Cost-effectiveness of using Intravenous Ferric Carboxymaltose compared to Intravenous Iron Sucrose for treatment of iron deficiency anemia in pregnancy

BACKGROUND: Iron deficiency anemia (IDA) in pregnancy is a major public health concern in India, contributing significantly to adverse maternal and perinatal outcomes. Intravenous iron sucrose (IV ISC) is widely used; however, its low permissible dose necessitates multiple visits, reducing adherence and increasing out-of-pocket expenditure. Intravenous ferric carboxymaltose (IV FCM) offers an advantage of complete dose administration in a single visit, but the higher price of the drug is the major deterrent for its procurement. The study evaluates the cost-effectiveness of IV FCM versus IV ISC for managing moderate to severe IDA in pregnancy in the Indian public health system. METHODS: A decision tree model was developed from an abridged societal perspective. The time horizon was defined as the period from the second trimester to delivery, including early neonatal outcomes. Effectiveness inputs were derived from both primary and secondary sources. Costs were estimated using national costing databases and procurement records. The outcome was measured in incremental cost-effectiveness ratio (ICER) per quality-adjusted-life-years (QALY) gained and incremental health gains. Uncertainty was explored using deterministic and probabilistic sensitivity analysis. Budget impact analysis estimated the fiscal implication of adopting IV FCM. RESULTS: The use of IV FCM compared with IV ISC for managing moderate to severe IDA in pregnant women incurred an incremental cost of INR 1,316 (USD 15.62) for an additional 0.069 QALYs. The ICER of INR 19,091.66 (USD 226.69) per QALY gained-equivalent to 0.08 times the cost-effectiveness threshold of 1x Gross Domestic Product (GDP) per capita per QALY-demonstrates that IV FCM is cost-effective. IV FCM also provided measurable clinical benefits, including improved anemia correction and reductions in adverse drug events, adverse neonatal outcomes, and maternal mortality. Sensitivity analyses showed > 98% probability of cost-effectiveness. While the budget impact indicates a higher financial outlay for IV FCM, this increased expenditure is associated with substantial incremental health gains. CONCLUSIONS: IV FCM is likely to be a cost-effective alternative to IV ISC for managing moderate to severe IDA in pregnancy, improving anemia recovery, maternal and neonatal outcomes while reducing out-of-pocket expenditure, thereby strengthening Anemia Mukta Bharat and Universal Health Coverage in India.