Budget impact analysis of PCSK9 inhibitors costs from a community payers' perspective in Apulia, Italy

Introduction: Despite established clinical efficacy of PCSK9 inhibitors (PCSK9i) in reducing cardiovascular events, their cost still represents a big matter of debate. We therefore sought to estimate possible impact of PCSK9i therapy from a community taxpayers' perspective with a budget impact analysis based on data coming from two randomised trials (FOURIER (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk), ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab)). Methods: The analysis focused on Apulia region, South-Eastern Italy (4 million inhabitants). Costs per cardiovascular event saved were calculated from randomised trials data and annually indexed per Apulia's inhabitants. Results: On the base of actual cost in Apulia, individual costs per saved adverse event ranged from €0.12 to €0.78, with just €1 annually spent per Apulia's inhabitant, 2-8.3 events could be avoided thanks to the use of PCSK9i. When considering high-risk subgroups (baseline cholesterol levels >100 mg/dL, multivessel coronary disease), the annual cost per Apulia's inhabitant for one death avoided was more than halved to €0.19 and the cost for a saved major adverse cardiovascular event was €0.07. With €1 annually spent per Apulia's inhabitant, 10.9-15 major adverse cardiovascular events and 5.3 deaths could be saved. Conclusions: When considered from a large taxpayers' community perspective, relevant costs per cardiovascular event saved with PCSK9i may turn into very small individual costs per year. The selection of high-risk subgroups may further reduce individual costs