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Background: Varenicline has been shown to be an effective and well-tolerated intervention for smoking cessation in smokers with stable cardiovascular disease (CVD). The objective of this study was to evaluate the cost- effectiveness of varenicline and counselling compared to placebo and counselling based on extrapolating the results of a 52-week randomised controlled trial. Method: A Markov model was developed to simulate the outcomes of smokers with CVD. Outcomes included major forms of CVD (e.g. Coronary Heart Disease (CHD)) and other key chronic conditions attributable to smoking (e.g. Lung Cancer). The lifetime costs, Life-Years gained (LY) and Quality-Adjusted Life Years (QALY) were evaluated from a payer's perspective in Austria, Hungary and Germany. Additional analyses included a societal perspective, disease sub- group, and both one-way and probabilistic sensitivity analyses (PSA). Costs and outcomes were discounted at 3% per year. Results: From a payer's perspective, the incremental cost-effectiveness ratio per LY (or QALY) gained was  4 112 ( 5 278),  2 507 ( 3 183), and  4 567 ( 5 867) for Austria, Hungary and Germany, respectively. Sub-group analyses demonstrated that smoking cessation in patients with CHD was more cost-effective than in patients with baseline stroke or peripheral vascular disease. Sensitivity analysis demonstrated that outcomes were not sensitive to modelling assumptions. Varenicline was less costly and more effective than placebo from a societal perspective, and more costly and more effective than placebo in all iterations of the payer PSA. Conclusions: Varenicline is a cost-effective adjunct to counselling compared to counselling alone in patients with stable CVD.

Cost-Effectiveness of Varenicline Compared to Placebo as an Aid to Smoking Cessation in Patients with Cardiovascular Disease