1. Tobacco harm reduction: NICE guidance and recent developments Linda Bauld

2. Outline Where we are now Where we are now Background to guidance Background to guidance Key recommendations Key recommendations Economic analysis Economic analysis Considerations Considerations Gaps Gaps

3. Where we are now Quitting behaviour Source: West, 2013, www.smokinginengland.info (data for England only)www.smokinginengland.info

4. Where we are now Cutting down Source: West, 2013, www.smokinginengland.info (data for England only)www.smokinginengland.info

5. Background NICE guidance has played an important role in supporting the NHS and other organisations to introduce and deliver evidence-based tobacco control interventions NICE guidance has played an important role in supporting the NHS and other organisations to introduce and deliver evidence-based tobacco control interventions This has included guidance for smoking cessation interventions and services, but to date these have been aimed at supporting people to stop smoking in one step. This has included guidance for smoking cessation interventions and services, but to date these have been aimed at supporting people to stop smoking in one step.

6. Background The Department of Health asked NICE to produce this guidance The Department of Health asked NICE to produce this guidance A Programme Development Group was formed and met to consider the evidence and develop the guidance over two years. A Programme Development Group was formed and met to consider the evidence and develop the guidance over two years. Draft guidance was published on October 24 th 2012. Draft guidance was published on October 24 th 2012. A consultation and fieldwork period followed A consultation and fieldwork period followed The amended final guidance was published on June 5 th 2013. The amended final guidance was published on June 5 th 2013.

7. Focus of Guidance The guidance aims to reduce the illnesses and deaths caused by smoking tobacco among people who smoke and those around them. People who smoke can do this by: stopping smoking cutting down prior to stopping smoking smoking less abstaining from smoking temporarily.

8. Licensed Nicotine Products The harm reduction approaches set out in the guidance can involve substituting the nicotine in tobacco with nicotine from less harmful, nicotine-containing products. These include NRT products that are licensed by the MHRA as pharmaceutical treatments for smoking. There are also unregulated products such as electronic cigarettes. The guidance only recommends use of licensed products recognising that when electronic cigarettes become licensed, they can be recommended for use. Nicotine-containing products might be used either temporarily or indefinitely and as a partial or complete substitute for tobacco

9. Nicotine-containing products The guidance states that: There is reason to believe that lifetime use of licensed nicotine-containing products will be considerably less harmful than smoking There is reason to believe that lifetime use of licensed nicotine-containing products will be considerably less harmful than smoking There is little direct evidence on the effectiveness, quality and safety of nicotine-containing products that are not regulated by the MHRA. However, they are expected to be less harmful than tobacco. There is little direct evidence on the effectiveness, quality and safety of nicotine-containing products that are not regulated by the MHRA. However, they are expected to be less harmful than tobacco.

10. Evidence The PDG considered a wide range of evidence contained in commissioned systematic reviews and expert briefing papers The PDG considered a wide range of evidence contained in commissioned systematic reviews and expert briefing papers Some key examples follow Some key examples follow

11. Cutting down alone Source: Godtfredsen et al, Am J Epidemiol 2002;156: 994-1001 A number of studies found little or no health benefits to just cutting down

12. Cutting down with & without NRT Source: Beard, E., & West. R. (2012) Use of nicotine replacement therapy for smoking reduction and temporary abstinence: an update to Beard et al. Addiction, 107, 1185-1187.

13. 10 trials pooled using Mantel-Haenszel fixed-effect model Abstinence outcome of at least 6 months follow-up, ITT analysis Reduction produced similar quit rates to abrupt cessation, any difference non-significant Risk ratio for reduction vs abrupt cessation= 0.94, 95% CI= 0.79-1.13. Risk ratios varied across individual studies suggesting the success of different reduction methods vary. Cutting down to quit

14. Options in the guidance Stop smoking in one step and then to use licensed nicotine containing products as a substitute for tobacco, possibly indefinitely. Cut down prior to quitting with or without the help of one or more licensed nicotine-containing products. Smoke less with or without the help of one or more licensed nicotine-containing products. Temporarily abstain with or without the help of one or more licensed nicotine-containing products.

15. Content of Recommendations 1-7 Raising awareness of licensed nicotine containing products Self-help materials Choosing a harm reduction approach Behavioural support Advising on licensed nicotine-containing products Supplying licensed nicotine-containing products Follow-up appointments

16. Example: Recommendation 1 Raising awareness of licensed nicotine-containing products to reduce the harm from smoking Aimed at national regional and local organisations responsible for public health and tackling tobacco use who should: Aimed at national regional and local organisations responsible for public health and tackling tobacco use who should: Raise awareness among the public of the harm caused by smoking and secondhand smoke. Provide information on how people who smoke can reduce the risk of illness and death (to themselves and others) by using one or more licensed nicotine-containing products.

17. Barriers to implementation: Beliefs about nicotine and NRT Source: Siahpush et al, Tobacco Control 2006;(Suppl III):iii65-70.

18. Barriers to implementation: Smoking cessation staff views Source: Beard et al, 2012

19. Content of Recommendations 8-14 Supporting temporary abstinence People working in closed institutions (such as secure mental health units, prisons) Staff working in closed institutions Commissioning stop smoking services Education and training for practitioners Point of sale promotion of licensed nicotine containing products Manufacturer information on licensed nicotine containing products

20. Economics An economic model was developed to assess a wide range of potential harm-reduction approaches. All interventions in the model (apart from temporary abstinence with no support) were highly cost effective. Only when a nicotine containing product is provided for more than 5 or 10 years, and the quit rate is less than 6%, do the costs (to the NHS) potentially outweigh the benefits

21. Considerations The guidance covers primarily individual level approaches to harm reduction. These need to be supported by wider tobacco control policies The guidance covers primarily individual level approaches to harm reduction. These need to be supported by wider tobacco control policies The guidance makes clear the current limitations of the evidence regarding NCPs other than NRT & the link with the MHRA’s work The guidance makes clear the current limitations of the evidence regarding NCPs other than NRT & the link with the MHRA’s work The guidance will be rapidly updated to reflect changes in licensing The guidance will be rapidly updated to reflect changes in licensing

22. Gaps A considerable number of gaps in the evidence were identified during the guidance development process, particularly around population level harm reduction strategies, the benefits of smoking less, longer term NRT use (beyond 5 years) and e-cigarettes A considerable number of gaps in the evidence were identified during the guidance development process, particularly around population level harm reduction strategies, the benefits of smoking less, longer term NRT use (beyond 5 years) and e-cigarettes The guidance also includes research recommendations, particularly around the need for surveillance studies of harm reduction strategies and impact of these strategies on different sub-populations. The guidance also includes research recommendations, particularly around the need for surveillance studies of harm reduction strategies and impact of these strategies on different sub-populations.

23. Thank you Linda.Bauld@stir.ac.uk Acknowledgements: Simon Ellis and other colleagues from NICE, the tobacco harm reduction PDG members, Emma Beard. tobacco harm reduction PDG members, Emma Beard.