1

Appraisal Committee’s preliminary recommendations

1.1

Continuous positive airways pressure (CPAP) is recommended as a treatment option for people with moderate and severe symptomatic obstructive sleep apnoea/hypopnoea syndrome.

1.2

Continuous positive airways pressure (CPAP) is also recommended as a treatment option for people with mild symptomatic obstructive sleep apnoea/hypopnoea syndrome if lifestyle advice and any other relevant treatment options have been considered and deemed inappropriate or unsuccessful.

1.3

The diagnosis of obstructive sleep apnoea/hypopnoea, the prescription of CPAP treatment and monitoring of the initial response should be carried out by specialists in sleep medicine.

<#comment(Section 1, Comment on Section 1: Appraisal Committee's preliminary recommendations)#>

2

Clinical need and practice

2.1

Apnoea is defined as a temporary absence or cessation of breathing. Obstructive sleep apnoea/hypopnoea syndrome (OSAHS) is a condition in which a person experiences repeated episodes of apnoea because of a narrowing or closure of the pharyngeal airway during sleep. This is caused by a decrease in the tone of the muscles supporting the airway during sleep. Complete closure (obstruction) stops airflow (apnoea) whereas partial obstruction decreases airflow (hypopnoea). OSAHS results in episodes of brief awakening from sleep to restore normal breathing.

2.2

OSAHS is usually diagnosed by a sleep medicine specialist by overnight oximetry carried out in the person’s home, or occasionally by an overnight polysomnography in a sleep medicine centre. The severity of OSAHS is usually defined by the number of episodes of apnoea/hypopnoea per hour of sleep, expressed by the apnoea/hyponoea index (AHI) (mild OSAHS, AHI = 5–14; moderate, AHI =  15–30; severe, AHI = over 30).

2.3

Major risk factors for developing OSAHS are increasing age, obesity and being male. OSAHS is also associated with certain craniofacial abnormalities (such as retrognathia), enlarged tonsils and enlarged tongue. Use of alcohol or sedatives can also increase the risk or severity of the condition. OSAHS has been reported to affect up to 4% of middle-aged men and 2% of middle-aged women in the UK. It is estimated that 1% of men in the UK may have severe OSAHS.

2.4

The symptoms of OSAHS include impaired alertness, cognitive dysfunction, excessive daytime sleepiness and snoring. Excessive daytime sleepiness can adversely affect c ognitive function, mood and quality of life. OSAHS is associated with high blood pressure, increasing the risk of cardiovascular disease and stroke. OSAHS has also been associated with an increased risk of road traffic accidents.

2.5

Treatments aim to reduce daytime sleepiness by reducing the number of episodes of apnoea/hypopnoea experienced during sleep. The alternatives to continuous positive airway pressure (CPAP) are life-style management, dental devices and surgery. Conservative management involves helping people to lose weight, stop smoking and/or decrease alcohol consumption. Dental devices are designed to keep the upper airway open during sleep. The efficacy of dental devices has been established in clinical trials, but these devices are traditionally viewed as a treatment option only for mild and moderate OSAHS. S urgery involves resection of the uvula and redundant retrolingual soft tissue. However, there is a lack of evidence of clinical effectiveness, and surgery is considered only if non-surgical techniques are inappropriate.

3

The technology

3.1

A CPAP device consists of a unit that generates airflow, which is directed to the airways via a mask. Positive pressure is generated by the airflow, which prevents upper airway collapse. For CPAP treatment to be effective the person must always wear their device when they go to sleep.

3.2

Studies of adherence to CPAP treatment have identified several reasons for non-use, including poor mask fit, pressure intolerance and, more commonly, upper airway symptoms such as nasal dryness, nasal bleeding and throat irritation. Humidification devices are now commonly used in conjunction with CPAP devices in order to reduce these side effects.

3.3

A fixed CPAP device delivers air at constant pressure throughout the night, and the person will continue to receive this pressure until a further titration study is performed to determine whether the set pressure is still appropriate. Auto-titrating CPAP devices continually adjust the pressure delivered throughout the night, with the aim of improving comfort and thus adherence.

3.4

Devices available in the UK are the HC230 and HC600 (Fisher & Paykel Healthcare), the S6 and S7 range (ResMed UK), the RPM BiLevel 9055, RPM 9054, AutoAdjust and Horizon range (Sunrise Medical), the GoodKnight range (Tyco Healthcare), the Breas range (Vital Signs) and the REMstar range (Respironics UK).

