The Programme Development Group (PDG) took account of a number of factors and issues when developing the recommendations, as follows. Please note: this section does not contain recommendations. (See Recommendations.)
3.1 Stopping smoking leads to considerable health benefits – for smokers and those around them. These include: a reduction in the incidence and severity of chronic smoking-related conditions such as cardiovascular and peripheral vascular disease, stroke, certain cancers, chronic obstructive pulmonary disease and asthma. In addition, the need for medications (for example, neuroleptics, bronchodilators and antibiotics) is reduced, leading to subsequent cost savings.
3.2 Eliminating children and young people's exposure to cigarette smoking removes smoking role models and may, in turn, reduce the likelihood that they will smoke. This is in addition to the health benefits they will gain from reducing their exposure to secondhand smoke.
3.3 Harm-reduction strategies can be applied at both the individual and population level. However the PDG recognised that wider strategies, not included here, also have a contribution to make. These include: regulation (for example, to restrict where smoking can take place); community-led strategies (such as making it the norm not to smoke); and pricing (so people stop or reduce the amount they smoke because it becomes too expensive).
3.4 People may temporarily abstain from smoking for a variety of reasons. Some may do this as a way of protecting the health of those around them – and reducing the harm to themselves. Sometimes people use it as a way of working towards stopping smoking. Smoke-free legislation requires abstinence in the workplace and work vehicles, in public places and on public transport. For people in closed institutions, such as secure mental health units and prisons, temporary abstinence may be imposed for lengthy periods, even years.
3.5 Trained health professionals and stop smoking services can provide advice on how to reduce the amount smoked, or how to stop smoking temporarily. They can also supply licensed nicotine-containing products. In each case, contact with someone who smokes will also provide an opportunity to start people thinking about longer-term harm-reduction approaches or stopping smoking altogether.
3.6 The PDG considered forthcoming changes in how stop smoking services will be commissioned as they move under local authority control in England.
3.7 The PDG was aware that stop smoking services would need service provision guidance on the range of support to offer people. This includes support for those who are trying to stop smoking, but are unable (or unwilling) to give up nicotine. For example, decisions would be needed on how long to provide support, funding of licensed nicotine-containing products and appropriate targets.
3.8 Evidence is available from studies with up to 5 years follow-up which suggests that 'pure' nicotine, in the form available in nicotine replacement therapy (NRT) products, does not pose a significant health risk. This is the case whether it is used as a substitute for, or in combination with, cigarettes. Although there is a lack of data on using NRT products beyond 5 years, expert opinion is that lifetime use will be considerably less harmful than smoking.
3.9 The PDG recognised that electronic cigarettes and similar products could, without regulation, be marketed in a way that may ultimately promote smoking. They were concerned that steps be taken to ensure that such products would be promoted in a way that was compatible with promotion of current licensed nicotine-containing products. The PDG was concerned that people might be put off by the cost of some licensed nicotine-containing products. Of even more concern was the lower price of illicit tobacco. The Group believed some people may be at risk of a relapse after their prescriptions for licensed nicotine-containing products run out if they find cigarettes (legal or contraband) are cheaper.
3.10 In recommending licensed nicotine-containing products, the PDG weighed the cost of prescriptions and health professionals' time against the risk of people not using the products.
3.11 In reality, people trying to stop smoking often do not receive enough support and do not use enough of one or more licensed nicotine-containing product (or use it inappropriately). This may also be a problem for people who are cutting down to quit or are reducing the amount they smoke.
3.12 The technology of nicotine delivery systems is likely to develop further in the near future and the PDG took this into account in its research recommendations.
3.13 A range of evidence was considered. Some international evidence was not directly applicable to the UK but provided an indication of potential outcomes.
3.14 There is limited evidence on the effectiveness of some elements of strategies to reduce the harm from smoking (this includes a lack of evidence on any unintended consequences). There were few robust studies evaluating the impact at population and subpopulation level.
3.15 The PDG was aware of several benefits that could result from different harm-reduction approaches which are difficult to capture or quantify. They include: improved physical and mental wellbeing and reduced exposure to smoke for non-smokers. For smokers who are ill, stopping or reducing the amount they smoke can mean they have more time to participate in therapeutic activities.
