Pharmacy Prior Authorization Criteria

Iron Products

Indications for Prior Authorization

Accrufer (ferric maltol)

• For diagnosis of Iron deficiency
  Indicated for the treatment of iron deficiency in adults

Feraheme (ferumoxytol injection)

• For diagnosis of Iron deficiency
  Indicated for the treatment of iron deficiency anemia (IDA) in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron or who have chronic kidney disease (CKD).

Injectafer (ferric carboxymaltose injection)

• For diagnosis of Iron Deficiency Anemia
  Indicated for the treatment of iron deficiency anemia (IDA) in adult and pediatric patients 1 year of age and older who have either intolerance to oral iron or an unsatisfactory response to oral iron or adult patients who have non-dialysis dependent chronic kidney disease (CKD).

• For diagnosis of Iron Deficiency
  Indicated for the treatment of iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity.

Monoferric (ferric derisomaltose injection)

• For diagnosis of Iron deficiency
  Indicated for the treatment of iron deficiency anemia (IDA) in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron or who have non-hemodialysis dependent chronic kidney disease (CKD).

Criteria

Accrufer, Brand Feraheme, generic ferumoxytol, Monoferric

Step Therapy

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Trial and failure of a minimum 30-day supply or intolerance to one of the following generics:
• ferrous sulfate
• ferrous gluconate
• ferrous fumarate

Injectafer

Step Therapy

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• One of the following:
• Trial and failure of a minimum 30-day supply or intolerance to one of the following generics:
• ferrous sulfate
• ferrous gluconate
• ferrous fumarate
OR
• Patient has New York Heart Association class II or III Heart Failure [A]

P & T Revisions

2024-03-14, 2023-07-17, 2022-03-03, 2021-10-06

References

1. Accrufer Prescribing Information. Shield Therapeutics Inc. October 2023.
2. Feraheme Prescribing Information. AMAG Pharmaceuticals, Inc. Waltham, MA. June 2022.
3. Injectafer Prescribing Information. American Regent, Inc. Shirley, NY. May 2023.
4. Monoferric Prescribing Information. Pharmacosmos Therapeutics, Inc. Morristown, NJ. February 2022.
5. Heidenreich, P. A., Bozkurt, B., Aguilar, D., Allen, L. A., Byun, J. J., Colvin, M. M., Deswal, A., Drazner, M. H., Dunlay, S. M., Evers, L. R., Fang, J. C., Fedson, S. E., Fonarow, G. C., Hayek, S. S., Hernandez, A. F., Khazanie, P., Kittleson, M. M., Lee, C. S., Link, M. S., Milano, C. A., … Yancy, C. W. (2022). 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation, 145(18), e876–e894.

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End Notes

1. 2022 ACC/AHA guidelines note that oral iron supplementation is not adequate to treat iron deficiency anemia in patients with heart failure so having patients try oral iron supplementation is not clinically appropriate. In patients with heart failure with reduced ejection fraction and iron deficiency with or without anemia, IV iron replacement is reasonable to improve functional status and quality of life. Oral iron supplementation did not demonstrate the same effective compared to IV formulations. [5]

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Revision History

• 2024-03-14: 2024 Annual Review - updated references
• 2023-07-17: Updated Injectafer criteria for its new indication of iron deficiency in adult patients with heart failure and New York Heart Association class II/III.
• 2022-03-03: Updated to add Feraheme, Injectafer, and Monoferric as targets
• 2021-10-06: New UM program

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