Economic Evaluation alongside the Trial of Selective Early Treatment of Patent Ductus Arteriosus with Ibuprofen in Extreme Preterm Babies

ObjectiveTo conduct an economic evaluation alongside the placebo-controlled trial of selective early treatment of patent ductus arteriosus with ibuprofen in extreme preterm babies. DesignWithin-trial economic evaluation alongside a multicentre, randomized, masked, placebo-controlled trial. SettingThirty-two UK tertiary neonatal intensive care units. SampleBabies born between 23+0 to 28+6 weeks gestation, less than 72 hours old and confirmed by echocardiography to have a large PDA. MethodsA cost-effectiveness analysis was conducted from the National Health Service (NHS) and NHS and Personal Social Services perspectives. Nonparametric bootstrapping was used to estimate incremental costs and outcomes which were reported as cost-effectiveness acceptability curves. Main outcome measuresCost per additional major outcome averted. ResultsIbuprofen is less costly with an average cost per participant of {pound}126,465 compared to {pound}133,260 (-{pound}6,808 (95% CI: {pound}-17,154 to {pound}3,537) for placebo. But it is less effective in terms of major outcomes averted with an absolute effect difference of 0.054 (95% CI: -0.014 to 0.121). The differences in mean cost were mainly attributable to the costs of high dependency care ({pound}2,345, 95% CI -{pound}3,435 to {pound}8,126) and intensive care ({pound}6,718, 95% CI - {pound}12,627 to {pound}26,063) which were higher in the placebo arm. The incremental cost-effectiveness ratio was estimated at {pound}126,846 for an additional case of death, or severe or moderate bronchopulmonary dysplasia avoided by 36 weeks of post-menstrual age. ConclusionsBased on the evidence from this trial, ibuprofen would not be recommended. There is insufficient evidence to suggest that any of the observed detrimental impact on effectiveness would be outweighed by the opportunity cost associated of any saving in costs.