CurrentCareSourcePolicy N/A

Feraheme (ferumoxytol) IV iron replacement — Prior Authorization and Coverage Criteria

Defines prior authorization, coverage criteria, dosing limits, and required specialist involvement for Feraheme (ferumoxytol) intravenous iron replacement for iron deficiency anemia in specified populations.

Policy Summary

PayerCareSource

PolicyFeraheme (ferumoxytol) IV iron replacement — Prior Authorization and Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateJan 15, 2025

Key ActionSubmit prior authorization with documentation that the patient meets indication-specific criteria and dosing limits (maximum 1020 mg per 30 days).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1020 mgmax dose /30 days

3 yrsCKD on dialysis approval

1 yrOther indications approval

Age ≥ 18minimum age

Authorization and Coverage Criteria

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CKD on dialysis (FDA-approved): Iron Deficiency Anemia in patients with chronic kidney disease who are on dialysisApprove for 3 years; dosing limit up to a maximum cumulative total dose of 1020 mg IV per 30 days

CKD not on dialysis (FDA-approved): Iron Deficiency Anemia in patients with chronic kidney disease who are not on dialysisPatient is >= 18 years; medication prescribed by or in consultation with a nephrologist or hematologist; Approve for 1 year; dosing limit up to a maximum cumulative total dose of 1020 mg IV per 30 days

Iron Deficiency Anemia, Other (non-CKD)

Required subcriteria (both A and B)
- A: Patient is >= 18 years
- B
  - i: Patient has tried oral iron supplementation
  - ii: Prescriber documents a condition that will interfere with oral iron absorption (e.g., inflammatory bowel disease such as Crohn's disease or ulcerative colitis)
  - iii: Prescriber documents that oral iron supplementation was ineffective or intolerable
  - iv: Medication is being requested for cancer- or chemotherapy-related anemia

Heart failure-associated iron deficiency: Iron deficiency associated with heart failurePatient is >= 18 years; medication prescribed by or in consultation with a cardiologist or hematologist; Approve for 1 year; dosing limit up to a maximum cumulative total dose of 1020 mg IV per 30 days

Coverage of Feraheme (ferumoxytol) is not recommended for circumstances that are not listed in the Recommended Authorization Criteria. The policy’s authorization criteria define the covered indications, required documentation, and dosing limits; requests falling outside those specified criteria may be denied. The criteria will be reviewed and updated as new published data are available to reflect evolving evidence.

Billing and Laboratory Codes & Thresholds

Covered/Referenced Codesmixed

No specific CPT/HCPCS/ICD-10 codes listed

Document does not enumerate procedure or diagnosis billing codes; only product name Feraheme (ferumoxytol) and prescribing information referenced.

Laboratory thresholds referenced in guidelines — examples

KDIGO hemodialysis thresholdTransferrin saturation (TSAT) < 30% AND ferritin < 500 ng/mL

KDIGO non-dialysis thresholdsInitiate oral or IV iron if TSAT < 40% and ferritin < 100 ng/mL OR TSAT < 25% with ferritin ≥ 100 ng/mL and < 300 ng/mL

KDIGO profound deficiency (no anemia)Consider oral or IV iron for TSAT ≤ 20% AND ferritin ≤ 30 ng/mL

NCCN oncology thresholdsAbsolute iron deficiency: ferritin ≤ 30 ng/mL AND TSAT ≤ 20%; Functional iron deficiency: ferritin 30–500 ng/mL with TSAT ≤ 50% (use with ESA guidance)

ACC/AHA heart failure thresholdsAbsolute iron deficiency: ferritin < 100 ng/mL; Functional iron deficiency: ferritin 100–300 ng/mL with low TSAT

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior authorization required

Prior authorization is recommended for medical benefit coverage of Feraheme; approvals are granted when the patient meets the policy's criteria and dosing limits, with durations noted per indication.

Step Therapy

Oral iron trial or documented contraindication

For the 'Iron Deficiency Anemia, Other' indication, the patient must have tried oral iron supplementation or the prescriber must document that oral iron is ineffective, intolerable, or that a condition will interfere with oral iron absorption (examples include inflammatory bowel disease).

Patient has tried oral iron supplementation; OR
Prescriber documents oral iron was ineffective or intolerable; OR
Prescriber documents a condition that interferes with oral iron absorption (e.g., Crohn’s disease, ulcerative colitis)

Documentation Required

Required documentation for PA

Submit documentation showing the patient meets the listed criteria for the requested indication (age, indication-specific clinical/laboratory criteria), the prescribing specialist or consultation when required, and adherence to dosing limits (maximum cumulative total dose up to 1020 mg IV per 30 days). Approvals are provided for the duration noted by indication (e.g., 3 years for CKD on dialysis; 1 year for other covered indications).

Evidence of age (≥18 years where specified) and indication-specific criteria
Prescriber specialty or documented consultation when required (nephrologist, hematologist, or cardiologist as specified)
Dosing records showing cumulative dose ≤1020 mg per 30 days

Denial Risk

Denial triggers — non‑listed circumstances or dosing outside policy

Requests for coverage in circumstances not listed in the Recommended Authorization Criteria are not recommended for approval; requests for doses outside the established dosing in this policy will be considered case‑by‑case and may be denied.

Clinical Background

Feraheme (ferumoxytol) is an intravenous iron replacement product indicated for treatment of iron deficiency anemia, including in patients with chronic kidney disease and in those who are intolerant of or unresponsive to oral iron. Recommended administration consists of an initial 510 mg IV dose followed 3–8 days later by a second 510 mg dose per treatment cycle, with the policy limiting cumulative dosing to 1020 mg per 30 days. Clinical guidelines (KDIGO, ACC/AHA, NCCN) provide iron-status parameters such as transferrin saturation and ferritin thresholds to guide IV iron use in CKD, oncology, and heart failure contexts.

Dosing and Iron Status Parameters

Recommended dosing

Initial dose510 mg IV single dose

Second dose timingSecond 510 mg IV dose administered 3–8 days after the initial dose

Per-treatment-cycle totalTwo doses of 510 mg (total 1,020 mg) per treatment cycle

Cumulative limitMaximum cumulative dose 1,020 mg per 30 days

Iron status parameters (examples from guidelines)

TSAT example thresholdsTSAT thresholds cited by guidelines include values such as ≤20% (profound deficiency), <25% and <30% depending on context

Ferritin example thresholdsFerritin thresholds cited include ≤30 ng/mL (absolute deficiency), 100 ng/mL, 300 ng/mL, and <500 ng/mL for dialysis patients

Use in decision-makingGuidelines use combined TSAT and ferritin cutoffs to define absolute vs functional iron deficiency and to guide initiation of IV iron