NICE PUBLIC HEALTH PROGRAMME GUIDANCE Smoking Cessation Services

Transcription

1 NICE PUBLIC HEALTH PROGRAMME GUIDANCE Smoking Cessation Services 5th meeting of the Programme Development Group Thursday 23/ Friday 24 November 2006, Royal College of Anaesthetists Churchill House, 35 Red Lion Square, London, WC1R 4SG Attendees: Members Alexander Macara (Chair), Deborah Arnott, Paul Aveyard, Ruth Bosworth, David Geldard, Ron Gould, Gerard Hastings (23 Nov only) Andrew Hayes, Paul Hooper, Carmel O Gorman Christine Owens, Kiran Patel (23 Nov. only), Pam Rees, Mike Ward Reviewers (23 November) West Midlands Health Technology Assessment Collaboration, University of Birmingham David Moore, Martin Connock, Dechao Wang, Pelham Barton York Health Economics Consortium Sarah Flack, Paul Trueman NICE Hugo Crombie, Alastair Fischer, Mike Kelly (23 Nov), Lesley Owen, Patti White and Tricia Younger Apologies: John Britton, Hilary Graham, Ian Gray, Robert West ACTION POINTS UNDERLINED Agenda Item Minutes Action: 1 Welcome and Introductions (Alexander Macara) The Chair welcomed all the members of the PDG and the two review teams from the West Midlands Health Technology Assessment Collaboration, University of Birmingham and from the York Health Economics Consortium. PDG member Mike Ward had agreed to lead the discussions about the technology appraisal on Cut Down to Quit and new NRT indications. Ron Gould had agreed to lead the discussion of the cost effectiveness review presented by the York team. 2 Declarations of interest Tricia asked to be informed in writing about changes in declarations of interest. PDG 1

2 (Tricia Younger) 3 Brief overview of Technology Appraisal on Cut down to quit (Martin Connock and Pelham Barton ) Martin Connock reported on clinical effectiveness. The main points were: 7 RCTs satisfied the inclusion criteria, six of them industry-sponsored. Of these, treatment duration varied the most common was 12 months. Follow up also varied. The primary outcome described in all of them was smoking reduction. Quitting was the secondary outcome. Both outcomes were reported in two ways, point prevalence at particular time points and as sustained reduction or sustained quitting. Measured from a start before 6 weeks of treatment, only 1½% to 2% achieved a sustained quit at 6 or 12 months but point prevalence at 12 months showed 8.6% quitting. However examination of the individual patient data shows that people who started their quits after 6 weeks were not counted, even though they may have sustained their quit. Point prevalence of quitting at 12 months is also problematic so a new measure of any continuous quit lasting 6 months or more started in the treatment period was developed. This showed 6.8% continuous quitters using NRT. Pelham Barton reported on the economic analysis. 4 Discussion of Cut down to quit (Mike Ward) The cost-effectiveness model compares different quit methods in 2 ways: 1. options for individuals i.e. over the counter/prescription only/ prescription + counselling. 2. the proportion of smokers choosing the different options. A third analysis was added estimating the proportion of smokers choosing CDTQ who might have attempted an abrupt quit if cutting down to quit had not been available. The outcome considered for the cost effectiveness perspective is a successful lifetime quit. Each successful lifetime quit gains about 1or 2 quality adjusted life years (QALYs). The baseline success rate for CDTQ is less than for abrupt quitting though it is unclear if this is because it is less successful of itself or because the studies have been done on different populations. A wide range of possibilities was modelled for CDTQ always allowing that some individuals choosing this option who might otherwise have chosen to quit. CDTQ is highly cost-effective as long as the dilution from abrupt quit forms a small proportion of the CDTQ attempts, though this reduces if the dilution is 25-50%, assuming that CDTQ is intrinsically less effective than quitting abruptly. If there is no dilution or if people who switch from abrupt quits to cut down keep the same success rate then cut down to quit is highly cost effective. Points raised included: Populations in the included studies were all very similar those aged about 45 years. 2

