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The Stretta procedure versus proton pump inhibitors and laparoscopic Nissen fundoplication in the management of gastroesophageal reflux disease: a cost-effectiveness analysis |
Comay D, Adam V, da Silveira EB, Kennedy W, Mayrand S, Barkun AN |
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Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. CRD summary This study investigated the cost-effectiveness of the endoscopic Stretta procedure compared with the proton-pump inhibitor (PPI) omeprazole and laparoscopic Nissen fundoplication in the management of patients with long-term gastro-oesophageal reflux disease. The authors concluded that PPIs were the cost-effective option when symptom-free months and quality-adjusted life-years were used as benefit measures. In summary, with a few exceptions, the methods were transparent and clearly reported. The authors’ conclusions appear to be appropriate. Type of economic evaluation Cost-effectiveness analysis, cost-utility analysis Study objective The aim was to assess the cost-effectiveness of an endoscopic therapy using the Stretta procedure for long-term gastro-oesophageal reflux disease (GORD). Interventions The Stretta endoscopic procedure was compared with two existing treatments, which were a daily proton-pump inhibitor (PPI) omeprazole 20mg and laparoscopic Nissen fundoplication, for individuals with long-term GORD. When the endoscopic or laparoscopic procedures failed, a daily PPI was used. Methods Analytical approach:A Markov model was used to synthesise the best available data from a variety of sources, including a key prospective study on the Stretta procedure (Corley, et al. 2003, See ‘Other Publications of Related Interest’ below for bibliographic details). The hypothetical cohort analysis was carried out over a five-year period, and the authors stated that the perspective was that of the Canadian Ministry of Health.
Effectiveness data:The clinical data for the effectiveness of the Stretta procedure and its comparators included measures of GORD symptom-free months, GORD relapse rates, stricture rates, and bleeding oesophageal ulcers. A literature review was undertaken, in the MEDLINE database, to retrieve relevant studies published prior to 2004. Review papers and conference abstracts were also handsearched.
Monetary benefit and utility valuations:The published literature provided health state values for four parameters and assumptions were made by the authors for the remaining three parameters.
Measure of benefit:The measures of benefit were symptom-free months and quality-adjusted life-years (QALYs). Discounting was applied at an annual rate of 3%.
Cost data:The direct medical costs were included for all medical treatments, which were surgical and endoscopic procedures, medications, doctors’ consultations, hospitalisations, follow-up procedures, and adverse events. The data for resource costs were abstracted from published studies, publicly available databases, and expert advice. The costs were discounted at 3% and were reported in 2006 Canadian dollars (CAD).
Analysis of uncertainty:The uncertainty was measured in a probabilistic sensitivity analysis with 10,000 Monte Carlo simulations and 95% confidence intervals were generated. The overall uncertainty of the results was expressed in cost-effectiveness acceptability curves. One-way sensitivity analyses were also undertaken on the key parameters. Results The mean discounted QALYs were 4.6381 for the Stretta procedure, 4.6357 for the PPI, and 4.6487 for the laparoscopic procedure. The symptom-free months were 56.77 for the Stretta procedure, 60.00 for the PPI, and 58.32 for the laparoscopic procedure. The discounted mean cost per patient at five years was CAD 3,239 for the Stretta procedure, CAD 2,394 for the PPI, and CAD 7,395 for the laparoscopic procedure.
Using symptom-free months as the effectiveness measure, PPI was the dominant strategy producing more symptom-free months at a lower cost than the other two options. Using QALYs, over five years, the incremental cost per QALY gained for the Stretta procedure compared with the PPI was CAD 352,925 and, for the laparoscopic procedure it was CAD 392,432.
The sensitivity analyses showed that the Stretta procedure yielded a lower cost-effectiveness ratio than the PPI, when symptom-free months were used and the price of the PPI (omeprazole) increased beyond CAD 2.40 per tablet. At a willingness-to-pay of up to CAD 350,000 per QALY gained, the PPI was most likely to be cost-effective. After this and up to CAD 400,000 per QALY gained, the Stretta procedure was more likely to be cost-effective. Authors' conclusions The authors concluded that PPIs were the cost-effective choice for decision-makers, yielding more symptom-free months at a lower cost and having the lowest cost-effectiveness ratio, compared with the other two strategies. CRD commentary Interventions:The interventions were clearly reported, including their dosage and the selection of the interventions was justified. You should decide if these are appropriate strategies in your own setting.
Effectiveness/benefits:The effectiveness data were derived from published sources. A systematic review of the literature for the efficacy data appears to have been undertaken, which should ensure that the clinical estimates were robust. Wide ranges of all values were also tested in the sensitivity analyses. The utility values were derived from the published literature and authors’ assumptions. QALYs were appropriately used as the measure of benefit, but their derivation methods were not reported. Further evidence on the utility values and transition probabilities is required to substantiate the authors’ assumptions.
Costs:The perspective was that of the Canadian Ministry of Health and all the relevant direct medical resources appear to have been analysed, including several adverse events, over five years. Thorough sensitivity analyses were performed to address the uncertainty in the resource and cost data estimates and these were clearly reported.
Analysis and results:The model structure was presented in a diagram along with all the relevant details and modelling assumptions. The authors conducted an appropriate incremental analysis, and the results for the non-dominated strategies were fully and clearly presented. Sensitivity analyses were conducted on the modelling assumptions and parameters, enhancing the generalisability of the findings. The authors’ acknowledged some limitations to their study including its application to only a specific GORD patient group, generalising within different settings, the lack of data on long-term durability of the Stretta procedure beyond three years, and the need for further clinical trial work, which means that this study could be considered to be an exploratory analysis.
Concluding remarks:Despite some limitations to the data estimation due to a lack of available data, the methods were appropriate and comprehensive. The authors’ conclusions appear to be appropriate. Funding Funding received from the Canadian Association of Gastroenterology and the Canadian Institutes of Health Research in association with Pentax Precision Instruments. Bibliographic details Comay D, Adam V, da Silveira EB, Kennedy W, Mayrand S, Barkun AN. The Stretta procedure versus proton pump inhibitors and laparoscopic Nissen fundoplication in the management of gastroesophageal reflux disease: a cost-effectiveness analysis. Canadian Journal of Gastroenterology 2008; 22(6): 552-558 Other publications of related interest Corley DA, Katz P, Wo JM, et al. Improvement of gastroeosophageal reflux symptoms after radiofrequency energy: A randomized, sham-controlled trial. Gastroenterology 2003; 125: 668-676. Indexing Status Subject indexing assigned by NLM MeSH Adult; Fundoplication /economics /methods; Gastroesophageal Reflux /economics /therapy; Health Care Costs; Humans; Laparoscopy /economics /methods; Models, Economic; Proton Pump Inhibitors /economics /therapeutic use; Sensitivity and Specificity AccessionNumber 22008101514 Date bibliographic record published 06/05/2009 Date abstract record published 09/12/2009 |
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