Value Assessment and Quantitative Benefit-Risk Modelling of Biosimilar Infliximab for Crohn's Disease



Catt, Heather ORCID: 0000-0001-9515-7497, Bodger, Keith ORCID: 0000-0002-1825-3239, Kirkham, Jamie J ORCID: 0000-0003-2579-9325 and Hughes, Dyfrig A ORCID: 0000-0001-8247-7459
(2019) Value Assessment and Quantitative Benefit-Risk Modelling of Biosimilar Infliximab for Crohn's Disease. PHARMACOECONOMICS, 37 (12). pp. 1509-1523.

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Abstract

<h4>Background and objective</h4>Regulatory approval of biosimilars often depends on extrapolating evidence from one clinical indication to all of those of the originator biologic. We aimed to develop a quantitative benefit-risk analysis to assess whether the resulting increase in the uncertainty in the clinical performance of biosimilars (i.e. risk) may be countered by their lower pricing (benefit).<h4>Methods</h4>A 1-year decision-analytic model was developed for the biosimilar infliximab (Inflectra<sup>®</sup>) for Crohn's disease. The perspective was that of the National Health Service in the UK and costs were valued to 2015/16. A hypothetical cohort of biologic-naïve patients with moderate-to-severe Crohn's disease was simulated through the model. Immunogenicity to infliximab was a key modifier, influencing rates of non-response and infusion reactions. Net health benefit was estimated based on quality-adjusted life-years. A range of sensitivity analyses tested the robustness of the results and explored how the biosimilar price must respond to varying immunogenicity to remain the preferred option.<h4>Results</h4>The base-case analysis predicted a positive incremental net health benefit of 0.04 (95% central range 0.00-0.09) favouring the biosimilar, based on 0.803 quality-adjusted life-years, and costs of £18,087 and £19,176 for the biosimilar and originator, respectively. Two-way sensitivity analyses suggested that if 50% of patients developed antibodies, the value-based price of £410 per vial must be lower than that of the originator (£420), but remain higher than the actual market price (£378).<h4>Conclusions</h4>The model supports the use of Inflecta<sup>®</sup> for Crohn's disease in the UK, and provides a framework for the quantitative evaluation of biosimilars in the context of a health technology assessment. Value-based pricing using this methodology could protect health systems from the potential risks of biosimilars where they are untested in the approved populations.

Item Type: Article
Uncontrolled Keywords: Humans, Crohn Disease, Gastrointestinal Agents, Models, Economic, Monte Carlo Method, Risk Assessment, Cohort Studies, Decision Trees, Quality-Adjusted Life Years, Cost-Benefit Analysis, Biosimilar Pharmaceuticals, Infliximab
Depositing User: Symplectic Admin
Date Deposited: 17 Jul 2019 08:41
Last Modified: 19 Jan 2023 00:37
DOI: 10.1007/s40273-019-00826-0
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3050053