engleski

Introduction of New Combination Therapy for Treatment of Experienced HCV GT1 Patients: Budget Impact Analysis, The Croatian Perspective

OBJECTIVES: The new combination therapy of paritaprevir, ombitasvir, dasabuvir, with/without ribavirin is highly tolerable, all-oral, interferon-free regimen for treatment of chronic hepatitis C virus (HCV) infection. The objective of present study was to evaluate the financial impact on the Croatian Health Insurance Fund (CHIF) budget following the introduction of the therapy for experienced HCV genotype 1 (GT1) patients. METHODS: The size of the eligible population for the new pharmaceutical combination was estimated by local demographics information, literature, and experts' opinion. Only direct costs of pharmaceuticals were taken into account. Budget impact calculations were based on health- economic outcomes of the new therapy in comparison to alternative interventions (standard dual- therapy and triple therapies that include boceprevir, telaprevir and simeprevir) for different patient subpopulations. Patient subpopulations were differentiated by response to previous treatment (relapse, partial response and null response), presence of cirrhosis and HCV GT1 subtype. Sensitivity analysis was performed in the form of alternative scenarios. Final parameters were estimated by Monte Carlo simulations. RESULTS: The new combination therapy showed better efficiency, shorter duration and better tolerance in comparison to alternative interventions. For certain patient subpopulations, the new therapy is cheaper per achieved SVR in comparison to other therapies. The estimated number of patients eligible for the new combination therapy is 90-100 per year and the expected annual value of increased expenditures for CIHF budget is in between approximately 200, 000 – 900, 000 €. CONCLUSIONS: Although the impact on CHIF budget is significant, due to high efficiency and high tolerability, the new combination therapy for some patient subpopulations is cost-effective, that being the reason for its consideration as an alternative to standard therapies. Further, this economic evaluation could be the starting point for negotiations between pharmaceutical industry and insurance companies, as well as an introduction of specific contracts and some new technical solutions in those negotiations.

hepatitis C; new combination therapy; budget impact

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