Iron isomaltoside 1000 (Monoferric), also known as ferric derisomaltose, consists of iron and isomaltoside, a carbohydrate, forming a matrix structure designed for the controlled release of iron in the body. Iron isomaltoside 1000 is indicated for the treatment of iron deficiency anemia (IDA) in adult patients who have intolerance or unresponsiveness to oral iron therapy. The diagnosis must be based on laboratory tests. It is available as 100 mg/mL of elemental iron in 1 mL, 5 mL, and 10 mL vial sizes, at submitted prices of $45, $225, and $450, respectively, or $45 per mL.

Iron isomaltoside 1000 can be dosed in one of two ways: first, by using the Ganzoni formula, accounting for individual patient weight, assumed iron stores, and target and actual hemoglobin (Hb) levels; or, second, according to a simplified dosing table leading to doses of 1,000 mg, 1,500 mg, or 2,000 mg (see Table 4). As a bolus injection, up to 500 mg of iron isomaltoside 1000 may be administered up to once weekly at a rate of 250 mg per minute. As an infusion, if the cumulative required iron dose exceeds 20 mg iron/kg body weight, the dose should be split into two administrations given at least a week apart. Single doses above 1,500 mg are not recommended. Using the simplified table, the drug acquisition cost per course of therapy is $450 to $900.

The sponsor submitted a cost-utility analysis (CUA) comparing iron isomaltoside 1000 to iron sucrose (Venofer) for adults with IDA who have intolerance or unresponsiveness to oral iron therapy, from the perspective of a Canadian publicly funded health care system over a six-month time horizon. Patients entered the model in the IDA health state and, at the end of the first week, transitioned into either a responder or a nonresponder health state. Patients could become responders during any of the first five weeks. The efficacy of iron sucrose, in terms of the proportion of patients who had responded to treatment in each of the first five weeks of the model, was based on the percentage of patients with an Hb increase of 2 g/dL or more in the iron sucrose group of the PROVIDE trial. Relative response in the iron isomaltoside 1000 group was estimated using a hazard ratio (HR) of 2.488 over the first five weeks as reported in PROVIDE.

The utility values for patients in the responder health state was assumed to be 0.863, the average Canadian utility value. Nonresponders were assigned a utility of 0.713, based on a disutility of 0.15 reported in US patients with anemia. From week 6 onward, all patients in 1,000 mg and 200 mg for iron isomaltoside 1000 and iron sucrose, respectively). Additional costs included those associated with drug administration.

The sponsor reported that iron isomaltoside 1000 was associated with cost savings of $570 compared to iron sucrose and 0.0026 additional quality-adjusted life-years (QALYs). Iron isomaltoside 1000 was dominant over iron sucrose.

Contents

• Abbreviations
• Executive Summary
  • Background
  • Summary of Identified Limitations and Key Results
  • Conclusions
• Information on the Pharmacoeconomic Submission
  • Summary of the Sponsor’s Pharmacoeconomic Submission
  • Sponsor’s Base Case
  • Summary of Sponsor’s Sensitivity Analyses
  • Limitations of Sponsor’s Submission
  • CDR Reanalyses
  • Issues for Consideration
  • Patient Input
  • Conclusions
• Appendix 1. Cost Comparison
• Appendix 2. Summary of Key Outcomes
• Appendix 3. Additional Information
• Appendix 4. Summary of Other Health Technology Assessment Reviews of Drug
• Appendix 5. Reviewer Worksheets
• References

Version: Final

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