CurrentHealth NetPolicy N/A

Ferric carboxymaltose (Injectafer) IV iron therapy — coverage criteria

Defines medical necessity, coverage criteria, dosing limits, and documentation requirements for Injectafer (ferric carboxymaltose) for members across commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerHealth Net

PolicyFerric carboxymaltose (Injectafer) IV iron therapy — coverage criteria

Policy CodePolicy N/A

Change TypeNo material clinical changes

Effective DateJun 1, 2016

Next Review DateN/A

Key ActionSubmit prior authorization with supporting clinical documentation (chart notes and labs) showing the member meets specified approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 monthstypical approval duration

≤2 x 750 mg or 1,000 mgmax single-course dose allowed

Commercial, HIM, Medicaidcovered lines

J1439HCPCS code

Hypersensitivitycontraindication

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Initial Therapy — IDA with CKD

Covered for Iron Deficiency Anemia with Chronic Kidney Disease when ALL of the following are met

CKD IDA initial criteria: 1) Diagnosis of iron deficiency anemia (IDA) with chronic kidney disease (CKD). 2) IDA confirmed by either: serum ferritin < 500 ng/mL OR transferrin saturation (TSAT) < 30%. 3) If member is not on hemodialysis or peritoneal dialysis, oral iron therapy is not optimal due to at least one of: TSAT < 12%; hemoglobin (Hgb) < 7 g/dL; symptomatic anemia; oral iron intolerance; severe or ongoing blood loss; inability to achieve therapeutic targets with oral iron; or a co‑existing condition likely refractory to oral iron. 4) Failure of both Ferrlecit and iron sucrose (generic Venofer), unless clinically significant adverse effects are experienced or both are contraindicated. If criterion 4 is satisfied, failure of generic Feraheme is required unless contraindicated. 5) Requested dose does not exceed two 750 mg elemental iron infusions/injections (cumulative 1,500 mg) or a single 1,000 mg elemental iron infusion/injection. Approval duration: 3 months.

Initial Therapy — IDA without CKD

Covered for Iron Deficiency Anemia without Chronic Kidney Disease when ALL of the following are met

non-CKD IDA initial criteria: 1) Diagnosis of iron deficiency anemia (IDA) confirmed by one of the following: serum ferritin <15 ng/mL (or pregnancy threshold as specified), serum ferritin <41 ng/mL with Hgb <12 g/dL (women) or <13 g/dL (men), TSAT <20%, absence of stainable iron in bone marrow, increased erythrocyte protoporphyrin, or increased soluble transferrin receptor (sTfR) or sTfR‑ferritin index. 2) Oral iron therapy is not optimal due to at least one of: 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 time of request. 4) Failure of two of the following agents (unless clinically significant adverse effects or contraindicated): Ferrlecit, Infed, or iron sucrose (generic Venofer). If criterion 4a is met, failure of generic Feraheme is required unless contraindicated. 5) Dose does not exceed two 750 mg elemental iron infusions/injections or a single 1,000 mg elemental iron infusion/injection. Approval duration: 3 months.

Initial Therapy — Iron deficiency with heart failure

Covered for Iron Deficiency with Heart Failure when ALL of the following are met

Heart failure iron deficiency criteria: 1) Iron deficiency confirmed by either: serum ferritin <100 ng/mL OR serum ferritin 100–300 ng/mL with TSAT <20%. 2) Hemoglobin <15 g/dL. 3) Left ventricular ejection fraction (LVEF) <45%. 4) New York Heart Association (NYHA) class II or III. 5) Age ≥18 years. 6) Dose does not exceed 1,000 mg elemental iron per infusion/injection (follow heart failure–specific dosing regimen as applicable). Approval duration: 3 months.

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

Covered (off‑label) for Management of Cancer- and Chemotherapy-Induced Anemia when ALL of the following are met

Cancer/chemo-induced anemia criteria: 1) Absolute or functional iron deficiency documented by specified ferritin/TSAT patterns (examples include absolute ferritin <30 ng/mL; functional ferritin 30–500 ng/mL with TSAT thresholds or patterns as described). 2) Member is receiving chemotherapy and therapy is prescribed by or in consultation with an oncologist. 3) Failure of two of the following agents, unless clinically significant adverse effects or contraindications exist: Ferrlecit, Infed, or iron sucrose (generic Venofer). If criterion 3 is satisfied, failure of generic Feraheme is required unless contraindicated. 4) Requested dose is within FDA maximum limits for any FDA‑approved indication or is supported by practice guidelines or peer‑reviewed literature for the off‑label use; prescriber must submit supporting evidence. 5) Prescribed regimen should be FDA‑approved or recommended by NCCN for the indication. Approval duration: 3 months.

