CurrentCignaPolicy IP0749

Iron Replacement - Monoferric

Defines Cigna's coverage and prior authorization requirements for Monoferric for treatment of iron deficiency and iron deficiency anemia in adults, including CKD, dialysis, heart failure, cancer-related, and other supported uses.

Policy Summary

PayerCigna

PolicyIron Replacement - Monoferric

Policy CodePolicy IP0749

Change TypeNew policy

Effective Date

Next Review Date

Key ActionObtain prior authorization for Monoferric; approvals are provided for the durations specified per indication.

SourceLink

POLICY UPDATE CHANGES

New policy created for coverage of Monoferric (ferric derisomaltose).

≥18minimum patient age for coverage

1000 mgmaximum IV dosing per 30 days

PA requiredauthorization requirement

J1437HCPCS code

Up to 3 yrsdialysis CKD approval duration

Coverage Criteria for Monoferric (ferric derisomaltose)

Medically necessary indications and criteria

Monoferric is considered medically necessary when ONE of the following indications is met.

FDA-Approved Indications - CKD Non‑Dialysis

Required criteria: A) Patient is ≥ 18 years of age; B) Medication is prescribed by or in consultation with a nephrologist or hematologist; C) Preferred product criteria is met as listed in plan-specific tables.

FDA-Approved Indications - Other: Other FDA‑approved iron deficiency anemia indications: Approve for 1 year when criteria analogous to CKD non‑dialysis (age ≥18, appropriate prescriber/consultation, and any indication‑specific requirements) are met.

Other Uses with Supportive Evidence - Dialysis CKD: Iron deficiency anemia in patients with chronic kidney disease who are on dialysis: Approve for up to 3 years when prescribed by or in consultation with an appropriate specialist and dosing limits are observed.

Policy Summary

PayerCigna

PolicyIron Replacement - Monoferric

Policy CodePolicy IP0749

Change TypeNew policy

Effective Date

Next Review Date

Key ActionObtain prior authorization for Monoferric; approvals are provided for the durations specified per indication.

SourceLink

On This Page

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Other Uses with Supportive Evidence - Heart Failure: Iron deficiency associated with heart failure: Approve for 1 year if patient is ≥ 18 years and medication is prescribed by or in consultation with a cardiologist or hematologist; dosing limits apply.

Monoferric (ferric derisomaltose) for any indication not explicitly listed in this policy is considered not medically necessary. This includes uses outside the FDA‑approved indications and the supportive evidence-based uses described in the policy. Criteria will be updated if new published data become available.

Any use of Monoferric that is not specified in this policy — that is, other than the listed FDA‑approved indications and the supportive evidence uses addressed in the coverage criteria — is considered not medically necessary. Providers should rely on the policy’s stated indications and supporting criteria when requesting coverage.

Coding and Billing

Considered Medically Necessary when criteria metHCPCSCovered

J1437

Injection, ferric derisomaltose, 10 mg

KDIGO iron therapy thresholds (examples referenced)

KDIGO — hemodialysis initiationInitiate IV iron if TSAT ≤ 30% and ferritin ≤ 500 ng/mL

KDIGO — non‑hemodialysis initiation (option 1)Initiate oral or IV iron if TSAT < 40% and ferritin < 100 ng/mL

KDIGO — non‑hemodialysis initiation (option 2)Initiate oral or IV iron if TSAT < 25% with ferritin ≥ 100 ng/mL and < 300 ng/mL

KDIGO — profound iron deficiency (no anemia)Consider treatment with oral or IV iron if TSAT < 20% and ferritin < 30 ng/mL

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization is required for Monoferric; approvals are provided for the durations specified per indication (e.g., 1 year or 3 years). Because of the specialized skills required for evaluation and diagnosis of patients treated with Monoferric as well as the monitoring required for adverse events and long-term efficacy, particular approvals require Monoferric to be prescribed by or in consultation with a physician who specializes in the condition being treated.

Step Therapy

Preferred Product / Step Therapy

Employer and Individual/Family plans have step therapy / preferred product requirements for the CKD non-dialysis indication. For Employer plans the patient must either have tried at least one alternative IV iron product (INFeD, sodium ferric gluconate complex [Ferrlecit, generics], Venofer) or have initiated therapy with Monoferric and require additional medication to complete the current course. Individual and Family plans have the same requirements.

Documentation Required

Prescriber Specialty / Consultation

Monoferric must be prescribed by or in consultation with a specialist appropriate to the treated condition (for example, a nephrologist or hematologist for CKD-related iron deficiency anemia).

Note

Sample Product

Receipt of sample product does not satisfy any criteria requirements for coverage. Coverage decisions require documentation that the member meets the policy criteria; providing a sample does not fulfill prior trial or step-therapy requirements.

Billing Rule

Coding and Claims Submission

Claims must be submitted with the covered diagnosis and/or procedure codes listed in the policy. When billing, providers must use the most appropriate codes as of the date of service. Claims submitted without the covered diagnosis or procedure codes specified in the policy will be denied as not covered.

Background

Monoferric (ferric derisomaltose) is an intravenous iron replacement therapy indicated for the treatment of iron deficiency anemia in adults. The policy requires prior authorization for Monoferric and specifies covered indications and approval durations (for example, approvals of up to 1 year for most FDA‑approved indications and up to 3 years for dialysis CKD). Coverage applies when the patient and prescribing conditions meet the criteria listed in the policy, including age (adult patients ≥ 18 years) and any specialty consultation or plan‑specific step therapy requirements.

Definitions and Guideline Thresholds

Iron deficiency definitions (per cited guidelines)

Absolute iron deficiency (NCCN/KDIGO examples)Ferritin < 30 ng/mL and TSAT < 20%

Functional iron deficiency (NCCN)Ferritin 30–500 ng/mL and TSAT < 50%

Possible functional iron deficiency (NCCN)Ferritin 501–800 ng/mL and TSAT < 50%

Heart failure threshold (ACC/AHA)Absolute iron deficiency ferritin < 100 ng/mL; or functional ferritin 100–300 ng/mL if TSAT < 20%