3.5

The price of CPAP devices ranges from £250 to £550 (pricing information obtained from manufacturers’ submissions or NCCHTA briefing notes). Costs may vary in different settings because of negotiated procurement discounts. The lifespan of a CPAP device has been reported to be approximately 7 years.

4

Evidence and interpretation

4.1

The Appraisal Committee (appendix A) considered evidence from a number of sources (appendix B).

4.1.1

Clinical effectiveness

4.1.2

The assessment report included 48 randomised controlled trials (RCTs) that compared the efficacy of CPAP with placebo/usual care or dental devices. Submissions were obtained from three manufacturers. Fisher & Paykel Healthcare included one RCT that compared CPAP with placebo/usual care. This study was excluded by the Assessment Group on grounds of study quality. Respironics did not carry out a review of clinical effectiveness, and ResMed presented the findings of a Cochrane systematic review carried out in 2006.

4.1.3

The Assessment Group identified 23 RCTS that compared CPAP with placebo/usual care using the Epworth sleepiness scale (ESS). A meta-analysis of these studies identified a statistically significantly greater reduction in daytime sleepiness with CPAP compared with placebo/usual care (weighted mean difference in ESS score −2.7; 95% confidence interval [CI] −3.5 to −2.0).

The Assessment Group undertook a series of meta-analyses that compared the effect of CPAP on levels of daytime sleepiness in different populations. This showed a statistically significant greater reduction in daytime sleepiness with CPAP compared with control for moderate and severe categories of OSAHS. For mild OSAHS (meta-analysis of 3 studies; AHI 5–14 events/hour) a weighted mean difference in ESS score of −1.5 (95% CI −3.4 to 0.4) was found. For moderate OSAHS (meta-analysis of 7 studies;
AHI 15–30 events/hour) a weighted mean difference in ESS score of −2.0 (95% CI −3.0 to −1.1) was found. For severe OSAHS (meta-analysis of 13 studies; AHI >30 events/hour) a weighted mean difference in ESS score of −3.4 (95% CI −4.6 to −2.3) was found.

4.1.4

The Cochrane systematic review submitted by ResMed included 36 RCTs. A meta-analysis of the parallel-group studies found a statistically significantly greater reduction in daytime sleepiness with CPAP compared with control (weighted mean difference in ESS score −3.8; 95% CI −4.6 to −3.1). A meta-analysis of the crossover studies showed a statistically significantly greater reduction in daytime sleepiness with CPAP compared with control (weighted mean difference in ESS score −1.9; 95% CI −2.6 to −1.3). The RCT included by Fisher & Paykel compared CPAP with placebo, and reported improvements in subjective sleepiness (measured by the ESS) and in objective wakefulness (measured by the ‘modified maintenance of wakefulness’ test) with CPAP.

4.1.5

The Assessment Group identified six RCTs that compared the effects on daytime sleepiness (ESS score) of CPAP and dental devices. A meta-analysis of these studies did not identify a statistically significant difference between the two treatments (weighted mean difference in ESS score −0.9; 95% CI −2.1 to 0.4). The Assessment Group also found that removing individual trials from the analysis, use of a fixed-effect model or conducting subgroup analysis by study design (parallel group or crossover) did not result in any statistically significant differences in daytime sleepiness between CPAP and dental devices.

4.1.6

A meta-analysis from the Cochrane systematic review identified statistically significant improvements in the AHI and in sleeping minimum oxygen saturation in favour of CPAP compared with dental devices.

4.1.7

The Assessment Group identified six RCTs that measured daytime mean arterial blood pressure. A meta-analysis of these trials found that CPAP was associated with a reduction in arterial blood pressure compared with placebo/usual care (mean difference −2.1 mmHg; 95% CI −4.3 to 0.0 mmHg). However, when these RCTs were analysed by severity of OSAHS classified by baseline ESS, a statistically significant treatment effect in favour of CPAP was identified only for severe OSAHS (mean difference −4.2 mmHg; 95% CI −6.4 to −2.0 mmHg), but not for mild (mean difference 1.1 mmHg; 95% CI −2.9 to 5.1 mmHg) or moderate (mean difference −3.4 mmHg; 95% CI −7.9 to 1.2 mmHg) OSAHS.

