[Cost-Consequence Analysis of Vedolizumab Initiation Timing Strategies in Crohn’s Disease in Italy]

BACKGROUND: Moderate-to-severe Crohn’s disease (CD) significantly impacts patients and the healthcare system. Timely initiation of biologic therapy is crucial for clinical outcomes and economic efficiency. In Italy, however, many patients eligible for treatment remain on “conventional” drugs, highlighting an undertreatment phenomenon. In this context, this study assessed the clinical and economic impact of early use of vedolizumab compared to delayed management, based on the multicenter LOVE-CD study. MATERIALS AND METHODS: A cost-consequence model was developed from the perspective of the Italian National Health Service and Italian society. The objective was to compare two therapeutic strategies for CD management: early and late approaches, differing in disease duration and prior anti-TNF exposure. Efficacy data were drawn from the LOVE-CD study, while estimates of direct and indirect costs were derived from the National Tariff and literature. Two scenarios were analyzed: the base case evaluated treatment costs with vedolizumab, including the subsequent phase over 52 weeks; the second scenario, developed with a multidisciplinary panel of Italian experts, included direct costs of the pre-treatment phase, estimating the duration and costs of treatments administered before starting vedolizumab. RESULTS: The base case analysis showed that the early approach reduces overall costs compared to the late approach in CD management, with a per-patient saving of €6,086 (–10%). The early approach also proved more efficient in terms of cost per responder, both for endoscopic response (–38%) and endoscopic remission (–47%). The scenario analysis extended the evaluation to include the pre-treatment phase: considering these additional costs, the per-patient saving rose to €44,893 (–43%), highlighting even greater economic efficiency for early treatment. CONCLUSIONS: The results suggested that early initiation of vedolizumab therapy in moderate-to-severe CD can generate significant clinical and economic benefits. These findings support the adoption of more timely and personalized treatment strategies.