CurrentCentenePolicy CP PHAR.165

Ferumoxytol (Feraheme) intravenous iron therapy — coverage criteria

Policy governing medical necessity criteria, prior authorization and coverage for ferumoxytol (Feraheme) for treatment of iron deficiency anemia (with and without chronic kidney disease) and certain off-label uses for members covered by Centene lines of business.

Policy Summary

PayerCentene

PolicyFerumoxytol (Feraheme) intravenous iron therapy — coverage criteria

Policy CodePolicy CP PHAR.165

Change TypeNo material change

Effective DateMar 1, 2016

Next Review Date

Key ActionPrior authorization is required with documentation that the member meets the policy's medical necessity criteria for ferumoxytol.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

510 mgmaximum elemental iron per infusion/injection

3 monthsapproval duration

adult patientsFDA-indicated population

510 mg vialproduct availability

Q0138, Q0139HCPCS codes referenced

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Coverage Criteria for Ferumoxytol (Feraheme)

Initial Therapy — IDA with CKD

Covered when ALL of the following are met

IDA with CKD initial criteria: 1) Diagnosis of iron deficiency anemia (IDA) associated with chronic kidney disease (CKD); 2) IDA is confirmed by laboratory criteria: transferrin saturation (TSAT) < 30% OR serum ferritin < 500 ng/mL; 3) If CKD does not require hemodialysis or peritoneal dialysis, oral iron therapy is not optimal due to any of: hemoglobin (Hgb) < 7 g/dL; severe or ongoing blood loss; symptomatic anemia; oral iron intolerance; inability to achieve therapeutic targets with oral iron; co-existing condition refractory to oral iron therapy; 4) Failure of both Ferrlecit and iron sucrose (Venofer) unless adverse effects or contraindications documented; 5) If request is for brand Feraheme, member must use generic ferumoxytol unless contraindicated or clinically significant adverse effects are experienced; 6) Dose does not exceed 510 mg elemental iron per infusion/injection.

Approval duration: 3 months

Initial Therapy — IDA without CKD

Covered when ALL of the following are met

IDA without CKD initial criteria: 1) Diagnosis of iron deficiency anemia confirmed by one or more laboratory findings (examples: serum ferritin ≤ 15 ng/mL [or 30 ng/mL if pregnant]; serum ferritin < 41 ng/mL with low Hgb; TSAT < 20%; absence of stainable iron in bone marrow; increased erythrocyte protoporphyrin; increased sTfR or sTfR‑ferritin index); 2) Oral iron therapy is not optimal due to any of: Hgb < 7 g/dL; severe or ongoing blood loss; symptomatic anemia; oral iron intolerance; inability to achieve therapeutic targets with oral iron; co‑existing condition refractory to oral iron therapy; 3) Member does not have CKD at time of request; 4) Failure of two of Ferrlecit, Infed, or iron sucrose (Venofer) unless adverse effects or contraindications documented; 5) If request is for brand Feraheme, member must use generic ferumoxytol unless contraindicated or clinically significant adverse effects are experienced; 6) Dose does not exceed 510 mg elemental iron per infusion/injection.

Approval duration: 3 months

Initial Therapy — Cancer- and Chemotherapy-Induced Anemia (off-label)

Covered when ALL of the following are met

Cancer/chemotherapy-induced anemia initial criteria: 1) Absolute iron deficiency or functional iron deficiency documented with laboratory ranges as specified in policy (examples: serum ferritin < 30 ng/mL for absolute deficiency; serum ferritin 30–500 ng/mL with TSAT < 50% for possible/functional deficiency); 2) Prescribed by or in consultation with an oncologist; 3) Member is prescribed chemotherapy for cancer; 4) An erythropoietin‑stimulating agent (ESA) is prescribed in combination when specified by the policy; 5) Failure of two of Ferrlecit, Infed, or iron sucrose (Venofer) unless adverse effects or contraindications documented; 6) If request is for Feraheme, member must use generic ferumoxytol unless contraindicated or clinically significant adverse effects are experienced; 7) Prescribed regimen must be FDA‑approved or recommended by NCCN and dose must be within FDA limit or supported by practice guidelines/peer‑reviewed literature (prescriber must submit supporting evidence).

