The Socio-Economic Burden of Pruritus in Patients with Primary Biliary Cholangitis (PBC) in Italy: a Comprehensive Model-Based Cost-of-Illness Analysis

BACKGROUND: Cholestatic pruritus represents one of the most debilitating symptoms in patients with Primary Biliary Cholangitis (PBC), affecting 50-90% of them. Aim of this study was to estimate the annual socio-economic burden associated with pruritus in patients with PBC in Italy. METHODS: A prevalent-based cost-of-illness (COI) probabilistic model was developed with a one-year time horizon, adopting the Italian societal perspective. The model simulated adult patients with PBC characterized by presence and severity level of pruritus. The model included data retrieved from the literature and related to PBC with pruritus epidemiology, direct costs, indirect costs, and intangible costs to estimate the one year direct and indirect costs associated to pruritus and the Quality-Adjusted Life Years (QALYs) lost. Deterministic and probabilistic sensitivity analysis were performed to test alternative scenarios and define the proper 95% Confidence Interval (CI). RESULTS: The model estimates a prevalence of 10,076 adult patients with a diagnosis of PBC: 5,141 with mild pruritus, 2,013 with moderate and 1,006 with severe. The socio-economic annual burden associated with pruritus was € 6.75 million (95%CI 4.85-7.64). Indirect costs represent the main driver at € 5.00 million (95%CI: 3.52-5.59). The model reported a high impact on patients’ quality of life with 1,220 QALYs lost due to pruritus. Scenario analysis showed a significant higher burden if unemployment due to pruritus was included in the analysis and a significant variability associated with prevalence. Reduction of pruritus of 30%, 50% and 70% could lead to a potential burden reduction of € 0.89, € 1.49 and € 2.09 million and a QALY gain of 366, 610, and 850, respectively. CONCLUSIONS: Pruritus in PBC generates a significant socio-economic burden, primarily driven by loss of work productivity, highlighting the need for more effective therapeutic strategies to reduce the impact and improve the quality of life of these patients.