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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 costeffectiveness
of varenicline and counselling compared to placebo and counselling based on extrapolating the results of a
52-week randomised controlled trial.
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 subgroup,
and both one-way and probabilistic sensitivity analyses (PSA). Costs and outcomes were discounted at 3% per
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.
Varenicline is a cost-effective adjunct to counselling compared to counselling alone in patients with stable