3.16 It is not clear whether there are any long-term health benefits from adopting a smoking reduction approach (apart from the fact that someone who reduces may ultimately stop smoking). As a consequence, the PDG made a research recommendation.
3.17 There is mixed evidence on the effectiveness of behavioural support without also using NRT as part of a harm-reduction approach. A limited number of studies evaluated interventions where the primary outcome was to help people cut down prior to stopping smoking (mainly cognitive behavioural therapy and counselling). These studies showed a positive effect. There were more studies evaluating interventions where the primary outcome was smoking reduction (mainly motivational interviewing and counselling). The majority of these studies found no effect. The PDG therefore exercised caution when making recommendations about behavioural interventions.
3.18 An economic model was developed to assess a wide range of harm-reduction approaches. The PDG noted that all 21 interventions modelled (apart from temporary abstinence with no support) were highly cost effective compared with 'no intervention'. This included 3 that were cost saving. However, harm reduction approaches are not as cost effective as smoking cessation.
3.19 Many people who smoke may choose to replace smoking with licensed nicotine-containing products and may continue to use these products for very long periods of time. A two-way sensitivity analysis was used to vary the effectiveness and duration of use of a licensed nicotine-containing product. The PDG noted that providing NCPs for a period of up to 10 years would be considered a cost effective use of NHS resources for an intervention which achieves a quit rate of 6%. This would fall to 5 years for an intervention with a 4% quit rate. A supplementary analysis assumed there were no benefits from smoking reduction (in terms of quality-adjusted life years [QALYs] and comorbidities), other than an increased likelihood of stopping at 6 months. The analysis showed that, as the effectiveness of an intervention diminishes, so the time during which it is considered cost effective to provide NCPs reduces. For example, the costs potentially outweigh the benefits, when the reduction rate is 6% or less and someone uses a licensed nicotine-containing product for 12 months or longer. When a reduction of 20% or more is achieved, the cost of extending licensed nicotine-containing product use to 2 years may be outweighed by the benefits. (The 6% and 20% figures provide a useful benchmark for judging cost effectiveness in relation to duration of use of NCPs.)
3.20 A harm-reduction approach can lead to a range of economic benefits. These include savings for employers by reducing the number of staff cigarette breaks and the amount of sickness absence caused by chronic, smoking-related conditions. (Reducing the latter will also reduce social care costs for local authorities.) In addition, there will be a reduction in the number of house fires leading to savings for fire and rescue services and local authorities. (The latter will make savings on insurance for social housing.) For more details see NICE guidance on workplace interventions to promote smoking cessation. Also see NICE's local government briefing on tobacco.
3.21 People who use NRT to stop smoking, but fail in their attempt, are more likely to use it again – should they try again. Modelling the cost effectiveness of using NRT for a single attempt to stop smoking, or treating subsequent attempts as independent may, therefore, underestimate its cost effectiveness.
3.22 When the impact of secondhand smoke was included in the economic model, the cost per QALY was reduced for all the interventions modelled. The other potential benefits associated with tobacco harm-reduction (listed above) were not included. This may have resulted in an underestimation of the benefits of reducing and stopping smoking. If, for example, a smoker lost an average of 2 days productivity per year (relative to a former smoker), then this would amount to nearly £4000 in lost productivity over 30 years. (This estimate includes discounting at 3.5% per year.)
3.23 The PDG noted that offering a smoking reduction approach could potentially attract people who would otherwise have carried on smoking as usual. Moreover, some of those who choose to reduce the amount they smoke may go on to stop. Conversely, offering services to help people reduce their smoking may discourage others from stopping. For harm reduction approaches to be cost effective, at least 2 more 'reducers' would be needed to offset each person who decided to reduce the amount they smoke, instead of stopping. A supplementary analysis assumed there were no benefits from smoking reduction (in terms of QALYs and comorbidities), other than an increased likelihood of stopping at 6 months. This analysis showed that for each potential 'quitter' lost, 6 more 'reducers' would be needed to offset the lost benefits.
3.24 As with any economic evaluation, the model has limitations. These include a lack of data on how comorbidities varied with recent or long-term abstinence, and the assumption that smokers use only one type of intervention in any one attempt to stop smoking.