Post-liver transplant recurrent hepatitis C virus (HCV) infection severely limits the prognosis of HCV-infected patients. Sofosbuvir in combination with ribavirin (SOF/RBV) is a novel interferon-free treatment able to suppress HCV viremia when applied to HCV patients listed for transplant, thereby preventing HCV recurrence. Aim of this study was to assess the cost-effectiveness of this regimens in patients listed for transplant for cirrhosis (HCV-cirrhosis) or for hepatocellular carcinoma in cirrhosis (HCV-HCC). A semi-Markov model was developed to assess the cost-effectiveness of pre-transplant SOF/RBV treatment in patients listed for HCV-cirrhosis and HCV-related HCC. The model simulates the progression of HCV-cirrhosis or HCV-HCC patients from the time of listing until death considering the risk of HCV recurrence post-transplant. The model compared 2 different strategies: 1) SOF/RBV up to a maximum of 24 weeks or until OLT if performed before the 24th week from the initiation of treatment, 2) No antiviral treatment. The model estimated the costs related to the treatment with SOF/RBV, the costs associated to each health state, the life-years (LYSs), the quality-adjusted life-years (QALYs), and the incremental cost-effectiveness ratio (ICER) expressed as € per QALY gained. The analysis was performed from the Italian National Health System perspective with a lifetime time horizon and one-month Markov cycles. Future costs and clinical benefits, expressed as QALYs, were discounted at 3% per year. Results: in the base-case analysis the ICER for 24 weeks of SOF/RBVR was €30,518 per QALY gained in HCV-cirrhosis patients and €41,610 in HCV-HCC patients. The reliability of our results was confirmed by the one way sensitivity-analysis and by the cost-effectiveness acceptability curve that reported 97.5% probability of SOF/RBV to be cost-effective at a willingness to pay threshold of €60,000 in the HCV–cirrhosis scenario, and 88.1% in the HCV-HCC scenario. Further, SOF/RBV cost-effectiveness was clearly sensitive to the duration of treatment; assuming 12 weeks SOF/RBV treatment duration, the ICER decreased to €19,317 in HCV-Cirrhosis and €29,540 in HCV-HCC. In conclusion, our study shows that treating patients with HCV-cirrhosis or HCV-HCC in the transplant waiting list with SOF/RBV is cost-effective and may become the new standard of care for these patients. However a well-defined prospective study is needed to confirm the value of the parameters assumed in the model and the results. Furthermore, associations of direct acting antivirals will soon appear into the horizon also in the transplant setting and bring new challenges and opportunities.
Cortesi, P., Mantovani, L., Ciaccio, A., Rota, M., Cesana, G., Strazzabosco, M., et al. (2014). Sofosbuvir and ribavirinin in HCV-infected patients listed for liver transplantation: A cost-effectiveness analysis. HEPATOLOGY, 60(Supplement 1), 534A-534A.
Sofosbuvir and ribavirinin in HCV-infected patients listed for liver transplantation: A cost-effectiveness analysis
CORTESI, PAOLO ANGELO;MANTOVANI, LORENZO GIOVANNI;CIACCIO, ANTONIO;ROTA, MATTEO;CESANA, GIANCARLO;STRAZZABOSCO, MARIO;
2014
Abstract
Post-liver transplant recurrent hepatitis C virus (HCV) infection severely limits the prognosis of HCV-infected patients. Sofosbuvir in combination with ribavirin (SOF/RBV) is a novel interferon-free treatment able to suppress HCV viremia when applied to HCV patients listed for transplant, thereby preventing HCV recurrence. Aim of this study was to assess the cost-effectiveness of this regimens in patients listed for transplant for cirrhosis (HCV-cirrhosis) or for hepatocellular carcinoma in cirrhosis (HCV-HCC). A semi-Markov model was developed to assess the cost-effectiveness of pre-transplant SOF/RBV treatment in patients listed for HCV-cirrhosis and HCV-related HCC. The model simulates the progression of HCV-cirrhosis or HCV-HCC patients from the time of listing until death considering the risk of HCV recurrence post-transplant. The model compared 2 different strategies: 1) SOF/RBV up to a maximum of 24 weeks or until OLT if performed before the 24th week from the initiation of treatment, 2) No antiviral treatment. The model estimated the costs related to the treatment with SOF/RBV, the costs associated to each health state, the life-years (LYSs), the quality-adjusted life-years (QALYs), and the incremental cost-effectiveness ratio (ICER) expressed as € per QALY gained. The analysis was performed from the Italian National Health System perspective with a lifetime time horizon and one-month Markov cycles. Future costs and clinical benefits, expressed as QALYs, were discounted at 3% per year. Results: in the base-case analysis the ICER for 24 weeks of SOF/RBVR was €30,518 per QALY gained in HCV-cirrhosis patients and €41,610 in HCV-HCC patients. The reliability of our results was confirmed by the one way sensitivity-analysis and by the cost-effectiveness acceptability curve that reported 97.5% probability of SOF/RBV to be cost-effective at a willingness to pay threshold of €60,000 in the HCV–cirrhosis scenario, and 88.1% in the HCV-HCC scenario. Further, SOF/RBV cost-effectiveness was clearly sensitive to the duration of treatment; assuming 12 weeks SOF/RBV treatment duration, the ICER decreased to €19,317 in HCV-Cirrhosis and €29,540 in HCV-HCC. In conclusion, our study shows that treating patients with HCV-cirrhosis or HCV-HCC in the transplant waiting list with SOF/RBV is cost-effective and may become the new standard of care for these patients. However a well-defined prospective study is needed to confirm the value of the parameters assumed in the model and the results. Furthermore, associations of direct acting antivirals will soon appear into the horizon also in the transplant setting and bring new challenges and opportunities.
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