Budget impact analysis of empagliflozin in T2D patients with a previous cardiovascular disease

Introduction The EMPA-REG OUTCOME study demonstrated that empagliflozin is effective in reducing cardiovascular morbidity and mortality in T2D patients with high risk linked to a previous cardiovascular condition. The objective of this study is the budget impact analysis of the use of empagliflozin in this population in Italy. Methods The analysis was conducted from the cost perspective of the Italian NHS with a 3-year time horizon. The target population, defined as T2D patients with a known cardiovascular disease, was estimated based on epidemiologic and market data. An uptake of empagliflozin growing from 10% to 30% was considered to add up or substitute combinations of metformin, insulin, glitazones and DPP-4. The uptake of 80-100% was considered to substitute sulfonylureas and repaglinide. Costs, including drugs, glycaemia monitoring, management of severe hypoglycaemia events, and cardiovascular and renal events, were estimated based on published literature and current tariffs. Results The target population was estimated in 243,693 in the first year. The incremental cost for drugs (17.6 million Euro) is entirely offset by the savings in glycaemia monitoring (8.1 million Euro), cardiovascular and renal events (8.8 million Euro) and severe hypoglycaemic events (3.1 million Euro), with a net saving of 2.3 million Euro, approximately corresponding to -0.7% of the total expenditure. The cumulative budget impact in the 3 years was 4.9 million Euro (-0.5%). Conclusions The progressive adoption of empagliflozin to treat T2D patients with known cardiovascular disease in Italy, would provide significant clinical benefit without entailing additional expense for the Italian NHS.