In the paper by Gulácsi et al. [1], the authors stated that biosimilars have the potential to reduce costs and increase patient access to biologicals in the treatment of rheumatoid arthritis (RA) and other chronic inflammatory rheumatic and bowel diseases.
The first biosimilar (CT-P13) for the treatment of inflammatory conditions was authorized in 2013 by the European Medicines Agency (EMA) [2]. The budget impact of the introduction of CT-P13 for treating RA in France, Germany, Italy and the UK was predicted to be Euros 433.5 million (30% discount) over five years [3]. CT-P13 could lead to cost savings of Euros 5 million and Euros 47 million in Ireland and Italy, respectively, over five years [4, 5].
The budget impact of CT-P13 introduction had been estimated for patients with RA in Bulgaria, Czech Republic, Hungary, Poland, Romania and Slovakia [6]. Two scenarios were compared. In the first scenario, only biologically naïve patients received CT-P13, and in the second, swapping from the reference biological to CT‑P13 was permitted. Over three years (25% discount), savings of Euros 15.3‒20.8 million could be made. This would allow the treatment of an additional 1,200‒1,800 patients (8‒10% increase).
Budget savings have also been demonstrated with CT-P13 in inflammatory bowel disease. The total savings from the introduction of CT-P13 to treat Crohn’s disease in France, Italy and the UK, over five years ranged from Euros 76‒336 million [3]. The total savings in Belgium, Germany, Italy, the Netherlands and the UK ranged from Euros 0.7 million (Italy) to Euros 17.9 million (Germany) for Crohn’s disease, and from Euros 0.3 million (UK) to Euros 6.3 million (Germany) for ulcerative colitis, over one year [7]. Considerable savings are predicted in Crohn’s disease in a budget impact analysis conducted in Bulgaria, Czech Republic, Hungary, Poland, Romania and Slovakia [8].
Significant differences in access to biologicals were reported by authors in patients with RA [9], even among countries with similar gross domestic product (GDP) per capita. Great heterogeneity ranging up to 96-fold difference in access of Crohn’s disease patients to biologicals can be found across Central and Eastern Europe [10].
In order for biosimilars to be accepted by healthcare professionals and patients, and therefore be used with confidence, there needs to be robust evidence that they show comparable efficacy and safety to their respective reference biological. Clinical trials and meta-analyses proved that CT-P13 is equivalent to originator infliximab in terms of efficacy and pharmacokinetics, and highly comparable with respect to safety [11].
Another aspect influencing the attitudes of physicians toward biosimilars is reimbursement conditions and gain sharing. Physicians are likely to offer patients already on biological therapy a change to a biosimilar if their patients are the beneficiaries of the cost savings. These savings have the potential to be used either to increase the number of patients with access to biologicals, or to be diverted into other aspects of care [12]. The attitudes and incentives of physicians and patients towards biosimilars are the key issues today; gain-sharing incentive plans should be established to achieve the potential benefit of the introduction of biosimilars.
Conflict of interest
The authors of the research paper [1] reported conflicts of interest including being employees of Celltrion, having been paid as a consultant by Celltrion or having received funding and support for research on biosimilars from EGIS Pharma, the distributor of CT-P13 in Hungary. For full details of the authors’ conflicts of interest, see the research paper [1].
Abstracted by Assistant Professor László Gulácsi, Health Economics and Technology Assessment Research Centre, Department of Public Policy and Management, Corvinus University Budapest, Budapest, Hungary.
References
1. Gulácsi L, Brodszky V, Baji P, et al. Biosimilars for the management of rheumatoid arthritis: economic considerations. Expert Rev Clin Immunol. 2015;11 Suppl 1:43-52.
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 13]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. Kim J, Hong J, Kudrin A. 5 year budget impact analysis of biosimilar infliximab for the treatment of rheumatoid arthritis in UK, Italy, France and Germany. ACR/ARHP Annual Meeting, Boston, MA, USA; November 14-19. 2014.
4. Lucioni C, Mazzi S, Caporali R. Budget impact analysis of infliximab biosimilar: the Italian scenery. GRHTA. 2015;2(2):69-115.
5. McCarthy G, Bitoun CE, Guy H. Introduction of an infliximab biosimilar (CT-P13): a five-year budget impact analysis for the treatment of rheumatoid arthritis in Ireland. Value Health. 2013;16(7):A558.
6. Brodszky V, Baji P, Balogh O, et al. Budget impact analysis of biosimilar infliximab (CT-P13) for the treatment of rheumatoid arthritis in six Central and Eastern European countries. Eur J Health Econ. 2014;15 Suppl 1:S65-71.
7. Jha A, Dunlop W, Upton A. Budget impact analysis of introducing biosimilar infliximab for the treatment of gastro intestinal disorders in five European countries. 10th Congress of the European Crohn’s and Colitis Organisation (ECCO); 2015 Feb 18‒21; Barcelona, Spain.
8. Brodszky N, Rencz F, Péntek M, et al. A budget impact model for biosimilar infliximab in Crohn’s disease in Bulgaria, the Czech Republic, Hungary, Poland, Romania and Slovakia. Expert Rev Pharmacoecon Outcomes Res. 2015;15:1-7. [Epub ahead of print]
9. Péntek M, Poor G, Wiland P, et al. Biological therapy in inflammatory rheumatic diseases: issues in Central and Eastern European countries. Eur J Health Econ 2014;15 Suppl 1:S35-43.
10. Rencz F, Péntek M, Bortlik M, et al. Biological therapy in inflammatory bowel diseases: access in Central and Eastern Europe. World J Gastroenterol. 2015;21(6):1728-37.
11. Baji P, Péntek M, Szántó S, et al. Comparative efficacy and safety of biosimilar infliximab and other biological treatments in ankylosing spondylitis: systematic literature review and meta-analysis. Eur J Health Econ. 2014;15 Suppl 1:S45-52.
12. Baji P, Gulácsi L, Lovasz D, et al. Treatment preferences of originator versus biosimilar drugs in Crohn's disease; discrete choice experiment among gastroenterologists. Scand J Gastroenterol. 2016;51(1):22-7.
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