CurrentAdvanced HealthPolicy N/A

Intravenous Iron Drug Use Criteria

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This policy governs prior authorization and medical-necessity criteria for selected intravenous iron products used to treat iron deficiency anemia or iron deficiency without anemia. It applies to members requesting covered intravenous iron drugs; Venofer (iron sucrose) does not require prior authorization.

Policy Summary

PayerAdvanced Health

PolicyIntravenous Iron Drug Use Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit laboratory results from within the last 30 days and document the required Venofer failure, contraindication, or dosing barrier.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

30 daysLaboratory recency

12 monthsMaximum approval duration

3Preferred alternatives

No PAVenofer prior authorization

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CurrentAdvanced HealthPolicy N/A

Intravenous Iron Drug Use Criteria

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Policy Summary

PayerAdvanced Health

PolicyIntravenous Iron Drug Use Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit laboratory results from within the last 30 days and document the required Venofer failure, contraindication, or dosing barrier.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

30 daysLaboratory recency

12 monthsMaximum approval duration

3Preferred alternatives

No PAVenofer prior authorization

Coverage Criteria

Qualifying iron deficiency diagnosis

Covered when the member meets either the iron deficiency anemia pathway or the iron deficiency without anemia pathway.

Qualifying diagnosis

Iron deficiency anemia
- Iron deficiency marker: Ferritin is <100 ng/mL or TSAT is <20%.
Iron deficiency without anemia
- Iron deficiency marker: Ferritin is <30 ng/mL, or <100 ng/mL in heart failure, or TSAT is <20%.

Venofer failure, contraindication, or dosing barrier

After qualifying laboratory confirmation, all formulary-sequencing requirements must be met.

Formulary alternative requirement: The member has failed or has a contraindication to Venofer (iron sucrose), or documentation shows that the Venofer dosing schedule would be a barrier.

If this requirement is not met, the request is denied as nonformulary; iron sucrose is the formulary alternative.

Requested intravenous iron product

Product-specific criteria apply after the clinical and Venofer requirements are satisfied.

Requested product pathway

Preferred intravenous iron products: The requested product is Feraheme (ferumoxytol), Ferrlecit (sodium ferric gluconate), or InFed (iron dextran).
Nonpreferred intravenous iron products: The requested product is Injectafer (ferric carboxymaltose) or Monoferric (ferric derisomaltose), and the member has failed or has contraindications to Feraheme, Ferrlecit, and InFed.

Venofer (iron sucrose) does not require prior authorization. Prior authorization applies to the other intravenous iron products addressed by this policy.

A request is not medically necessary when laboratory results obtained within the last 30 days do not confirm either iron deficiency anemia or iron deficiency without anemia. Confirmation requires the applicable hemoglobin and ferritin and/or TSAT findings: hemoglobin 13 g/dL in males or <12 g/dL in females with ferritin <100 ng/mL or TSAT <20% for iron deficiency anemia; or normal hemoglobin with ferritin <30 ng/mL (or <100 ng/mL in heart failure) or TSAT <20% for iron deficiency without anemia.

Clinical Laboratory Thresholds

Hemoglobin for iron deficiency anemia

Male threshold<13 g/dL

Female threshold<12 g/dL

Applies toHemoglobin criterion for iron deficiency anemia

Ferritin for iron deficiency anemia

Qualifying threshold<100 ng/mL

Laboratory markerFerritin

Applies toIron deficiency anemia pathway

Prior Authorization and Documentation

Prior Authorization

Intravenous Iron Prior Authorization

Prior authorization is required for intravenous iron products including InFed (iron dextran), Ferrlecit (sodium ferric gluconate), Feraheme (ferumoxytol), Injectafer (ferric carboxymaltose), and Monoferric (ferric derisomaltose). Venofer (iron sucrose) does not require prior authorization.

PA-required products: InFed, Ferrlecit, Feraheme, Injectafer, and Monoferric.
PA exemption: Venofer (iron sucrose).

Note

Approval Duration

For eligible requests, approval may be granted for the requested treatment duration, subject to a maximum approval period of 12 months.

Eligible products: Feraheme (ferumoxytol), Ferrlecit (sodium ferric gluconate), and InFed (iron dextran).
Maximum approval period: 12 months.

Policy Background

This policy evaluates intravenous iron treatment for iron deficiency anemia and iron deficiency without anemia using hemoglobin, ferritin, and transferrin saturation (TSAT). Coverage requires laboratory confirmation from within the last 30 days and generally requires failure of, contraindication to, or a documented dosing-schedule barrier to the formulary alternative, Venofer (iron sucrose).

Clinical Definitions

Iron deficiency anemia

Hemoglobin<13 g/dL in males or <12 g/dL in females

Iron deficiency markerFerritin <100 ng/mL or TSAT <20%

Laboratory recencyResults obtained within the last 30 days

Iron deficiency without anemia

HemoglobinNormal: >13 g/dL in males or >12 g/dL in females

Iron deficiency markerFerritin <30 ng/mL, or <100 ng/mL in heart failure, or TSAT <20%

Laboratory recencyResults obtained within the last 30 days

Initial Therapy Requirements

Initial therapy requirements

Initial approval requires qualifying laboratory confirmation, satisfaction of the Venofer prerequisite, and compliance with product-specific sequencing.