4.1.8

The Assessment Group identified six RCTs that evaluated the effect of CPAP treatment on driving ability, using the Steerclear computerised driving simulator program. A meta-analysis of the four studies that reported the number of obstacles hit did not identify a statistically significant difference between CPAP treatment and placebo (weighted mean difference −5.74; 95% CI −14.75 to 3.27). A meta-analysis of the two trials that reported percentage of obstacles hit did not show a statistically significant difference in favour of CPAP (weighted mean difference 0.00; 95% CI − 3.35 to 3.35).

4.1.9

The Assessment Group identified one trial that used a computerised simulated driving program that assessed night-time driving ability. Statistically significant improvements in standard deviation of position on the road (p = 0.03), minutes spent driving accurately (p = 0.02) and deterioration in driving ability (p = 0.007) were identified in favour of CPAP compared with placebo.

4.1.10

The Assessment Group identified two studies that estimated the impact of CPAP on the rate of road traffic accidents. The first study (a meta-analysis of 8 before-and-after studies) estimated that use of CPAP reduced the odds of a road traffic accident by 85% (odds ratio 0.15; variance 0.00094). The second study showed reduced odds of a road traffic accident with CPAP therapy (odds ratio 0.33; variance 0.02075). A meta-analysis of these two studies identified an 83% reduction in road traffic accidents (odds ratio 0.17; variance 0.00098). The ResMed submission reported the findings of a 3-year case–control study which estimated the annual number of road traffic accidents among people with OSAHS as 0.18 per year before and as 0.06 per year after initiation of CPAP therapy.

4.1.11

The Assessment Group found that there were not enough studies for meta-analyses to be performed for most of the quality-of-life outcome measures reported. Six studies were identified that used the SF-36 instrument for measuring health-related quality of life. None of these studies found a statistically significant difference between CPAP and placebo/usual care in any of the subscales, but there was a trend towards an improvement in favour of CPAP in the vitality and physical role subscales. Four studies were identified that used the Functional Outcomes of Sleep Questionnaire. A statistically significant benefit in favour of CPAP was identified for the activity level and social outcome subscales, but not for the general productivity, intimacy and sexual activity or vigilance subscales, or total scores. Only two studies reported the Sleep Apnoea Quality of Life Index total score: one reported a significant benefit with CPAP compared with control, but in the other study there was no statistically significant difference.

4.1.12

There was no statistically significant difference between CPAP and dental devices when the results from two studies reporting the Functional Outcomes of Sleep Questionnaire and two studies reporting the Sleep Apnoea Quality of Life Index were pooled. Three studies used the SF-36 instrument, but they each used different subscales and the findings were not consistent.

4.1.13

The ResMed submission identified seven studies that reported short- and longer-term rates of adherence with CPAP therapy. The average rate of adherence across the studies was 71% (range 23–82%) up to 12 months and 79% (range 68–90%) at 12 months or more. The Assessment Group reported on one of these studies, which was an observational study carried out over 6 years in a Scottish cohort. The adherence rates were 84% at 1 year, 74% at 2 years, 73% at 3 years and 68% after 4 years.

4.1.14

Statements from the patient experts and clinical specialists asserted that a greater number of healthcare scientists will be needed in order to treat OSAHS, and that there are currently insufficient resources and training available to treat OSAHS in primary care.

4.2

Cost effectiveness

4.2.1

Four published economic evaluations were identified by the Assessment Group, all of which compared CPAP with a ’do nothing’ alternative. The resulting base-case incremental cost-effectiveness ratios (ICERs) were (1) £1688.23 per quality-adjusted life year (QALY) gained from a third party payer perspective and £158.05 per QALY gained from a societal perspective; (2)£5,347.62 per QALY gained over a 5-year time horizon and £3,359.18 per QALY gained for a lifetime time horizon; (3) £8300 per QALY gained at 1 year and £5200 per QALY gained at 2 years; (4) £4,654.77 per QALY gained for the high-cost estimate and Can £1,671.81 per QALY gained for the low-cost estimate.

4.2.2

Fisher & Paykel and Respironics did not submit their own cost-effectiveness analyses. The Assessment Group therefore evaluated only the economic model submitted by ResMed.

