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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/28693

Title: Restrictions for reimbursement of interferon-free direct-acting antiviral drugs for HCV infection in Europe
Authors: Marshall, Alison D.
Cunningham, Evan B.
Nielsen, Stine
Aghemo, Alessio
Alho, Hannu
Backmund, Markus
Bruggmann, Philip
Dalgard, Olav
Seguin-Devaux, Carole
Flisiak, Robert
Foster, Graham R.
Gheorghe, Liana
Goldberg, David
Goulis, Ioannis
Hickman, Matthew
Hoffmann, Patrick
Jancoriene, Ligita
Jarcuska, Peter
Kaberg, Martin
Kostrikis, Leondios G.
Makara, Mihaly
Maimets, Matti
Marinho, Rui Tato
Maticic, Mojca
Norris, Suzanne
Olafsson, Sigurour
Ovrehus, Anne
Pawlotsky, Jean-Michel
Pocock, James
Robaeys, Geert
Roncero, Carlos
Simonova, Marieta
Sperl, Jan
Tait, Michele
Tolmane, Ieva
Tomaselli, Stefan
van der Valk, Marc
Vince, Adriana
Dore, Gregory J.
Lazarus, Jeffrey V.
Grebely, Jason
Issue Date: 2018
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.
Notes: [Marshall, Alison D.; Cunningham, Evan B.; Dore, Gregory J.; Grebely, Jason] UNSW Sydney, Kirby Inst, Sydney, NSW, Australia. [Nielsen, Stine] INHSU, Madrid, Spain. [Aghemo, Alessio] Humanitas Univ, Dept Biomed Sci, Milan, Italy. [Aghemo, Alessio] Humanitas Univ, Humanitas Clin & Res Ctr, Milan, Italy. [Alho, Hannu] Univ Helsinki, Abdominal Ctr, Helsinki Univ Hosp, Helsinki, Finland. [Backmund, Markus] Ludwig Maximilians Univ Munchen, Munich, Germany. [Bruggmann, Philip] Arud Ctr Addict Med, Zurich, Switzerland. [Dalgard, Olav] Univ Oslo, Akershus Univ Hosp, Dept Infect Dis, Oslo, Norway. [Seguin-Devaux, Carole] Luxembourg Inst Hlth, Dept Infect & Immun, Luxembourg, Luxembourg. [Flisiak, Robert] Med Univ Bialystok, Dept Infect Dis & Hepatol, Bialystok, Poland. [Foster, Graham R.] Queen Mary Univ London, London, England. [Gheorghe, Liana] Fundeni Clin Inst, Gastroenterol & Hepatol, Bucharest, Romania. [Goldberg, David] Hlth Protect Scotland, Glasgow, Lanark, Scotland. [Goulis, Ioannis] Aristotle Univ Thessaloniki, Dept Internal Med, Thessaloniki, Greece. [Hickman, Matthew] Univ Bristol, Social Med, Bristol, Avon, England. [Hoffmann, Patrick] Minist Hlth, Luxembourg, Luxembourg. [Jancoriene, Ligita] Vilnius Univ, Vilnius Univ Hosp Santaros Klinikos, Ctr Infect Dis, Vilnius, Lithuania. [Jarcuska, Peter] Univ Pavol Jozef Safarik, Dept Internal Med 1, Kosice, Slovakia. [Kaberg, Martin] Karolinska Univ Hosp, Dept Infect Dis, Stockholm, Sweden. [Kostrikis, Leondios G.] Univ Cyprus, Nicosia, Cyprus. [Makara, Mihaly] St Istvan & St Laszlo Hosp, Hepatol Ctr, Budapest, Hungary. [Maimets, Matti] Univ Tartu, Dept Internal Med, Tartu, Estonia. [Marinho, Rui Tato] Univ Lisbon, Dept Gastroenterol & Hepatol, Hosp Santa Maria, Med Sch Lisbon, Lisbon, Portugal. [Maticic, Mojca] Univ Med Ctr, Clin Infect Dis & Febrile Illnesses, Ljubljana, Slovenia. [Norris, Suzanne] Dr Steevens Hosp, Hlth Serv Execut, Natl Hepatitis Treatment Programme C, Dublin, Ireland. [Olafsson, Sigurour] Landspitali Univ Hosp, Dept Med, Div Gastroenterol, Reykjavik, Iceland. [Ovrehus, Anne] Univ Southern Denmark, Dept Infect Dis, Odense Univ Hosp, Odense, Denmark. [Pawlotsky, Jean-Michel] Univ Paris Est, Hop Henri Mondor, Creteil, France. [Pocock, James] Mater Dei Hosp, Gastroenterol Dept, Msida, Malta. [Robaeys, Geert] Ziekenhuis Oost Limburg, Dept Gastroenterol & Hepatol, Genk, Belgium. [Robaeys, Geert] Univ Hasselt, Dept Med & Life Sci, Hasselt, Belgium. [Robaeys, Geert] UZ Leuven, Dept Hepatol, Leuven, Belgium. [Roncero, Carlos] Univ Autonoma Barcelona, Addict & Dual Diag Unit, Psychiat Dept, Hosp Univ Vall dHebron, Barcelona, Spain. [Simonova, Marieta] Mil Med Acad, Dept Gastroenterol Hepato Pancreato Biliary Surg, Sofia, Bulgaria. [Sperl, Jan] Inst Clin & Expt Med, Dept Hepatogastroenterol, Prague, Czech Republic. [Tolmane, Ieva] Riga East Univ Hosp, Dept Hepatol, Infectol Ctr Latvia, Riga, Latvia. [Tolmane, Ieva] Univ Latvia, Fac Med, Riga, Latvia. [Tomaselli, Stefan] Off Publ Hlth, Vaduz, Liechtenstein. [van der Valk, Marc] Acad Med Ctr, Dept Infect Dis, Amsterdam, Netherlands. [Vince, Adriana] Univ Zagreb, Univ Hosp Infect Dis, Zagreb, Croatia. [Lazarus, Jeffrey V.] Univ Barcelona, Hosp Clin, Barcelona Inst Global Hlth ISGlobal, Barcelona, Spain. [Lazarus, Jeffrey V.] Univ Copenhagen, CHIP, Rigshosp, Copenhagen, Denmark.
URI: http://hdl.handle.net/1942/28693
DOI: 10.1016/S2468-1253(17)30284-4
ISI #: 000426997300020
ISSN: 2468-1253
Category: A1
Type: Journal Contribution
Appears in Collections: Research publications

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