Heather Catt1,2, Keith Bodger1,3, Jamie J Kirkham1,4, Dyfrig A Hughes5. 1. MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Liverpool, UK. 2. School of Health Sciences, Division of Population Health, Health Services Research and Primary Care, Manchester University, Manchester, UK. 3. Aintree University Hospital NHS Trust, Digestive Diseases Centre, Liverpool, UK. 4. Centre for Biostatistics, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK. 5. Centre for Health Economics and Medicines Evaluation, Bangor University, Ardudwy, Holyhead Road, Bangor, LL57 2PZ, UK. d.a.hughes@bangor.ac.uk.
Abstract
BACKGROUND AND OBJECTIVE: 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). METHODS: A 1-year decision-analytic model was developed for the biosimilar infliximab (Inflectra®) 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. RESULTS: 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). CONCLUSIONS: The model supports the use of Inflecta® 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.
BACKGROUND AND OBJECTIVE: 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). METHODS: A 1-year decision-analytic model was developed for the biosimilar infliximab (Inflectra®) 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. RESULTS: 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). CONCLUSIONS: The model supports the use of Inflecta® 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.
Authors: Corey A Siegel; Samuel R G Finlayson; Bruce E Sands; Anna N A Tosteson Journal: Clin Gastroenterol Hepatol Date: 2011-10-01 Impact factor: 11.382
Authors: Nicholas A Kennedy; Graham A Heap; Harry D Green; Benjamin Hamilton; Claire Bewshea; Gareth J Walker; Amanda Thomas; Rachel Nice; Mandy H Perry; Sonia Bouri; Neil Chanchlani; Neel M Heerasing; Peter Hendy; Simeng Lin; Daniel R Gaya; J R Fraser Cummings; Christian P Selinger; Charlie W Lees; Ailsa L Hart; Miles Parkes; Shaji Sebastian; John C Mansfield; Peter M Irving; James Lindsay; Richard K Russell; Timothy J McDonald; Dermot McGovern; James R Goodhand; Tariq Ahmad Journal: Lancet Gastroenterol Hepatol Date: 2019-02-27
Authors: Fernando Gomollón; Axel Dignass; Vito Annese; Herbert Tilg; Gert Van Assche; James O Lindsay; Laurent Peyrin-Biroulet; Garret J Cullen; Marco Daperno; Torsten Kucharzik; Florian Rieder; Sven Almer; Alessandro Armuzzi; Marcus Harbord; Jost Langhorst; Miquel Sans; Yehuda Chowers; Gionata Fiorino; Pascal Juillerat; Gerassimos J Mantzaris; Fernando Rizzello; Stephan Vavricka; Paolo Gionchetti Journal: J Crohns Colitis Date: 2016-09-22 Impact factor: 9.071
Authors: Brian G Feagan; William J Sandborn; Christopher Gasink; Douglas Jacobstein; Yinghua Lang; Joshua R Friedman; Marion A Blank; Jewel Johanns; Long-Long Gao; Ye Miao; Omoniyi J Adedokun; Bruce E Sands; Stephen B Hanauer; Severine Vermeire; Stephan Targan; Subrata Ghosh; Willem J de Villiers; Jean-Frédéric Colombel; Zsolt Tulassay; Ursula Seidler; Bruce A Salzberg; Pierre Desreumaux; Scott D Lee; Edward V Loftus; Levinus A Dieleman; Seymour Katz; Paul Rutgeerts Journal: N Engl J Med Date: 2016-11-17 Impact factor: 91.245
Authors: Paul Moayyedi; Eric I Benchimol; David Armstrong; Cathy Yuan; Aida Fernandes; Grigorios I Leontiadis Journal: J Can Assoc Gastroenterol Date: 2019-11-08