Scottish Health Technologies Group: Response to query on Scottish patient pathways for surgical interventions for morbid obesity

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Scottish Health Technologies Group: Response to query on Scottish patient pathways for surgical interventions for morbid obesity International HTA evidence presented at the April 2008 meeting of SHTG indicated that bariatic surgery is a clinically and cost effective intervention for patients with morbid obesity 1,2. However, there was concern among the group that, while the actual techniques may be cost effective, existing evidence did not address the complete patient pathway or account for the pre- and postoperative care that are lengthy and complicated. Specifically, members queried whether existing cost effectiveness evidence included the costs associated with plastic surgery undertaken after bariatric surgery, eg body contouring and removal of excess skin. Consequently, NHS QIS has undertaken scoping work to find out more information about the patient pathways for bariatric surgery in Scotland, addressing a number of questions outlined below: At what point is bariatric surgery recommended on the patient pathway? NICE clinical guidelines and recent international HTAs generally recommended bariatric surgery as a treatment option for obese patients with a BMI 35 kg/m 2 and other risk factors or a BMI 40 kg/m 2 after all appropriate non-surgical measures have been tried and failed 1-3. Are there agreed patient pathways for bariatric surgery in Scotland? No nationally agreed patient pathways currently exist for patients undergoing bariatric surgery in Scotland. Patient pathways are currently under development in the two main bariatric centres in Aberdeen and Glasgow. These include 12 month follow-up periods but neither currently includes plastic surgery followup 4,5. However, an exceptional referral patient pathway exists within the Scottish plastic surgery guidelines to enable patients who have achieved significant weight-loss to be considered for plastic surgeries 6. Grampian routinely offers two plastic surgery procedures after bariatric surgery if clients have maintained their weight-loss at two years and have a BMI of <30. The Glasgow centre does not routinely offer plastic surgery after bariatric surgery. Bariatric surgery query 030908 (web version).doc 1

Does the existing cost effectiveness evidence include estimates for preand post-operative care and any follow-up plastic surgery? Available cost effectiveness evidence is based largely on a technology assessment report by Clegg et al that built an economic model with a time horizon of 20 years. This model reports favourable cost effectiveness ratios associated with bariatric surgery with cost per QALY estimates ranging between 6,289 10,237 and authors concluding that the economic case for surgery is strong 7. The Clegg et al model was central in informing the broadly similar conclusions reached in the more recent Canadian and New Zealand HTAs presented to SHTG in April 1,2. The Clegg et al model did include pre- and post-operative follow-up care (see Appendix 1). The base case also assumed (based on expert opinion) that 10% of patients in the gastric bypass group underwent apronectomy at three years (cost estimate 1,058 per procedure) 7. However, the accuracy and comprehensiveness of the Clegg et al model have been questioned. The 2006 NICE clinical guideline on obesity noted that many of the assumptions underpinning the Clegg et al model do not reflect current practice. Specifically, it was indicated that the pre- and post-operative support contacts and complication rates exaggerate current practice 3. It is not clear if this criticism also referred to the apronectomy rates included in the model. The NICE clinical guideline suggests that revising the assumptions is likely to reduce the incremental cost effectiveness ratio 3. In addition, in the more recent international HTA evidence, the Canadian authors explicitly noted that their review did not address adjustments after surgery and the New Zealand team that all available economic evidence was limited due to the exclusion of the costs of plastic surgery post-procedure 1,2. The patient pathway underpinning the Clegg et al model appears to be more extensive than that outlined within the Grampian and Glasgow patient pathways (See Appendix 1). This would suggest that the favourable cost effectiveness ratios reported are likely to generalise to Scotland. However, the impact on cost effectiveness associated with plastic surgeries undertaken after bariatric procedures is less clear. Are there any Scottish based cost estimates for bariatric surgery and related pre- and post-operative care? Current activity in Scotland for bariatric surgery is approximately 70 cases per year 5. Current cost estimates for procedures range between 5,000 8,500 5. Discussion with experts indicated that there is no recent Scottish cost effectiveness evidence available. Efforts to produce this have been hampered by the absence of procedure codes for bariatric surgery and by the difficulty in linking patient records to track their resource utilisation throughout the complete patient pathway. Bariatric surgery query 030908 (web version).doc 2

