Intravenous ferric carboxymaltose versus oral ferrous sulphate for iron deficiency anaemia in pregnancy in Nigeria: a cost-utility analysis.

Background: Iron deficiency anaemia (IDA), a prevalent condition in pregnancy, is often treated with oral iron, but with poor adherence. Evidence from trials has shown that ferric carboxymaltose, an intravenous iron therapy, is safe and highly effective. We aimed to conduct a cost-utility analysis of intravenous iron for moderate-to-severe IDA in pregnancy. This was a prespecified analysis of the Intravenous Versus Oral Iron for Iron Deficiency Anaemia in Pregnant Nigerian Women (IVON) trial. Methods: We developed a decision-tree model to evaluate the cost-utility of intravenous ferric carboxymaltose compared with oral ferrous sulphate for women with moderate-to-severe IDA during pregnancy in Nigeria. The model used data from the IVON trial, which was conducted in 11 health-care facilities in Nigeria and enrolled pregnant women aged 15-49 years between the gestational age of 20 weeks and 32 weeks with haemoglobin of less than 10 g/dL. By use of data from the IVON trial and secondary sources, we estimated intervention costs and did a base-case analysis to estimate the relative cost-utility of ferric carboxymaltose compared with ferrous sulphate. Model outputs included the total expected cost and health outcomes per pregnant woman for each intervention. Health outcomes were measured as disability-adjusted life-years (DALYs) averted. We calculated the incremental cost-utility ratio (ICUR) and compared it with the opportunity cost-based threshold. We considered ferric carboxymaltose as very cost-effective if the ICUR was less than 0·5 times the gross domestic product (GDP) per capita and cost-effective if it fell between 0·5 and 1·0 times the GDP per capita. The analysis focused on a time horizon of less than 1 year from a partial societal perspective. Additionally, we conducted sensitivity analyses to assess the robustness of findings in relation to parameter uncertainty. The IVON trial was registered with ISRCTN (ISRCTN63484804) and ClinicalTrials.gov (NCT04976179) and is complete. Findings: In the base-case analysis, treatment with ferric carboxymaltose incurred a higher cost per pregnant woman (US$139·71) than treatment with ferrous sulphate ($104·33). Ferric carboxymaltose showed greater effectiveness by incurring fewer DALYs (0·0111) than ferrous sulphate (0·0377). The resulting ICUR was $1331·12 per DALY averted, which is between 0·5 and 1·0 times Nigeria's GDP per capita, making ferric carboxymaltose cost-effective. The ICUR was most sensitive to the acquisition costs of the ferric carboxymaltose vials, followed by the associated productivity costs. These costs exceeded the threshold when they surpassed $103·61 (for acquisition costs) and $49·75 (for productivity costs). Interpretation: Ferric carboxymaltose is a cost-effective intervention to reduce the maternal morbidity burden associated with IDA in pregnancy. Integration of ferric carboxymaltose into national guidelines for antenatal care and health insurance schemes, based on negotiated prices, will enhance health equity and improve outcomes for pregnant women. Funding: Bill & Melinda Gates Foundation.