Off‑label coverage requires oncologist involvement and supporting evidence

Initial therapy and step therapy requirements

Covered when meeting dosing and prior‑failure criteria specified by the plan

Adult IDA dosing: Patient is to receive ferumoxytol 510 mg IV infusion followed by a second 510 mg IV infusion 3 to 8 days later (total 1,020 mg). For patients on hemodialysis, administer after at least one hour of dialysis.510 mg per dose; total 1,020 mg

Treatment may be repeated

Step therapy / prior failure requirements: Initial criteria require documented failure of specified alternative IV iron products: for IDA with CKD — Ferrlecit and Venofer; for IDA without CKD — failure of two of Ferrlecit, Infed, or Venofer. Documentation of prior failures must be submitted with the request.failure of alternatives as stated

Policy includes redirection to preferred iron products for certain indications (e.g., NCCN‑supported cancer‑ and chemotherapy‑induced anemia)

Non‑FDA approved indications that are not specifically addressed by this policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety per the applicable off‑label use policy (for Medicaid, see policy CP.PMN.53) or other evidence of coverage documents.

This policy was revised to redirect certain indications — including NCCN‑supported management of cancer‑ and chemotherapy‑induced anemia — to preferred intravenous iron products in lieu of ferumoxytol in some cases. Requests for ferumoxytol for these redirected indications will be evaluated against the plan’s step‑therapy and product‑preference rules and may require prior failure of preferred alternatives.

Non‑FDA approved indications which are not otherwise addressed in this policy are not authorized unless the request is supported in accordance with applicable off‑label use policies and accompanied by sufficient clinical documentation demonstrating efficacy and safety.

Initial Therapy Rules and Requirements

Initial therapy rules

Covered when indication‑specific requirements are documented

Initial therapy general: Initial therapy is permitted when indication‑specific diagnostic laboratory criteria are met, prior failures of alternative IV iron agents (as specified by indication) are documented, and intolerance or contraindication to oral iron is documented. If the request is for brand Feraheme, generic ferumoxytol should be used unless contraindicated or clinically significant adverse effects are noted.

Documentation requirement: Provider must submit supporting documentation (office chart notes, laboratory results, or other clinical information) demonstrating that the member meets all applicable initial therapy criteria, including prior‑failure documentation for step therapy requirements.

Failure to submit documentation may trigger denial

Initial Therapy — Initial dosing and product-failure requirements for approval

Covered when dosing and product‑failure requirements are met

Dosing: Administer 510 mg IV infusion followed by a second 510 mg IV infusion 3 to 8 days later (total 1,020 mg). For hemodialysis patients, administer after at least one hour of dialysis.510 mg per dose

Treatment may be repeated

Prior failure of alternatives: Prior failure of specified IV iron products is required as part of initial authorization: IDA with CKD — Ferrlecit and Venofer; IDA without CKD — failure of two of Ferrlecit, Infed, or Venofer. Documentation of these failures must be provided.as stated

Requirement added per 02.21.23 updates

Criteria for Continued Therapy

Continued Therapy — IDA with CKD

Covered when ALL of the following are met

Continued therapy CKD: 1) Member is currently receiving ferumoxytol via the Centene benefit or previously met the initial approval criteria; 2) Documentation since the last IV iron administration shows TSAT < 30% OR serum ferritin < 500 ng/mL; 3) Failure of both Ferrlecit and iron sucrose (Venofer) remains documented unless adverse effects/contraindications; 4) If request is for a dose increase, the new dose does not exceed 510 mg elemental iron per infusion/injection; 5) If request is for Feraheme, member must use generic ferumoxytol unless contraindicated or clinically significant adverse effects are experienced.

Approval duration: 3 months

Continued Therapy — IDA without CKD

Covered when ALL of the following are met

Continued therapy non-CKD: 1) Member is currently receiving ferumoxytol via the Centene benefit or previously met the initial approval criteria; 2) Documentation since the last IV iron administration demonstrates appropriate laboratory evidence (examples: serum ferritin ≤ 15 ng/mL or 30 ng/mL if pregnant; TSAT < 20%; serum ferritin < 41 ng/mL with Hb thresholds; absence of stainable iron in bone marrow; increased erythrocyte protoporphyrin; increased sTfR or sTfR‑ferritin index); 3) Member does not have CKD at time of request; 4) Failure of two of Ferrlecit, Infed, or iron sucrose (Venofer) unless adverse effects/contraindications; 5) If request is for Feraheme, member must use generic ferumoxytol unless contraindicated or clinically significant adverse effects are experienced; 6) If dose increase requested, new dose does not exceed 510 mg elemental iron per infusion/injection.

Approval duration: 3 months

Continued Therapy — Cancer- and Chemotherapy-Induced Anemia

Covered when ALL of the following are met

Continued therapy cancer-induced anemia: 1) Member is currently receiving ferumoxytol via the Centene benefit or documentation supports that member has received ferumoxytol for a covered indication for at least 30 days; 2) Member is responding positively to therapy; 3) Failure of two of Ferrlecit, Infed, or iron sucrose (Venofer) unless adverse effects/contraindications; 4) If request is for a dose increase, the new dose is within FDA maximum limits for approved indications or is supported by practice guidelines/peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence); 5) If request is for Feraheme, member must use generic ferumoxytol unless contraindicated or clinically significant adverse effects are experienced.