Initial intravenous iron authorization

Qualifying laboratory pathway
- Iron deficiency anemia: Hemoglobin is <13 g/dL in males or <12 g/dL in females, and ferritin is <100 ng/mL or TSAT is <20%.Laboratory results within the last 30 days
- Iron deficiency without anemia: Hemoglobin is normal (>13 g/dL for males or >12 g/dL for females), and ferritin is <30 ng/mL, or <100 ng/mL in heart failure, or TSAT is <20%.Laboratory results within the last 30 days

Preferred Product Sequencing

Step	Requirement	Applies before requesting	Documentation
1	Try Venofer (iron sucrose), or document failure, contraindication, or that its dosing schedule would be a barrier.	Other intravenous iron products	Document the Venofer trial or the applicable clinical justification.

Step	Requirement	Applies before requesting	Documentation
2	Try Feraheme (ferumoxytol), Ferrlecit (sodium ferric gluconate), and InFed (iron dextran), or document a contraindication to each.	Injectafer (ferric carboxymaltose) or Monoferric (ferric derisomaltose)	Document failure or contraindications to all three preferred products.

Policy Summary

PayerAdvanced Health

PolicyIntravenous Iron Drug Use Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit laboratory results from within the last 30 days and document the required Venofer failure, contraindication, or dosing barrier.

SourceLink

On This Page

TSAT for iron deficiency

Qualifying threshold<20%

Laboratory markerTransferrin saturation (TSAT)

Applies toIron deficiency anemia or iron deficiency without anemia

Normal hemoglobin for iron deficiency without anemia

Male threshold>13 g/dL

Female threshold>12 g/dL

Applies toNormal hemoglobin criterion for iron deficiency without anemia

Ferritin for iron deficiency without anemia

Standard threshold<30 ng/mL

Heart failure threshold<100 ng/mL

Laboratory markerFerritin for iron deficiency without anemia

Laboratory recency

Required timeframeWithin the last 30 days

Applies toQualifying laboratory results

Required valuesApplicable hemoglobin, ferritin, and/or TSAT values

Step Therapy

Venofer Prerequisite

Document that the member has failed Venofer, has a contraindication to Venofer, or cannot use Venofer because its dosing schedule would be a barrier.

Failure of Venofer (iron sucrose).
Contraindication to Venofer.
Documentation that the Venofer dosing schedule would be a barrier.

Step Therapy

Preferred Intravenous Iron Sequencing

Before requesting Injectafer or Monoferric, the member must have failed or have contraindications to the preferred intravenous iron alternatives Venofer, Feraheme, Ferrlecit, and InFed, as applicable under the policy sequence.

First document failure, contraindication, or dosing-schedule barrier involving Venofer (iron sucrose).
For Injectafer or Monoferric, also document failure or contraindications to Feraheme (ferumoxytol), Ferrlecit (sodium ferric gluconate), and InFed (iron dextran).

Documentation Required

Required Clinical and Formulary Documentation

Submit clinical laboratory results and treatment-history documentation supporting the diagnosis and required formulary sequencing. Laboratory results must be from within the last 30 days.

For iron deficiency anemia: hemoglobin <13 g/dL in males or <12 g/dL in females, and ferritin <100 ng/mL or TSAT <20%.
For iron deficiency without anemia: normal hemoglobin (>13 g/dL in males or >12 g/dL in females), and ferritin <30 ng/mL (<100 ng/mL in heart failure) or TSAT <20%.
Document failure, contraindication, or dosing-schedule barrier for Venofer when applicable.
For Injectafer or Monoferric, document failure or contraindications to Feraheme, Ferrlecit, and InFed.

Denial Risk

Failure to Meet Clinical or Formulary Criteria

Requests are denied when the member does not meet the required clinical criteria or when the required formulary prerequisite is not established.

Deny when iron deficiency anemia or iron deficiency without anemia is not confirmed by the required laboratory results within the last 30 days.
Deny as nonformulary when the member has not failed Venofer, has no Venofer contraindication, and has no documented Venofer dosing-schedule barrier.
Oral iron is on formulary through the pharmacy benefit when the clinical criteria are not met.

Denial Risk

Insufficient Preferred-Product Trials

Injectafer and Monoferric requests are denied when the member has not demonstrated failure of or contraindications to the required preferred alternatives. Request trials of Feraheme, Ferrlecit, and InFed when those prerequisites are insufficiently documented.

Required alternatives: Feraheme (ferumoxytol), Ferrlecit (sodium ferric gluconate), and InFed (iron dextran).
If the required trials or contraindications are not documented, deny as not meeting criteria and request trials of all three alternatives.

TSAT

TermTSAT

DefinitionTransferrin saturation

Qualifying threshold<20%

Venofer prerequisite: The member has failed or has a contraindication to Venofer, or documentation shows that the Venofer dosing schedule would be a barrier.

Requested-product requirements: The requested product is Feraheme, Ferrlecit, or InFed; or the requested product is Injectafer or Monoferric and the member has failed or has contraindications to Feraheme, Ferrlecit, and InFed.