Presentation (CTI)

OBJECTIVES: Despite the therapeutic innovation in new biologic treatments for Crohn’s Disease and Ulcerative Colitis, real-world response rates remain capped at ~40% (“efficacy ceiling”), regardless of treatment mechanism or line of therapy. Evidence suggests that combination therapy using biologics with complementary mechanisms of action may increase response up to 60%. However, access to such combinations is typically restricted to patients who have failed at least two previous biologic lines, largely due to pharmaceutical cost considerations. This study aims to estimate the budget impact of integrating novel diagnostic non-invasive technologies and to evaluate their potential to offset drug acquisition costs and expand early access to combination therapy under cost-neutral conditions.
METHODS: A 5-year budget impact model was developed from the perspective of the Italian National Health Service. Two connected modules were implemented: the first quantifying the ability to defer invasive diagnostic methodologies and downstream costs (e.g., colonoscopies) due to improved novel non-invasive diagnostic test specificity; and the second assessing the reinvestment potential of these savings into earlier use of combination biologics in first- and second-line settings, without increasing overall expenditure.
RESULTS: Improved specificity, due to novel diagnostic non-invasive technologies implementation, while assessing for IBD first diagnosis, leads to deferred colonoscopies, generating annual savings of approximately €20 million. Full reinvestment of these savings into pharmacological budgets dedicated to first- and second-line biologic treatments would support progressive adoption of combination therapy, reaching 50% of biologic-treated patients by year five. The shift would enable improved response, earlier combination use, improved remission, and reduced surgical interventions over the analysis period.
CONCLUSIONS: Innovative non-invasive diagnostic technologies can unlock substantial economic value by optimizing the IBD diagnostic pathway. Reinvesting these savings into early combination biologic therapy could improve clinical outcomes while maintaining budget neutrality, supporting a more effective and sustainable management strategy for one IBD patient over two by year five.