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 Jancorienė, Peter Jarcuska, Martin Kåberg, Leondios G KostrikisMihály Makara, Matti Maimets, Rui Tato Marinho, Mojca Matičič, 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, International Network on Hepatitis in Substance Users (INHSU)

Publikation: Bidrag til tidsskriftReviewForskningpeer review

Resumé

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.

OriginalsprogEngelsk
TidsskriftThe Lancet Gastroenterology & Hepatology
Vol/bind3
Udgave nummer2
Sider (fra-til)125-133
ISSN2468-1253
DOI
StatusUdgivet - feb. 2018

Fingeraftryk

Hepacivirus
Alcohols
Ritonavir
Ribavirin
European Union
Coinfection
Pharmaceutical Preparations
Documentation
HIV
Guidelines
Liver
ABT-450
ABT-333
ABT-267

Citer dette

Marshall, A. D., Cunningham, E. B., Nielsen, S., Aghemo, A., Alho, H., Backmund, M., ... International Network on Hepatitis in Substance Users (INHSU) (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
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 ; Jancorienė, Ligita ; Jarcuska, Peter ; Kåberg, Martin ; Kostrikis, Leondios G ; Makara, Mihály ; Maimets, Matti ; Marinho, Rui Tato ; Matičič, Mojca ; Norris, Suzanne ; Ólafsson, Sigurður ; Øvrehus, 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 ; International Network on Hepatitis in Substance Users (INHSU). / Restrictions for reimbursement of interferon-free direct-acting antiviral drugs for HCV infection in Europe. I: The Lancet Gastroenterology & Hepatology. 2018 ; Bind 3, Nr. 2. s. 125-133.
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title = "Restrictions for reimbursement of interferon-free direct-acting antiviral drugs for HCV infection in Europe",
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.",
keywords = "Antiviral Agents/economics, Coinfection, Drug Costs, European Union, HIV Infections/complications, Health Policy, Hepatitis C, Chronic/complications, Humans, Insurance, Health, Reimbursement, Switzerland",
author = "Marshall, {Alison D} and Cunningham, {Evan B} and Stine Nielsen and Alessio Aghemo and Hannu Alho and Markus Backmund and Philip Bruggmann and Olav Dalgard and Carole Seguin-Devaux and Robert Flisiak and Foster, {Graham R} and Liana Gheorghe and David Goldberg and Ioannis Goulis and Matthew Hickman and Patrick Hoffmann and Ligita Jancorienė and Peter Jarcuska and Martin K{\aa}berg and Kostrikis, {Leondios G} and Mih{\'a}ly Makara and Matti Maimets and Marinho, {Rui Tato} and Mojca Matičič and Suzanne Norris and Sigur{\dh}ur {\'O}lafsson and Anne {\O}vrehus and Jean-Michel Pawlotsky and James Pocock and Geert Robaeys and Carlos Roncero and Marieta Simonova and Jan Sperl and Michele Tait and Ieva Tolmane and Stefan Tomaselli and {van der Valk}, Marc and Adriana Vince and Dore, {Gregory J} and Lazarus, {Jeffrey V} and Jason Grebely and {International Network on Hepatitis in Substance Users (INHSU)}",
note = "Copyright {\circledC} 2017 Elsevier Ltd. All rights reserved.",
year = "2018",
month = "2",
doi = "10.1016/S2468-1253(17)30284-4",
language = "English",
volume = "3",
pages = "125--133",
journal = "The Lancet Gastroenterology & Hepatology",
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Marshall, AD, Cunningham, EB, Nielsen, S, Aghemo, A, Alho, H, Backmund, M, Bruggmann, P, Dalgard, O, Seguin-Devaux, C, Flisiak, R, Foster, GR, Gheorghe, L, Goldberg, D, Goulis, I, Hickman, M, Hoffmann, P, Jancorienė, L, Jarcuska, P, Kåberg, M, Kostrikis, LG, Makara, M, Maimets, M, Marinho, RT, 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, GJ, Lazarus, JV, Grebely, J & International Network on Hepatitis in Substance Users (INHSU) 2018, 'Restrictions for reimbursement of interferon-free direct-acting antiviral drugs for HCV infection in Europe', The Lancet Gastroenterology & Hepatology, bind 3, nr. 2, s. 125-133. https://doi.org/10.1016/S2468-1253(17)30284-4

Restrictions for reimbursement of interferon-free direct-acting antiviral drugs for HCV infection in Europe. / 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; Jancorienė, Ligita; Jarcuska, Peter; Kåberg, Martin; Kostrikis, Leondios G; Makara, Mihály; Maimets, Matti; Marinho, Rui Tato; Matičič, Mojca; Norris, Suzanne; Ólafsson, Sigurður; Øvrehus, 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; International Network on Hepatitis in Substance Users (INHSU).

I: The Lancet Gastroenterology & Hepatology, Bind 3, Nr. 2, 02.2018, s. 125-133.

Publikation: Bidrag til tidsskriftReviewForskningpeer review

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 - Jancorienė, Ligita

AU - Jarcuska, Peter

AU - Kåberg, Martin

AU - Kostrikis, Leondios G

AU - Makara, Mihály

AU - Maimets, Matti

AU - Marinho, Rui Tato

AU - Matičič, 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

AU - International Network on Hepatitis in Substance Users (INHSU)

N1 - Copyright © 2017 Elsevier Ltd. All rights reserved.

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 - Antiviral Agents/economics

KW - Coinfection

KW - Drug Costs

KW - European Union

KW - HIV Infections/complications

KW - Health Policy

KW - Hepatitis C, Chronic/complications

KW - Humans

KW - Insurance, Health, Reimbursement

KW - Switzerland

U2 - 10.1016/S2468-1253(17)30284-4

DO - 10.1016/S2468-1253(17)30284-4

M3 - Review

C2 - 28986139

VL - 3

SP - 125

EP - 133

JO - The Lancet Gastroenterology & Hepatology

JF - The Lancet Gastroenterology & Hepatology

SN - 2468-1253

IS - 2

ER -