP.CPA.190, HIM.PA.33, CP.PMN.255) OR if the requested use is not listed under coverage-excluded diagnoses and criterion 1 of section III does not apply, refer to the off‑label use policy for the relevant line of business (e.g., CP.CPA.09, HIM.PA.154, CP.PMN.53). 2. Diagnoses/indications that are non‑FDA approved and not addressed in this policy are not authorized unless sufficient documentation of efficacy and safety is provided per the referenced off‑label use policies. Exclusion: serious hypersensitivity to Monoferric or any of its components is a contraindication to coverage.

Dosing / Repeat Treatment

Covered when dosing and product limits are followed

Monoferric dosing: Administer 20 mg/kg actual body weight by IV infusion as a single dose (example: 50 kg = 20 mg/kg) with a maximum of 1,000 mg elemental iron per dose. Treatment may be repeated if IDA recurs.<= 1000 mg per dose

Repeat dosing allowed if IDA recurs

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy for the member's line of business: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), or CP.PMN.53 (Medicaid).

Monoferric is contraindicated in individuals with a history of serious hypersensitivity to ferric derisomaltose (Monoferric) or any of its components. This contraindication must be considered before authorizing treatment.

For uses not covered by the FDA labeling and not addressed by this policy, coverage will not be authorized unless the request includes sufficient clinical documentation per the referenced off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) demonstrating efficacy and safety for the proposed indication.

Coding, Lab Thresholds, and Dose Limits

HCPCS Codes referencedHCPCS

J1437

Serum ferritin thresholds

Threshold for IDA with CKDSerum ferritin < 500 ng/mL (per initial and continued therapy criteria)

Threshold for IDA without CKD (example)Serum ferritin 15 ng/mL (30 ng/mL if pregnant) or serum ferritin < 41 ng/mL when accompanied by low Hgb

Continuation requirementSerum ferritin < 500 ng/mL acceptable evidence for continued therapy in IDA with CKD

TSAT thresholds

TSAT threshold for IDA with CKDTSAT < 30%

TSAT threshold for IDA without CKDTSAT < 20% (alternative listed thresholds include TSAT < 12% as a reason oral iron not optimal)

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization and Coding

Prior authorization required. Monoferric (ferric derisomaltose) may require prior authorization per the member's health plan. Providers must obtain approval before administration when plan eligibility rules apply.

Prior authorization may be required by the health plan for Monoferric (ferric derisomaltose).
Providers should reference current professional coding guidance; inclusion of a code in this policy does not guarantee coverage.

Documentation Required

Documentation Required for Approval

Provider must submit clinical documentation to support that the member meets ALL approval criteria. Failure to submit required documentation will result in denial of the request.

Acceptable documentation: office visit notes, recent lab results (serum ferritin, transferrin saturation (TSAT), hemoglobin), prior treatment history (oral and injectable iron trials), and relevant specialist consultation notes.

Clinical Background and Indications

Ferric derisomaltose (Monoferric) is an intravenous iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in adults, including adults with non‑hemodialysis‑dependent chronic kidney disease and those intolerant of or unresponsive to oral iron. Dosing guidance includes administration of 20 mg/kg actual body weight by IV infusion (example: 50 kg) with a maximum of 1,000 mg per dose; repeat dosing is permitted if IDA recurs. Prescribing information and clinical guidelines are cited to support indications and dosing.

Definitions and Dosing Notes

CKD — definition

Definition: CKDChronic kidney disease

Abbreviation noteNDD-CKD denotes non-hemodialysis-dependent chronic kidney disease

Context of useCKD referenced throughout policy for indication stratification (patients with CKD have separate IDA criteria)

Hgb — hemoglobin definition

Definition: HgbHemoglobin

Threshold referencesHgb thresholds referenced in policy (e.g., Hgb < 7 g/dL used as criterion for oral iron not optimal; ferritin <41 ng/mL paired with low Hgb)

Abbreviation usage

Initial Therapy — Decision Logic

Initial therapy — initial therapy criteria sets for covered indications

Initial therapy criteria sets for covered indications

Initial IDA with CKD: See Initial Approval Criteria — Iron Deficiency Anemia with Chronic Kidney Disease: diagnosis of IDA with CKD, confirmatory labs (ferritin <500 ng/mL or TSAT <30%), oral iron not optimal, required failures of Ferrlecit and iron sucrose (unless contraindicated), redirection to generic Feraheme if prior failures met, and dose limit of 1000 mg per infusion. Approval duration: 3 months.

Initial IDA without CKD: See Initial Approval Criteria — Iron Deficiency Anemia without Chronic Kidney Disease: laboratory confirmation (e.g., ferritin thresholds, TSAT <20%, or other listed markers), oral iron not optimal per listed reasons, required failure of two of Ferrlecit, Infed, or iron sucrose (unless contraindicated), redirection to generic Feraheme if prior failures met, and dose limit of 1000 mg per infusion.

