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Limited coverage criteria – ferric carboxymaltose for iron deficiency with heart failure

Last updated on April 8, 2026

 

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Generic name

ferric carboxymaltose

Strength & form

50 mg/mL vial (100 mg/2 mL, 500 mg/10 mL, 1000 mg/20 mL)

Special Authority criteria

Approval period

For the treatment of iron deficiency in adult patients with heart failure who meet ALL of the following criteria:

  • New York Heart Association (NYHA) functional class II or III

AND

  • Documented left ventricular ejection fraction (LVEF) of  ≤ 40% determined by echocardiography1

AND

  • Ferritin ≤ 300 mcg/L2 with a transferrin saturation (TSAT) < 15%2

AND

  • Special Authority is requested by a cardiologist or an internal medicine specialist experienced in the management of chronic heart failure

AND

  • Ferric carboxymaltose is administered in a setting where appropriate monitoring and management of hypersensitivity reactions can be provided

24 weeks3

Practitioner exemptions

  • None

Special notes

  • 1At minimum, patients should have received an echocardiogram within six months prior to submitting a Special Authority request
  • 2A copy of the patient's most recent ferritin and TSAT laboratory results within the past 3 months is required. For renewals, laboratory results must be completed after the patient's most recent dose of Ferinject to confirm ongoing need
  • 3The individual iron need for repletion using Ferinject is determined based on the patient's body weight and hemoglobin (Hb) level. The maximum recommended cumulative dose of Ferinject is 1,000 mg of iron (20 mL ferric carboxymaltose) per week. If the total iron need is higher, then the administration of an additional dose should be a minimum of 7 days after the first dose. As per the product monograph, re-assessment for iron repletion should be performed by the clinician based on the individual patient's condition. The Hb level should be re-assessed no earlier than 4 weeks post final Ferinject administration. In the event the patient requires further iron repletion, the iron need should be recalculated

Special Authority requests