CurrentCignaPolicy IP0748

Iron Replacement - Injectafer (ferric carboxymaltose)

Clinical coverage and prior authorization requirements for Injectafer (ferric carboxymaltose) for treatment of iron deficiency anemia and related indications under Cigna benefit plans; includes indications, dosing limits, required prescriber specialties, and plan-specific criteria.

Policy Summary

PayerCigna

PolicyIron Replacement - Injectafer (ferric carboxymaltose)

Policy CodePolicy IP0748

Change TypeNo material clinical changes

Effective Date

Next Review DateApr 1, 2026

Key ActionObtain prior authorization and ensure the medication is prescribed by or in consultation with the relevant specialist (nephrologist, hematologist, or cardiologist) as required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Prior Auth requiredAuthorization stance

1500 mgMax cumulative dose/30d

1 yr / 3 yrTypical approvals

J1439HCPCS code

Coverage Criteria for Injectafer (ferric carboxymaltose)

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FDA-Approved Indications (Initial Authorization Criteria)

Covered for FDA-approved indications when ALL specified criteria are met:

IDA in CKD (not on dialysis): Approve for 1 year if ALL: (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 policy.Dosing: Approve up to a maximum cumulative total dose of 1500 mg given intravenously per 30 days

From FDA-approved indication 1

Iron Deficiency Anemia, Other: Approve for 1 year if ALL: (A) patient is ≥ 1 year of age; AND (B) patient meets ONE of the following: i) patient has tried oral iron supplementation AND according to the prescriber oral iron was ineffective or intolerable; OR ii) patient has a condition that will interfere with oral iron absorption (e.g., inflammatory bowel disease such as Crohn’s disease or ulcerative colitis); OR iii) patient is currently receiving an erythropoiesis-stimulating agent; OR iv) the medication is being requested for cancer- or chemotherapy-related anemia.Dosing: Approve up to a maximum cumulative total dose of 1500 mg given intravenously per 30 days

From FDA-approved indication 2

Iron Deficiency Associated with Heart Failure: Approve for 1 year if ALL: (A) patient is ≥ 18 years of age; AND (B) Injectafer is being prescribed by or in consultation with a cardiologist or hematologist.Dosing: Approve up to a maximum cumulative total dose of 1500 mg given intravenously per 30 days

From FDA-approved indication 3

Other Uses with Supportive Evidence / Plan-Specific Criteria

Other uses with supportive evidence and plan-specific coverage:

IDA in CKD on dialysis: Approve for 3 years when requested for patients with chronic kidney disease who are on dialysis.

From Other Uses with Supportive Evidence

Employer and Individual/Family plan criteria for non-dialysis CKD: Patient meets ONE of: 1) patient has tried at least one alternative IV iron (INFeD, sodium ferric gluconate complex/Ferrlecit, 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.

Plan-specific step therapy exceptions listed in Employer and Individual/Family plan sections

Coding, Dosing, and Limits

Considered Medically Necessary when criteria metHCPCSCovered

J1439

Injection, ferric carboxymaltose, 1 mg

Injectafer dosing and cumulative limits

Dose per administration (patients ≥50 kg)Up to 750 mg per dose (IV infusion or slow injection); alternative single-dose option of 15 mg/kg up to a maximum of 1,000 mg for adults ≥50 kg.

Dose per administration (patients <50 kg)15 mg/kg given in two doses separated by at least 7 days per course.

Maximum cumulative dose per treatment courseTotal cumulative dose generally not to exceed 1500 mg per treatment course.

Policy-approved interval limitPolicy approves up to 1500 mg per 30 days (treatment courses and repeat treatment if iron deficiency persists).

Heart failure dosing/maintenanceSpecified heart-failure schedule with initial and week-6 doses and maintenance 500 mg doses at 12, 24, and 36 weeks based on ferritin and hemoglobin criteria.

