COSTS AND NEONATAL OUTCOMES AFTER INSULIN ASPART COMPARED WITH HUMAN INSULIN IN PREGNANT WOMEN WITH TYPE 1 DIABETES

OBJECTIVES: Poor glycaemic control during pregnancy in women with type 1 diabetes is associated with high risk of pre-term delivery, neonatal mortality and morbidity. Improving control might improve outcomes and reduce the cost of managing pre-term infants. This study assessed costs and outcomes associated with insulin aspart (IAsp) and human insulin (HI) in pregnant women with type 1 diabetes. METHODS: Women with type 1 diabetes were enrolled if £ 10 weeks pregnant or planning to become pregnant, and had HbA1C £ 8% at confirmation of pregnancy. Subjects were randomised to treatment with IAsp or HI in a basal-bolus regimen with NPH insulin, with doses titrated to American Diabetes Association guidelines. The effectiveness endpoint in this analysis was the percentage of women with a live birth at term (³37 weeks gestation). We considered costs of insulin and of inpatient care for pre-term infants. Length of stay in intensive care was estimated from gestational age. Costs were calculated from the perspective of the UK National Health Service. Non-parametric bootstrapping was used to generate confidence intervals. RESULTS: Of 417 women randomised, 322 became pregnant and effectiveness was evaluable for 302, 151 in each arm. Significantly more women experienced a live birth at term with IAsp (72.8%) than with HI (60.9%), difference 11.9% (95% CI 0.7%, 22.5%). Mean cost per woman was £3347 for HI, and £3359 for IAsp, difference £13 (95% CI -£612, £966). Insulin accounted for 9.7% of costs for IAsp and 5.6% for HI. The incremental cost-effectiveness ratio was £106 per additional live birth at term (95% CI dominant, £58076). CONCLUSION: IAsp was associated with a significantly higher proportion of live births at term than HI. The cost of managing pre-term births was large compared to the cost of insulin administered.