3 Some PCTs are already looking at withdrawing funding or reducing from 12 weeks to 6 weeks for NRT rather than providing additional funds for CDTQ. People s readiness to quit is important. It might be assumed that the people studied were those who were not ready to quit abruptly, as quitting was the secondary outcome not the primary outcome looked for. There were no studies on cut down to quit. These studies were on reduction with NRT that just happened to measure quits as well. The review team had some reservations about the quality of these studies. The studies may have included mainly heavy smokers, even if the bias was introduced inadvertently, as participants were recruited from those unwilling to quit in the short term. The proportion of people relapsing was felt to be important because cut down and stop should not be substituted for quitting. It is possible that those sustained quitters for 6 months or more might have relapsed by 12 months but 6 months was used as it was regarded as long enough from which to extract the data. Most of the studies were done on NRT methods other than patches. Is there something about this sample that would allow us to make inferences about the heavy smokers in general many of whom may also be those in the most socio-economically deprived groups? Pharmacists observe that young people tend to choose NRT gum rather than patch. The services may need guidance on treatment options for those who have tried to quit abruptly and are still struggling. What are the treatment options for those who have difficulties with abrupt quitting? ASH has published some guidance to services suggesting that smokers should be offered NRT on the basis of cutting down by 50% in 6 weeks. 5 Brief overview of Technology Appraisal on new NRT indications (David Moore) David Moore introduced the report on the new indications for NRT. The report identified the best available evidence on the clinical and cost effectiveness of NRT for: adolescents pregnant women breastfeeding cardiovascular disease NRT NRT combination NRT bupropion combination Adolescents It is not certain that NRT is as effective in adolescents to the same degree that it is in adults. It might be possible given the absence of evidence of cost effectiveness to 3

4 Discussion (Mike Ward) develop a model to identify what the minimum effect on cessation in adolescents might be to make it a cost effective treatment. Pregnancy 2 placebo controlled trials no benefit of NRT with counselling. One study cut short because of possible adverse effects on the fetus. There is an ongoing RCT in Nottingham, unlikely to complete before Breastfeeding Only one before and after study identified. Nicotine was transferred through breast milk, amount from a 21mg patch equivalent to smoking 20 cigarettes per day. No economic analysis found. Cardiovascular disease Studies show risk of NRT lower than the risk of smoking. No economic analysis available NRT plus NRT e.g. patch plus gum Trend towards improved efficacy in combination, but much heterogeneity in the studies. NRT plus bupropion TA no 39 said there was insufficient evidence. Preliminary results of recent studies suggest that combination may possibly have a benefit. No new economic evidence. Discussion points included: Parents buy NRT OTC for their children. Little evidence that adolescent smoking cessation services are beneficial. Young people may need a different kind of support; NRT on its own may not be enough. It seems that putting the person at the centre of the service is important. Young people may prefer to get support from the pharmacist- easy to get to no stigma. Action research may be needed. It is legitimate for the PDG to make recommendations on reducing inequalities either in access to treatment or opportunity to benefit from it. The best advice for pregnant women is to quit without NRT. Services allow the pregnant woman to choose to take NRT or not reminding them that it is a balance of risks and NRT not completely safe for the fetus. Breastfeeding on demand poses problems. It is not realistic to ask women to limit NRT use to say, 2hrs after breastfeeding as mothers may breastfeed 10 times in 24 hours. The Nottingham trial would like providers not to use NRT routinely in pregnant women to avoid compromising their work. However, pregnant women are using NRT already as it is available OTC. Robert West may be able to provide details of a recently completed trial on combination treatments. 6 Sarah Flack from the York Health Economics 4

5 Brief presentation of the evidence reviews of cost effectiveness (Sarah Flack) Consortium presented an overview of four costeffectiveness reviews on NHS interventions, non-nhs treatments, workplace interventions and mass media interventions. NHS interventions 18 Studies included stages of change, routine visit advice, intensive interventions, interventions in hospital. Range of outcome measures used: cost per quitter, cost per life year saved/gained, cost per QALY. All results highly cost effective. Highest cost per quitter for the most intensive intervention with pharmacotherapies was 11k. A study of the English smoking cessation services in 2001 showed cost per life year gained of less than Discussion on cost effectiveness (Ron Gould ) Non-NHS interventions No studies met the inclusion criteria. Workplace interventions 10 studies of a range of interventions from clinics, individual and group counselling with or without pharmacotherapies. Evidence suggests all are cost effective. Bupropion is cost beneficial with or without counselling, NRT patches with smoking cessation programme or advice from pharmacist all provide a net benefit to the employer. However these studies were carried out in large companies and there are concerns that some of the US studies may not be applicable to the UK as they focus on incentives related to US health insurance schemes and benefits. Mass media interventions 10 studies including quitlines, mass mailings, media campaigns and a quit and win competition. Outcome measures vary but all appear to be cost effective. Discussion points included: Non NHS treatments Of the non NHS treatments only Cytisine (Tabex) was shown to be effective and appeared to be cost effective. But there were no studies of its cost effectiveness in the English language literature. Paul Trueman offered to see if there were studies of cost effectiveness in other languages on this product. Was there sufficient information or analysis available to determine whether non-nhs interventions might represent a valuable use of NHS resources given the success claimed by some of them. NHS treatments Doctors can give advice in the course of a normal consultation which is effective and must be inexpensive though it is not done as often as it should be. YHEC/Paul Trueman 5

