IDEAS home Printed from https://ideas.repec.org/a/spr/pharme/v37y2019i12d10.1007_s40273-019-00826-0.html
   My bibliography  Save this article

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

Author

Listed:
  • Heather Catt

    (University of Liverpool
    Manchester University)

  • Keith Bodger

    (University of Liverpool
    Digestive Diseases Centre)

  • Jamie J. Kirkham

    (University of Liverpool
    University of Manchester)

  • Dyfrig A. Hughes

    (Centre for Health Economics and Medicines Evaluation, Bangor University)

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.

Suggested Citation

  • Heather Catt & Keith Bodger & Jamie J. Kirkham & Dyfrig A. Hughes, 2019. "Value Assessment and Quantitative Benefit-Risk Modelling of Biosimilar Infliximab for Crohn’s Disease," PharmacoEconomics, Springer, vol. 37(12), pages 1509-1523, December.
    • Handle: RePEc:spr:pharme:v:37:y:2019:i:12:d:10.1007_s40273-019-00826-0
    DOI: 10.1007/s40273-019-00826-0
    as

    Download full text from publisher

    File URL: http://link.springer.com/10.1007/s40273-019-00826-0
    File Function: Abstract
    Download Restriction: Access to the full text of the articles in this series is restricted.
    File URL: https://libkey.io/10.1007/s40273-019-00826-0?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    As the access to this document is restricted, you may want to search for a different version of it.

    References listed on IDEAS

    as
    1. Aaron A. Stinnett & John Mullahy, 1998. "Net Health Benefits: A New Framework for the Analysis of Uncertainty in Cost-Effectiveness Analysis," NBER Technical Working Papers 0227, National Bureau of Economic Research, Inc.
    Full references (including those not matched with items on IDEAS)

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Manuel Antonio Espinoza & Andrea Manca & Karl Claxton & Mark Sculpher, 2018. "Social value and individual choice: The value of a choice‐based decision‐making process in a collectively funded health system," Health Economics, John Wiley & Sons, Ltd., vol. 27(2), pages 28-40, February.
    2. A. E. Ades & Karl Claxton & Mark Sculpher, 2006. "Evidence synthesis, parameter correlation and probabilistic sensitivity analysis," Health Economics, John Wiley & Sons, Ltd., vol. 15(4), pages 373-381, April.
    3. Basu, Anirban & Jena, Anupam B. & Philipson, Tomas J., 2011. "The impact of comparative effectiveness research on health and health care spending," Journal of Health Economics, Elsevier, vol. 30(4), pages 695-706, July.
    4. Karl Claxton & Elisabeth Fenwick & Mark J. Sculpher, 2012. "Decision-making with Uncertainty: The Value of Information," Chapters, in: Andrew M. Jones (ed.), The Elgar Companion to Health Economics, Second Edition, chapter 51, Edward Elgar Publishing.
    5. Simon Eckermann & Tim Coelli, 2008. "Including quality attributes in a model of health care efficiency: A net benefit approach," CEPA Working Papers Series WP032008, School of Economics, University of Queensland, Australia.
    6. Frank G. Sandmann & Julie V. Robotham & Sarah R. Deeny & W. John Edmunds & Mark Jit, 2018. "Estimating the opportunity costs of bed‐days," Health Economics, John Wiley & Sons, Ltd., vol. 27(3), pages 592-605, March.
    7. Clarke, Philip M. & Hayes, Alison J., 2009. "Measuring achievement: Changes in risk factors for cardiovascular disease in Australia," Social Science & Medicine, Elsevier, vol. 68(3), pages 552-561, February.
    8. Niklas Zethraeus & Magnus Johannesson & Bengt Jönsson & Mickael Löthgren & Magnus Tambour, 2003. "Advantages of Using the Net-Benefit Approach for Analysing Uncertainty in Economic Evaluation Studies," PharmacoEconomics, Springer, vol. 21(1), pages 39-48, January.
    9. Moreno, Elías & Girón, F.J. & Vázquez-Polo, F.J. & Negrín, M.A., 2012. "Optimal healthcare decisions: The importance of the covariates in cost–effectiveness analysis," European Journal of Operational Research, Elsevier, vol. 218(2), pages 512-522.
    10. Jordan Amdahl & Jose Diaz & Arati Sharma & Jinhee Park & David Chandiwana & Thomas E Delea, 2017. "Cost-effectiveness of pazopanib versus sunitinib for metastatic renal cell carcinoma in the United Kingdom," PLOS ONE, Public Library of Science, vol. 12(6), pages 1-18, June.
    11. Emma McIntosh, 2006. "Using Discrete Choice Experiments within a Cost-Benefit Analysis Framework," PharmacoEconomics, Springer, vol. 24(9), pages 855-868, September.
    12. Martin Henriksson & Fredrik Lundgren & Per Carlsson, 2006. "Informing the efficient use of health care and health care research resources ‐ the case of screening for abdominal aortic aneurysm in Sweden," Health Economics, John Wiley & Sons, Ltd., vol. 15(12), pages 1311-1322, December.
    13. Jing Voon Chen & Julia L. Higle & Michael Hintlian, 2018. "A systematic approach for examining the impact of calibration uncertainty in disease modeling," Computational Management Science, Springer, vol. 15(3), pages 541-561, October.
    14. Rachael L. Fleurence, 2007. "Setting priorities for research: a practical application of 'payback' and expected value of information," Health Economics, John Wiley & Sons, Ltd., vol. 16(12), pages 1345-1357.
    15. Claxton, Karl & Asaria, Miqdad & Chansa, Collins & Jamison, Julian & Lomas, James & Ochalek, Jessica & Paulden, Mike, 2019. "Accounting for timing when assessing health-related policies," LSE Research Online Documents on Economics 100038, London School of Economics and Political Science, LSE Library.
    16. Marta O. Soares & Simon Walker & Stephen J. Palmer & Mark J. Sculpher, 2018. "Establishing the Value of Diagnostic and Prognostic Tests in Health Technology Assessment," Medical Decision Making, , vol. 38(4), pages 495-508, May.
    17. Helen Dakin & Sarah Wordsworth, 2013. "Cost‐Minimisation Analysis Versus Cost‐Effectiveness Analysis, Revisited," Health Economics, John Wiley & Sons, Ltd., vol. 22(1), pages 22-34, January.
    18. David Brain & Ruth Tulleners & Xing Lee & Qinglu Cheng & Nicholas Graves & Rosana Pacella, 2019. "Cost-effectiveness analysis of an innovative model of care for chronic wounds patients," PLOS ONE, Public Library of Science, vol. 14(3), pages 1-13, March.
    19. Claire McKenna & Karl Claxton, 2011. "Addressing Adoption and Research Design Decisions Simultaneously," Medical Decision Making, , vol. 31(6), pages 853-865, November.
    20. Fabienne Abadie & Christian Boehler, 2015. "Monitoring and Assessment Framework for the European Innovation Partnership on Active and Healthy Ageing (MAFEIP) - Conceptual description of the Monitoring and Assessment Framework for the EIP on AHA," JRC Research Reports JRC96205, Joint Research Centre.

    More about this item

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:spr:pharme:v:37:y:2019:i:12:d:10.1007_s40273-019-00826-0. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Sonal Shukla or Springer Nature Abstracting and Indexing (email available below). General contact details of provider: http://www.springer.com .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.