Improving patient access to biosimilar tumor necrosis factor inhibitors in immune-mediated inflammatory disease: lessons learned from Norway

被引:8
作者
Goll, Guro L. [1 ]
Kvien, Tore K. [1 ,2 ]
机构
[1] Diakonhjemmet Hosp, Ctr Treatment Rheumat & Musculoskeletal Dis REMEDY, Box 23 Vindern, N-0319 Oslo, Norway
[2] Univ Oslo, Inst Clin Med, Oslo, Norway
关键词
TNF inhibitors; biosimilars; etanercept; adalimumab; infliximab; rheumatoid arthritis; spondyloarthritis; psoriatic arthritis; DOUBLE-BLIND; ORIGINATOR INFLIXIMAB; RHEUMATOID-ARTHRITIS; INNOVATOR INFLIXIMAB; PARALLEL-GROUP; CT-P13; RECOMMENDATIONS; EFFICACY; SAFETY; SWITCH;
D O I
10.1080/14712598.2023.2273938
中图分类号
Q81 [生物工程学(生物技术)]; Q93 [微生物学];
学科分类号
071005 ; 0836 ; 090102 ; 100705 ;
摘要
Introduction: TNF inhibitors (TNFi) are in widespread use to treat a range of immune-mediated inflammatory diseases. However, the use of less expensive, biosimilar versions of these costly agents varies considerably around the world. Along with other Scandinavian countries, Norway has been successful in implementing the consistent clinical use of biosimilars rather than originator compounds.Areas covered: We discuss the implementation of biosimilar TNFi in Norway, explain how this work was carried out over the past 10 years and highlight factors that have been key in securing their acceptance and use. This implementation is discussed in relation to the situation in other countries.Expert opinion: The Norwegian tender and procurement system has been important to lower the cost of TNFi. Importantly, the emergence of biosimilar alternatives has lowered the cost not just of biosimilar TNFi but also originators due to competition. The involvement of the clinical communities through expert advisory boards has been important in securing acceptance of biosimilars early on. We suggest that the Norwegian procurement and tender system for biologic drugs may serve as a model for other countries, but has to be adjusted and modified according to specific national health-care systems and national contextual factors.
引用
收藏
页码:1203 / 1209
页数:7
相关论文
共 28 条
[1]   Time trends in disease activity, response and remission rates in rheumatoid arthritis during the past decade: results from the NOR-DMARD study 2000-2010 [J].
Aga, Anna-Birgitte ;
Lie, Elisabeth ;
Uhlig, Till ;
Olsen, Inge Christoffer ;
Wierod, Ada ;
Kalstad, Synove ;
Rodevand, Erik ;
Mikkelsen, Knut ;
Kvien, Tore K. ;
Haavardsholm, Espen A. .
ANNALS OF THE RHEUMATIC DISEASES, 2015, 74 (02) :381-388
[2]   Biosimilar Uptake in Academic and Veterans Health Administration Settings: Influence of Institutional Incentives [J].
Baker, Joshua F. ;
Leonard, Charles E. ;
Lo Re, Vincent, III ;
Weisman, Michael H. ;
George, Michael D. ;
Kay, Jonathan .
ARTHRITIS & RHEUMATOLOGY, 2020, 72 (07) :1067-1071
[3]   The role of biosimilars in the treatment of rheumatic diseases [J].
Doerner, Thomas ;
Strand, Vibeke ;
Castaneda-Hernandez, Gilberto ;
Ferraccioli, Gianfranco ;
Isaacs, John D. ;
Kvien, Tore K. ;
Martin-Mola, Emilio ;
Mittendorf, Thomas ;
Smolen, Josef S. ;
Burmester, Gerd R. .
ANNALS OF THE RHEUMATIC DISEASES, 2013, 72 (03) :322-328
[4]   A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy [J].
Emery, Paul ;
Vencovsky, Jiri ;
Sylwestrzak, Anna ;
Leszczynski, Piotr ;
Porawska, Wieslawa ;
Baranauskaite, Asta ;
Tseluyko, Vira ;
Zhdan, Vyacheslav M. ;
Stasiuk, Barbara ;
Milasiene, Roma ;
Rodriguez, Aaron Alejandro Barrera ;
Cheong, Soo Yeon ;
Ghil, Jeehoon .
ANNALS OF THE RHEUMATIC DISEASES, 2017, 76 (01) :51-57
[5]   To switch or not to switch: results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry [J].
Glintborg, Bente ;
Loft, Anne Gitte ;
Omerovic, Emina ;
Hendricks, Oliver ;
Linauskas, Asta ;
Espesen, Jakob ;
Danebod, Kamilla ;
Jensen, Dorte Vendelbo ;
Nordin, Henrik ;
Dalgaard, Emil Barner ;
Chrysidis, Stavros ;
Kristensen, Salome ;
Raun, Johnny Lillelund ;
Lindegaard, Hanne ;
Manilo, Natalia ;
Jakobsen, Susanne Hojmark ;
Hansen, Inger Marie Jensen ;
Pedersen, Dorte Dalsgaard ;
Sorensen, Inge Juul ;
Andersen, Lis Smedegaard ;
Grydehoj, Jolanta ;
Mehnert, Frank ;
Krogh, Niels Steen ;
Hetland, Merete Lund .