6 A survey in one hospital showed that only a quarter of smokers admitted for surgery had been advised to quit. Experience shows that coronary patients advised by doctors to stop smoking will comply. The QoF target only relates to people with pre-existing disease and is only related to advice, not to the SS services. Suggested a recommendation that advice is given at every opportunity NICE brief intervention guidance recommended advice once a year in primary care. Should there be a level of training required for those giving advice and if so should this apply to GPs? Evidence from the brief intervention guidance shows that advice from a doctor is effective and cost effective. It would be helpful to have the brief intervention guidance recommendations available when re-drafting these recommendations. Stop smoking interventions for pregnant women are cost effective but some of the studies may not capture all the costs and benefits to mother and child. The NICE team offered to put the YHEC team in touch with the health economists at the National Perinatal Epidemiology Unit in Oxford who have done work on costs and benefits to mother and fetus/infant. With regard to pregnancy the interventions often involve home visiting and the costs of this need to be taken into account. NICE NICE Workplace Some of the evidence relates to bupropion which is not prescribed as often as it once was. It requires a prescription as well as a letter from the smoking cessation services. Even then it may not be prescribed.. However bupropion may be used more often in secondary care. NRT is more accessible and costs about the same as bupropion. The guidance needs to consider those people working in small concerns where workers may not have time off to access services, occupational health etc and there is little or no evidence on the cost effectiveness of smoking cessation in the report. It will be important to convince employers in small businesses that the benefits shown in large concerns will apply to them. Any recommendations need to tie in with the recommendations that PHIAC is developing for employers. It will be important to think beyond the published evidence to make recommendations Recommendations for disadvantaged groups are still 6

7 likely to be cost effective. 8 Discussion on the nature of the evidence (Mike Kelly) Mass media Cost per quitter is likely to be very low for any national interventions. There will be another chance to consider mass media at the next meeting when social marketing consultant to CDC, Karen Gutierrez presents her paper. MK made a number of points: It is widely believed that NICE is driven by a narrow focus on evidence. This is not the case. The evidence base is often a less firm foundation for building public health guidance than one might have hoped. Evidence that has been considered so far, though imperfect and despite uncertainties, does indicate a direction of travel It is quite appropriate for the committee to make inferential judgements- considering the steps and stages in reaching these judgements. This logical sequence will need to be documented in the minutes. 9 Minutes of the last meeting (Chair) The relationship between the STA on varenicline, the update of TA no 39 on NRT and bupropion and the rest of this programme guidance. NICE procedures state that when a technology appraisal is updated the Funding Direction ceases so that the current Funding Directions for NRT and bupropion will no longer apply when this guidance is published. The STA on varenicline is due to be available in draft form in April 2007 and, if found to be effective and cost effective, the assumption is varenicline will receive a Funding Direction. Public health guidance is part of the developmental standards for the NHS. The Healthcare Commission will performance manage trusts against NICE recommendations but there will be no specific Direction to trusts that funding needs to be made available to support these recommendations. The coordination of the public health guidance, the new technology appraisal and the update of the existing technology appraisal are being actively discussed to ensure that the guidance is consistent and that there is clarity for the services and the NHS more broadly. The minutes of the last meeting on 7 th September were discussed Corrections Page 2.Christine Owens not Owen. Carmel O Gorman was present Page 4. Deborah Arnott s point about focusing interventions specifically on young people needs to added to the discussion. NICE 7

