Restrictions for reimbursement of interferon-free direct-acting antiviral drugs for HCV infection in Europe

Alison D. Marshall, Evan B. Cunningham, Stine Nielsen, Alessio Aghemo, Hannu Alho, Markus Backmund, Philip Bruggmann, Olav Dalgard, Carole Seguin-Devaux, Robert Flisiak, Graham R. Foster, Liana Gheorghe, David Goldberg, Ioannis Goulis, Matthew Hickman, Patrick Hoffmann, Ligita Jancoriene, Peter Jarcuska, Martin Kåberg, Leondios G. KostrikisMihály Makara, Matti Maimets, Rui Tato Marinho, Mojca Maticic, Suzanne Norris, Sigurður Ólafsson, Anne Øvrehus, Jean-Michel Pawlotsky, James Pocock, Geert Robaeys, Carlos Roncero, Marieta Simonova, Jan Sperl, Michele Tait, Ieva Tolmane, Stefan Tomaselli, Marc van der Valk, Adriana Vince, Gregory J. Dore, Jeffrey V. Lazarus, Jason Grebely

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Abstract

All-oral direct-acting antiviral drugs (DAAs) for hepatitis C virus, which have response rates of 95% or more, represent a major clinical advance. However, the high list price of DAAs has led many governments to restrict their reimbursement. We reviewed the availability of, and national criteria for, interferon-free DAA reimbursement among countries in the European Union and European Economic Area, and Switzerland. Reimbursement documentation was reviewed between Nov 18, 2016, and Aug 1, 2017. Primary outcomes were fibrosis stage, drug or alcohol use, prescriber type, and HIV co-infection restrictions. Among the 35 European countries and jurisdictions included, the most commonly reimbursed DAA was ombitasvir, paritaprevir, and ritonavir, with dasabuvir, and with or without ribavirin (33 [94%] countries and jurisdictions). 16 (46%) countries and jurisdictions required patients to have fibrosis at stage F2 or higher, 29 (83%) had no listed restrictions based on drug or alcohol use, 33 (94%) required a specialist prescriber, and 34 (97%) had no additional restrictions for people co-infected with HIV and hepatitis C virus. These findings have implications for meeting WHO targets, with evidence of some countries not following the 2016 hepatitis C virus treatment guidelines by the European Association for the Study of Liver.
Original languageEnglish
Pages (from-to)125–133
JournalThe Lancet Gastroenterology & Hepatology
Volume3
Issue number2
Early online date3 Oct 2017
DOIs
Publication statusPublished - Feb 2018

Keywords

  • interferon
  • antiviral drugs
  • HCV infection
  • virology

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    Marshall, A. D., Cunningham, E. B., Nielsen, S., Aghemo, A., Alho, H., Backmund, M., Bruggmann, P., Dalgard, O., Seguin-Devaux, C., Flisiak, R., Foster, G. R., Gheorghe, L., Goldberg, D., Goulis, I., Hickman, M., Hoffmann, P., Jancoriene, L., Jarcuska, P., Kåberg, M., ... Grebely, J. (2018). Restrictions for reimbursement of interferon-free direct-acting antiviral drugs for HCV infection in Europe. The Lancet Gastroenterology & Hepatology, 3(2), 125–133. https://doi.org/10.1016/S2468-1253(17)30284-4