Is there any ongoing or planned research that will assist in addressing these questions? There are a number of proposed or ongoing projects underway, expected to report in the near future, that should assist in contextualising the existing evidence base to the Scottish setting (see Appendix 2). A SIGN guideline on obesity is currently being developed and is expected to be published in November 2009 8. This guideline will address evidence relating to: the effectiveness of bariatric surgery in patients in various BMI ranges, factors influencing safety and efficacy of surgery that should be assessed at referral, and the types of follow-up most beneficial to patients following bariatric surgery. In addition, multiple initiatives aiming to develop detailed patient pathways for bariatric surgery and gain consensus around them are underway (SEAT Group, Scottish Bariatric Surgery Group, Robert Gordon University and the Scottish Plastic Surgery Task & Finish Group). Further, new research updating the previous Clegg et al report is underway 9 and research to develop hierarchies of cost effectiveness evidence to inform patient selection criteria proposed (NIHR HTA Programme and Aberdeen University/NHS Grampian). In summary, available international and UK-based evidence generalises to Scottish patient pathways with no reason to change current guidance that bariatric surgery is clinically and cost effective. What options might policy makers consider now to further address this query? A number of options are available to SHTG to progress their queries further, including: awaiting the outcome of ongoing research efforts instructing NHS QIS to feedback their queries and liaise with the groups involved in progressing bariatric surgery agendas commissioning new research to investigate these issues further in Scotland. Bariatric surgery query 030908 (web version).doc 3

References 1. Boudreau R, Hodgson A. Laparoscopic adjustable gastric banding for weight loss in obese adults: clinical and economic review. 2007 [cited 2008 Sept 1]; Available from: http://cadth.ca/media/pdf/l3009_lagb_tr_e.pdf. 2. Stephenson M, Hogan S. The safety, effectiveness and cost effectiveness of surgical and non-surgical interventions for patients with morbid obesity. 2007 [cited 2008 Sept 1]; Available from: http://nzhta.chmeds.ac.nz/publications/morbidob07.pdf. 3. National Institute for Health and Clinical Excellence. Obesity: guidance on the prevention, identification, assessment and management of overweight and obesity in adults and children. NICE clinical guideline 43. 2006 [cited 2008 Sept 1]; Available from: http://www.nice.org.uk/nicemedia/pdf/cg43niceguideline.pdf. 4. F Sim, U Kulkarni, D Bruce. Outline care pathway for bariatric surgery patients in NHS Grampian. Aberdeen: Robert Gordon University. Centre for Obesity Research and Epidemiology (CORE); 2007. [In confidence] 5. South East and Tayside (SEAT) regional planning group. Proposals to set up a bariatric surgical service across SEAT. Appendix 1 - Suggested patient pathway for bariatric surgery (developed from the Glasgow Weight Management Service). 2006. 6. Scottish Executive Health Department. Centre for Change and Innovation. Plastic surgery: exceptional referrals patient pathway. 2005 [cited 2008 Sept 1]; Available from: http://www.pathways.scot.nhs.uk/plastic%20surgery/plastics%20exceptiona l%20referrals%20apr05.pdf. 7. Clegg AJ, Colquitt J, Sidhu MK, Royle P, Loveman E, Walker A. The clinical effectiveness and cost-effectiveness of surgery for people with morbid obesity: a systematic review and economic evaluation. 2002 [cited 2008 Sept 1]; Available from: http://www.ncchta.org/fullmono/mon612.pdf. 8. Scottish Intercollegiate Guidelines Network. Obesity: national clinical guideline. In press 2009. 9. Southampton Health Technology Assessment Centre (SHTAC). The clinicaleffectiveness and cost-effectiveness of bariatric surgery for obesity: a systematic review and economic evaluation. In press 2009 [project details cited 2008 Sept 1]; Available from: http://www.ncchta.org/project/1742.asp. Bariatric surgery query 030908 (web version).doc 4

