The Health Information and Quality Authority (HIQA) carried out a health technology assessment (HTA) of smoking cessation interventions in Ireland to examine the clinical effectiveness, safety and cost-effectiveness of smoking cessation interventions, as well as the organisational, societal and ethical implications of potential changes to the mix of treatments that people use to help them stop smoking.

The key findings of the HTA that precede and inform HIQA’s advice are as follows:
• Smoking continues to be a major public health problem in Ireland, and is associated with a considerable burden on the public health system. The prevalence of smoking in Ireland is 22.7% in people aged 15 years and over. The prevalence is higher in men (24.3%) than in women (21.2%), and highest in people aged 25 to 29 years (33.4%). Smoking prevalence follows a socio-economic gradient, whereby the prevalence is highest in those of the lowest socio-economic group.
• A diverse range of pharmacological and behavioural smoking cessation interventions are currently funded by the HSE, including both prescription and non-prescription medications, as well as brief intervention training for healthcare professionals who come in contact with smokers. The total annual expenditure on smoking cessation activity in Ireland is estimated to be over €40 million.
• HSE has prioritised that brief interventions in the form of brief advice or written materials are to be promoted as part of the routine delivery of care, and have been assumed to form the standard of care in Ireland.
• Approximately half of smokers in Ireland report making at least one quit attempt every year. The most popular cessation method is unassisted quitting (50%), followed by quit attempts involving e-cigarettes (29%) and nicotine replacement therapy (NRT, 12%). Less than 4% report using prescription-only interventions such as varenicline or bupropion.
• The average quit rate for an unassisted quit attempt after 12 months from the attempt is 7.8%.
• All pharmacological interventions included in this analysis were found to be effective. Varenicline was the most effective single therapy, more than two and half times as effective as the control. Varenicline used in combination with NRT was the most effective dual therapy, more than three and a half times as effective as the control. Using NRT products in combination was more effective than a single form of NRT alone.
• Based on two small clinical trials of first-generation devices, e-cigarettes were twice as effective as the control. Six ongoing trials, due to complete between 2017 and 2022, should provide further evidence for e-cigarettes as a smoking cessation intervention in a general population of unselected adults.
• In addition to the uncertainty about the effectiveness of e-cigarettes as a smoking cessation aid, there are also concerns that the social normalisation of e-cigarettes may lead to new use by people who have never smoked, later migration to tobacco cigarettes, long-term nicotine dependency, and other potential and as yet unknown harms.
• E-cigarettes are not currently advocated by the HSE as a means of quitting due to lack of long-term data on their safety. However, behavioural support is provided by HSE smoking cessation services to smokers who choose to use e-cigarettes in their quit attempt.
• All behavioural interventions included in the analysis were found to be effective compared to no treatment. Group behaviour therapy was the most effective behavioural intervention, almost twice as effective as an active control, defined as brief advice or written materials. Individual counselling, intensive advice and telephone support were all found to be more effective than the active control. The effectiveness of pharmacological interventions is improved by an average of 18% by providing any type of adjunct behavioural therapy.
• The volume of evidence for smoking cessation interventions in pregnant women and those attending specialist secondary mental health services was considerably lower than that available for the general population of unselected adults.
• Pregnant women who smoke should be offered a psychosocial intervention in the first instance. The psychosocial intervention with the largest body of evidence to support its effectiveness is counselling.
• Smoking prevalence is particularly high among people with a mental illness. High-intensity interventions combining pharmacotherapy and behavioural support have been shown to improve quit outcomes in people attending secondary mental health services (defined as inpatient, residential and long-term care for serious mental illness in hospitals, psychiatric and specialist units and secure hospitals and patients who are within the care of specialist community-based multidisciplinary mental health teams).
• A review of the safety profile of smoking cessation interventions found that pharmacological therapies are generally safe and well-tolerated in those for whom these treatments are medically indicated for use. The safety of e-cigarettes is an evolving area of research; while potentially safer than smoking, evidence on long-term safety has yet to be established.
• A cost-effectiveness analysis found that all cessation interventions included in the analysis would be considered cost-effective when compared with unassisted quitting. E-cigarettes and using varenicline, alone or in combination with NRT, were found to be the most cost-effective strategies when individual therapies are compared with each other.
• The cost-effectiveness of e-cigarettes is extremely sensitive to changes in the estimated cost and effects of this intervention. This is of particular significance given the high degree of uncertainty that exists in relation to both of these parameters.
• A comparison of alternatives to the current mix of smoking cessation interventions used in Ireland found that maximising the uptake of combination varenicline and NRT is the most cost-effective strategy.
• A budget impact analysis found that maximising the use of combination varenicline and NRT would be associated with an average increase of approximately €7 million in the annual cost of providing pharmacological smoking cessation interventions in Ireland.
• However, an examination of the evidence on the effect of different policy initiatives on influencing population level smoking cessation preferences was outside the scope of this analysis, so it is unclear to what extent the uptake of the most effective and efficient treatments can be increased among smokers making a quit attempt in Ireland.
• Increasing the smoking cessation budget to promote the use of varenicline-based regimens, and combination NRT therapy for those for whom varenicline is not suitable, would be a cost-effective use of resources.
• To facilitate this, potential barriers to increased uptake of smoking cessation interventions should be examined by the HSE and the Department of Health. This should include a review of dispensing rules for NRT on the General Medical Services (GMS), current exclusion of NRT from Drugs Payment Scheme (DPS) reimbursement, as well as the very limited number of nurse prescribers within smoking cessation services in Ireland.
• From an ethical perspective, any smoking cessation intervention must be made available in a way that promotes individual choice. This can be achieved by providing information concerning the risks and benefits associated with a particular intervention.
• From an organisational perspective, efforts to increase the use of combination varenicline and NRT will place additional demands on general practitioner (GP) or nurse prescriber services. In the event that use of this intervention reaches plausible maximum levels, the number of prescriptions required could increase by over 50%.