Utilization data and cost-effectiveness of infliximab biosimilar Posted 25/05/2018

Studies of Celltrion/Hospira’s infliximab biosimilar (CT‑P13, Remsima/Inflectra) carried out in Canada and Germany have shown that, although there are large savings to be made, there are ‘significant differences in real-world utilization patterns’ of patients prescribed originator infliximab compared to those prescribed biosimilar infliximab (CT‑P13) [1, 2].

The data was originally presented at the Canadian Digestive Diseases Week (CDDW) 2017 held in Banff, Alberta, Canada on 3–6 March 2017.

Infliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α). It is used to treat autoimmune diseases such as ankylosing spondylitis, Crohn’s disease. psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.

The originator product, Johnson & Johnson and Merck’s Remicade (infliximab), was approved by the US Food and Drug Administration (FDA) in August 1998 and by the European Medicines Agency (EMA) in August 1999 [3]. The infliximab biosimilar CT‑P13 was approved in Europe in September 2013 [4] and in Canada in January 2014 [5].

Researchers from Canada compared the cost-effectiveness of infliximab biosimilar (Inflectra) to originator infliximab (Remicade) for the management of Crohn’s disease [1]. They found that, using a Markov model with a 5-year time horizon, originator infliximab costs CA$190,632 per patient and yields 3.63 quality-adjusted life years (QALYs). Infliximab-dyyb costs CA$128,306 per patient and yields 3.15 QALYs. Using a willingness-to-pay (WTP) threshold of CA$50,000 per QALY, infliximab-dyyb has an 83% probability of being cost-effective, whereas originator infliximab has a 17% probability of being cost-effective.

The authors concluded that ‘infliximab biosmilar resulted in large cost savings despite similar effectiveness to originator infliximab for patients with moderate-to-severe CD’. They added that, based on the results of their model, ‘the mainstream usage of infliximab biosimilar (Inflectra) may help reduce the economic burden associated with CD’.

Due to the low uptake of biosimilars in Canada, researchers carried out an evaluation of treatment initiation and discontinuation in a proxy country, Germany, which has a similar healthcare environment [2]. They evaluated Quintiles IMS longitudinal health insurance prescription data captured patients with an initial claim of originator infliximab (IFX) or CT‑P13 prescribed by a gastroenterologist between February 2015 and October 2016. A total of 636 and 655 patients had follow-up time for inclusion in the 12-month treatment naïve and 6-month post-switch analyses, respectively. Only IFX to CT‑P13 switch utilization was investigated (n = 42). In the matched 6-month post-switch analysis the risk adjusted probability of being retained on treatment was 48% greater in the IFX maintenance group than in the CT‑P13 switch group (RR IFX = 1.48, 95% CI: 1.19–1.85, p = 0.0005).

The authors concluded that ‘findings from Germany demonstrate significant differences in real-world utilization patterns of patients prescribed IFX or CT‑P13 by a gastroenterologist’. They did admit, however, that the sample size of the 6-month analysis was small. In addition, limitations include no distinction between Crohn’s disease and ulcerative colitis, disease severity and the reasons for staying on treatment or switching could not be determined. They ended by saying that ‘future analyses should capture clinical outcomes to better understand observed utilization patterns’.

Conflict of interest
The authors of the abstract [1] declared that the study was funded by the Centre of Excellence for Gastrointestinal Inflammation and Immunity Research.

The authors of the abstract [2] declared that the study was funded by Janssen Inc.

Editor’s Comment
It should be noted that data of the studies presented in this article were published as an abstract and presented at a conference.  These data and conclusions should be considered preliminary until published in a peer-reviewed journal.

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1.  Beilman CL, Ma C, McCabe C, Fedorak R, Halloran BP. A73 Cost-effectiveness of infliximab biosimilar compared to originator infliximab for the management of Crohn’s disease. J Can Assoc Gastroent. 2018;1(S2):114-5.
2.  Ewara E, Jairath V, Marrache M, Baraliakos X. A214 A comparison of real-world utilization patterns of innovator and biosimilar infliximab: a prescription claims data subgroup analysis of German gastroenterologists. J Can Assoc Gastroent. 2018;1(S2):317-8.
3.  Derbyshire M. Patent expiry dates for biologicals: 2017 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1):29-34. doi:10.5639/gabij.2018.0701.007
4.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 25]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
5.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 25]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Canada

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