Continued Therapy

Continued therapy criteria (for ongoing treatment) — member must meet ONE of the following sets depending on diagnosis

Continued therapy general: Member must meet one of the diagnosis‑specific continued therapy pathways below. Generally required elements include: currently receiving Injectafer via the plan benefit or previously met initial approval criteria; documentation of laboratory evidence since the last IV iron (examples by diagnosis include TSAT <30% or ferritin thresholds per the relevant diagnosis); documentation of prior failures to preferred IV iron agents as required by initial criteria; if request is for a dose increase, new dose must not exceed two 750 mg elemental iron infusions/injections or a single 1,000 mg elemental iron infusion/injection. Approval duration: 3 months.

Coverage criteria and dosing

Covered when dosing and indication align with FDA-approved uses and plan-specific redirection/step therapy requirements are met

Indication and dosing: 1) Use must align with FDA‑approved indications (including specified CKD and heart failure populations) or, for approved off‑label scenarios, be supported by guidelines/peer‑reviewed literature as required. 2) Dosing options include: two‑dose course of 750 mg per dose separated by at least 7 days for a cumulative 1,500 mg per course; or a single‑dose course of 15 mg/kg up to a maximum of 1,000 mg. 3) Treatment may be repeated per clinical need and policy dosing limits. 4) For heart failure, follow the heart‑failure–specific dosing regimen and maximums as described.see dosing

Exact pediatric age and NYHA class details are noted in policy history.

Step therapy/alternative agents: 1) Initial therapy requires prior failure, intolerance, or contraindication to preferred injectable IV iron agents per plan redirection: examples include Ferrlecit, iron sucrose (Venofer), and Infed. 2) If the member has failed or cannot tolerate preferred agents, redirection to generic Feraheme is required before approval of Injectafer unless contraindicated. 3) Plan‑specific prior authorization and redirection rules apply; providers should follow prior authorization processes and submit supporting documentation.N/A

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient clinical documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policy (for example, CPCPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, or CP PMN.53 for Medicaid) or provides evidence of coverage documentation.

Requests for uses outside FDA‑approved indications require submission of off‑label supporting documentation or evidence of coverage. Approval for these non‑FDA uses will be considered only when the documentation meets the criteria defined in the relevant off‑label use policy for the member’s line of business.

For requested uses not listed in this policy, providers should follow plan routing: refer to the formulary/PDL or non‑formulary policy for the applicable line of business, or to the off‑label use policy when the requested diagnosis, age, or dosing regimen is not covered here. Relevant plan policies include CP.CPA.190 (Commercial), HIM.PA.33/HIM.PA.103 (Marketplace), and CP PMN.255/CP PMN.16 (Medicaid) as appropriate.

If an indication is not addressed in this policy and sufficient off‑label documentation is not provided, the request may be considered not medically necessary and can be denied. Providers should submit the required off‑label justification or direct the request to the appropriate formulary/non‑formulary or off‑label review pathway to avoid denial.

Prior Authorization, Documentation & Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required. Submit supporting clinical documentation (office chart notes, recent lab results, and other relevant clinical information) demonstrating that the member meets the approval criteria. Typical approval duration: 3 months for initial and continued therapy when criteria are met.

Approval duration: 3 months
Required supporting documentation: office notes, lab results, other clinical information

Denial Risk

Documentation & Denial Risk

Providers must supply documentation supporting medical necessity. Requests lacking adequate documentation to show the member meets all approval criteria may be denied. Non‑FDA (off‑label) indications that are not addressed by this policy require sufficient supporting evidence per applicable off‑label use policies; absent that, coverage may be denied.

Documentation-based denials possible if approval criteria are not met or documentation is insufficient
Non‑FDA/off‑label requests require supporting evidence per off‑label use policies (e.g., CPCPA.09, HIM.PA.154, CP PMN.53) or will be denied

Documentation Required

Required Documentation

Required documentation includes recent laboratory results (e.g., hemoglobin, serum ferritin, TSAT), office/clinic notes detailing prior therapies and reasons for intolerance or contraindication, and records of prior injectable iron trials (Ferrlecit, iron sucrose/Venofer, Infed, generic Feraheme) when applicable. For off‑label uses, include peer‑reviewed literature or guideline support when requested.

