Immediate endoscopy or initial Helicobacter pylori serological testing for suspected peptic ulcer disease: estimating cost-effectiveness using decision analysis Fendrick A M, Chernew M E, Hirth R A, Bloom B S 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. Health technology Serological testing and endoscopy with biopsy for suspected peptic ulcer disease. Type of intervention Diagnosis. Economic study type Cost-effectiveness analysis. Study population Hypothetical patients, not currently taking non-steroidal anti-inflammatory drugs (NSAIDs), with symptoms suggestive of peptic ulcer disease. Setting Hospital. The economic study was performed in the USA. Dates to which data relate Effectiveness data were extracted from published studies dated 1989-1994 and unpublished data from 1994. Dates for the cost estimates used were not stated. Source of effectiveness data Effectiveness data were derived from a review of previously completed studies and estimates Modelling Expected net benefits and costs were derived using a decision tree model. Outcomes assessed in the review Ulcer healing and eradication rates. Study designs and other criteria for inclusion in the review English language studies were included. Sources searched to identify primary studies Page: 1 / 5
MEDLINE andbibliographies of retrieved database articles were searched. Handsearches of peer-reviewed general medicine, infectious disease and gastroenterology literature and unpublished data from the National Institutes of Health Consensus Development Meeting were carried out. Criteria used to ensure the validity of primary studies Methods used to judge relevance and validity, and for extracting data Number of primary studies included Methods of combining primary studies Investigation of differences between primary studies Results of the review Clinical estimates from the review were (base case, range): active ulcer disease (20%, 5-30); H. pylori infection ulcer present (95%, 75-95); H. pylori infection ulcer absent (50%, 20-60); ulcer healing rate after anti-secretory therapy (75%, 50-90); H. pylori eradication after antibiotic course (includes compliance) (80%, 50-90); recurrent symptom rate, active ulcer (90%, 50-90); recurrent symptom rate, healed ulcer (10%, 0-30); recurrent symptoms, no ulcer (30%/year, 10-70); ulcer recurrence, H. pylori infection (2.7%/100 patient months. 2.0-6.6); ulcer recurrence, no infection (0.6%/100 patient months, 0.1-2.0); serious antibiotic complication per course (0.5%, 0.1-1.0); qualitative H.pylori serology test sensitivity (0.95, 0.5-1.0) and qualitative H.pylori serology specificity (0.95, 0.5-1.0). These data formed the principal input parameters of the decision tree. Page: 2 / 5
Methods used to derive estimates of effectiveness Authors' assumptions were also used to derive effectiveness estimates. Estimates of effectiveness and key assumptions Endoscopy was assumed to be a perfect test to diagnose ulcer disease and was presumed to have no associated adverse events. Also ulcer recurrence, not associated with NSAID use was related to H. pylori status and concurrent use of antisecretory therapy. Spontaneous ulcer development was assumed not to occur in patients whose initial symptomswere secondary to non-ulcer causes. Measure of benefits used in the economic analysis The benefit measure was ulcers cured. Direct costs Quantities and costs were analysed separately. Only direct provider/purchaser costs were considered. Actual payments, not charges, for ambulatory services, inpatient care and physician fees were obtained from a large private third-party payer in the Eastern United States. The national average of charges allowed by the Health Care Financing Administration for Medicare reimbursement was used to determine the lower bound of cost estimates. The price date is unknown. Statistical analysis of costs Not performed. Indirect Costs Not measured. Currency US dollars ($). Sensitivity analysis A sensitivity analysis was carried out to evaluate the effect of variations in clinical probabilities and cost estimates on results. Only those input values that were likely to have an impact on the cost-effectiveness of the immediate endoscopy strategy or initial non-invasive management were investigated. Estimated benefits used in the economic analysis Ulcer healing rate after anti-secretory therapy was 75% and H. pylori eradication after antibiotic course (includes compliance) was 80%. Cost results Cost estimates were: endoscopy cost, $1,180; biopsy for H. pylori, $210; anti-secretory therapy - 6 week, full dose, $160; Page: 3 / 5
maintenance anti-secretory therapy, $45 per month; antibiotic course including adverse events, $30; qualitative H. pylori serology test, $20; urea breath test, $200; physician office visit, $39; hospitalisation for ulcer complication, no surgery, $7,095; hospitalisation for ulcer complication, surgery, $24,081. Synthesis of costs and benefits The non-invasive strategy of empiric treatment and serology testing costs $4,481 per ulcer cured and the immediate endoscopy strategy was $8,045 per ulcer cured. The non-invasive strategy became less favourable as the cost of endoscopy fell, or as the probability of recurrent symptoms rose, in patients initially managed without endoscopy. Endoscopy costs ($1,180 in the base case) must fall below $500 for the cost-effectiveness ratios of both strategies to become equivalent. The cost-effectiveness of non-invasive management was unchanged if biopsy was replaced by less expensive CLO test. Although the cost-effectiveness ratios included antibiotic related adverse events, the analysis did not include the non- drug costs of over prescribing antibiotics which in theory increases the likelihood of H. pylori resistance. Authors' conclusions The study supports the continued practice of initial non-invasive management of patients with symptoms suggestive of peptic ulcer disease, but achieves the benefits of H pylori eradication through the use of serologic testing to guide antibiotic use. CRD COMMENTARY - Selection of comparators A justification was given for the comparator used (empiric anti-secretory theory), which has been widely recommended for the initial management of patients presenting with presumed peptic ulcer disease. You, as a user of this database, should consider whether this is an appropriate comparator in your own setting. Validity of estimate of measure of benefit The estimates of benefit were derived from a review of studies. It is not known whether this review was systematic as specific details of the sources used and the overview were not reported. The assumptions made (for example, that endoscopy is not associated with adverse events) may have influenced the results in favour of endoscopy. Validity of estimate of costs Sufficient details were given of the source and nature of the costs, but no price date was reported. Costs were only from the perspective of the purchaser/provider and excluded costs experienced by others in society such as patients. Other issues The cost data from one large third party payer in the Eastern USA, are unlikely to be generalisable to other settings or countries, although the authors recognised the potential for geographic variation in the US and used the national average of charges allowed by the Health Care Financing Administration for Medicare reimbursement to determine the lower bounds for sensitivity analysis. Source of funding None stated. Page: 4 / 5
Powered by TCPDF (www.tcpdf.org) Bibliographic details Fendrick A M, Chernew M E, Hirth R A, Bloom B S. Immediate endoscopy or initial Helicobacter pylori serological testing for suspected peptic ulcer disease: estimating cost-effectiveness using decision analysis. Yale Journal of Biology and Medicine 1996; 69(2): 187-195 PubMedID 9112750 Indexing Status Subject indexing assigned by NLM MeSH Computer Simulation; Cost-Benefit Analysis /methods; Endoscopy, Gastrointestinal /economics; Helicobacter Infections /diagnosis /drug therapy; Helicobacter pylori /immunology; Humans; Peptic Ulcer /diagnosis /drug therapy /microbiology; Serologic Tests /economics AccessionNumber 21997006754 Date bibliographic record published 31/08/1999 Date abstract record published 31/08/1999 Page: 5 / 5