Patients with IBD often require treatment with the costly biological infliximab. Publicly subsidized drug plans in Canada and elsewhere have introduced polices requiring newly diagnosed IBD patients to use lower cost but similarly effective biosimilars; or require a non-medical switch to a biosimilar for established IBD patients. 

These polices have caused controversy among some patients and clinicians due to a lack of long-term data on the safety and efficacy of biosimilars and the erosion of treatment choice [2]. Drug plans rely on results from economic evaluations to inform formulary listing decisions for new medications. 

Typically, pharmacoeconomic evaluations include a sensitivity analysis whereby drug price is varied to determine the cost-effectiveness of new drugs at various decision-maker willingness-to-pay (WTP) thresholds. In the absence of head-to-head comparisons of originator to biosimilar infliximab, examining published economic evaluations of infliximab that included sensitivity analysis of biological drug price could provide insight into the cost-effectiveness of biosimilar alternatives. 

Bashir NS et al. conducted a systematic literature review to examine the effect of infliximab price variation on cost-effectiveness to inform drug plan decision-making [1]. A search of 10 medical literature databases including MEDLINE and Embase, as well as repositories of economic evaluations and health technology assessment agency reports resulted in 31 publications examining infliximab for the treatment of IBD that varied infliximab price in 42 sensitivity analyses. 

Studies were conducted in the US, Canada, Spain, Sweden, the UK, The Netherlands, France, Italy, Japan, China, and Iran. The infliximab price deemed to be cost-effective within each study ranged from CAD 66 to CAD 1,260 per 100 mg vial. In 18 (58%) analyses, the results were above the country’s WTP threshold for adopting new medications. Analyses exceeding the WTP threshold were conducted in the US (9), Canada (3), Spain (3), Sweden (1), Italy (1) and Iran (1). Studies with results below the WTP threshold were conducted in Canada (3), UK (3), US (2), Germany (2), Belgium (2), Italy (2), France (2), Netherlands (2), Hungary (2), Sweden (2), Spain (1) and Japan (1).

The review by Bashir NS et al. highlighted that if policy decisions are based on price, then originator infliximab manufacturers could consider reducing the price or negotiating alternative pricing schemes to enable IBD patients to stay on their current medications. 

Bashir NS et al. reported limitations of the research were that drug prices were not always reported separately, WTP thresholds varied between countries, and study funding sources were not always reported.

Conflict of interest
The authors of the research paper [1] declare that there were no conflicts of interest.

Abstracted by Wendy J Ungar, Senior Scientist in Child Health Evaluative Sciences at the Hospital for Sick Children Research Institute, Toronto, Canada.

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Extrapolation of biosimilar infliximab indications to inflammatory bowel disease

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References
1. Bashir NS, Hughes A, Ungar WJ. Infliximab pricing in international economic evaluations in inflammatory bowel disease to inform biologic and biosimilar access policies: a systematic review. MDM Policy Pract. 2023;8(1):23814683231156433. 
2. Kaplan GG, Ma C, Seow CH, Kroeker KI, Panaccione R. The argument against a biosimilar switch policy for infliximab in patients with inflammatory bowel disease living in Alberta. J Can Assoc Gastroenterol. 2020;3(5):234-42.

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