Prescribed regimen must be FDA‑approved or NCCN‑recommended for off‑label use; Approval duration: 3 months

Continuation therapy rules

Continuation therapy is allowed when prior criteria or ongoing treatment requirements are met and labs since last administration show continued deficiency within policy thresholds.

Continuation general: Member must be currently receiving medication via Centene benefit or have previously met initial approval criteria; must have laboratory documentation since the last IV iron administration showing TSAT and/or ferritin values within specified thresholds; failure of specified alternative IV iron agents remains applicable; dose increases must not exceed policy maximums or must be supported by guidelines for off‑label uses.

Continued therapy redirection

Continued therapy is available with redirections from initial approval criteria to continued therapy per plan revisions.

Continuation: Policy includes redirections from initial approval criteria to continued therapy as added per health plan request (August 2023).per plan

See health plan for continuation specifics

Step Therapy and Therapeutic Alternatives

Prior Authorization

Prior Authorization Required

Prior authorization is required for all IV iron product requests. Providers must submit documentation of diagnosis, relevant laboratory results (e.g., TSAT, serum ferritin, hemoglobin) measured since the last IV iron administration, and evidence of prior treatment failures or contraindications to required step-therapy alternatives. If the request is for Feraheme (ferumoxytol), document use of generic ferumoxytol (or clinical justification for brand). Approval is time-limited (typically 3 months) and dose limits apply (do not exceed 510 mg elemental iron per infusion/injection unless supported by FDA limits or guideline/peer‑reviewed literature for off-label use).

Submit prior authorization for IV iron products
Include diagnosis and recent labs (TSAT, serum ferritin, Hgb)
Document prior failures of required alternative IV iron agents or contraindications/intolerances
If requesting Feraheme, document trial of generic ferumoxytol or provide clinical justification
Include dose and regimen; dose increases must not exceed 510 mg elemental iron per infusion/injection unless supported by documentation

Documentation Required

Providers must include supporting documentation showing: (1) diagnosis of iron deficiency anemia (and CKD status if applicable); (2) laboratory confirmation since last IV iron administration (TSAT and/or serum ferritin and Hgb where applicable); (3) documentation of failure, intolerance, or contraindication to specified alternative IV iron agents (for IDA with CKD: failure of Ferrlecit and iron sucrose [Venofer]; for IDA without CKD: failure of two of Ferrlecit, Infed, or iron sucrose [Venofer]; for cancer-related anemia: failure of two of Ferrlecit, Infed, or Venofer); and (4) when requesting Feraheme, evidence of use of generic ferumoxytol unless contraindicated or adverse effects documented. Include copies of prior therapy notes, dates of trials, reasons for discontinuation, and any relevant oncologist consultation or ESA co-therapy documentation for cancer-related use.

Diagnosis and CKD status
Laboratory results (TSAT, serum ferritin, Hgb) measured since last IV iron dose
Records showing prior trials: dates, agent names, duration, and reason for failure/intolerance/contraindication
If Feraheme requested, documentation of generic ferumoxytol trial or clinical rationale for brand use
For off‑label cancer/chemotherapy use: oncologist prescribing/consultation and evidence of ESA combination when required

Coding and Laboratory Thresholds

Referenced HCPCS CodesHCPCS

Q0138	Injection, ferumoxytol, for treatment of iron deficiency anemia, 1 mg (non-ESRD use)
Q0139	Injection, ferumoxytol, for treatment of iron deficiency anemia, 1 mg for ESRD on dialysis

Transferrin saturation (TSAT)

ThresholdsTransferrin saturation (TSAT) < 30% for IDA associated with chronic kidney disease (CKD); TSAT < 20% for IDA without CKD.

Use in continuation criteriaDocumentation since last IV iron may include TSAT < 30% (CKD) or TSAT < 20% (non-CKD) to support continued therapy.

Role in initial approvalTSAT measurement is an accepted confirmatory laboratory for initial approval of ferumoxytol for IDA with or without CKD.

Serum ferritin

CKD-associated IDASerum ferritin < 500 ng/mL is an acceptable confirmatory laboratory for IDA associated with chronic kidney disease.

Non-CKD IDA (pregnancy consideration)Serum ferritin ≤ 15 ng/mL (or 30 ng/mL if pregnant) is listed as a diagnostic criterion for IDA without CKD.

Other non-CKD thresholdsSerum ferritin < 41 ng/mL in combination with low hemoglobin is an accepted criterion for IDA without CKD.

Hemoglobin (Hb)

Symptomatic/subgroup thresholdHemoglobin (Hb) < 7 g/dL is referenced as a criterion for symptomatic anemia or as a reason oral iron is not optimal in both CKD and non-CKD criteria.

