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Cost-effectiveness analysis of the use of daclatasvir + sofosbuvir + ribavirin (16 weeks and 12 weeks) vs sofosbuvir + ribavirin (16 weeks and 24 weeks) for the treatment of cirrhotic patients affected with hepatitis C virus genotype 3 in Italy

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Abstract

The WHO estimates that more than 185 million people are infected with hepatitis C virus (HCV) worldwide. The aim of the study is to assess the incremental cost-effectiveness ratio (ICER) of the use of daclatasvir (DCV) + sofosbuvir (SOF) + ribavirin (RBV) for 12 and 16 weeks vs SOF + RBV for 16 and 24 weeks for the treatment of genotype 3 HCV infected cirrhotic patients from the Italian National Health Service (NHS) perspective. A published cohort-based Markov model was used to perform the analysis estimating the lifetime direct medical costs associated with the management of the pathology and the quality adjusted life years gained by patients. Deterministic and probabilistic sensitivity analyses were performed to test the robustness of the results. SOF + RBV for 16 weeks was excluded from the analysis due to the significant lower effectiveness, compared with SOF + RBV for 24 weeks (51% vs 79%). DCV + SOF + RBV would increase QALYs and costs in all the comparisons: the ICERs obtained comparing DCV + SOF + RBV for 12 and 16 weeks with SOF + RBV for 24 weeks (reference scenario) are 38,572 €/QALY and 16,436 €/QALY, respectively, both below the 40,000 €/QALY threshold identified by the Italian Health Economics Association. Sensitivity analyses confirmed the robustness of the results. The use of DCV + SOF + RBV is likely to be cost-effective compared with SOF + RBV (for 24 weeks) for the treatment of cirrhotic patients infected with genotype 3 HCV considering a threshold value of 40,000 €/QALY.

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Acknowledgements

This study was supported by Bristol-Myers Squibb. Professional medical writing and editorial assistance was provided by A.L. and A.A., and was funded by Bristol-Myers Squibb. U.R. declares speaker fees (Janssen Cilag). A.A. declares research grants (Abbvie, Gilead, Janssen, MSD), advisory board fees: (Abbvie, Gilead, Janssen, MSD, BMS), and speaker fees (Abbvie, Gilead, Janssen, BMS). A.L. declares advisory board honorarium and speaker fees (BMS, Abbvie, ViiV, Gilead, Janssen Cilag). M.B. declares no competing interests. C.N. is employed by Bristol Myers Squibb S.r.l. D.C. declares advisory board fees (MSD, Abbvie).

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Authors and Affiliations

  1. School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

    Umberto Restelli & Davide Croce

  2. Centre for Research on Health Economics, Social and Health Care Management (CREMS)-LIUC-Carlo Cattaneo Univerity, Castellanza, VA, Italy

    Umberto Restelli, Marzia Bonfanti & Davide Croce

  3. Department of Molecular Medicine, University of Padua, Padua, Italy

    Alfredo Alberti

  4. Università Vita-Salute San Raffaele, Milan, Italy

    Adriano Lazzarin

  5. Health Economic and Outcome Research Bristol Myers Squibb S.r.l., Rome, Italy

    Carmela Nappi

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  1. Umberto Restelli
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  2. Alfredo Alberti
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Correspondence to Umberto Restelli.

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Restelli, U., Alberti, A., Lazzarin, A. et al. Cost-effectiveness analysis of the use of daclatasvir + sofosbuvir + ribavirin (16 weeks and 12 weeks) vs sofosbuvir + ribavirin (16 weeks and 24 weeks) for the treatment of cirrhotic patients affected with hepatitis C virus genotype 3 in Italy. Eur J Health Econ 19, 37–44 (2018). https://doi.org/10.1007/s10198-016-0865-3

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