Budget impact analysis of empagliflozin for the treatment of type 2 diabetes in Italy

BACKGROUND: Empagliflozin is the most recent molecule in the SGLT-2i class, new antidiabetic drugs that reduce renal glucose absorption by determining the excretion in the urine. The high prevalence of T2D, the chronicity of the condition and the severe economic and social burden caused by the disease, impose the need for a careful health economic assessment on each therapeutic innovation in this area. AIM: The aim of this study was to assess the budget impact of adopting empagliflozin in the diabetic population currently treated with sulfonylureas and potentially eligible for treatment with SGLT-2i. METHODS: The budget impact analysis was conducted from the perspective of the Italian National Health Service over a period of three years, through an analytic model developed in MS Excel. The target population was estimated in about 170,000 patients currently treated with sulfonylureas, based on the growth forecasts of the Italian population, epidemiological estimates and drug-use information available in the literature on diabetes in Italy. In the base case was assumed a replacement rate of sulfonylureas equal to 10%, 20% and 30% respectively at the first, second and third year of analysis. A scenario analysis was considered assuming a constant uptake of 100% since the first year. The following direct healthcare costs were considered: 1) acquisition of antidiabetic drugs as the main therapy and as rescue therapy; 2) self-monitoring of blood glucose; 3) management of severe hypoglycemic events and 4) management of major cardiovascular events. Clinical effectiveness data was based on the published literature and unit costs were derived from current prices and tariffs. Oneway sensitivity analysis was developed to assess the impact of input’s uncertainty on the overall result. RESULTS: The base case analysis presented a substantially neutral impact on the budget. The 3-year cumulative impact was -454.337 €, corresponding to a 0.1% saving. This means that the replacement of sulphonylureas with empagliflozin determines an increase in acquisition costs of drugs, which is entirely offset by the reduction in costs of self-monitoring of blood glucose, management of hypoglycemic events and cardiovascular events. The scenario analysis, based on the assumption of a full substitution of sulphonylureas with empagliflozin at the first year, yielded a more enhanced savings. The cumulative impact was -2.269.517 €, corresponding to a 0.6% saving. CONCLUSIONS: The present study shows that the replacement of sulfonylureas (a class of generic products) with empagliflozin, motivated by the advantageous efficacy and safety profile, can take place optimizing healthcare expenditure for the management of DT2. [In Italian]