Use for non-CKD confirmationLow Hb values are used in combination with ferritin/TSAT criteria to confirm IDA without CKD.

Role in dosing decisionsHemoglobin thresholds inform the determination that oral iron is not optimal and support initial IV ferumoxytol use.

Provider Actions, Documentation, and Billing

Prior Authorization

Prior authorization required

Prior authorization is required. Requests must include documentation demonstrating the member meets the policy's medical necessity criteria for ferumoxytol (Feraheme) before coverage will be authorized.

Authorization must document diagnosis, relevant laboratory values, and prior-failure or intolerance information per the policy criteria

Prior Authorization

Prior authorization and coding (Q0138, Q0139 referenced)

Prior authorization criteria apply to ferumoxytol requests and have been periodically revised; the policy references HCPCS codes Q0138 and Q0139 for informational billing guidance. Inclusion or reference to these codes does not by itself guarantee coverage.

Q0138 — Injection, ferumoxytol, 1 mg (non-ESRD use)
Q0139 — Injection, ferumoxytol, 1 mg for ESRD on dialysis
Prior authorization criteria have been updated over time (see policy revision notes)

Documentation Required

Submit supporting clinical documentation

Provider must submit supporting clinical documentation with the prior authorization request, such as office chart notes, relevant laboratory results, or other clinical information showing the member meets all approval criteria.

Include documentation of diagnosis, TSAT and/or ferritin and hemoglobin values, and records of prior failures or intolerances to alternative IV iron agents

Billing Rule

Coding guidance: reference current professional coding sources

When submitting claims, providers should reference current professional coding guidance for ferumoxytol; the policy lists HCPCS Q0138 and Q0139 as the informational codes for ferumoxytol administration.

Q0138 and Q0139 are cited in the policy for informational purposes — follow up-to-date coding resources when billing

Denial Risk

Denial risk if documentation not provided

Failure to submit required documentation (office chart notes, laboratory results, or other clinical information) demonstrating that the member meets the policy's approval criteria may result in denial of the request.

Ensure documentation of labs, prior agent failures, and any contraindications/intolerances accompanies the authorization

Denial Risk

Coding-related denial risk

Inclusion or exclusion of procedural codes in the policy does not guarantee coverage. Claims should follow the most up-to-date professional coding guidance and requests lacking appropriate coding or supporting documentation may be denied.

Refer to current coding sources when submitting claims; policy-cited codes are informational only

Definitions and Abbreviations

CKD

DefinitionCKD: chronic kidney disease.

ContextUsed throughout the policy to distinguish IDA with versus without CKD for criteria and prior-failure requirements.

Appendix sourceListed in Appendix A: Abbreviation/Acronym Key.

ESA

DefinitionESA: erythropoiesis stimulating agent.

Clinical roleReferenced for combination therapy in cancer- and chemotherapy-induced anemia off-label criteria.

Appendix sourceListed in Appendix A: Abbreviation/Acronym Key.

DefinitionHb: hemoglobin.

Use in criteriaHemoglobin values (e.g., Hb < 7 g/dL) are used to determine when oral iron is not optimal and to confirm severity of anemia.

Appendix sourceListed in Appendix A: Abbreviation/Acronym Key.

TSAT

DefinitionTSAT: transferrin saturation.

Use in policyTSAT thresholds (<30% CKD; <20% non-CKD) are used to confirm iron deficiency and support initial or continued therapy.

Appendix sourceListed in Appendix A: Abbreviation/Acronym Key and used throughout criteria sections.

Treatment course

Standard regimenTwo 510 mg IV infusions (total 1,020 mg) administered 3 to 8 days apart; treatment may be repeated.

Policy noteTreatment course (1,020 mg) is referenced in dosing and quantity-limit sections of the policy.

Administration windowSecond infusion typically given 3 to 8 days after the first per dosing guidance.

Hemodialysis timing

Hemodialysis timingFor patients receiving hemodialysis, administer ferumoxytol after at least one hour of hemodialysis.

Setting relevanceApplies to administration scheduling in dialysis units, infusion centers, and hospital outpatient settings.

SourceSpecified in the Dosage and Administration section of the policy.

OpenPayer

Ferumoxytol (Feraheme) intravenous iron therapy — coverage criteria

Coverage Criteria for Ferumoxytol (Feraheme)

Initial Therapy Rules and Requirements

Criteria for Continued Therapy

Step Therapy and Therapeutic Alternatives

Coding and Laboratory Thresholds

Provider Actions, Documentation, and Billing

Quantity Limits and Dosing

Site of Care and Administration Considerations

Definitions and Abbreviations

Background