Lab results: Hgb, serum ferritin, TSAT (values and dates)
Clinical notes documenting failure/intolerance/contraindication to preferred oral and injectable irons
Evidence supporting off‑label use (when applicable): guidelines, peer‑reviewed literature, or oncologist consultation

Billing Rule

Coding Documentation

Coding guidance for claim submission: reference HCPCS code J1439 (Injection, ferric carboxymaltose; 1 mg) for ferric carboxymaltose products. Codes listed in the policy are informational — providers must follow current professional coding guidance when submitting claims.

HCPCS: J1439 — Injection, ferric carboxymaltose; 1 mg
Codes are informational; verify up‑to‑date professional coding guidance prior to claim submission

Step Therapy

Step Therapy and Preferred Injectable Agents

Step therapy/redirection: Prior authorization requires documented failure, intolerance, or contraindication to preferred alternative IV iron agents before approval for ferric carboxymaltose. The policy directs step‑wise redirection to preferred injectable iron products (examples include Ferrlecit, iron sucrose/Venofer, Infed). If the member has intolerance or contraindication to all preferred agents, redirection to generic Feraheme may be required per criteria.

Step therapy requires failure/intolerance/contraindication to preferred agents (e.g., Ferrlecit, Infed, iron sucrose/Venofer)
If preferred agents are not suitable, redirection to generic Feraheme may be required before approval

Note

Preferred Injectable Agents & Redirection

Preferred injectable agents should be tried as specified in the clinical criteria. The policy includes redirection language to preferred products and to generic Feraheme in a step‑wise fashion when clinically indicated; providers should document trials and outcomes of these alternatives.

Preferred agents referenced: Ferrlecit, Infed, iron sucrose (Venofer)
Redirection to generic Feraheme is required per step‑therapy rules when applicable

Key Terms and Laboratory Definitions

IDA — Iron deficiency anemia definition and lab thresholds (ferritin, TSAT, Hb)

DefinitionIron deficiency anemia (IDA): clinical diagnosis referenced throughout the policy, confirmed using laboratory thresholds (serum ferritin, TSAT, hemoglobin)

Ferritin thresholdsExamples include serum ferritin < 500 ng/mL for CKD; < 15 ng/mL (or < 41 ng/mL with corresponding low Hb) for non-CKD; 100 ng/mL or 100–300 ng/mL with TSAT < 20% for heart failure

TSAT thresholdsTSAT thresholds cited include < 30% for CKD, < 20% for heart failure and some non-CKD criteria, and < 12% as a reason oral iron is not optimal

Hemoglobin thresholdsHemoglobin examples used: Hb < 7 g/dL as criterion for oral iron not optimal; Hb < 15 g/dL in heart failure criteria; other Hb cutoffs referenced with ferritin for non-CKD

TSAT — Transferrin saturation definition

DefinitionTSAT (transferrin saturation): laboratory measure of circulating iron availability used as a criterion to confirm iron deficiency (examples: TSAT < 30% for CKD; TSAT < 20% for heart failure)

Role in criteriaTSAT thresholds appear both as diagnostic criteria (e.g., TSAT < 20% or < 30%) and as justification that oral iron is not optimal (e.g., TSAT < 12%)

Use in continued therapyTSAT < 30% is listed among laboratory results acceptable for continued therapy documentation in CKD

erythropoiesis stimulating agent — ESA definition

DefinitionErythropoiesis stimulating agent (ESA): listed in appendix as abbreviation 'ESA' (erythropoiesis stimulating agent)

ContextESA referenced in appendices/general information as an abbreviation relevant to anemia management

transferrin saturation — TSAT (alternate index)

DefinitionTransferrin saturation (TSAT): percentage of transferrin bound with iron; used throughout policy as a laboratory index for iron deficiency

Synonym/usageTSAT is used interchangeably with 'transferrin saturation' in diagnostic and continued therapy criteria

Relevant cutoffsCutoffs cited include TSAT < 30% (CKD), TSAT < 20% (heart failure/non-CKD), and TSAT < 12% as a marker that oral iron is not optimal

chronic kidney disease — CKD definition

DefinitionChronic kidney disease (CKD): abbreviated as CKD in the policy; Injectafer is indicated for IDA in adult patients with non-dialysis dependent CKD

Policy roleCKD status determines specific diagnostic thresholds and criteria (e.g., ferritin < 500 ng/mL or TSAT < 30% used for IDA with CKD)

Appendix referenceCKD listed in the appendices/abbreviation key as 'chronic kidney disease'

OpenPayer

Ferric carboxymaltose (Injectafer) IV iron therapy — coverage criteria

Coverage and Medical Necessity Criteria

Billing and Coding

Prior Authorization, Documentation & Step Therapy

Product Background

Key Terms and Laboratory Definitions