P685 Healthcare resource use associated with ferric maltol and IV iron treatment for iron deficiency anaemia in patients with inflammatory bowel disease
S. Howaldt1, I. Jacob2, M. Sampson3, F. Akriche4
1MZV für Immunologie, Gastroenterology, Hamburg, Germany, 2Health Economics and Outcomes Research Ltd., Health economics, Cardiff, UK, 3Shield Therapeutics PLC, Medical, London, UK, 4Norgine Ltd., Medical, Rueil Malmaison, France
Corrigendum
In the originally published version of this poster presentation, the below corrections have been made.
Upon the original publication, the following sentence in Results section should read: “The primary endpoint was not met.” instead of “The non-inferiority endpoint was met.”.
Upon the original publication, the final concluding remarks should read: “FM is associated with substantially lower HCRU than IV FCM, and may provide a cost-effective oral alternative to IV iron in patients with IBD.” instead of “FM is associated with non-inferior efficacy and substantially lower HCRU than IV FCM, and may provide a cost-effective oral alternative to IV iron in patients with IBD.”.
Background
Iron deficiency anaemia (IDA) is common in patients with inflammatory bowel disease (IBD). IDA imposes a substantial economic burden on healthcare payers resulting primarily from increased medical costs and increased rates of hospital admission. Most guidelines recommend oral iron as first-line treatment, with IV iron if oral supplementation is ineffective or poorly tolerated. Intolerance to ferrous (Fe2+) oral iron is common in patients with IBD. Ferric maltol (FM), a stable oral complex of ferric (Fe3+) iron and maltol, is designed to reduce exposure to elemental iron and thus limit gastrointestinal damage. This analysis compares the Healthcare resource use (HCRU) associated with oral FM and IV ferric carboxymaltose (FCM) treatment.
Methods
Patients with IBD and IDA (haemoglobin [Hb] ≥8.0 g/dl and ≤11.0 g/dl for women or ≥8.0 g/dl and ≤12.0 g/dl for men, and ferritin <30 ng/ml or ferritin <100 ng/ml with transferrin saturation <20%) were randomised to FM (30 mg b.i.d) or IV FCM (as per local SmPC) in an open-label, Phase 3b non-inferiority study. The primary endpoint was Hb responder rate (proportion of patients achieving a ≥2 g/dl increase or normalisation of Hb at week 12); the margin for non-inferiority was 20%. HCRU was assessed based on the total costs of iron therapy (including drug costs and administration), and the number of hospital/outpatient visits during the initial 12-week study period. Costs of IV FCM and FM were applied to a German setting.
Results
250 patients were randomised: 125 to FM and 125 to IV FCM. The non-inferiority endpoint was met. Mean (standard deviation; SD) total treatment costs per patient in the FM and IV FCM arms were €302.27 (€80.68) and €489.37 (€147.19) respectively. Eighty-seven per cent of FM patients were still receiving treatment at week 12, and 45% and 36% of IV FCM patients required a repeat course of IV iron at weeks 4 and 12, respectively. The mean (SD) number of hospital/outpatient visits during the study period for patients receiving IV FCM was 2.30 (0.88) and the total dose of IV FCM received was 1621 mg (491 mg).
Conclusion
Total per patient drug costs were approximately 1.6 times higher for treatment with IV FCM than FM. The total cost of IV FCM is not only influenced by the higher drug cost, but additional costs associated with IV administration which was required to be carried out in a hospital or outpatient setting. FM has no additional costs or resource use associated with administration and is, therefore, less of a burden on local healthcare systems. FM is associated with non-inferior efficacy and substantially lower HCRU than IV FCM, and may provide a cost-effective oral alternative to IV iron in patients with IBD.