Ferric Carboxymaltose (Injectafer) coverage
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Defines medical necessity criteria, prior authorization and continuation rules for ferric carboxymaltose (Injectafer) for commercial, HIM and Medicaid lines of business in Health Net of California.
New California policy with redirection to two preferred IV iron products, one of which must be Feraheme (generic when available).
Updated initial criteria to require failure of specified preferred injectable agents (Ferrlecit and Venofer for IDA with CKD; for IDA without CKD require failure of two of Ferrlecit, Infed, or Venofer) and added redirection to Feraheme if intolerance/contraindication to preferred agents.
FDA-approved indication for iron deficiency with heart failure was added to the indications section.
Coverage and Medical Necessity Criteria
Initial — IDA with CKD
Initial Approval — Iron Deficiency Anemia with Chronic Kidney Disease (must meet ALL):
Approval duration: 3 months
Initial — IDA without CKD
Initial Approval — Iron Deficiency Anemia without Chronic Kidney Disease (must meet ALL):
Approval duration: 3 months
Initial — Iron deficiency with heart failure
Initial Approval — Iron Deficiency in Heart Failure (must meet ALL):
Approval duration: 3 months
Initial — Cancer/chemotherapy‑induced anemia (off‑label)
Initial Approval — Management of Cancer‑ and Chemotherapy‑Induced Anemia (off‑label) (must meet ALL):
Prescribed regimen must be FDA‑approved or NCCN recommended. Approval duration: 3 months
Continuation Therapy
Continued Therapy (must meet criteria):
Approval duration: 3 months
Initial Therapy and Indication-specific Requirements
Covered when criteria in the policy are met, including documented indication and prior agent failures where required.
Redirection to preferred agents required per policy; see step therapy
If member has intolerance or contraindication to all preferred injectable agents, redirection to Feraheme (generic when available) is required per policy
See dosing nodes for Hb‑based dosing
Step Therapy / Redirection
Stepwise redirection and continued therapy
Continued therapy redirection language applies to IDA with and without CKD
Non‑FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the provider submits adequate documentation of efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09 for commercial and HIM.PA.154 for health insurance marketplace, as applicable).
Hypersensitivity to Injectafer (ferric carboxymaltose) or to any of its inactive components is a contraindication to use and precludes coverage.
Requests for treatment of non‑FDA approved indications that are not addressed in this policy will not be authorized unless sufficient supporting evidence is provided per the applicable off‑label use policy for the member’s line of business (for example, CP.CPA.09 for commercial or HIM.PA.154 for health insurance marketplace).
Coding references included in this policy are provided for informational purposes only; inclusion or omission of a code does not guarantee coverage. Coverage decisions are determined by whether the member meets the medical necessity criteria in this policy, and providers should follow current professional coding guidance when submitting claims.
Initial Therapy: Indication-Specific Rules
Initial therapy
Initial therapy criteria by indication
Dosing and Initial agent-failure requirements
Initial dosing options and agent failure requirements
Continuation and Ongoing Therapy
Continuation therapy
Continuation therapy
Continued therapy redirection
Continued therapy and redirection language applied to IDA with and without CKD.
Policy simplified redirection language and removed age‑based redirection
Step Therapy and Agent-Failure Requirements
| Step | Requirement | Provider documentation |
|---|---|---|
| 1 | Document prior failure, intolerance, or contraindication to specified alternative IV iron products before approving Injectafer. Examples of alternatives include Ferrlecit (sodium ferric gluconate), Venofer (iron sucrose), Infed (iron dextran), or Feraheme (ferumoxytol). For IDA with CKD the policy requires failure of Ferrlecit and Venofer; for IDA without CKD failure of two of Ferrlecit, Infed, or Venofer is required. | Submit clinical records demonstrating prior therapy attempts, adverse reactions, or contraindications (e.g., chart notes, lab results, medication history) showing failure or intolerance to the listed alternative IV iron agents. |
| 2 | If prior failure of the listed alternatives has occurred, provider may proceed with approval of Injectafer within dosing limits (no more than two 750 mg infusions for a cumulative 1,500 mg course, or a single 1,000 mg infusion per policy dosing rules). | Provide documentation of prior failed dosing regimens and the proposed Injectafer dosing; include serum ferritin, TSAT, and hemoglobin values supporting medical necessity. |
| Step | Redirection condition | Required redirection and rationale |
|---|---|---|
| 1 | If the member has documented intolerance or contraindication to all preferred injectable agents specified by the policy (e.g., Ferrlecit and Venofer for IDA with CKD; two of Ferrlecit, Infed, or Venofer for IDA without CKD). | Policy redirects to Feraheme (generic ferumoxytol) when the member cannot tolerate or has contraindications to all preferred agents; provider must document the intolerance/contraindication to support redirection. |
| 2 | When redirection to Feraheme is required, ensure prior failure or intolerance to other alternatives per indication-specific requirements before approval of Injectafer or alternative authorization pathways are considered. | Include clinical evidence of adverse effects or contraindications to each preferred agent, and documentation of any trial of generic Feraheme if required by the indication (e.g., cancer/chemotherapy‑induced anemia sequence). |
Prior Authorization, Documentation, and Submission Requirements
Prior Authorization Required
Prior authorization is required. Providers must demonstrate that the member meets the applicable initial or continuation criteria and submit supporting clinical documentation. Requests will be reviewed for prior failure or intolerance of preferred IV iron agents and may be redirected to preferred products (including generic Feraheme when available) per step-therapy requirements.
