CurrentCignaPolicy IP0750

Iron Replacement - Ferumoxytol

Defines Cigna prior authorization and coverage criteria for ferumoxytol (Feraheme) IV iron for adults with iron deficiency anemia across CKD, cancer/chemotherapy-related anemia, heart failure–associated iron deficiency, and other non-dialysis indications.

Policy Summary

PayerCigna

PolicyIron Replacement - Ferumoxytol

Policy CodePolicy IP0750

Change TypeNew policyterminology standardized

Effective Date

Next Review Date

Key ActionObtain prior authorization for ferumoxytol (Feraheme) with documentation of age, indication, prior therapy or intolerance, specialist consultation when required, and dosing limits.

SourceLink

POLICY UPDATE CHANGES

The policy was newly created and named; references to 'Feraheme' were changed to 'ferumoxytol.'

≥18minimum age for covered indications

1020 mgmax dose per 30 days

3 yrsapproval duration (CKD on dialysis)

1 yrapproval duration (other indications)

Black boxsafety warning

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Coverage Criteria for Ferumoxytol (Feraheme)

FDA-Approved Indication: CKD on dialysis

Covered for FDA-approved indications when ALL requirements below are met:

CKD on dialysis: 1. Iron Deficiency Anemia in patients with chronic kidney disease who are on dialysis.Approve for 3 years

No additional specialty prescriber requirement listed for this group in the policy.

FDA-Approved Indication: CKD not on dialysis

Covered for CKD not on dialysis when ALL of the following are met:

CKD not on dialysis: 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.Approve for 1 year; dosing limit: maximum cumulative total 1020 mg IV per 30 days

For certain employer and individual/family plans, the member may be required to have tried an alternative IV iron product (INFeD, Ferrlecit, Venofer) or have initiated the requested medication and require completion of the current course as acceptable prior therapy evidence.

FDA-Approved Indication: Other iron deficiency anemia

Covered for other iron deficiency anemia indications when ALL of the following are met:

Other iron deficiency anemia: A) Patient is ≥ 18 years of age; AND B) Patient meets ONE of: 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.Approve for 1 year; dosing limit: maximum cumulative total 1020 mg IV per 30 days

Examples of erythropoiesis-stimulating agents include epoetin alfa, darbepoetin alfa, or methoxy polyethylene glycol-epoetin beta.

Other Uses with Supportive Evidence: Heart failure

Covered for heart failure92associated iron deficiency when ALL of the following are met:

Heart failure: A) Patient is ≥ 18 years of age; AND B) The medication is being prescribed by or in consultation with a cardiologist or hematologist.Approve for 1 year; dosing limit: maximum cumulative total 1020 mg IV per 30 days

Policy rationale aligns with guideline evidence supporting IV iron to improve functional status in patients with heart failure and iron deficiency.

Ferumoxytol for any use not specifically listed in this policy is not medically necessary. Criteria will be updated if new published data become available.

Requests for ferumoxytol for indications that are not described in this policy (i.e., any other use) are considered not medically necessary and will be denied.

Coding and Billing

Considered medically necessary when criteria metHCPCSCovered

Q0138

Injection, ferumoxytol, for treatment of iron deficiency anemia, 1 mg (non-ESRD use)

Guideline thresholds — iron parameters (TSAT, ferritin)

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

KDIGO (CKD, not on dialysis)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.

NCCN (cancer-related anemia)IV iron considered for absolute iron deficiency (ferritin < 30 ng/mL and TSAT < 20%) and for possible/functional iron deficiency per specified ferritin and TSAT ranges (e.g., ferritin 30–500 ng/mL with TSAT < 50%); used with ESAs in selected patients.

ACC/AHA (heart failure, HFrEF ≤40% LVEF)IV iron reasonable for absolute iron deficiency (ferritin < 100 ng/mL) or functional iron deficiency (ferritin 100–300 ng/mL if TSAT < 20%) to improve functional status and quality of life.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization Required — Prior authorization is required for ferumoxytol (Feraheme) for benefit coverage. Approvals vary by indication: 3 years for iron deficiency anemia in patients with chronic kidney disease (CKD) who are on dialysis; 1 year for CKD patients not on dialysis, for other FDA‑approved indications, and for other uses when criteria are met. Because of the specialized evaluation and monitoring required, approvals for certain indications require the medication to be prescribed by or in consultation with a physician who specializes in the condition being treated.

Approvals: 3 years for CKD on dialysis; 1 year for non‑dialysis CKD, other FDA‑approved indications.
Prior authorization is required; claims submitted without prior authorization when required will be denied.