8 The issues arising from the discussion groups were reported faithfully in the minutes but are not recommendations. The minutes were accepted as a correct record. 1 Welcome and recap on yesterday s meeting 2 Joining up initiatives on smoking cessation (Andrew Hayes) Matters arising from the minutes The declarations of interest will be shared once they are all available. Information about the smoking ban in Guernsey is being included in the report to PHIAC on research on impact on smoking cessation of the legislation in other jurisdictions. Friday, 24 November 2007 The Chair welcomed the PDG members to the second day of the meeting and noted that two members, Kiran Patel and Gerard Hastings, were not able to attend the second day of the meeting. CPHE Director Mike Kelly was also not able to attend. The Chair asked Andrew Hayes to expand on a discussion he had initiated at the previous PDG meeting about the number of policy and practice initiatives on smoking cessation services. He made the following points: Monitoring cessation at four-weeks as a basis of reaching targets/ securing funding was problematical: setting an arbitrary target did not take into account the different composition and needs of different localities; there were questions of accuracy in reporting; services were not being encouraged to offer long term support; the basis for setting targets was changing. The Healthcare Commission evaluation of the services raised questions about the methodology used: almost all services received high ratings despite great variations in declared results. The Report would be published shortly and would probably be pertinent to the work of the PDG. The Department of Health had set up the National Support Team that was helping struggling services. There had been two pilots and from January onwards the project was to include 20% of PCTs. There was some confusion in the field about the difference between statutory guidance and best practice. There may well be an expectation that this would be addressed in the SC Programme guidance. Things that might emerge from both of these projects are: the need for better local data; clarity about local policies and procedures; working more closely with local communities; targeting support to captive audiences. These were just some of the issues arising in the field and Andrew strongly recommended that the NICE team should consult with counterparts in the Healthcare Commission, Association of Public Health 8

9 Observatories (who were working on reducing health inequalities) and the DH National Support Team to ensure that all parties were aware of efforts being made by the others. NICE 3 Group session to consider recommendations 4 Recommendations for Non-NHS treatment 5 Recommendations for NHS treatment The PDG met in two groups to discuss the recommendations on Non-NHS and NHS treatments for smoking cessation. The PDG re convened to consider the discussions on recommendations. They made the following recommendations on non-nhs treatments: Acupuncture, acupressure, laser therapy or electrostimulation should not be used in the NHS to promote smoking cessation. There is [some] evidence to show that these are ineffective in producing long term smoking cessation Allen Carr s Easyway programme is not recommended for the NHS as there is no adequate evidence on its effectiveness. Hypnotherapy should not be used in the NHS to promote smoking cessation. There is [some] evidence to show that it is ineffective in producing long term smoking cessation Use of NicoBloc, for smoking cessation is not recommended for the NHS. There is some evidence to show that NicoBloc is not effective for long term smoking cessation. Use of Nicobrevin is not recommended for the NHS. It should only be used within a research study to determine its effectiveness. Routine use of rapid smoking to support smoking cessation in the NHS is not recommenced for practical reasons, but there is evidence that it improves six-month abstinence rates. OR Rapid smoking is not recommended for routine use in the NHS. Given the indications of effectiveness and cost effectiveness of Cytisine in aiding smoking cessation, studies sound be undertaken to determine its long term effectiveness. Adjuvant use of glucose by patients trying to quit smoking should not be discouraged, but it should not be provided by the NHS. Studies should be undertaken to determine if glucose might reduce cravings when used with other proven smoking cessation treatments. St John s Wort should not be used in the NHS to promote smoking cessation. There is no evidence to suggest that it is effective. As a general principle, people who want to stop smoking should be offered the most effective treatments first. 9

