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| Cost effectiveness of high-dose intravenous esomeprazole for peptic ulcer bleeding |
| Barkun AN, Adam V, Sung JJ, Kuipers EJ, Mossner J, Jensen D, Stuart R, Lau JY, Naucler E, Kilhamn J, Granstedt H, Liljas B, Lind T |
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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 assessed the cost-effectiveness of high-dose intravenous esomeprazole, versus no intravenous proton-pump inhibitor, to prevent re-bleeding, after successful endoscopic haemostasis, in patients with peptic ulcer bleeding. The authors concluded that high-dose intravenous esomeprazole improved the clinical outcomes, at a modest increase in costs in the USA and Sweden, and a reduction in costs in Spain. The cost-effectiveness methodology was conventional and the uncertainty was investigated, enhancing the validity of the authors’ conclusions. Type of economic evaluation Cost-effectiveness analysis Study objective This study assessed the cost-effectiveness of high-dose intravenous esomeprazole, versus no intravenous proton-pump inhibitor, to prevent re-bleeding, after successful endoscopic haemostasis, in patients with peptic ulcer bleeding. Interventions The strategies were intravenous esomeprazole 80mg infusion over 30 minutes, then 8mg per hour for 71.5 hours (days one to three), and no intravenous esomeprazole. In both strategies, patients received oral esomeprazole 40mg once daily from days four to 30. Location/setting USA, Sweden, and Spain/in-patient and out-patient. Methods Analytical approach:The economic evaluation was carried out alongside a clinical trial and was based on a decision-tree model, with a 30-day horizon. The authors stated that the analysis was carried out from the perspective of the third-party payer.
Effectiveness data:The clinical data came from a published multinational, double-blind, randomised controlled trial (RCT), with 375 patients in the intravenous esomeprazole group and 389 patients in the placebo group (Sung, et al. 2009, see 'Other Publications of Related Interest' below for bibliographic details). The patients were from 16 countries, mainly in Europe, and they were followed-up for 30 days. The probability of re-bleeding was the key endpoint and the primary clinical outcome.
Monetary benefit and utility valuations:Not considered.
Measure of benefit:The proportion of patients with no re-bleeding was the summary benefit measure.
Cost data:The economic analysis included three main cost categories: drugs, hospital services, and physician visits. The resource use data were from the RCT. The US costs for hospital services were from the Nationwide Inpatient Sample database, produced by the Healthcare Cost Utilization Project. Physician costs were from the published literature and other national databases, and drug costs were from average wholesale prices. The Swedish costs for hospital and physician services were based on diagnosis-related group (DRG) schedules from the Swedish Association of Local Authorities and Regions, and drug costs were from Swedish national authorities. The Spanish costs were all from official governmental sources. All costs were in 2007 US dollars ($) for the USA, 2006 Swedish kronor (SEK) for Sweden, and 2008 Euros (EUR) for Spain.
Analysis of uncertainty:One-way sensitivity analyses were carried out on all variables, using published or arbitrary ranges of values. Threshold analyses were also performed, when appropriate. Results Compared with placebo, intravenous esomeprazole increased the proportion with no re-bleeding by 0.0589. It increased the costs by $51 in the USA, resulting in an incremental cost per averted re-bleeding of $866. In Sweden, the increase was SEK 55, leading to an incremental cost per averted re-bleeding of SEK 938. In Spain, intravenous esomeprazole was dominant as it was more effective and less expensive (savings of EUR 70), compared with no intravenous esomeprazole.
The sensitivity analysis confirmed that the base-case findings were robust. The most influential input was the average length of stay for patients without re-bleeding. In Sweden and in the USA, favourable assumptions for this variable meant that intravenous esomeprazole was dominant. Authors' conclusions The authors concluded that high-dose intravenous esomeprazole improved the clinical outcomes, at modest increases in the costs in the USA and Sweden and at reduced costs in Spain. CRD commentary Interventions:The comparators were appropriately selected as they were two possible strategies for this patient population. The choice of placebo as the main comparator was based on the availability of data. A comparison with other oral proton pump inhibitors would have been interesting.
Effectiveness/benefits:An RCT was a valid source for the clinical evidence, due to the strengths of its design. Its multicentre and multinational nature increases the reliability of the data. The inclusion and exclusion criteria were reported, but other details of the trial were not given, as they were published elsewhere. The use of a single trial might limit the transferability of these results to clinical practice. The benefit measure was disease-specific, which might reduce the generalisability of the results, as they can only be compared with those of similar interventions.
Costs:The cost categories were consistent with the viewpoint of the third-party payer. The unit costs were presented for most items, but the resource quantities were not clearly reported. The resource use appears to have been taken from pooled data from the RCT and it is unclear whether these data were relevant for the US context, as this was not included in the trial. This is important as the length of hospital stay was the most influential model input. The data sources appear to have been appropriately selected, as they were conventional official sources for the three countries. The price year was reported for each country, allowing reflation exercises for other time periods. The impact of changes in the economic inputs was tested in the sensitivity analysis.
Analysis and results:The results were clearly presented and an appropriate incremental approach was used to synthesise the projected costs and benefits of the two strategies. The issue of uncertainty was explored, in depth, in a deterministic one-way sensitivity analysis, which considered wide variations in the model inputs and identified the most influential parameters. The results of the sensitivity analyses were clearly reported and discussed, for the each of the three countries. The authors provided a justification for the length of the follow-up, which was clinically relevant for capturing the effects of the preventive strategy. The authors acknowledged some limitations of their analysis, such as the use of a single source for the clinical data and the use of a disease-specific benefit measure. They also justified the exclusion of other outcomes, such as mortality, given the low number of cases in the trial.
Concluding remarks:The cost-effectiveness methodology was conventional and the uncertainty was investigated, enhancing the validity of the authors’ conclusions. Bibliographic details Barkun AN, Adam V, Sung JJ, Kuipers EJ, Mossner J, Jensen D, Stuart R, Lau JY, Naucler E, Kilhamn J, Granstedt H, Liljas B, Lind T. Cost effectiveness of high-dose intravenous esomeprazole for peptic ulcer bleeding. PharmacoEconomics 2010; 28(3): 217-230 Other publications of related interest Sung JJ, Barkun A, Kuipers EJ, et al. Intravenous esomeprazole for prevention of recurrent peptic ulcer bleeding: a randomized controlled trial. Annals of Internal Medicine 2009; 150(7): 455-464. Indexing Status Subject indexing assigned by NLM MeSH Administration, Oral; Anti-Ulcer Agents /administration & Combined Modality Therapy /economics; Cost-Benefit Analysis /methods /statistics & Decision Support Techniques; Esomeprazole /administration & Health Care Costs /statistics & Hemostasis, Endoscopic /economics; Humans; Infusions, Intravenous; Models, Economic; Peptic Ulcer Hemorrhage /drug therapy /economics /prevention & Randomized Controlled Trials as Topic; Spain; Sweden; Treatment Outcome; United States; control /therapy; dosage /economics; dosage /economics; numerical data; numerical data AccessionNumber 22010000758 Date bibliographic record published 10/11/2010 Date abstract record published 19/01/2011 |
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