Δημοσίευση

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

ΤίτλοςRestrictions for reimbursement of interferon-free direct-acting antiviral drugs for HCV infection in Europe.
Publication TypeJournal Article
Year of Publication2018
AuthorsMarshall, 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., Jancorienė L., Jarcuska P., Kåberg M., Kostrikis L. G., Makara M., Maimets M., Marinho R. Tato, Matičič M., Norris S., Ólafsson S., Øvrehus A., Pawlotsky J-M., Pocock J., Robaeys G., Roncero C., Simonova M., Sperl J., Tait M., Tolmane I., Tomaselli S., van der Valk M., Vince A., Dore G. J., Lazarus J. V., & Grebely J.
Corporate AuthorsInternational Network on Hepatitis in Substance Users(INHSU)
JournalLancet Gastroenterol Hepatol
Volume3
Issue2
Pagination125-133
Date Published2018 02
ISSN2468-1253
Λέξεις κλειδιάAntiviral Agents, Coinfection, Drug Costs, European Union, Health Policy, Hepatitis C, Chronic, HIV Infections, Humans, Insurance, Health, Reimbursement, Switzerland
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.

DOI10.1016/S2468-1253(17)30284-4
Alternate JournalLancet Gastroenterol Hepatol
PubMed ID28986139
Grant ListRP-DG-0610-10055 / / Department of Health / United Kingdom

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