4.2.3

ResMed submitted a cost–utility analysis comparing fixed and auto-titrating CPAP devices with a ‘do nothing’ alternative. The model included people with severe OSAHS and the following health states: event free, cardiovascular event, stroke and road traffic accident. People remained in one of the four health states for 1 year before moving to another state. People who had a cardiovascular event or road traffic accident in one year could have a stroke, cardiovascular event or road traffic accident in a later year. However, people who had experienced a stroke were considered unable to drive and therefore could not experience a subsequent road traffic accident. There was no limit to the total number of events each person could undergo in subsequent years. No complications or symptoms were included, and the model had a 14-year time horizon and was from a UK NHS perspective. Utility estimates were obtained from a published study reporting EQ-5D data. The results of the ResMed model showed that both fixed and auto-titrating CPAP dominated ‘non-treatment’ after a minimum of 2 years of treatment.

4.2.4

The Assessment Group provided a cost–utility analysis comparing CPAP with dental devices and with conservative management. The base-case model included people with moderate OSAHS and included the following health states: OSAHS, OSAHS post-coronary heart disease (CHD), OSAHS post-stroke, and death. People remained in one of the health states for 1 year, and could remain in the initial OSAHS state until death or until they experience CHD or stroke, which could result in disability. The OSAHS post CHD and OSAHS post-stroke states incorporate the increased mortality and morbidity associated with having these events. People could remain in the post-CHD state or in the post stroke state until death. No complications or symptoms were included, and the model had a lifetime time horizon and was from a UK NHS perspective.

4.2.5

Health effects in the model included decreased utility associated with ESS score, cardiovascular events, stroke and road traffic accidents, and effects on mortality associated with cardiovascular events, stroke and road traffic accidents. The Assessment Group developed its own mapping algorithm to transform ESS data into utility scores. For this, the Group used three sets of individual patient data that measured ESS score and SF-36 and/or EQ-5D profile in the same people. A simple linear regression model was fitted to predict absolute utility scores from absolute ESS scores, controlling for baseline utility and baseline ESS scores for CPAP. This utility mapping was then applied to data on mean difference in ESS score between CPAP and placebo (23 studies) and between CPAP and dental devices (6 studies).

4.2.6

The base-case ICERs for men were £2000 per QALY gained for dental devices compared with conservative management, and £3899 per QALY gained for CPAP compared with dental devices. The ICERs for women were similar. The Assessment Group undertook a series of subgroup analyses based on baseline severity of OSAHS as measured by the ESS. This analysis excluded road traffic accidents and cardiovascular events. The resulting ICERs for CPAP compared with conservative management were £20,585 per QALY gained for mild OSAHS, £9391 per QALY gained for moderate OSAHS and £4413 per QALY gained for severe OSAHS. Dental devices were extendedly dominated by CPAP for moderate OSAHS, and there were no data for dental devices for mild or severe OSAHS.

4.2.7

In the Assessment Group’s one-way sensitivity analyses, two parameters were found to affect the ICERs: changing the lifespan of the device from 7 to 5 years and using an auto-titrating device and a humidifier instead of a fixed-pressure device resulted in an ICER of £16,362 per QALY gained; and excluding cardiovascular events and road traffic accidents resulted in an ICER of approximately £8000 per QALY gained.

4.3

Consideration of the evidence

4.3.1

The Appraisal Committee reviewed the data available on the clinical and cost effectiveness of CPAP, having considered evidence on the nature of the condition and the value placed on the benefits of CPAP by people with obstructive sleep apnoea/hypopnoea syndrome, those who represent them, and clinical specialists. It was also mindful of the need to take account of the effective use of NHS resources.

4.3.2

The Committee sought the opinion of the clinical specialists and patient experts on the impact of OSAHS on people’s lives and on the experience of using CPAP devices. The Committee heard that OSAHS can be a debilitating condition that affects both the individual and their immediate family. It can also have a wider impact through the increased risk of road traffic accidents caused by people with untreated or undiagnosed OSAHS.

4.3.3

The Committee considered the alternative treatment options available for people with OSAHS, namely lifestyle advice, dental devices and surgery. The Committee heard that lifestyle advice to lose weight is often not effective, partly because people severely affected by OSAHS lack the energy to engage in weight loss activities. It also heard that dental devices are uncomfortable and of limited effectiveness, even in people with mild OSAHS. The Committee also discussed the use of surgical procedures to correct adverse craniofacial features associated with OSAHS, and understood that such forms of surgery were not usually considered viable treatment options because of lack of efficacy.

