TY - JOUR
T1 - Restrictions for reimbursement of interferon-free direct-acting antiviral drugs for HCV infection in Europe
AU - Marshall, Alison D.
AU - Cunningham, Evan B.
AU - Nielsen, Stine
AU - Aghemo, Alessio
AU - Alho, Hannu
AU - Backmund, Markus
AU - Bruggmann, Philip
AU - Dalgard, Olav
AU - Seguin-Devaux, Carole
AU - Flisiak, Robert
AU - Foster, Graham R.
AU - Gheorghe, Liana
AU - Goldberg, David
AU - Goulis, Ioannis
AU - Hickman, Matthew
AU - Hoffmann, Patrick
AU - Jancoriene, Ligita
AU - Jarcuska, Peter
AU - Kåberg, Martin
AU - Kostrikis, Leondios G.
AU - Makara, Mihály
AU - Maimets, Matti
AU - Marinho, Rui Tato
AU - Maticic, Mojca
AU - Norris, Suzanne
AU - Ólafsson, Sigurður
AU - Øvrehus, Anne
AU - Pawlotsky, Jean-Michel
AU - Pocock, James
AU - Robaeys, Geert
AU - Roncero, Carlos
AU - Simonova, Marieta
AU - Sperl, Jan
AU - Tait, Michele
AU - Tolmane, Ieva
AU - Tomaselli, Stefan
AU - van der Valk, Marc
AU - Vince, Adriana
AU - Dore, Gregory J.
AU - Lazarus, Jeffrey V.
AU - Grebely, Jason
N1 - Acceptance in SAN
^Acceptance email requested x 3 (admin has tried obtaining from the author)
AAM: 6m embargo
PY - 2018/2
Y1 - 2018/2
N2 - 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.
AB - 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.
KW - interferon
KW - antiviral drugs
KW - HCV infection
KW - virology
U2 - 10.1016/S2468-1253(17)30284-4
DO - 10.1016/S2468-1253(17)30284-4
M3 - Article
VL - 3
SP - 125
EP - 133
JO - The Lancet Gastroenterology & Hepatology
JF - The Lancet Gastroenterology & Hepatology
SN - 2468-1253
IS - 2
ER -