OBJECTIVES: To assess the cost-effectiveness of cytisine over and above brief behavioural support (BS) for smoking cessation among patients who are newly diagnosed with pulmonary tuberculosis (TB) in low-income and middle-income countries. DESIGN: An incremental cost-utility analysis was undertaken alongside a 12-month, double-blind, two-arm, individually randomised controlled trial from a public/voluntary healthcare sector perspective with the primary endpoint at 6 months post randomisation. SETTING: Seventeen subdistrict hospitals in Bangladesh and 15 secondary care hospitals in Pakistan. PARTICIPANTS: Adults (aged ≥18 years in Bangladesh and ≥15 years in Pakistan) with pulmonary TB diagnosed within the last 4 weeks who smoked tobacco daily (n=2472). INTERVENTIONS: Two brief BS sessions with a trained TB health worker were offered to all participants. Participants in the intervention arm (n=1239) were given cytisine (25-day course) while those in the control arm (n=1233) were given placebo. No significant difference was found between arms in 6-month abstinence. PRIMARY AND SECONDARY OUTCOME MEASURES: Costs of cytisine and BS sessions were estimated based on research team records. TB treatment costs were estimated based on TB registry records. Additional smoking cessation and healthcare costs and EQ-5D-5L data were collected at baseline, 6-month and 12-month follow-ups. Costs were presented in purchasing power parity (PPP) adjusted US dollars (US$). Quality-adjusted life years (QALYs) were derived from the EQ-5D-5L. Incremental total costs and incremental QALYs were estimated using regressions adjusting for respective baseline values and other baseline covariates. Uncertainty was assessed using bootstrapping. RESULTS: Mean total costs were PPP US$57.74 (95% CI 49.40 to 83.36) higher in the cytisine arm than in the placebo arm while the mean QALYs were -0.001 (95% CI -0.004 to 0.002) lower over 6 months. The cytisine arm was dominated by the placebo arm. CONCLUSIONS: Cytisine plus BS for smoking cessation among patients with TB was not cost-effective compared with placebo plus BS. TRIAL REGISTRATION NUMBER: ISRCTN43811467.

3rd Medical Department 1st Faculty of Medicine Charles University and General University Hospital Prague Praha Czech Republic

ARK Foundation Dhaka Bangladesh

Centre for Cancer Prevention Wolfson Institute of Preventive Medicine Queen Mary University of London London UK

Department of Economics University of Dhaka Dhaka Bangladesh

Department of Family Medicine CAPHRI School for Public Health and Primary Care Maastricht University Maastricht The Netherlands

Department of Health Sciences University of York York North Yorkshire UK

Hull York Medical School University of York York North Yorkshire UK

Institute of General Practice Addiction Research and Clinical Epidemiology Unit Medical Faculty Heinrich Heine Universität Düsseldorf Dusseldorf Nordrhein Westfalen Germany

Institute of Hygiene and Epidemiology 1st Faculty of Medicine Charles University and the General University Hospital Prague Praha Czech Republic

Institute of Psychiatry Rawalpindi Medical University Rawalpindi Pakistan

TB HIV and Malaria Common Management Unit Global Fund Grant Islamabad Pakistan

The Initiative Islamabad Pakistan

Usher Institute The University of Edinburgh Edinburgh UK

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