Abstract
Background: Peptic ulcer bleeding (PUB) is a serious and sometimes fatal condition. The outcome of PUB strongly depends on the risk of rebleeding. A recent multinational placebo-controlled clinical trial (ClinicalTrials.gov identifier: NCT00251979) showed that high-dose intravenous (IV) esomeprazole, when administered after successful endoscopic haemostasis in patients with PUB, is effective in preventing rebleeding. From a policy perspective it is important to assess the cost efficacy of this benefit so as to enable clinicians and payers to make an informed decision regarding the management of PUB.
Objective: Using a decision-tree model, we compared the cost efficacy of highdose IV esomeprazole versus an approach of no-IV proton pump inhibitor for prevention of rebleeding in patients with PUB.
Method: The model adopted a 30-day time horizon and the perspective of third-party payers in the USA and Europe. The main efficacy variable was the number of averted rebleedings. Healthcare resource utilization costs (physician fees, hospitalizations, surgeries, pharmacotherapies) relevant for the management of PUB were also determined. Data for unit costs (prices) were primarily taken from official governmental sources, and data for other model assumptions were retrieved from the original clinical trial and the literature.
After successful endoscopic haemostasis, patients received either highdose IV esomeprazole (80mg infusion over 30 min, then 8mg/hour for 71.5 hours) or no-IV esomeprazole treatment, with both groups receiving oral esomeprazole 40mg once daily from days 4 to 30.
Results: Rebleed rates at 30 days were 7.7% and 13.6%, respectively, for the high-dose IV esomeprazole and no-IV esomeprazole treatment groups (equating to a number needed to treat of 17 in order to prevent one additional patient from rebleeding). In the US setting, the average cost per patient for the high-dose IV esomeprazole strategy was $US14 290 compared with $US14 239 for the no-IV esomeprazole strategy (year 2007 values). For the European setting, Sweden and Spain were used as examples. In the Swedish setting the corresponding respective figures were Swedish kronor (SEK)67 862 ($US9220 at average 2006 interbank exchange rates) and SEK67 807 ($US9212) [year 2006 values]. Incremental cost-effectiveness ratios were $US866 and SEK938 ($US127), respectively, per averted rebleed when using IV esomeprazole. For the Spanish setting, the high-dose IV esomeprazole strategy was dominant (more effective and less costly than the no-IV esomeprazole strategy) [year 2008 values]. All results appeared robust to univariate/threshold sensitivity analysis, with high-dose IV esomeprazole becoming dominant with small variations in assumptions in the US and Swedish settings, while remaining a dominant approach in the Spanish scenario across a broad range of values. Sensitivity variables with prespecified ranges included lengths of stay and per diem assumptions, rebleeding rates and, in some cases, professional fees.
Conclusion: In patients with PUB, high-dose IV esomeprazole after successful endoscopic haemostasis appears to improve outcomes at a modest increase in costs relative to a no-IV esomeprazole strategy from the US and Swedish thirdparty payer perspective. Whereas, in the Spanish setting, the high-dose IV esomeprazole strategy appeared dominant, being more effective and less costly.
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Acknowledgements
Funding for this study was provided by AstraZeneca, who also had an advisory input into the design of the study, collected the data, monitored the conduct of the study, performed the statistical analyses and coordinated the writing of the manuscript with all authors.
Alan Barkun, Ernst Kuipers, Joachim Mössner, Robert Stuart, James Lau, Dennis Jensen and Joseph Sung acted as consultants for AstraZeneca for which they received payment, and E. Nauclér, J. Kilhamn, H. Granstedt, B. Liljas and T. Lind are employees of AstraZeneca.
The authors thank Richard Glover (inScience Communications, Chester, UK) who provided editorial assistance funded by AstraZeneca. All authors contributed to the various drafts and revisions and all approved the final manuscript. AstraZeneca had the opportunity to review the manuscript.
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Barkun, A.N., Adam, V., Sung, J.J.Y. et al. Cost Effectiveness of High-Dose Intravenous Esomeprazole for Peptic Ulcer Bleeding. Pharmacoeconomics 28, 217–230 (2010). https://doi.org/10.2165/11531480-000000000-00000
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DOI: https://doi.org/10.2165/11531480-000000000-00000