Abstract
Background: Lung cancer (LC) screening has proven to be an effective strategy in reducing LC mortality, with positive cost-effectiveness evidence. Since October 2022, the RISP trial (Rete Italiana Screening Polmonare), a feasibility study on LC screening using low-dose computed tomography (LDCT), is active across 18 centers. Here, we report preliminary data from the cost-benefit evaluation of the RISP. Methods: Data were collected from high-risk current or former smoker (≥30 pack-years, aged 55–75) volunteers enrolled. The analysis by a Markov model adopted the perspective of the Italian National Health Service and considered direct medical costs, including LDCTs, diagnostic procedures, and stage-specific LC treatments. Total costs were assessed across all patients without stratification by cancer stage. Effectiveness was expressed in terms of Quality-Adjusted Life Years (QALYs), derived from the cumulative survival gain (1,541.18 life-years) among screened patients diagnosed and treated for LC. QALYs were conservatively estimated assuming full health (utility weight = 1), given the predominance of early-stage diagnoses. Sensitivity analyses and long-term extrapolations are planned in future phases. Results: A total of 10,031 volunteers were enrolled and 17,418 LDCT scans were performed. Among these, 145 cases of LC were diagnosed, distributed across stages (8th TNM classification): I (84 cases), II (21), III (24), and IV (8); information was unavailable for 8 cases. Of the diagnosed patients, 132 are currently alive. The total cost of the biennial screening program amounted to €6,163,043. The cumulative QALYs gained were estimated at 1,541.18, corresponding to an average of 11.7 QALYs per survivor. Although based on early and conservative assumptions, these preliminary findings indicate a favorable impact in terms of life-years gained at a measurable cost. Conclusions: These initial findings support a favorable cost-effectiveness profile for biennial LDCT screening in high-risk populations. As further follow-up data are collected, the analysis will be expanded to include stage-specific outcomes, long-term survival projections, and differential utility weights, enabling a more comprehensive and nuanced assessment of the program’s value.