4.3.4

The Committee noted that the clinical effectiveness of CPAP was assessed in RCTs normally by measuring ESS score (self-reported episodes of daytime sleep or dozing). The Committee heard from the clinical specialists that the ESS score is not an ideal clinical outcome measure because it does not cover all effects of OSAHS, and may underestimate the effectiveness of CPAP. However, the Committee was persuaded on the basis of the RCT evidence and statements from the clinical specialists and patient experts that CPAP is associated with considerable reductions in daytime sleepiness compared with placebo or life-style management. The Committee noted that most of the available RCT evidence did not identify a statistically significant reduction in daytime sleepiness for CPAP compared with dental devices. It heard from the clinical specialists that the reason for this could be that dental devices are not normally used for treating severe OSAHS, so such comparisons were likely to be weighted towards the less severe end of the condition, where generally the treatment effects are smaller. The Committee noted that the absolute effect of CPAP increased with increasing severity of OSAHS.

4.3.5

The Committee reviewed the evidence on the impact of CPAP on quality of life. The Committee noted that most of the available evidence did not identify a statistically significant difference in favour of CPAP. However, the Committee noted that studies that included dimensions specifically related to sleepiness found evidence of improvements in quality of life with CPAP therapy.

4.3.6

The Committee discussed the variable levels of adherence with CPAP therapy. It heard that adherence or under-use can be monitored and that it is routine practice for those under-using a CPAP device to be asked to return it, so that it can be used for another person.

4.3.7

The Committee reviewed the available evidence on the cost effectiveness of CPAP, namely the analyses from one of the manufacturers (ResMed) and from the Assessment Group, and noted that the base-case ICERs in both sets of analyses were below £5000 per QALY gained.

4.3.8

The Committee reviewed the results of the sensitivity analyses available. It understood that there was a lack of conclusive evidence for a beneficial effect of CPAP on blood pressure, and that the effect on cardiovascular events was inferred in the economic model via this effect of lowering of blood pressure. However, the Committee noted that excluding the effect of CPAP on cardiovascular events in the model did not lead to significant changes in the ICER.

4.3.9

The Committee noted that there was a lack of evidence on which to base the lifespan of the device, and that reducing the lifespan of the device from 7 to 5 years increased the ICER considerably in both economic models. However, the Committee was persuaded by the clinical specialists and patient experts that the estimated 7­-year lifespan is plausible.

4.3.10

The Committee considered the regression mapping to predict utility values from ESS scores used in the Assessment Group model. The Committee was concerned that the utility values were not based on clinical trial evidence and also, given the reservations about the ESS, that these utility values are associated with some degree of uncertainty. However, the Committee agreed that in the absence of other plausible utility values, the approach taken by the Assessment Group was appropriate.

4.3.11

The Committee noted that the data on the likely beneficial effect of CPAP on the rate of road traffic accidents came from observational studies and were not consistently supported by the RCT evidence on driving performance, and therefore needed to be treated with caution. Furthermore, it heard from the clinical specialists that people diagnosed with OSAHS but not yet successfully treated are not permitted to drive by the UK Driver and Vehicle Licensing Authority. Therefore, the Committee agreed that it was important also to take into account the sensitivity analyses that excluded road traffic accidents.

4.3.12

The Committee therefore considered the findings of the subgroup analysis for different severity grades of OSAHS that excluded cardiovascular events and road traffic accidents. The Committee noted that the ICERs for moderate and severe OSAHS were below £10,000 per QALY gained. It therefore agreed that for people with moderate or severe OSAHS, CPAP would be an appropriate use of NHS resources and should be recommended as a treatment option. For people with mild OSAHS, the utility gains from using CPAP were lower than for those with moderate or severe OSAHS, which resulted in an ICER of £20,585 per QALY gained in this group of people. The Committee heard from the clinical specialists that usually CPAP was considered not to be appropriate for people with mild symptomatic CPAP, because the inconvenience associated with use of the device would outweigh the benefits in reduction of OSAHS symptoms. Therefore the Committee concluded that other treatment options should be considered first for this group. However, the Committee also heard that there may be people with mild severity grading by ESS who have considerable OSAHS symptoms and therefore could benefit from CPAP treatment. It agreed that, because of the relatively low ICER, CPAP should be available as a treatment option for these people if other options have been carefully considered and are deemed not appropriate or unsuccessful.

