OBJECTIVES: To analyze the cost-effectiveness of capsule endoscopy (CE) in diagnosing obscure gastrointestinal bleeding (OGIB) from a health care payer perspective in France, the United Kingdom, and Switzerland. METHODS: Based on clinical trial data, a microsimulation model incorporating first- and second-order Monte Carlo simulation was developed. The model calculates the costs per correctly diagnosed case in patients with OGIB. Sensitivity and specificity for CE and the comparator push enteroscopy (PE) as well as kind and number of other procedures performed prior to diagnosis were evaluated from 7 controlled clinical trials (n=184). Procedure cost, cost of diagnostic failure (false positive/negative diagnosis) were considered and incremental cost-effectiveness ratios dependent on disease prevalence are given. Cost data were estimated from a healthcare payer perspective using the "Assurance Maladie” (France), NHS Reference Cost (UK), and the TARMED (Switzerland). RESULTS: Sensitivity for CE was 89-99% and 27-60% for PE. Specificity values were 90-99% for CE and 50-70% for PE. In all 5 countries, CE was cost saving when the prevalence of the disease was 10% or higher. Most common use for CE is at a prevalence of 50%. Cost savings at a prevalence of 50% are 1508€ (France), 1695€ (UK) and 2240€ (Switzerland). Probabilistic sensitivity analyses approved a high robustness for these results. CONCLUSIONS: CE proved to have a higher effectiveness than PE when diagnosing obscure bleeding. Though procedure costs vary substantially from country to country, incremental analysis shows that the use of CE has a cost-saving potential in all three countries.