4 Consideration of the evidence

4 Consideration of the evidence

4.1 The Appraisal Committee reviewed the data available on the clinical and cost effectiveness of varenicline, having considered evidence on smoking cessation and the value placed on the benefits of varenicline by people who smoke tobacco products and want to quit, those who represent them, and clinical specialists. It was also mindful of the need to take account of the effective use of NHS resources.

4.2 The Committee considered the clinical effectiveness evidence presented by the manufacturer. It concluded that the evidence from the direct trials and the systematic reviews carried out by the manufacturer and ERG demonstrated that varenicline was superior to NRT and bupropion in achieving continuous abstinence. The Committee heard from the clinical specialists and patient experts that the success rates with varenicline made it a useful addition to the variety of interventions available in smoking cessation, particularly because many smokers need to make multiple quit attempts. The availability of an additional treatment choice was mentioned by clinical specialists and patient experts as beneficial to those having difficulty maintaining abstinence and avoiding relapse because it enabled them to have more control.

4.3 The Committee considered the evidence on the cost effectiveness of varenicline submitted by the manufacturer. The Committee noted the comments of the ERG that the submission was not transparent and possessed limited external validity. The model included an extrapolation of 1-year clinical data to a lifetime horizon and included an assumption of a single quit attempt. The Committee also noted the computational errors identified by the ERG, and noted that the ERG had expressed concerns about a number of other assumptions in the model, in particular the use of US data for baseline risk and the use of all-cause morbidity instead of other-cause morbidity. Nevertheless, the Committee considered that these concerns were not sufficient to undermine the inference that the use of varenicline in smoking cessation was likely to be a cost-effective use of NHS resources.

4.4 The Committee heard from clinical specialists about the importance of counselling and support in smoking cessation to reinforce the commitment required to quit smoking. It noted that varenicline had been provided alongside counselling and support in the clinical trials. However, the Committee also heard from the clinical specialists that counselling and support are not always used by people aiming to stop smoking and that pharmacotherapies can be effective in the absence of such programmes. The Committee concluded that varenicline should normally be provided in conjunction with counselling and support, but that if such support is refused or is not available, this should not preclude treatment with varenicline.