10 The NHS stop smoking services should be set realistic, appropriate targets that reflect the demographics of the local population. Service managers should be given clear guidance on data collection and performance management. Services should be audited appropriately The Department of Health should update guidance to NHS stop smoking service providers. It is especially important that this should include a standardised model for training for primary care and specialist staff, preferably using the HDA training standard. The Department of Health should fund research to (periodically) monitor the long-term outcome of selected services. It is too demanding of the time and resources of local services to measure more than short term (four week) quits. Local policy makers and commissioners should provide resources commensurate to need to enable the NHS Stop Smoking Services to provide a range of choices for cessation advice and support to all smokers including those groups service providers find hard to reach. Providers of NHS stop smoking services should actively promote accessible support and a range of choices for cessation treatment to smokers. The NHS Stop Smoking Services should continue to provide intensive comprehensive support to help smokers of all ages to quit. Community pharmacists should be trained to offer brief advice to stop smoking. Pharmacists who have been trained to provide specialist smoking cessation advice should do so in an appropriate setting. Those who have not had specialist training should refer smokers to the NHS stop smoking service To enable the appropriate use of NHS stop smoking services, the training of Health Care professionals by universities, colleges and professional organisations should include smoking cessation. Their curricula should detail how to give simple advice and therapy to smokers wishing to quit and also how to use NHS stop smoking services. Healthcare professionals should, at the first antenatal appointment, actively encourage pregnant women to stop smoking and encourage them to use the NHS stop smoking services. For those unwilling to use the services health professionals should continue to raise the subject of smoking sensitively throughout pregnancy so that the women who decide to stop smoking can get help to do so. OR Smoking Cessation programmes should aim for the woman to stop smoking permanently and therefore focus not only on successfully quitting in the short term, but also on supporting continuation of 10

11 abstinence in the long term. Outcomes should be evaluated throughout pregnancy and at least until delivery, including regular CO validation Health professionals should refer pregnant smokers to the members of the healthcare team most skilled in offering support to pregnant smokers and/or to the NHS Stop Smoking Services Members of the primary care team should advise all patients who smoke to quit. Those who want to stop should be offered a referral to the NHS stop smoking services. The smoking status of those who are not ready to quit should be recorded and reviewed on an annual basis. Support to stop smoking should be offered to hospital in-patients. The relevant clinical team should take responsibility to give timely pre-admission advice. Inpatients should receive appropriate advice and counselling, an offer of medication (on hospital formulary) and post-discharge referral to the local NHS Stop Smoking Service. Community workers, including Health Trainers, should be trained to offer brief advice on stopping smoking and to refer clients to the NHS stop smoking services. Those providing NHS stop smoking services should in the first instance offer a stop smoking group to clients. It should be explained to smokers that group participation is at least as good, if not better, than individual counselling A drop in service may offer the efficacy of a group intervention with the convenience of a one- to-one approach. Those offering one-to-one counselling should consider a buddy system where practicable. There is evidence that buddy systems more than double the short term effectiveness of one-to-one interventions. NHS stop smoking services should have a strategy to develop links with local community groups to ensure that services are responsive to the needs of ethnic minority groups. Specialist smoking cessation advice, counselling and support should be in the recipient s first language. Midwives, GPs and practice nurses and staff who work in Sure Start Children s Centres should be trained to give brief and sympathetic advice to stop smoking and brief advice on how to stop smoking. They should either be trained to give intensive support for smoking cessation or more likely know specifically how to refer women for that help. 11 Fieldwork (Hugo Crombie) In addition to the stakeholder consultation on the draft recommendations, they would also be presented to groups of practitioners who would be expected to work with them in order to get views on their practical application and utility. This consultation might be 11

12 12 Additional Mass media review (Patti White) 13 AOB carried out in a number of ways, such as small group or in-depth interviews. After all the fieldwork has been completed a report will be written for the PDG to use in their final review of the guidance. The invitation to tender was going out shortly and the work would be carried out in March and April Members of the PDG should let the NICE team know if they were interested in joining the panel to interview the short-listed agencies who were bidding for the work. Following the discussion at the last PDG meeting, the NICE team has commissioned an expert paper on the use of mass media for smoking cessation. Members had expressed the necessity of looking beyond the peer reviewed literature since much of the research in this field is not published in academic journals. The author is Karen Gutierrez, who is Director of the Global Dialogue for Effective Stop Smoking Campaigns. Ms Gutierrez is also one of the authors of the CDC/ WHO report on mass media interventions for smoking cessation that was tabled at the previous PDG meeting. She will present the paper at the PDG meeting on 17 January There was no further business and the Chair closed the meeting at 15:00. PDG DATE OF NEXT MEETING: Wednesday, 17 and Thursday 18 January 2007 NICE, Derwent Room, PAPERS FOR THE NEXT MEETING WILL BE ED: Wednesday, 10 January