engleski

Introduction of new combination therapy for naive HCV GT1 patients with IL28B TT genotype and compensated cirrhosis: the impact on the Croatian Health Insurance Fund’s budget

BACKGROUND AND OBJECTIVES: Chronic GT1 HCV infections have been historically difficult to treat with the standard dual pegIFN + RBV therapy that is currently the only available treatment for naive HCV patients in Croatia. HCV patients who fail to achieve SVR after a second cycle of treatment (with triple therapies that also include pegIFN), in Croatia have no further treatment options and for them the development of cirrhosis and hepatocellular carcinoma is inevitable. It is, therefore, of great importance to reduce the number of patients who should receive triple therapy i.e. to use effective therapy for treatment of naive patients. The aim of our study was to evaluate the financial impact on the Croatian Health Insurance Fund (CHIF) budget following the introduction of new combination therapy (paritaprevir, ombitasvir, dasabuvir + ribavirin) for naive HCV GT1 patients with unfavourable predictors for treatment with standard dual therapy (IL28B TT genotype and compensated cirrhosis). METHODS: The number of patients eligible for new pharmaceutical combination was estimated by literature, local demographic information and the practice experts' opinions. Only direct costs of pharmaceuticals were taken into account. Budget impact analysis was performed in accordance with ISPOR recommendations. We used a decision- analytic Markov model to examine 3 strategies: standard dual-therapy, new combination therapy and no antiviral treatment. Sensitivity analysis was performed in the form of scenarios, and values of final parameters were estimated by Monte Carlo simulations. RESULTS: According to literature, the combination of paritaprevir, ombitasvir, dasabuvir + ribavirin showed better efficiency (SVR: 95- 100%), shorter duration and better tolerance compared to interferon therapy. The estimated number of patients to be treated with the new combination therapy is not greater than 20 per year. The approximate expected annual value of increased expenditures for CIHF budget, considering the analysed scenarios, was about 0.5 million euros.

new combination therapy; hepatitis C; unfavourable predictors; budget impact

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