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Poster Session 3

(815) Cost-effectiveness of atosiban versus placebo in the treatment of threatened preterm birth (APOSTEL 8 trial)

Friday, January 31, 2025
10:30 AM – 12:30 PM  
Objective: Tocolytics such as atosiban as treatment for threatened preterm birth (PTB) is part of routine care in many countries. However, overall costs and benefits of atosiban compared to placebo have not been evaluated. We assessed the cost-effectiveness of atosiban compared to placebo in improving neonatal outcomes for threatened PTB between 30 and 34 weeks gestation.

Study Design: This was an economic analysis from societal perspective alongside the international randomized placebo controlled APOSTEL 8 study, conducted in 26 hospitals in the Netherlands, England and Ireland. Women with threatened PTB  from 30 to 34 weeks of gestation were randomized to atosiban or placebo. We included costs based on data from the case record form (CRF) and additional iMTA questionnaire sent three months after due date. Primary outcome was the difference in total mean costs per child between groups. Health outcome was the prevalence of composite adverse neonatal outcome. Complementary incremental cost-effectiveness ratio (ICERs) was calculated. Analyses were by intention to treat.

Results: In our complete case analysis, we included costs based on the CRFs of 752 mothers with 884 children and 376 completed questionnaires (198 atosiban, 178 placebo). Total mean costs did not significantly differ between groups: €37280 in the atosiban group (449 children) versus €37120 in the placebo group (435 children) (mean difference €160, 95% CI -€3936 to €4257). In pre- and postnatal costs no significant differences were observed. With an estimated difference of 1% in adverse neonatal outcome in favour of atosiban, the ICER was €16783. However, there was high uncertainty as a substantial distribution was located in the top left quadrant of the ICER plane, indicating scenarios where atosiban is both more expensive and less effective.

Conclusion: We observed high uncertainty of cost-effectiveness of atosiban compared to placebo as treatment for threatened PTB. As the main trial demonstrated that atosiban is not superior to placebo in improving neonatal outcomes, both clinical and economical findings should be considered in future guidelines.