ANNALS OF THE RHEUMATIC DISEASES, 2019, 78 (02) :192-200
[6]   A nationwide non-medical switch from originator infliximab to biosimilar CT-P13 in 802 patients with inflammatory arthritis: 1-year clinical outcomes from the DANBIO registry [J].
Glintborg, Bente ;
Sorensen, Inge Juul ;
Loft, Anne Gitte ;
Lindegaard, Hanne ;
Linauskas, Asta ;
Hendricks, Oliver ;
Hansen, Inger Marie Jensen ;
Jensen, Dorte Vendelbo ;
Manilo, Natalia ;
Espesen, Jakob ;
Klarlund, Mette ;
Grydehoj, Jolanta ;
Dieperink, Sabine Sparre ;
Kristensen, Salome ;
Olsen, Jimmi Sloth ;
Nordin, Henrik ;
Chrysidis, Stavros ;
Pedersen, Dorte Dalsgaard ;
Sorensen, Michael Veedfald ;
Andersen, Lis Smedegaard ;
Gron, Kathrine Lederballe ;
Krogh, Niels Steen ;
Pedersen, Lars ;
Hetland, Merete Lund .
ANNALS OF THE RHEUMATIC DISEASES, 2017, 76 (08) :1426-1431
[7]   Long-term efficacy and safety of biosimilar infliximab (CT-P13) after switching from originator infliximab: open-label extension of the NOR-SWITCH trial [J].
Goll, G. L. ;
Jorgensen, K. K. ;
Sexton, J. ;
Olsen, I. C. ;
Bolstad, N. ;
Haavardsholm, E. A. ;
Lundin, K. E. A. ;
Tveit, K. S. ;
Lorentzen, M. ;
Berset, I. P. ;
Fevang, B. T. S. ;
Kalstad, S. ;
Ryggen, K. ;
Warren, D. J. ;
Klaasen, R. A. ;
Asak, O. ;
Baigh, S. ;
Blomgren, I. M. ;
Brenna, O. ;
Bruun, T. J. ;
Dvergsnes, K. ;
Frigstad, S. O. ;
Hansen, I. M. ;
Hatten, I. S. H. ;
Huppertz-Hauss, G. ;
Henriksen, M. ;
Hoie, S. S. ;
Krogh, J. ;
Midtgard, I. P. ;
Mielnik, P. ;
Moum, B. ;
Noraberg, G. ;
Poyan, A. ;
Prestegard, U. ;
Rashid, H. U. ;
Strand, E. K. ;
Skjetne, K. ;
Seeberg, K. A. ;
Torp, R. ;
Ystrom, C. M. ;
Vold, C. ;
Zettel, C. C. ;
Waksvik, K. ;
Gulbrandsen, B. ;
Hagfors, J. ;
Mork, C. ;
Jahnsen, J. ;
Kvien, T. K. .
JOURNAL OF INTERNAL MEDICINE, 2019, 285 (06) :653-669
[8]   An Opportunity Missed: Biosimilars in the United States [J].
Goll, Guro L. ;
Kvien, Tore K. .
ARTHRITIS & RHEUMATOLOGY, 2020, 72 (07) :1046-1048
[9]   EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2019 update [J].
Gossec, Laure ;
Baraliakos, Xenofon ;
Kerschbaumer, Andreas ;
de Wit, Maarten ;
McInnes, Iain ;
Dougados, Maxime ;
Primdahl, Jette ;
McGonagle, Dennis G. ;
Aletaha, Daniel ;
Balanescu, Andra ;
Balint, Peter V. ;
Bertheussen, Heidi ;
Boehncke, Wolf-Henning ;
Burmester, Gerd R. ;
Canete, Juan D. ;
Damjanov, Nemanja S. ;
Kragstrup, Tue Wenzel ;
Kvien, Tore K. ;
Landewe, Robert B. M. ;
Lories, Rik Jozef Urbain ;
Marzo-Ortega, Helena ;
Poddubnyy, Denis ;
Rodrigues Manica, Santiago Andres ;
Schett, Georg ;
Veale, Douglas J. ;
Van den Bosch, Filip E. ;
van der Heijde, Desiree ;
Smolen, Josef S. .
ANNALS OF THE RHEUMATIC DISEASES, 2020, 79 (06) :700-712
[10]   Shift From Adalimumab Originator to Biosimilars in Denmark [J].
Jensen, Thomas Bo ;
Kim, Seoyoung C. ;
Jimenez-Solem, Espen ;
Bartels, Dorthe ;
Christensen, Hanne Rolighed ;
Andersen, Jon Traerup .
JAMA INTERNAL MEDICINE, 2020, 180 (06) :902-903