Initial Therapy / Step Requirements

Historical step therapy requirements referenced (plan-specific rules may apply):

Continuation and Renewal Criteria

Continuation therapy — continuation/renewal nodes

Continuation/renewal criteria:

Continuation general: Member must be currently receiving medication via the Centene benefit or have previously met initial approval criteria. Laboratory documentation measured since the last IV iron administration is required (labs per indication: e.g., TSAT and ferritin thresholds). Dose increases require that the new dose not exceed 1000 mg elemental iron per infusion. Approval durations are indication-specific (generally 3 months; oncology off-label 6 months).

Continued Therapy Redirections

Policy history indicates redirections from initial approval criteria to continued therapy were added per health plan requests. Follow plan-specific continued therapy rules.

continued therapy redirection: Policy revisions added redirection language moving some requests from initial approval pathways to continued therapy per health plan requests; follow health plan continued therapy rules and redirection requirements (e.g., redirection to generic Feraheme when prior alternatives failed).

Step Therapy Requirements and Plan Exceptions

Indication	Step therapy requirement / enforced	Plan exceptions / notes
Iron deficiency anemia (IDA) with chronic kidney disease (CKD)	Failure of both Ferrlecit and iron sucrose (Venofer) unless clinically significant adverse effects or contraindications; if those failures met, failure of generic Feraheme unless contraindicated	Step therapy requirements do not apply for Illinois HIM requests per IL HB 5395 effective 1/1/2026
Iron deficiency anemia (IDA) without CKD	Failure of two of Ferrlecit, Infed, or iron sucrose (Venofer) unless clinically significant adverse effects or contraindications; if those failures met, failure of generic Feraheme unless contraindicated	Step therapy requirements do not apply for Illinois HIM requests per IL HB 5395 effective 1/1/2026
Cancer- and chemotherapy-induced anemia (NCCN-supported, off-label)	Failure of two of Ferrlecit, Infed, or iron sucrose (Venofer) unless clinically significant adverse effects or contraindications; if those failures met, failure of generic Feraheme unless contraindicated	Prescribed by or in consultation with an oncologist; step therapy bypass for Illinois HIM requests per IL HB 5395 effective 1/1/2026

Plan / policy note	Step/redirect history / instruction	Action for providers
Centene clinical policy and plan-specific rules	Policy history documents additions of step therapy and redirections among injectable iron agents (e.g., required failure of preferred alternatives and later redirection to continued therapy); modifications include redirecting brand Venofer to generic and adding plan-specific bypass per IL HB 5395	Providers must follow current plan-specific step therapy and continued-therapy rules as indicated by the member's health plan; reference plan guidance when submitting authorization requests
Historical revisions (SDC/plan requests)	Per health plan requests and SDC, redirections from initial approval to continued therapy were added (dates noted in policy history). Recent edits included requiring failure of generic Feraheme and adding step therapy bypass for Illinois HIM	Check policy revision history and the member's plan rules; contact plan for clarification if step therapy or redirection is unclear

Quantity and Product Limits

Ferric derisomaltose (Monoferric) — quantity limit 1000 mg

Quantity limitFerric derisomaltose (Monoferric) quantity limit: 1,000 mg per infusion

Dose/formulation linkSingle-dose vial available: 1,000 mg/10 mL (product availability supports 1,000 mg administration)

Policy recurrencePolicy restates 1,000 mg per infusion as the controlled quantity limit across initial and continued therapy nodes

Ferric derisomaltose (Monoferric) — 1,000 mg (reaffirmed)

Reaffirmed maximumFerric derisomaltose (Monoferric) maximum single administration: 1,000 mg

Vial presentation supporting limitAvailable as 1,000 mg/10 mL single-dose vial (also 500 mg/5 mL and 100 mg/mL strengths)

Administration Site and Infusion Guidance

Note

Infusion center administration — IV infusion site of care

Monoferric is administered by IV infusion; when requesting authorization or scheduling treatment, recognize the drug is typically given in an infusion center and site‑of‑care specifics should be confirmed with the member's plan.

Dose regimen example: 20 mg/kg actual body weight by IV infusion (example: 50 kg), maximum 1,000 mg per dose.
Confirm any plan-specific site‑of‑care or facility requirements prior to administration.

Policy History and References

2021-02-23annual_review

2Q 2021 annual review updated maximum dose information (updated max).

2022-02-25annual_review

2Q 2022 annual review; references reviewed and template changes applied to other diagnoses/indications and continued therapy section (template changes recorded 10/03/22).

2023-02-21policy_change

2Q 2023 annual review updated initial criteria to require failure of specified injectable alternatives (Ferrlecit and Venofer for IDA with CKD; two of Ferrlecit, Infed, or Venofer for IDA without CKD) and added redirection requirements to continued therapy.

OpenPayer

Ferric Derisomaltose (Monoferric) coverage