Step Therapy

Plan‑Specific Step Therapy May Apply

Plan‑specific Step Therapy — Certain employer, individual, and family plans require trial of alternative IV iron products for patients with CKD who are not on dialysis before approving ferumoxytol. For these plans, the patient must meet ONE of the following: (1) trial of at least one alternative IV iron (e.g., INFeD, sodium ferric gluconate complex [Ferrlecit, generics], Venofer); OR (2) the patient has already initiated ferumoxytol therapy and requires additional doses to complete the current course of therapy.

Background

Ferumoxytol is an intravenous iron replacement indicated for the treatment of iron deficiency anemia in adults, including anemia related to chronic kidney disease. The product is administered by IV infusion and treatment may be repeated if iron deficiency persists or recurs; it carries a black box warning for potentially fatal hypersensitivity reactions.

Definitions and Guideline References

Ferumoxytol — drug and trade name

Generic nameFerumoxytol

Trade nameFeraheme

Formulation/routeIntravenous (IV) iron replacement; recommended dosing: 510 mg IV followed by 510 mg 3–8 days later per treatment cycle.

Guideline references — KDIGO, NCCN, ACC/AHA

KDIGO (anemia in CKD)Suggests IV iron initiation for hemodialysis patients if TSAT ≤ 30% and ferritin ≤ 500 ng/mL; for non-hemodialysis CKD suggests oral or IV iron if TSAT < 40% and ferritin < 100 ng/mL, or TSAT < 25% with ferritin ≥ 100 and < 300 ng/mL.

NCCN (cancer-related anemia)Defines iron status categories and considers IV iron for absolute iron deficiency (ferritin < 30 ng/mL and TSAT < 20%) and for functional/possible functional iron deficiency per ferritin and TSAT thresholds; IV iron may be used with ESAs in selected patients.

Revision History / Policy Changes

2026-04-01Annual revisionLatest

Policy name and terminology were updated: references to 'Feraheme' were changed to 'ferumoxytol' as part of the annual revision.

2025-09-15Policy created

New policy was created (initial publication recorded on 09/15/2025).

Policy Summary

PayerCigna

PolicyIron Replacement - Ferumoxytol

Policy CodePolicy IP0750

Change TypeNew policyterminology standardized

Effective Date

Next Review Date

Key ActionObtain prior authorization for ferumoxytol (Feraheme) with documentation of age, indication, prior therapy or intolerance, specialist consultation when required, and dosing limits.

SourceLink

On This Page

Affected populations: Non‑dialysis CKD patients on certain Employer and Individual/Family plans.
Required alternatives: INFeD, sodium ferric gluconate complex (Ferrlecit, generics), Venofer.

Documentation Required

Documentation Required with Prior Authorization

Required Documentation — For approvals that require specialist involvement, the prescription must be provided by or in consultation with an appropriate specialist: nephrologist or hematologist for CKD indications; cardiologist may be required for heart‑failure related indications per plan criteria. Documentation must support the covered diagnosis and fulfillment of the applicable criteria (e.g., age ≥ 18 years, prior trial/intolerance of oral iron when required, conditions interfering with oral absorption, use of erythropoiesis‑stimulating agents, cancer/chemotherapy‑related anemia). Include dosing intent (cumulative dose up to 1020 mg per 30 days when applicable) and rationale for step‑therapy exceptions when non‑preferred products were not appropriate.

Prescriber requirement: prescribed by or in consultation with a specialist (nephrologist, hematologist, or cardiologist as applicable).
Clinical documentation: diagnosis, prior therapies and response/intolerance, rationale for use, planned dosing (max 1020 mg per 30 days).
Plan‑specific notes: evidence of trial of alternative IV iron or documentation of medical reason for exception when step therapy is in effect.

Denial Risk

Denial Risk — Missing Authorization or Documentation

Denial Triggers — Claims or authorization requests missing a covered diagnosis, required specialist consultation, or necessary supporting documentation (including evidence of required step‑therapy failure or exception) will be denied as not covered. Prior authorization is required; submissions without prior authorization where one is required will be denied.

Submissions without a covered diagnosis or without required procedure/diagnosis codes will be denied as not covered.
Missing specialist prescription/consultation or missing documentation of prior trials/intolerance or other required clinical criteria will trigger denial.

ACC/AHA (heart failure)In HFrEF (LVEF ≤ 40%), IV iron reasonable for absolute iron deficiency (ferritin < 100 ng/mL) or functional iron deficiency (ferritin 100–300 ng/mL if TSAT < 20%) to improve functional status (2a recommendation).