Tobacco harm Tobacco harm reduction: NICE reduction: NICE

guidance and recent guidance and recent developmentsdevelopments

Linda BauldLinda Bauld

Outline Outline

Where we are nowWhere we are now Background to guidanceBackground to guidance Key recommendationsKey recommendations Economic analysisEconomic analysis Considerations Considerations Gaps Gaps

Where we are nowWhere we are nowQuitting behaviourQuitting behaviour

Source: West, 2013, www.smokinginengland.info (data for England only)

Where we are nowWhere we are nowCutting downCutting down

Source: West, 2013, www.smokinginengland.info (data for England only)

BackgroundBackground

NICE guidance has played an NICE guidance has played an important role in supporting the important role in supporting the NHS and other organisations to NHS and other organisations to introduce and deliver evidence-introduce and deliver evidence-based tobacco control interventions based tobacco control interventions

This has included guidance for This has included guidance for smoking cessation interventions and smoking cessation interventions and services, but to date these have been services, but to date these have been aimed at supporting people to stop aimed at supporting people to stop smoking in one step. smoking in one step.

BackgroundBackground The Department of Health asked NICE to The Department of Health asked NICE to

produce this guidance produce this guidance A Programme Development Group was A Programme Development Group was

formed and met to consider the evidence formed and met to consider the evidence and develop the guidance over two years. and develop the guidance over two years.

Draft guidance was published on October Draft guidance was published on October 2424thth 2012. 2012.

A consultation and fieldwork period A consultation and fieldwork period followedfollowed

The amended final guidance was published The amended final guidance was published on June 5on June 5thth2013. 2013.

Focus of GuidanceFocus 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.

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

Nicotine-containing Nicotine-containing productsproducts

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

Evidence Evidence

The PDG considered a wide range of The PDG considered a wide range of evidence contained in commissioned evidence contained in commissioned systematic reviews and expert systematic reviews and expert briefing papersbriefing papers

Some key examples followSome key examples follow

Cutting down aloneCutting 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

Cutting down with & Cutting down with & without NRTwithout 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.

• 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 quitCutting down to quit

Options in the guidanceOptions 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.

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

Example: Recommendation Example: Recommendation 11

Raising awareness of licensed nicotine-containing Raising awareness of licensed nicotine-containing products to reduce the harm from smokingproducts to reduce the harm from smokingAimed at national regional and local Aimed at national regional and local organisations responsible for public health and organisations responsible for public health and tackling tobacco use who should: 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.

Barriers to implementation: Barriers to implementation: Beliefs about nicotine and NRTBeliefs about nicotine and NRT

Canada Aust. U.K. U.S.

Nicotine causes most cancer (% answering “true”)

41% 45% 49% 44%

Nicotine causes most cancer (% answering “true”) LOW INCOME

46% 52% 57% 51%

NRT might harm health (% agree strongly + somewhat)

37% 33% 25% 33%

Source: Siahpush et al, Tobacco Control 2006;(Suppl III):iii65-70.

Barriers to Barriers to implementation: implementation:

Smoking cessation staff Smoking cessation staff viewsviews

Source: Beard et al, 2012

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

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

ConsiderationsConsiderations The guidance covers primarily individual The guidance covers primarily individual

level approaches to harm reduction. level approaches to harm reduction. These need to be supported by wider These need to be supported by wider tobacco control policies tobacco control policies

The guidance makes clear the current The guidance makes clear the current limitations of the evidence regarding limitations of the evidence regarding NCPs other than NRT & the link with the NCPs other than NRT & the link with the MHRAMHRA’’s works work

The guidance will be rapidly updated to The guidance will be rapidly updated to reflect changes in licensing reflect changes in licensing

GapsGaps

A considerable number of gaps in the A considerable number of gaps in the evidence were identified during the guidance evidence were identified during the guidance development process, particularly around development process, particularly around population level harm reduction strategies, population level harm reduction strategies, the benefits of smoking less, longer term NRT the benefits of smoking less, longer term NRT use (beyond 5 years) and e-cigarettesuse (beyond 5 years) and e-cigarettes

The guidance also includes research The guidance also includes research recommendations, particularly around the recommendations, particularly around the need for surveillance studies of harm need for surveillance studies of harm reduction strategies and impact of these reduction strategies and impact of these strategies on different sub-populations. strategies on different sub-populations.

Thank youThank youLinda.Bauld@stir.ac.uk

Acknowledgements: Acknowledgements:

Simon Ellis and other colleagues from NICE, theSimon Ellis and other colleagues from NICE, the

tobacco harm reduction PDG members, Emma tobacco harm reduction PDG members, Emma Beard.Beard.