- Prior authorization required for Injectafer (ferric carboxymaltose) prior to administration.
- Step therapy: initial and continued use requires documented failure or intolerance of specified preferred IV iron products; if member is intolerant or has contraindications to all preferred agents, redirection to generic Feraheme may be required.
- Approval duration: typically 3 months for initial and continued therapy (per policy-specific criteria).
Required Documentation
Providers must submit clinical documentation supporting that the member meets all approval criteria. Acceptable documentation includes but is not limited to office chart notes, relevant laboratory results (e.g., hemoglobin, serum ferritin, TSAT), prior treatment history showing use and response to oral and/or alternative IV iron products, and documentation of contraindications or adverse reactions to preferred agents.
- Include recent laboratory values since the last IV iron administration (e.g., serum ferritin, TSAT, hemoglobin).
- Provide documentation of prior therapies tried (oral iron, Ferrlecit, Venofer, Infed, etc.), dates of therapy, doses, and reasons for discontinuation (e.g., intolerance, adverse effects, lack of efficacy).
- If requesting an off‑label indication, include supporting evidence per the off‑label use policy (CP.CPA.09 or applicable plan-specific off‑label policy).
Step Therapy Requirement and Redirection to Preferred IV Iron
Step therapy is required before approval. For IDA with CKD and IDA without CKD the policy requires documented failure of or intolerance to specified alternative IV iron products prior to approval of ferric carboxymaltose. If the member has failed or cannot tolerate all preferred injectable agents, the request may be redirected to generic Feraheme (when available) per the policy's step-wise redirection rules.
- IDA with CKD: failure of Ferrlecit and Venofer is required before approval of ferric carboxymaltose unless both are contraindicated or cause clinically significant adverse effects.
- IDA without CKD: failure of two of Ferrlecit, Infed, or Venofer is required before approval unless contraindicated or cause clinically significant adverse effects.
- If the member has met failure/intolerance to the preferred agents, documentation must show dates and reasons for failure/intolerance; only then can continuation or redirection to Feraheme be considered.
Coding, Clinical Thresholds, and Dosing Reference
| J1439 | Injection, ferric carboxymaltose, 1 mg |
Dose and Quantity Limits
Site of Care and Administration
Infusion center not specified
Site of care for IV infusion administration is not specified in this portion of the policy.
Infusion administration setting
IV infusion preparation and administration typically occur in an appropriate infusion setting consistent with standard practice; ensure infusions are performed in an appropriate setting per usual clinical standards.
Background and Product Information
Injectafer (ferric carboxymaltose) is an intravenous iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in patients 1 year of age and older who are intolerant of or have an unsatisfactory response to oral iron; FDA‑approved indications include IDA in adults with non‑dialysis dependent chronic kidney disease and iron deficiency in adult patients with heart failure (NYHA class II/III) to improve exercise capacity.
Definitions and Abbreviations
Policy Revision History
Added criteria for NCCN‑supported indication of cancer- and chemotherapy‑induced anemia with redirection to preferred IV iron products.
Published new California policy operationalizing redirection to two preferred IV iron products (one must be generic Feraheme when available).
Corrected NYHA class for the heart failure FDA‑approved indication in the policy.
Per health plan request, revised redirection language to require generic Feraheme and simplified template redirection language for preferred agents.
Added redirections from initial approval criteria to continued therapy for IDA with and without CKD per health plan request.
Updated FDA‑approved indications to include iron deficiency with heart failure per updated prescribing information.
Updated initial criteria to require failure of specified preferred injectable agents for IDA (Ferrlecit and Venofer for IDA with CKD; two of Ferrlecit, Infed, or Venofer for IDA without CKD) and added redirection to Feraheme if intolerance/contraindication to preferred agents.
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