Oral Antihyperglycemic Agents Versus Insulin for Gestational Diabetes Mellitus: Societal Cost‐Effectiveness Analysis of the SUGAR ‐ DIP Randomized Controlled Trial

OBJECTIVE: To assess the cost-effectiveness of treatment with sequential oral antihyperglycemic agents (OHA; metformin and glibenclamide) versus insulin for gestational diabetes (GDM). DESIGN: Cost-effectiveness analysis from a societal and healthcare perspective alongside a randomized controlled trial (SUGAR-DIP). SETTING: Twenty-five hospitals in the Netherlands. POPULATION: Women with GDM and a singleton pregnancy, randomized to OHA (n = 409) or insulin (n = 411) between 16 to 34 weeks' gestation. METHODS: Missing data were handled using multiple imputation. Differences in costs and effects were estimated using bivariate regression with bootstrapping to derive incremental cost-effectiveness ratios. Cost-effectiveness acceptability curves were constructed across a range of willingness-to-pay (WTP) thresholds. MAIN OUTCOME MEASURES: Large for gestational age (LGA), quality-adjusted life-years (QALYs), costs and cost-effectiveness. RESULTS: OHA slightly increased QALYs (0.009; 95% CI 0.004 to 0.014), corresponding to approximately 3 days in perfect health. There were no statistically significant differences in LGA avoided (-0.039; 95% CI-0.097 to 0.018) or societal costs (mean difference-€1004; 95% CI-€3503 to €1495). OHA were less costly and less effective than insulin for LGA, whereas for QALYs they were less costly and more effective. The probability of OHA being cost-effective at a WTP threshold of €0 was 79% for both outcomes. CONCLUSIONS: OHA have a high probability of being cost-effective compared with insulin for QALYs, although the QALY gain is small and of limited clinical relevance. For LGA, OHA were less costly but less effective, and cost-effectiveness depends on acceptable trade-offs between costs and neonatal outcomes.