CurrentCignaPolicy IP0748

Iron Replacement - Injectafer (ferric carboxymaltose) Coverage and Prior Authorization

Defines prior authorization, coverage criteria, dosing limits, and approved indications for Injectafer for Cigna-administered health benefit plans; applies to providers prescribing IV ferric carboxymaltose for eligible patients.

Policy Summary

PayerCigna

PolicyIron Replacement - Injectafer

Policy CodePolicy IP0748

Change TypeNew policy

Effective Date

Next Review Date

Key ActionPrior authorization is required; approvals are provided for the duration specified by indication and may require specialist involvement.

SourceLink

POLICY UPDATE CHANGES

New policy created for coverage and prior authorization of Injectafer with specified FDA-approved and other supported indications.

3FDA-approved indication groups listed

1500 mgMax dose per 30 days

Prior authAuthorization

3 yearsDialysis-dependent approval duration

Coverage and Medical Necessity Criteria

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CKD (not on dialysis) — FDA-approved

Approve for 1 year if ALL of the following are met

CKD non-dialysis FDA indication: A) Patient is ≥ 18 years of age; AND B) The medication is prescribed by or in consultation with a nephrologist or hematologist; AND C) Preferred product criteria is met for the product(s) as listed in the below table(s)max 1500 mg per 30 days

Approve for 1 year

Iron Deficiency Anemia (general/pediatric) — FDA-approved

Approve for 1 year if ALL of the following are met

Iron Deficiency Anemia, Other: A) Patient is ≥ 1 year of age; AND B) Patient meets ONE of the following: (i) BOTH tried oral iron supplementation AND oral iron was ineffective or intolerable; OR (ii) condition that will interfere with oral iron absorption; OR (iii) patient is currently receiving an erythropoiesis-stimulating agent; OR (iv) medication is requested for cancer- or chemotherapy-related anemiamax 1500 mg per 30 days

Approve for 1 year

Heart Failure-associated Iron Deficiency — FDA-approved

Approve for 1 year if ALL of the following are met

Heart failure-associated iron deficiency: A) Patient is ≥ 18 years of age; AND B) Injectafer is being prescribed by or in consultation with a cardiologist or hematologistmax 1500 mg per 30 days

Approve for 1 year

CKD on Dialysis — Other Use with Supportive Evidence

Approve when supportive evidence criteria met

CKD on dialysis (other use with supportive evidence): Iron deficiency anemia in patients with chronic kidney disease who are on dialysisapproval duration 3 years

Listed as other use with supportive evidence

Plan-specific Step/Previous Therapy Criteria

For certain employer and individual/family plans, for CKD non-dialysis indication patient must meet ONE of the following

Plan-specific criteria: 1) Patient has tried at least one of INFeD, sodium ferric gluconate (Ferrlecit), or Venofer; OR 2) Patient is < 2 years of age; OR 3) Patient has initiated therapy with the requested medication and requires further medication to complete the current course of therapy

Applies to Employer and Individual/Family Plans as specified

Billing Codes, Dose Limits, and Related Coding Notes

Considered Medically Necessary when criteria are metHCPCSCovered

J1439

Injection, ferric carboxymaltose, 1 mg

inv-09: Maximum cumulative dose per 30 days — 1500 mg

Maximum cumulative dose per 30 days1500 mg (maximum cumulative total dose given intravenously per 30 days)

Approval duration (non-dialysis CKD)Approve for 1 year when coverage criteria are met

Approval duration (other FDA indications)Approve for 1 year for other FDA-approved indications when criteria are met

Dose contextApplies to IV administration of ferric carboxymaltose (Injectafer) across listed indications

Prior Authorization, Documentation, and Submission Guidance

Prior Authorization

Prior Authorization Required

Prior authorization required. All approvals are provided for the duration specified by indication (typically 1 year; 3 years for dialysis-dependent CKD). Injectafer must be prescribed by or in consultation with a physician who specializes in the condition being treated when required by the indication (e.g., nephrologist for CKD, cardiologist for heart failure, hematologist as applicable).

Approvals provided per indication: 1 year for most indications; 3 years for patients with CKD on dialysis.
Maximum cumulative dosing: up to 1500 mg IV per 30 days (per dosing guidance).

Prior Authorization

Plan-Specific Prior Authorization Actions

For patients covered under certain plans (Employer, Individual and Family), additional criteria apply for the indication Iron Deficiency Anemia in Patients with CKD who are NOT on dialysis. Patient must meet ONE of the following: trial of other IV iron products (INFeD, sodium ferric gluconate complex [Ferrlecit, generics], Venofer); OR patient is < 2 years of age; OR patient has initiated therapy with the requested medication and requires further medication to complete the current course of therapy.

Applies to Employer Plans and Individual/Family Plans for CKD (not on dialysis) indication.
Required trial of at least one alternative IV iron product when applicable: INFeD, sodium ferric gluconate complex, or Venofer.

Documentation Required

Documentation and Submission Guidance

Claims submitted without covered diagnosis or procedure codes or not meeting the Coverage Policy criteria will be denied. Receipt of sample product does not satisfy criteria requirements for coverage. Ensure documentation demonstrates the applicable indication, specialist involvement when required, prior trials or intolerance of oral iron when relevant, and dosing/frequency consistent with policy.

Claims lacking covered diagnosis/procedure codes will be denied.
Document specialist consultation/prescription when required (nephrologist, cardiologist, or hematologist as noted by indication).
Document trials of oral iron or alternative IV iron products, intolerance, or reasons oral therapy is inappropriate when applicable.
Receipt of samples does not meet criteria for coverage.

Drug and Clinical Background

Injectafer (ferric carboxymaltose) is an intravenous iron formulation indicated for treatment of iron deficiency anemia in specific populations. Coverage under this policy is limited to the listed FDA‑approved indications (for example, iron deficiency anemia in patients with chronic kidney disease who are not on dialysis, pediatric and other FDA‑approved groups, and iron deficiency associated with heart failure) and certain other uses with supportive evidence (such as dialysis‑dependent CKD) where specified. Prior authorization is required for benefit coverage, and approvals are provided only when the documented patient presentation and required specialist consultation and prior‑therapy criteria (if applicable) meet the policy’s coverage rules. Requests for uses outside those described will be considered not medically necessary.

Clinical Thresholds and Definitions

inv-15: Iron deficiency states and guideline thresholds — KDIGO and other guideline thresholds

KDIGO thresholds (CKD, hemodialysis)Initiation of IV iron suggested if TSAT ≤ 30% and ferritin ≤ 500 ng/mL

KDIGO thresholds (CKD, non-dialysis/peritoneal)Initiation of oral or IV iron suggested if TSAT < 40% and ferritin < 100 ng/mL, or if TSAT < 25% with ferritin ≥ 100 ng/mL and < 300 ng/mL

KDIGO profound deficiencyConsider oral or IV iron for TSAT < 20% and ferritin < 30 ng/mL even without anemia

ACC/AHA heart failure thresholdsAbsolute iron deficiency ferritin < 100 ng/mL or functional iron deficiency ferritin 100–300 ng/mL with TSAT < 20% — IV iron reasonable to improve functional status

NCCN cancer-related guidanceDefines absolute iron deficiency (ferritin < 30 ng/mL and TSAT < 20%) and functional deficiency parameters to guide IV iron use in patients receiving ESA therapy

Policy Summary

PayerCigna

PolicyIron Replacement - Injectafer

Policy CodePolicy IP0748

Change TypeNew policy

Effective Date

Next Review Date

Key ActionPrior authorization is required; approvals are provided for the duration specified by indication and may require specialist involvement.

SourceLink

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