Economic and organizational impact of a paediatric mass screening program for coeliac disease in Italy

Background and Aims: Italy is launching a nationwide paediatric mass screening for coeliac disease (CeD). This study evaluates its economic and organizational impact at the regional level. Methods: A comprehensive multistakeholder cost analysis was conducted at a regional level over a ten-year time horizon. A diagnostic and follow-up model was developed, aligned with the national mass screening program project. The target population included children aged 2, 6, and 10 undergoing serological screening and HLA genotyping. Epidemiological and demographic data were drawn from regional databases and a previous Italian screening initiative. Results: Annual projections estimate 3076 new CeD cases over the first 4 years of regional mass screening. Over 10 years, the average annual cost is €19.9 million: €8.7 million for screening, €1.7 million for follow-up, and €9.5 million for gluten-free diet (GFD) support. Screening dominates early costs, while GFD expenses become the main long-term burden. The regional healthcare system bears an annual financial burden of €18 million in direct costs while caregivers incur €350,000 in opportunity costs per year. Conclusion: Paediatric CeD mass screening may significantly burden the healthcare system, with costs extending beyond screening to lifelong care. These findings underscore the need for careful assessment of feasibility and sustainability to guide effective planning.