OBJECTIVES:  The objective of the study was to perform a Budget Impact Analysis (BIA) assessing the introduction of Cosyrel for the treatment of hypertension into the Italian market. Cosyrel is a single pill combination of a beta-blocker (bisoprolol fumarate) and an angiotensin-converting enzyme inhibitor (perindopril arginine) indicated as substitution therapy for the treatment of hypertension and/or stable coronary artery and/or stable chronic heart failure with reduced systolic left ventricular function in adult patients adequately controlled with bisoprolol and perindopril. METHODS:  BIA compared two different scenarios: Scenario 1 without a dual fixed combination therapy vs. Scenario 2 with the introduction of Cosyrel. Population data were obtained from IMS database. The time horizon was 3 years from the introduction of Cosyrel. Total number of patients was the same for the two scenarios, as the model allows only the switch of patients from monotherapy (bisoprolol) or dual combination (perindopril+bisoprolol) to Cosyrel. The perspective of the Italian National Healthcare Service was considered. RESULTS: The study showed that the introduction of Cosyrel leads to a reduction in the quantity of packages (13.369.949, 11.175.633 and 8.213.623 in Scenario 1 and 11.815.421, 8.615.834 and 5.604.864 in Scenario 2, respectively in year 1, 2 and 3). At a cost of 6,27 €/month, the introduction of Cosyrel generates savings for the Italian NHS of 512.994, 844.733 and 860.890 € respectively in year 1, 2 and 3 over a total expenditure of 43.238.583, 36.689.857 and 27.064.154 € related to year 1, 2 and 3 in the first scenario. CONCLUSIONS:  The present study indicates that the introduction of Cosyrel generates savings for the Italian NHS, also improving 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.