OBJECTIVES:  To compare the cost and effectiveness of LacTest® versus other diagnostic procedures available to identify lactose intolerance using the perspective of Spanish National Health System. METHODS: A cost-effectiveness analysis was carried out using a decision tree comparing LacTest® with the hydrogen breath test, the capillary blood glucose test and the intestinal biopsy. Data on the effectiveness of each diagnostic procedure, expressed as the sensitivity of each test or the proportion of true positives identified by the test for all patients, were taken from the clinical results of the EUDRA study. The use of healthcare resources associated with the tests and their costs were obtained from literature review. Costs considered included diagnostic tests, laboratory tests, physician visits and time of healthcare personnel. The time horizon of the analysis was one year. All costs are expressed in Euro 2012. Results were expressed as the effectiveness and costs of LacTest® compared with those of the other diagnostic procedures. RESULTS: The proportion of diagnosed patients, as measured by sensitivity, was higher for LacTest® with 0.991 than for the other diagnostic procedures with values of 0.953 for the intestinal biopsy, 0.785 for the hydrogen breath test and 0.748 for the capillary blood glucose test, respectively. Direct healthcare costs per patient were €187 with LacTest®, €143 with the hydrogen breath test, €140 with the capillary blood glucose test and € 458 for the intestinal biopsy. CONCLUSIONS: The results indicate that LacTest® is demonstrating a higher sensitivity in the diagnosis of new cases of hypolactasia compared with the other tests in this study. LacTest® showed to be the dominant option compared with the intestinal biopsy. When compared with the hydrogen breath test and the capillary blood glucose test, LacTest® showed to be more effective at an incremental cost of €44 and €40, respectively.