Economic Evaluation of the Hepatitis C Virus Treatment Extension to Early-Stage Fibrosis Patients: Evidence from the PITER Real-World Cohort

Eichler, 2012, Adaptive licensing: taking the next step in the evolution of drug approval, Clin Pharmacol Ther, 91, 426, 10.1038/clpt.2011.345 Briggs, 1998, An introduction to Markov modelling for economic evaluation, Pharmacoeconomics, 13, 397, 10.2165/00019053-199813040-00003 Ruggeri, 2015, Investigating the generalizability of economic evaluations conducted in Italy: a critical review, Value Health, 18, 709, 10.1016/j.jval.2015.03.1795 Weinstein, 2003, Principles of good practice for decision analytic modeling in health-care evaluation: report of the ISPOR Task Force on Good Research Practices—Modeling Studies, Value Health, 6, 9, 10.1046/j.1524-4733.2003.00234.x Garrison, 2007, Using real-world data for coverage and payment decisions: the ISPOR Real-World Data Task Force Report, Value Health, 10, 326, 10.1111/j.1524-4733.2007.00186.x Kondili, 2015, PITER-HCV cohort study as part of the Italian platform for the study of viral hepatitis therapies Shepard, 2005, Global epidemiology of hepatitis C virus infection, Lancet Infect Dis, 5, 558, 10.1016/S1473-3099(05)70216-4 Lozano, 2012, Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010, Lancet, 380, 2095, 10.1016/S0140-6736(12)61728-0 Mariano, 2009, Estimating the incidence, prevalence and clinical burden of hepatitis C over time in Italy, Scand J Infect Dis, 41, 689, 10.1080/00365540903095358 Guadagnino, 2013, Hepatitis C virus infection in an endemic area of Southern Italy 14 years later: evidence for a vanishing infection, Dig Liver Dis, 45, 403, 10.1016/j.dld.2012.10.014 Razavi, 2013, Chronic hepatitis C virus (HCV) disease burden and cost in the United States, Hepatology (Baltimore), 57, 2164, 10.1002/hep.26218 Marcellusi, 2015, The economic burden of HCV-induced diseases in Italy: a probabilistic cost of illness model, Eur Rev Med Pharmacol Sci, 19, 1610 Asselah, 2016, Direct-acting antivirals for the treatment of hepatitis C virus infection: optimizing current IFN-free treatment and future perspectives, Liver Int, 36, 47, 10.1111/liv.13027 Shahid, 2016, Hepatitis C virus infection treatment: an era of game changer direct acting antivirals and novel treatment strategies, Crit Rev Microbiol, 42, 535, 10.3109/1040841X.2014.970123 Chung, 2014, Curing chronic hepatitis C—the arc of a medical triumph, N Engl J Med, 370, 1576, 10.1056/NEJMp1400986 Lange, 2014, Emerging therapies for the treatment of hepatitis C, EMBO Mol Med, 6, 4, 10.1002/emmm.201303131 Thomas, 2013, Global control of hepatitis C: where challenge meets opportunity, Nat Med, 19, 850, 10.1038/nm.3184 Reau, 2014, Sticker shock and the price of new therapies for hepatitis C: Is it worth it?, Hepatology, 59, 1246, 10.1002/hep.27039 Obach, 2015, How to optimize HCV treatment impact on life years saved in resource-constrained countries, Hepatology, 62, 31, 10.1002/hep.27691 McGowan, 2012, Barriers to hepatitis C treatment, Liver Int, 32, 151, 10.1111/j.1478-3231.2011.02706.x Chhatwal, 2015, Cost-effectiveness and budget impact of hepatitis C virus treatment with sofosbuvir and ledipasvir in the United States, Ann Intern Med, 162, 397, 10.7326/M14-1336 Kondili, 2015, PITER: an ongoing nationwide study on chronic HCV infection and the real -life impact of DAA in Italy, Dig Liver Dis, 47, 741, 10.1016/j.dld.2015.05.022 