Cost-utility and cost-effectiveness analysis of an AI-driven platform for standard postnatal care and breastfeeding: results from the COMLACT study.

OBJECTIVE: To assess whether an AI-driven technology for neonatal care is costeffective compared to usual primary care in improving women's health-related quality of life and breastfeeding self-efficacy. METHODS: We conducted a cost-effectiveness analysis from the perspective of the healthcare payer, families, and society. Data from a randomised controlled trial with a six-month follow-up were used to obtain utility values and breastfeeding self-efficacy. Missing values were handled using multiple imputations by chained equations, and a complete case analysis was conducted as a sensitivity analysis. Incremental cost and effect differences were adjusted using seemingly unrelated regression, based on baseline participant characteristics. RESULTS: The study included 174 women (mean age 33 years), 91% of whom were from European countries, recruited from Spanish primary care centres. Direct healthcare costs (€87.64) accounted for 35% of total costs (€248.50), while breastfeeding-related material costs (€146.26) represented the highest family expenses during follow-up. After adjusting for baseline covariates, the ICUR was €3,363/QALY from the healthcare payer's perspective and €2,964/QALY from the societal perspective, respectively. A slight cost-saving was observed from the family perspective (€ - 2.49, 95% CI: - 67.76 to 63.77), with minimal improvements in healthrelated quality of life (0.01, 95% CI: - 0.02 to 0.03) and slight worsening in breastfeeding self-efficacy scores (- 1.49, 95% CI: - 5.57 to 2.60) but with no clinical relevance. CONCLUSIONS: The mobile app's ICURs were below the commonly used European cost-effectiveness thresholds, due to a slight improvement in the health-related quality of life and low direct healthcare costs from the family perspective. However, usual care dominated the mobile app for improving breastfeeding self-efficacy, regardless of the cost perspective. TRIAL REGISTRATION NUMBER (CLINICALTRIALS.GOV): NCT05432700, prospectively registered.