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Lancet Gastroenterol Hepatol. 2018 Feb;3(2):125-133. doi: 10.1016/S2468-1253(17)30284-4. Epub 2017 Oct 3.

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

Author information

1
The Kirby Institute, UNSW Sydney, NSW, Australia. Electronic address: amarshall@kirby.unsw.edu.au.
2
The Kirby Institute, UNSW Sydney, NSW, Australia.
3
INHSU, Madrid, Spain.
4
Department of Biomedical Sciences and Humanitas Clinical and Research Center, Humanitas University, Milan, Italy.
5
Abdominal Center, Helsinki University Hospital, Helsinki University, Helsinki, Finland.
6
Ludwig-Maximilians-University, Munich, Germany.
7
Arud Centres for Addiction Medicine, Zürich, Switzerland.
8
Department of Infectious Diseases, Akershus University Hospital, University of Oslo, Oslo, Norway.
9
Department of Infection and Immunity, Luxembourg Institute of Health, Luxembourg City, Luxembourg.
10
Department of Infectious Diseases and Hepatology, Medical University of Bialystok, Bialystok, Poland.
11
Queen Mary University of London, London, UK.
12
Gastroenterology and Hepatology, Fundeni Clinical Institute, Bucharest, Romania.
13
Health Protection Scotland, Glasgow, UK.
14
Department of Internal Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.
15
Social Medicine, University of Bristol, Bristol, UK.
16
Ministry of Health, Luxembourg City, Luxembourg.
17
Centre of Infectious Diseases, Vilnius University Hospital Santaros Klinikos, Vilnius University, Vilnius, Lithuania.
18
First Department of Internal Medicine, University Hospital, University of Pavol Jozef Safarik, Kosice, Slovakia.
19
Department of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden.
20
University of Cyprus, Nicosia, Cyprus.
21
Hepatology Center, St István and St László Hospital, Budapest, Hungary.
22
Department of Internal Medicine, University of Tartu, Estonia.
23
Department of Gastroenterology and Hepatology, Hospital Santa Maria, Medical School Lisbon, University of Lisbon, Lisbon, Portugal.
24
Clinic for Infectious Diseases and Febrile Illnesses, University Medical Centre, Ljubljana, Slovenia.
25
National Hepatitis C Treatment Programme, Health Service Executive, Dr Steevens' Hospital, Dublin, Ireland.
26
Division of Gastroenterology, Department of Medicine, Landspitali University Hospital, Reykjavik, Iceland.
27
Department of Infectious Diseases, Odense University Hospital, University of Southern Denmark, Odense, Denmark.
28
Hopital Henri Mondor, Universite Paris Est, Créteil, France.
29
Gastroenterology Department, Mater Dei Hospital, Msida, Malta.
30
Department of Gastroenterology and Hepatology, Ziekenhuis Oost Limburg, Genk, Belgium; Department of Medicine and Life Sciences, University of Hasselt, Hasselt, Belgium; Department of Hepatology, UZ Leuven, Leuven, Belgium.
31
Addiction and Dual Diagnosis Unit, Psychiatric Department, Hospital Universitario Vall d'Hebron, Universidad Autónoma de Barcelona, Barcelona, Spain.
32
Department of Gastroenterology, Hepato-Pancreato-Biliary Surgery and Transplantology, Military Medical Academy, Sofia, Bulgaria.
33
Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.
34
Department of Hepatology, Infectology Center of Latvia, Riga East University Hospital, Riga, Latvia; Faculty of Medicine, University of Latvia, Riga, Latvia.
35
Office of Public Health, Vaduz, Liechtenstein.
36
Department of Infectious Diseases, Academic Medical Center, Amsterdam, Netherlands.
37
University Hospital for Infectious Diseases, University of Zagreb, Zagreb, Croatia.
38
Barcelona Institute for Global Health (ISGlobal), Hospital Clínic, Univeristy of Barcelona, Barcelona, Spain; CHIP, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.

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.

PMID:
28986139
DOI:
10.1016/S2468-1253(17)30284-4
[Indexed for MEDLINE]

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