Provider Actions, Prior Authorization, and Billing Guidance

Prior Authorization

Prior Authorization Required — prior authorization required

Prior Authorization is required for benefit coverage of Injectafer. All approvals are provided for the durations specified in the policy's FDA‑Approved Indications and Other Uses sections. Injectafer must be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., nephrologist for CKD, hematologist for anemia, cardiologist for heart failure) when the approval criteria require specialist involvement.

Approvals durations: 1 year for most FDA‑approved indications (see policy), 3 years for dialysis-dependent CKD indication (Other Uses).
Injectafer prescriptions requiring specialist involvement: nephrologist, hematologist, or cardiologist as noted in indications.

Step Therapy

Step Therapy / Fail First for Non‑Dialysis CKD (plan-specific) — requirement to try alternative IV iron for some plans

Step therapy / fail‑first applies for Non‑Dialysis CKD (plan‑specific): certain employer and individual/family plans require trial of alternative IV iron products before approving Injectafer for iron deficiency anemia in patients with non‑dialysis CKD.

Employer and Individual/Family Plans: Patient must meet ONE of the following for non‑dialysis CKD indication: 1) trial of at least one alternative IV iron (INFeD, sodium ferric gluconate complex [Ferrlecit, generics], or Venofer); 2) patient is < 2 years of age; or 3) patient has already initiated Injectafer and requires completion of the current course.
This step therapy / fail‑first requirement is plan‑specific — confirm the member's benefit plan and apply employer vs individual/family criteria accordingly.

Documentation Required

PROVIDER ACTIONS — prescribing specialist/consultation and prior auth prescriber requirements

Prescribing requirements: Injectafer approvals require that the medication be prescribed by or in consultation with a specialist appropriate to the indication. Ensure the prior authorization request documents the specialist consultation or that the prescriber is the specialist.

Specialists noted in policy: nephrologist for CKD indications, hematologist for anemia indications, cardiologist for heart‑failure indication.
Include evidence of specialist consultation in the prior authorization submission when required (e.g., documented consult note, co‑signature, or specialist prescriber NPI).

Denial Risk

PROVIDER ACTIONS — claims submitted without covered diagnosis/procedure codes or using deleted/invalid codes will be denied; benefit plan documents may supersede

Claims submitted without covered diagnosis/procedure codes or using deleted/invalid codes will be denied. Benefit plan documents may supersede this policy; always verify the member's plan terms and applicable coverage documents before billing.

Use the most appropriate and current diagnosis and procedure codes as of the date of service.
If the member's benefit plan document contains different or more restrictive terms, the plan document governs coverage decisions.

Definitions and Safety Notes

Symptomatic hypophosphatemia

Safety concernSymptomatic hypophosphatemia reported in postmarketing with Injectafer, which can have serious outcomes including osteomalacia and fractures requiring clinical intervention.

Source of warningProduct carries a unique warning and precaution regarding symptomatic hypophosphatemia noted in the safety section of the policy.

Clinical impactReported cases have included serious outcomes that necessitate clinical intervention (e.g., osteomalacia, fractures).

Iron status definitions referenced

Absolute iron deficiency (KDIGO / NCCN / ACC/AHA examples)Ferritin < 30 ng/mL and TSAT < 20% (NCCN definition for absolute iron deficiency; also used to identify patients for IV iron therapy).

Functional iron deficiency (examples)Ferritin 30–500 ng/mL with TSAT < 50% (NCCN) or ferritin 100–300 ng/mL with TSAT < 20% in heart failure guidance (ACC/AHA).

KDIGO thresholds for CKDSuggest initiation of IV iron in hemodialysis patients if TSAT ≤ 30% and ferritin ≤ 500 ng/mL; for non-dialysis CKD, suggest oral or IV if TSAT < 40% and ferritin < 100 ng/mL (or TSAT < 25% with ferritin 100–300 ng/mL).

OpenPayer

Iron Replacement - Injectafer (ferric carboxymaltose)

Coverage Criteria for Injectafer (ferric carboxymaltose)

Coding, Dosing, and Limits

Provider Actions, Prior Authorization, and Billing Guidance

Definitions and Safety Notes

Background