4.3.13

The Committee discussed the use of CPAP therapy for children and adolescents with OSAHS. The Committee heard that OSAHS is very rare even among young people who are obese, and that the clinical issues affecting this population are different from the issues encountered in adults. The Committee concluded that the recommendation for CPAP should apply only to adults with OSAHS.

4.3.14

The Committee discussed whether there are important differences between models and makes of CPAP devices, for example between fixed and auto-titrating devices or between those with and without a humidifier. The Committee heard from the clinical specialists and patient experts that the available CPAP devices are broadly similar, and that there is no robust evidence on patient preferences. The Committee therefore concluded that decisions on the make and type of CPAP device to be used should be made on the basis of the requirements of the individual.

<#comment(Section 4, Comment on Section 4: Evidence and Interpretation)#>

5

Implementation

5.1

The Healthcare Commission assesses the performance of NHS organisations in meeting core and developmental standards set by the Department of Health in ‘Standards for better health’ issued in July 2004. The Secretary of State has directed that the NHS provides funding and resources for medicines and treatments that have been recommended by NICE technology appraisals normally within 3 months from the date that NICE publishes the guidance. Core standard C5 states that healthcare organisations should ensure they conform to NICE technology appraisals.

5.2

'Healthcare Standards for Wales’ was issued by the Welsh Assembly Government in May 2005 and provides a framework both for self-assessment by healthcare organisations and for external review and investigation by Healthcare Inspectorate Wales. Standard 12a requires healthcare organisations to ensure that patients and service users are provided with effective treatment and care that conforms to NICE technology appraisal guidance. The Assembly Minister for Health and Social Services issued a Direction in October 2003 which requires local health boards and NHS trusts to make funding available to enable the implementation of NICE technology appraisal guidance, normally within 3 months.

5.3

NICE has developed tools to help organisations implement this guidance (listed below). These are available on our website (www.nice.org.uk/TAXXX). [NICE to amend list as needed at time of publication]

• Slides highlighting key messages for local discussion.
• Local costing template incorporating a costing report to estimate the savings and costs associated with implementation.
• Implementation advice on how to put the guidance into practice and national initiatives that support this locally.
• Audit criteria to monitor local practice.

6

Related NICE guidance

• Radiofrequency ablation of the soft palate for snoring. NICE interventional procedure guidance 124 (2005). Available from: www.nice.org.uk/IPG124

NICE is developing the following guidance (details available from www.nice.org.uk).

• Soft-palate implants for obstructive sleep apnoea. NICE interventional procedure guidance (publication expected December 2007).
• Soft-palate implants for simple snoring. NICE interventional procedure guidance (publication expected December 2007).

7

Proposed date for review of guidance

7.1

The review date for a technology appraisal refers to the month and year in which the Guidance Executive will consider whether the technology should be reviewed. This decision will be taken in the light of information gathered by the Institute, and in consultation with consultees and commentators.

7.2

It is proposed that the guidance on this technology is considered for review in August 2010. The Institute would particularly welcome comment on this proposed date.

Appendix A: Appraisal Committee members, and NICE project team

Appraisal Committee members

The Appraisal Committee is a standing advisory committee of the Institute. Its members are appointed for a 3-year term. A list of the Committee members who took part in the discussions for this appraisal appears below. The Appraisal Committee meets three times a month except in December, when there are no meetings. The Committee membership is split into three branches, each with a chair and vice-chair. Each branch considers its own list of technologies and ongoing topics are not moved between the branches.

Committee members are asked to declare any interests in the technology to be appraised. If it is considered there is a conflict of interest, the member is excluded from participating further in that appraisal.

The minutes of each Appraisal Committee meeting, which include the names of the members who attended and their declarations of interests, are posted on the NICE website.

