OBJECTIVES: The objective of this study was to perform a Budget Impact Analysis (BIA) assessing the introduction of Tripliam for the treatment of hypertension into the Italian market. Tripliam is the first and only available single-tablet triple combination antihypertensive therapy containing perindopril, amlodipine and indapamide, in line with current evidence-based recommendations for the treatment and management of hypertension. METHODS: The BIA compared two different scenarios: Scenario 1 without a triple fixed combination therapy vs. Scenario 2 with the introduction of Tripliam. Population data were obtained from a Local Project Database by Cegedim. The time horizon considered was 3 years from the introduction of Tripliam. Total number of patients in each of the 3 years was the same for the two Scenarios, because the model allows only the switch of patients from the dual or triple combinations to the fixed dose treatment with Tripliam. The perspective of the Italian National Healthcare Service was considered. RESULTS: The study showed that the introduction of Tripliam leads to a reduction in the quantity of pills taken by patients (7.014.644, 8.743.882 and 10.127.208 in Scenario 1 and 6.469.258, 7.762.951 and 8.657.031 in Scenario 2, respectively in year 1, 2 and 3). With a cost of 11,26 €/month, the introduction of Tripliam generates a very limited incremental costs in year 1 and 2 (respectively 2.977 € and 501 €) and a saving in the third year (3.478 €) over the total expenditure of 45.7, 51.9 and 56.7 respectively in year 1, 2 and 3 in the two scenarios. CONCLUSIONS: The present study indicates that the introduction of Tripliam does not imply additional treatment costs, but improves the adherence to the therapy, thanks to the reduction in the number of pills taken by patients. Better adherence is also linked to a reduction in the number of hospitalizations and related costs.