Additional reading National Institute for Health and Clinical Excellence. Guidance on the use of surgery to aid weight reduction for people with morbid obesity. London: NICE; 2002. Technology Appraisal (TA46). Scottish Executive Health Department. Scottish Medical and Scientific Advisory Committee (SMASAC). Review of bariatric surgical services in Scotland. 2004 [cited 2008 Sept 1]; Available from: http://www.scotland.gov.uk/resource/doc/35596/0012569.pdf. Robertson A, Douglas S, Waugh N. Gastric surgery for obesity. Aberdeen: Scottish Health Purchasing Information Centre (SHPIC); 1998. Bariatric surgery query 030908 (web version).doc 5

Appendix 1: Pre and post-operative care included in the Clegg et al model, Grampian and Glasgow patient pathways Pre- and postoperative care Pre-operative care elements Clegg et al Grampian pathway 4* model 2002 7 7 outpatient visits Education session 4 dietetic Psychological consultations assessment Psychologist Surgical assessment. session. Glasgow pathway 5 Information session Psychological assessment Surgical assessment 2 dietetic assessments Physiotherapy review Monthly pre-surgery group. Post-operative care elements Month 1: 6 GP visits 2 practice nurse visits 4 district nurse visits. Year 1: 4 outpatient clinics 12 community dietician visits 2 psychological consultation. Month 1: 2 dietetic review visits Band fill and adjustment (gastric band patients). Year 1: 4 dietetic review visits 2 medical clinic reviews Surgical follow-up. Monthly support groups (not compulsory) Psychological followup if indicated. Year 1: 9 dietetic review sessions. Year 2: 4 outpatient clinics 4 community dietician visits 2 psychological consultation. Year 2: 4 dietetic review sessions. Year 3 and thereafter: 2 outpatient visits 2 community dietician visits 1 psychological consultation. Thereafter: 6 monthly dietetic review visits 6 monthly medical clinic review for nutritional screening. Year 3: 1-2 dietetic review sessions. 10% apronectomy 5% incisional hernia repair. * Please do not quote this work without the authors permission. Bariatric surgery query 030908 (web version).doc 6

Appendix 2: work on the topic Organisation Project Stage SGHD, Obesity health improvement strategy and Autumn 2008 Patient Strategy Division healthy weight strategy paper. SIGN Obesity guideline national meeting. October 2008 GCI Health on behalf of the Scottish Bariatric Surgery Group Robert Gordon University Centre for Obesity Research and Epidemiology Obesity guideline publication. Press launch following the SIGN obesity guideline national meeting to highlight the gap between need and provision of bariatric surgery services in Scotland. Outline care pathway for bariatric surgery patients in NHS Grampian. Bariatric patient resource utilisation (12 months from initial referral). Developing clinical standards. November 2009 27 October 2008 October 2008 NIHR HTA Programme, Wessex Institute, University of Southampton South East and Tayside (SEAT) Planning Group Scottish Bariatric Surgery Group SGHD, Plastic Surgery Task and Finish Group NHS Grampian and Scottish Bariatric Surgery Group University of Aberdeen The clinical and cost-effectiveness of bariatric surgery for obesity: a systematic review and economic evaluation. Business case being developed to support a proposed bariatric surgical service in the SEAT region. Working Group on cost-effectiveness and development of a patient registry Developing patient pathways for patients referred for plastic surgery following bariatric procedures. Approach to the Scottish Public Health Network to discuss the place of surgery in the spectrum of interventions to prevent or correct obesity. Specifically, aim to reach a Scottish consensus on; number of patients a year to plan for, how many hospitals should provide surgery, and development of long-term audit systems to monitor outcomes. Development of hierarchy of costeffectiveness evidence to inform surgery selection criteria. Scoping Mid-2009 Proposal Scoping Bariatric surgery query 030908 (web version).doc 7