Cost-effectiveness of the carbon-13 urea breath test for the detection of Helicobacter pylori: an economic analysis.
OBJECTIVE
This analysis aimed to evaluate the cost-effectiveness of various testing strategies for Helicobacter pylori in patients with uninvestigated dyspepsia and to calculate the budgetary impact of these tests for the province of Ontario.


METHODS
Data on the sensitivity and specificity were obtained from the clinical evidence-based analysis. Resource items were obtained from expert opinion, and costs were applied on the basis of published sources as well as expert opinion.


METHODS
A decision analytic model was constructed to compare the costs and outcomes (false-positive results, false-negative results, and misdiagnoses avoided) of the carbon-13 (¹³C) urea breath test (UBT), enzyme-linked immunosorbent assay (ELISA) serology test, and a 2-step strategy of an ELISA serology test and a confirmatory ¹³C UBT based on the sensitivity and specificity of the tests and prevalence estimates.


RESULTS
The 2-step strategy is more costly and more effective than the ELISA serology test and results in $210 per misdiagnosis case avoided. The ¹³C UBT is dominated by the 2-step strategy, i.e., it is more costly and less effective. The budget impact analysis indicates that it will cost $7.9 million more to test a volume of 129,307 patients with the ¹³C UBT than with ELISA serology, and $4.7 million more to test these patients with the 2-step strategy.


CONCLUSIONS
The clinical studies that were pooled varied in the technique used to perform the breath test and in reference standards used to make comparisons with the breath test. However, these parameters were varied in a sensitivity analysis. The economic model was designed to consider intermediate outcomes only (i.e., misdiagnosed cases) and was not a complete model with final patient outcomes (e.g., quality-adjusted life years).


CONCLUSIONS
Results indicate that the 2-step strategy could be economically attractive for the testing of H. pylori. However, testing with the 2-step strategy will cost the Ministry of Health and Long-Term Care $4.7 million more than with the ELISA serology test.
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L
Masucci
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G
Blackhouse
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R
Goeree
D001944:Breath Tests / Q000379:methods; D002247:Carbon Isotopes; D003362:Cost-Benefit Analysis; D003951:Diagnostic Errors / Q000191:economics; D004797:Enzyme-Linked Immunosorbent Assay / Q000191:economics / Q000592:standards; D016481:Helicobacter Infections / Q000175:diagnosis* / Q000191:economics; D016480:Helicobacter pylori / Q000302:isolation & purification*; D006801:Humans; D008403:Mass Screening / Q000191:economics* / Q000592:standards*; D009864:Ontario / Q000453:epidemiology; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014508:Urea / Q000191:economics
D002247:Carbon Isotopes; D014508:Urea