Budget impact analysis of ticagrelor for preventive treatment of patients with acute coronary syndromes Background: Ticagrelor 90 mg BID is indicated for the prevention of thrombotic cardiovascular events in patients with acute coronary syndromes (ACS). Outcomes from the PLATO trial demonstrated that ticagrelor + ASA reduced the rate of a combined endpoint of cardiovascular death, myocardial infarction, or stroke compared to clopidogrel + ASA. Objective: This analysis estimated the budget impact of the use of ticagrelor and clopidogrel for the prevention of thrombotic cardiovascular events in patients with ACS in Italy, based on the PLATO trial results. Methods: A budget-impact model (BIM) was developed to estimate the direct costs up to 12 months after an ACS event from the Italian NHS perspective. Resource utilization (drugs, screening, monitoring, hospitalizations and transfusions) was derived from the PLATO trial. Only direct medical costs were considered. Ex-factory prices (including all discounts) and National Tariffs were used to estimate the costs of drugs and medical resource, respectively. The BIM showed the difference in expenditure and cardiovascular events (myocardial infarction and cardiovascular death -PLATO trial) generated by the base case as calculated for current prescription volumes (ticagrelor 50.6%, clopidogrel 49.4%), and for different prescription volume scenarios (ticagrelor at 75% and 100%). Key variables were tested in the sensitivity analysis. Results: Ticagrelor was associated with a medical cost offset driven by fewer hospitalizations; this partly offsets the incremental drug cost and results in an annual incremental cost per patient of €32.53 (€11,526.03 for ticagrelor and €11,493.50 for clopidogrel). Based on data from the PLATO trial, the incidence of ACS and current prescription volumes in Italy, the BIM predicts that the total number of cardiovascular events and costs are 6,169 and €652.3M, respectively. The BIM predicts that ticagrelor is associated with 550 fewer cardiovascular events at an incremental cost of €8.8M compared to generic clopidogrel. The impact of total annual costs for the Italian NHS would be limited if ticagrelor prescription volumes would be higher. The total cost is predicted to increase by 0.07% if ticagrelor prescription goes up to 75%, while the reduction of cardiovascular events is estimated to be considerably lower than -4.9%. Conclusions: Utilization of ticagrelor, as an alternative to generic clopidogrel to prevent cardiovascular events in patients with ACS, could represent an effective, low-cost treatment option for the Italian NHS. Keywords: ACS, Budget impact, Cost, Ticagrelor IntroduzioneLe sindromi coronariche acute (SCA) costituiscono una delle principali cause di mortalità e morbilità, contribuendo a causare circa il 20% di tutti i decessi (1, 2). Il principale meccanismo fisiopatologico che determina l'evento coronarico acuto è costituito dall'occlusione coronarica aterotrombotica (parziale o completa) che, a sua volta, genera una riduzione...
Budget impact analysis of ticagrelor for preventive treatment of patients with acute coronary syndromes Background: Ticagrelor 90 mg BID is indicated for the prevention of thrombotic cardiovascular events in patients with acute coronary syndromes (ACS). Outcomes from the PLATO trial demonstrated that ticagrelor + ASA reduced the rate of a combined endpoint of cardiovascular death, myocardial infarction, or stroke compared to clopidogrel + ASA. Objective: This analysis estimated the budget impact of the use of ticagrelor and clopidogrel for the prevention of thrombotic cardiovascular events in patients with ACS in Italy, based on the PLATO trial results. Methods: A budget-impact model (BIM) was developed to estimate the direct costs up to 12 months after an ACS event from the Italian NHS perspective. Resource utilization (drugs, screening, monitoring, hospitalizations and transfusions) was derived from the PLATO trial. Only direct medical costs were considered. Ex-factory prices (including all discounts) and National Tariffs were used to estimate the costs of drugs and medical resource, respectively. The BIM showed the difference in expenditure and cardiovascular events (myocardial infarction and cardiovascular death -PLATO trial) generated by the base case as calculated for current prescription volumes (ticagrelor 50.6%, clopidogrel 49.4%), and for different prescription volume scenarios (ticagrelor at 75% and 100%). Key variables were tested in the sensitivity analysis. Results: Ticagrelor was associated with a medical cost offset driven by fewer hospitalizations; this partly offsets the incremental drug cost and results in an annual incremental cost per patient of €32.53 (€11,526.03 for ticagrelor and €11,493.50 for clopidogrel). Based on data from the PLATO trial, the incidence of ACS and current prescription volumes in Italy, the BIM predicts that the total number of cardiovascular events and costs are 6,169 and €652.3M, respectively. The BIM predicts that ticagrelor is associated with 550 fewer cardiovascular events at an incremental cost of €8.8M compared to generic clopidogrel. The impact of total annual costs for the Italian NHS would be limited if ticagrelor prescription volumes would be higher. The total cost is predicted to increase by 0.07% if ticagrelor prescription goes up to 75%, while the reduction of cardiovascular events is estimated to be considerably lower than -4.9%. Conclusions: Utilization of ticagrelor, as an alternative to generic clopidogrel to prevent cardiovascular events in patients with ACS, could represent an effective, low-cost treatment option for the Italian NHS.
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