Professor David Barnett
Professor of Clinical Pharmacology, University of Leicester

Dr David W Black
Director of Public Health, Chesterfield PCT

Mr Brian Buckley
Chairman, Incontact

Professor Mike Campbell
Professor of Medical Statistics, University of Sheffield

Professor David Chadwick
Professor of Neurology, University of Liverpool

Ms Jude Cohen
Special Projects Consultant, UK Council for Psychotherapy

Dr Christine Davey
Senior Researcher, North Yorkshire Alliance R & D Unit

Dr Mike Davies
Consultant Physician, Manchester Royal Infirmary

Mr Richard Devereaux-Phillips
Public Affairs Manager, Medtronic

Dr Rachel A Elliott
Lord Trent Professor of Medicines and Health , the University of Nottingham

Mrs Eleanor Grey
Lay member

Dr Dyfrig Hughes
Senior Research Fellow in Pharmacoeconomics, Centre for the Economics of Health and Policy in Health, University of Wales

Dr Peter Jackson
Clinical Pharmacologist, the University of Sheffield

Professor Peter Jones
Pro Vice Chancellor for Research & Enterprise, Keele University

Ms Rachel Lewis
Nurse Adviser to the Department of Health

Dr Damien Longson
Consultant in Liaison Psychiatry, North Manchester General Hospital

Professor Jonathan Michaels
Professor of Vascular Surgery, University of Sheffield

Dr Katherine Payne
Health Economics Research Fellow, The University of Manchester

Mr Miles Scott
Chief Executive, Bradford Teaching Hospitals NHS Foundation Trust

Professor Andrew Stevens
Chair of Appraisal Committee C

Dr Cathryn Thomas
Senior Lecturer, Department of Primary Care & General Practice, University of Birmingham

NICE project team

Each technology appraisal is assigned to a team consisting of one or more health technology analysts (who act as technical leads for the appraisal), a technical adviser and a project manager.

Helen Tucker
Technical Lead

Dr Elisabeth George
Technical Adviser

Chris Feinmann
Project Manager

Appendix B: Sources of evidence considered by the Committee

The assessment report for this appraisal was prepared by NHS Centre for Reviews and Dissemination/Centre for Health Economics, University of York:

McDaid C et al, The continuous positive airway pressure for the treatment of obstructive sleep apnoea-hypopnoea syndrome: a systematic review and economic analysis, June 2007.

The following organisations accepted the invitation to participate in this appraisal. They were invited to comment on the draft scope, assessment report and the appraisal consultation document (ACD). Organisations listed in I and II were also invited to make written submissions and have the opportunity to appeal against the final appraisal determination.

I Manufacturers/sponsors:

• Fisher & Paykel Healthcare (SleepStyle)
• Respironics UK (REMstar)
• ResMed ( UK) (S8 Series)
• Sunrise Medical (DeVilbiss)
• Tyco Healthcare (G oodKnight 420 series )
• Vital Signs (Breas)

II Professional/specialist and patient/carer groups:

• Association for Respiratory Technology & Physiology
• British Sleep Society
• British Society of Dental Sleep Medicine
• British Thoracic Society
• Cochrane Airways Group
• General Practice Airways Group
• Royal College of Anaesthetists
• Royal College of General Practitioners
• Royal College of Nursing
• Royal College of Physicians
• Royal College of Physicians of Edinburgh
• Royal College of Surgeons
• Royal Society of Medicine – Sleep Medicine Section
• Sleep Apnoea Trust
• Welsh Assembly Government

III Commentator organisations (without the right of appeal):

• Department of Health, Social Services and Public Safety for Northern Ireland
• NHS Quality Improvement Scotland

The following individuals were selected from clinical specialist and patient advocate nominations from the non-manufacturer/sponsor consultees and commentators. They participated in the Appraisal Committee discussions and provided evidence to inform the Appraisal Committee’s deliberations. They gave their expert personal view on continuous positive airway pressure for the treatment of obstructive sleep apnoea/hypopnoea syndrome by attending the initial Committee discussion and/or providing written evidence to the Committee. They are invited to comment on the ACD.

Professor John Gibson
Professor of Respiratory Medicine nominated by British Thoracic Society – clinical expert

Professor John Stradling
Professor of Respiratory Medicine nominated by the Sleep Apnoea Trust – clinical expert

Mr Frank Govan
Chair of Trustees, Sleep Apnoea Trust nominated by the Sleep Apnoea Trust – patient expert

Mr Rob Holt
nominated by the Sleep Apnoea Trust – patient expert