2015, EASL Recommendations on Treatment of Hepatitis C 2015, J Hepatol, 63, 199, 10.1016/j.jhep.2015.03.025 Ruggeri, 2014, Il modello WEF per la valutazione economica delle innovazioni terapeutiche in epatologia, Farmeconomia e percorsi terapeutici, 2014, 75 Dienstag, 2011, A prospective study of the rate of progression in compensated, histologically advanced chronic hepatitis C, Hepatology, 54, 396, 10.1002/hep.24370 Townsend, 2011, Structural frameworks and key model parameters in cost-effectiveness analyses for current and future treatments of chronic hepatitis C, Value Health, 14, 1068, 10.1016/j.jval.2011.06.006 Wright, 2006, Health benefits of antiviral therapy for mild chronic hepatitis C: randomised controlled trial and economic evaluation, Health Technol Assess, 10, 1, 10.3310/hta10210 Morgan, 2010, Outcome of sustained virological responders with histologically advanced chronic hepatitis C, Hepatology, 52, 833, 10.1002/hep.23744 2014, Mortality tables American Association for the Study of Liver Diseases; Infectious Diseases Society of America. Recommendations for testing, managing, and treating hepatitis C. Available from: www.hcvguidelines.org. [Accessed November 3, 2016]. Sullivan, 2004, Cost effectiveness of peginterferon alpha-2a plus ribavirin versus interferon alpha-2b plus ribavirin as initial therapy for treatment-naïve chronic hepatitis C, Pharmacoeconomics, 22, 257, 10.2165/00019053-200422040-00004 Nakamura, 2008, Economic impact of extended treatment with peginterferon alpha-2a and ribavirin for slow hepatitis C virologic responders, J Viral Hepat, 15, 293, 10.1111/j.1365-2893.2007.00943.x Younossi, 2015, Improvement of health-related quality of life and work productivity in chronic hepatitis C patients with early and advanced fibrosis treated with ledipasvir and sofosbuvir, J Hepatol, 63, 337, 10.1016/j.jhep.2015.03.014 Romano, 2015, Economic assessment of eltrombopag in the treatment of thrombocytopenia, Expert Rev Pharmacoecon Outcomes Res, 15, 713, 10.1586/14737167.2015.1028373 2012, Allegato 1: Remunerazione delle prestazioni di assistenza ospedaliera per acuti, assistenza ospedaliera di riabilitazione e di lungodegenza post acuzie e di assistenza specialistica ambulatoriale, Decreto 18, ottobre Munari, 1996, Recombinant interferon alfa-2b therapy for chronic hepatitis C in Italy: an economic analysis, Forum (Genova), 6, 347 Briggs, 2012, Model parameter estimation and uncertainty: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force-6, Value Health, 15, 835, 10.1016/j.jval.2012.04.014 Claxton, 2008, Exploring uncertainty in cost-effectiveness analysis, Pharmacoeconomics, 26, 781, 10.2165/00019053-200826090-00008 Marcellusi, 2016, Early treatment in HCV: Is it a cost-utility option from the Italian perspective?, Clin Drug Investig, 36, 661, 10.1007/s40261-016-0414-y Leidner, 2015, Cost-effectiveness of hepatitis C treatment for patients in early stages of liver disease, Hepatology, 61, 1860, 10.1002/hep.27736 Gardini, 2016, HCV—estimation of the number of diagnosed patients eligible to the new anti-HCV therapies in Italy, Eur Rev Med Pharmacol Sci, 20, 7 Agenzia Italiana Del Farmaco. Determina 24 marzo 2017. Ridefinizione dei criteri di trattamento per la terapia dell’Epatite C cronica. (Determina n. 500/2017). [Online Source: available for download at: http://www.aifa.gov.it/sites/default/files/Determina_n._500-2017_Epatite-C.pdf].