title: Cost-effectiveness of bedaquiline in MDR and XDR tuberculosis in Italy.
abstract: Objective:To evaluate the cost-effectiveness of bedaquiline plus background drug regimens (BR) for multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB) in Italy.Methods: A Markov model was adapted to the Italian setting to estimate the incremental cost-effectiveness ratio (ICER) of bedaquiline plus BR (BBR) versus BR in the treatment of MDR-TB and XDR-TB over 10 years, from both the National Health Service (NHS) and societal perspective. Cost-effectiveness was evaluated in terms of life-years gained (LYG). Clinical data were sourced from trials; resource consumption for compared treatments was modelled according to advice from an expert clinicians panel. NHS tariffs for inpatient and outpatient resource consumption were retrieved from published Italian sources. Drug costs were provided by reference centres for disease treatment in Italy. A 3% annual discount was applied to both cost and effectiveness. Deterministic and probabilistic sensitivity analyses were conducted.Results: Over 10 years, BBR vs. BR alone is cost-effective, with ICERs of €16,639/LYG and €4081/LYG for the NHS and society, respectively. The sensitivity analyses confirmed the robustness of the results from both considered perspectives.Conclusion: In Italy, BBR vs. BR alone has proven to be cost-effective in the treatment of MDR-TB and XDR-TB under a range of scenarios.
authors.affiliation: Regional TB Reference Centre, Villa Marelli Institute/ASST Niguarda Ca' Granda , Milano , Italy.
authors.forename: Luigi R
authors.initials: LR
authors.lastname: Codecasa
authors.affiliation: Faculty of Medicine, Public Health Department, Aix-Marseille University , Marseille , France.
authors.forename: Mondher
authors.initials: M
authors.lastname: Toumi
authors.affiliation: Creativ-Ceutical , Milano , Italy.
authors.forename: Anna
authors.initials: A
authors.lastname: D'Ausilio
authors.affiliation: Creativ-Ceutical , Milano , Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Aiello
authors.affiliation: Janssen-Cilag , Cologno Monzese , Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Damele
authors.affiliation: Janssen-Cilag , Cologno Monzese , Italy.
authors.forename: Roberta
authors.initials: R
authors.lastname: Termini
authors.affiliation: Janssen-Cilag , Cologno Monzese , Italy.
authors.forename: Alessia
authors.initials: A
authors.lastname: Uglietti
authors.affiliation: Parexel International , London , UK.
authors.forename: Robert
authors.initials: R
authors.lastname: Hettle
authors.affiliation: Post-graduate Residency School in Hygiene and Preventive Medicine, University of Palermo , Palermo , Italy.
authors.forename: Giorgio
authors.initials: G
authors.lastname: Graziano
authors.affiliation: E. Morelli Hospital ASST, Reference Center for MDR-TB and HIV-TB , Sondalo , Italy.
authors.forename: Saverio
authors.initials: S
authors.lastname: De Lorenzo
keywords: Bedaquiline; Italy; MDR tuberculosis; XDR tuberculosis; cost-effectiveness