CurrentCareSourcePolicy N/A

Injectafer (ferric carboxymaltose) — Coverage Criteria and Prior Authorization

Defines prior authorization, coverage criteria, dosing limits, and prescriber requirements for IV ferric carboxymaltose (Injectafer) for iron deficiency/anemia indications for CareSource members.

Policy Summary

PayerCareSource

PolicyInjectafer (ferric carboxymaltose) — Coverage Criteria and Prior Authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateJan 15, 2025

Key ActionObtain prior authorization with documentation that the patient meets indication-specific criteria, dosing limits, specialist involvement, and oral iron trial or intolerance when applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1500 mgmaximum cumulative IV dose authorized per 30 days

1 yeartypical approval duration (CKD non-dialysis, HF, other FDA)

3 yearsapproval duration (CKD on dialysis)

requires specialistspecialist prescribing requirement

>=1 yr / >=18 yrdocumented age criteria

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Recommended Authorization Criteria

FDA-Approved Indications

Covered when ALL of the following per-indication criteria are met (criteria differ by indication):

Iron Deficiency Anemia in Patients with CKD who are NOT on Dialysis: Approve for 1 year if BOTH A and B are met: A) patient has iron deficiency anemia with chronic kidney disease who is NOT on dialysis; AND B) the medication is prescribed by or in consultation with a nephrologist or hematologist.1 year approval

Dosing limit: maximum cumulative total dose 1500 mg IV per 30 days.

Iron Deficiency Anemia, Other (FDA): Approve for 1 year if BOTH A and B are met: A) patient is ≥1 year of age; AND B) the medication is prescribed by or in consultation with a relevant specialist. For adult patients (≥18 years) one of the following must be met: a) patient has tried oral iron supplementation and, per the prescriber, oral iron was ineffective or intolerable; OR b) the patient has a condition that will interfere with oral iron absorption (examples: inflammatory bowel disease such as Crohn's disease or ulcerative colitis); OR c) the medication is requested for cancer- or chemotherapy-related anemia while the patient is currently receiving an erythropoiesis-stimulating agent.1 year approval

Dosing limit: maximum cumulative total dose 1500 mg IV per 30 days.

Iron Deficiency Associated with Heart Failure: Approve for 1 year if BOTH A and B are met: A) patient is ≥18 years of age; AND B) the medication is prescribed by or in consultation with a cardiologist or hematologist.1 year approval

Dosing limit: maximum cumulative total dose 1500 mg IV per 30 days.

Other Uses with Supportive Evidence

Covered with extended duration when criteria met:

Iron Deficiency Anemia in Patients with CKD who are on Dialysis: Approve for 3 years when the indication is dialysis-dependent CKD-associated iron deficiency anemia and the indication-specific criteria and dosing limits are met.3 year approval

Prescriber/specialist requirement and dosing limit (maximum cumulative total dose 1500 mg IV per 30 days) apply.

Coverage is not recommended for circumstances that are not explicitly included in the Recommended Authorization Criteria. Criteria are periodically updated as new published data become available; requests outside the listed criteria should be considered non-covered unless and until the criteria are revised.

Requests for indications that fall outside the Recommended Authorization Criteria are not recommended for approval and are considered not medically necessary under this policy.

Billing Codes and Dosing Rules

Covered HCPCS (example from policy context)HCPCSCovered

J1439

Injection, ferric carboxymaltose (Injectafer), per 1 mg (commonly used HCPCS code for ferric carboxymaltose)

Weight-based and hemoglobin dosing (Injectafer)

Standard adult weight-based dosing (≥50 kg)Up to 750 mg per dose with a total cumulative dose not to exceed 1500 mg per treatment course.

Alternative dosing for patients <50 kg15 mg/kg given as two doses separated by at least 7 days per treatment course.

Dose frequency/administrationAdministered by IV infusion or slow injection; treatment may be repeated if iron deficiency persists or recurs.

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

Reference to weight/Hb tableSee recommended dosage table for heart failure for specific weight and hemoglobin–based dosing and maintenance schedule.

Prior Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior authorization required

Prior authorization is recommended for medical benefit coverage of Injectafer. Approvals are provided for the durations specified per indication and for doses up to the maximum cumulative total of 1500 mg given intravenously per 30 days; approvals requiring specialist prescription/consultation are issued for the durations noted in the criteria (e.g., 1 year for CKD non-dialysis and heart failure, 3 years for dialysis-dependent CKD when criteria met).

Prior Authorization is recommended for medical benefit coverage of Injectafer.
Approvals provided for durations specified per indication (e.g., 1 year; 3 years for dialysis-dependent CKD) and dosing limits (max cumulative 1500 mg/30 days).
Certain approvals require the medication to be prescribed by or in consultation with a relevant specialist.

Step Therapy

Oral iron trial requirement

For FDA-indicated adult uses (including non-dialysis CKD), the patient must have tried oral iron supplementation and the prescriber must document that oral iron was ineffective or not tolerated; alternatively, the prescriber may document a condition expected to interfere with oral iron absorption.

Clinical Definitions and Thresholds

Functional iron deficiency

Definition (functional iron deficiency)Ferritin 100–300 ng/mL with transferrin saturation (TSAT) <20% (per ACC/AHA heart failure guideline context).

ACC/AHA contextIn heart failure with reduced EF, IV iron is reasonable for absolute iron deficiency (ferritin <100 ng/mL) or functional iron deficiency (ferritin 100–300 ng/mL with TSAT <20%).

KDIGO/NCCN noteGuideline frameworks also describe functional iron deficiency using overlapping ferritin and TSAT thresholds to guide IV iron initiation and maintenance.

Absolute iron deficiency

Definition (absolute iron deficiency)Ferritin ≤30 ng/mL and transferrin saturation (TSAT) <20% (as used in NCCN/KDIGO contexts).

NCCN/KDIGO contextAbsolute iron deficiency defined as ferritin ≤30 ng/mL with TSAT <20% guides IV iron consideration, particularly in oncology and CKD guidance.

Drug Background

Injectafer (ferric carboxymaltose) is an intravenous iron formulation indicated for treatment of iron deficiency anemia in multiple settings, including patients with chronic kidney disease not on dialysis, certain FDA‑approved non‑CKD indications (including heart failure–related iron deficiency), and other documented indications described in the Recommended Authorization Criteria. Use, dosing limits, prior authorization requirements, and approval durations are specified in the criteria sections and the policy may be updated as new evidence emerges.