[Cost-effectiveness and budget impact of ivabradine in heart failure therapy]. / Costo-utilità e budget impact di ivabradina nella terapia dell'insufficienza cardiaca.

ABSTRACT

BACKGROUND: Cost-effectiveness of ivabradine was assessed by the National Institute for Health and Clinical Excellence (NICE) in 2012, based on the data derived from the SHIFT trial NICE considered ivabradine cost-effective for treating chronic heart failure, supporting drug reimbursement by the national healthcare system (NHS). The aim of this study was to assess the cost-effectiveness of ivabradine on top of standard care in heart failure therapy, by adapting a Markovian model to the Italian population and organization, previously developed for submission to national regulatory bodies. METHODS: The demographic and clinical characteristics of the Italian population were derived from both the SHIFT trial and the IN-HF Outcome registry (Italian real practice data). Costs were drawn from the Italian NHS information system. All analyses adopted the Italian NHS perspective. RESULTS: In a lifetime horizon, in the base case, our assessment confirms that adoption of ivabradine seems socially acceptable with a cost per quality-adjusted life year (QALY) of €17,434.86 (incremental cost of €2,952.85 and QALYs gained 0.21). The incremental cost/life-year gained (LYG) is €15,557.24 (LYG gained 0.24) and hospitalization costs avoided are €3,420.77 (avoided hospitalizations 0.76). A probabilistic sensitivity analysis showed that ivabradine on top of standard treatment is cost-effective in more than 87% of cases accepting a threshold of €30,000, and in more than 93% of cases with a threshold of €40,000. CONCLUSIONS: The results obtained for the Italian population and in the organizational context of the Italian NHS show social acceptability (cost per QALY) of ivabradine therapy in the treatment of heart failure.