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AIM: The aim of this study was to evaluate the economic impact of the introduction of positron emission tomography (PET) in the clinical management of patients with known or suspected lung cancer through a cost-effectiveness analysis of different diagnostic strategies. METHODS: In Italy, 75 patients with known or suspected lung cancer were included in the study. Three different diagnostic strategies were compared: 1) baseline or traditional strategy, i.e. computed tomography (CT) alone; 2) strategy A, i.e. PET for indefinite CT; 3) strategy B, i.e. PET for all. For each strategy expected costs and life expectancy, as measured by life year saved (LYS), were evaluated. Incremental cost-effectiveness ratio (ICER) was calculated to identify the most effective strategy. RESULTS: Compared to the baseline strategy, the introduction of PET changed the clinical management in 40% of cases in strategy A and in 51% of cases in strategy B, with an optimization of the clinical management. Costs of strategy A (2 735.42 Euro) and strategy B (2 984.52 Euro) were, respectively, 8% and 18% higher than the baseline strategy (2 534.81 Euro). LYS was 2.04 and 2.64 for strategy A and B, which were, respectively, 4% and 35% higher than the baseline strategy (1.96 LYS). The ICERs were 2 507.63 Euro/LYS and 415.17 Euro/LYS for strategy A and B, respectively. Strategy A is dominated by strategy B, which is more expensive, but also more effective. CONCLUSION: In Italy, the introduction of PET in the clinical management of all patients with known or suspected lung cancer previously evaluated with CT is cost-effective and allows to gain 2.64 life years at an annual cost of about 415 Euro.