OBJECTIVES: To evaluate the cost-effectiveness of adding bedaquiline to a background regimen (BR) of drugs for multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB) in Italy. METHODS: A cohort-based Markov model was adapted to the Italian Healthcare setting. The model aims to estimate the incremental cost-effectiveness ratio (ICER) of bedaquiline plus BR (BBR) versus BR alone in the treatment of MDR-TB and XDR-TB, over a 10-year time horizon. The costs and effectiveness (life years gained [LYG]) of treatment were evaluated in the base case from both a National Health Service (NHS) and societal perspective. Clinical data were sourced from clinical trials. Resource utilisation data were obtained from interviewing a panel of clinicians. The study considered NHS tariffs for inpatient and outpatient resources and an average hospital stay, with active disease, of 63 days for MDR_TB patients and 76 days for XDR_TB patients according to expert opinion. Drug costs were provided by reference centres for the treatment of tuberculosis. A 3% annual discount rate was applied to costs and effectiveness. Sensitivity analyses were conducted to test the robustness of the results. RESULTS:Over a 10-year period, the ICERs for BBR versus BR alone were €16,639/LYG and €4,081/LYG for the NHS and societal perspectives, respectively. Similar results were observed across the deterministic sensitivity analysis. BBR dominated BR alone when considering a societal perspective, a 20% price decrease for bedaquiline and a mean hospital stay of 6 months. In the PSA, BBR was cost-effective in 88% – 96% of simulations, at thresholds of €40,000 and €60,000 (NHS perspective). From a societal perspective, BBR was dominant in 19% of simulations, and considered cost-effective in 94%-97% of simulations.CONCLUSIONS: In Italy, BBR is cost-effective vs BR alone in the treatment of MDR-TB and XDR-TB under a range of scenarios.