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Exploring the Assessment and Appraisal of Regenerative Medicines and Cell Therapy Products: Is the NICE Approach Fit for Purpose?


  • Marsden, G.
  • Towse, A.


In 2016 the University of York undertook a review exercise to determine whether NICE's existing methods and processes are appropriate for assessment of regenerative medicines. The purpose of this OHE report is to explore this review exercise and to assess whether or not the resulting conclusions are appropriate. The Report concludes that the York and NICE exercise provided a thorough mock appraisal of CAR T cell therapy. However, it did not seek to identify the most suitable approach for assessing regenerative medicines, but rather to test whether regenerative medicines could fit into the existing pathway developed for conventional medicines. The authors suggest a more interesting question would have been to look at whether or not use of the existing pathway is the most suitable approach, rather than whether or not it is possible. The report also questions the relevance of some additional parameters that were presented to the expert panel as part of the mock appraisal, arguing that the presentation of uncertainty is potentially misleading. It also suggests that NICE's end of life criteria and criteria for allowing use of a 1.5% discount rate should be amended in the context of regenerative medicines.

Suggested Citation

  • Marsden, G. & Towse, A., 2017. "Exploring the Assessment and Appraisal of Regenerative Medicines and Cell Therapy Products: Is the NICE Approach Fit for Purpose?," Consulting Reports 001802, Office of Health Economics.
  • Handle: RePEc:ohe:conrep:001802

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    References listed on IDEAS

    1. He, Xue-Zhong & Zheng, Huanhuan, 2016. "Trading heterogeneity under information uncertainty," Journal of Economic Behavior & Organization, Elsevier, vol. 130(C), pages 64-80.
    2. Kenneth Clements & Yihui Lan & Jiawei Si, 2018. "Uncertainty in currency mispricing," Applied Economics, Taylor & Francis Journals, vol. 50(20), pages 2297-2312, April.
    3. Barnsley, P. & Cubi-Molla, P. & Fischer, A. & Towse, A., 2016. "Uncertainty and Risk in HTA Decision Making," Research Papers 001764, Office of Health Economics.
    4. Sebastian Hinde & Eldon Spackman, 2015. "Bidirectional Citation Searching to Completion: An Exploration of Literature Searching Methods," PharmacoEconomics, Springer, vol. 33(1), pages 5-11, January.
    5. Huseyin Gulen & Mihai Ion, 2016. "Editor's Choice Policy Uncertainty and Corporate Investment," Review of Financial Studies, Society for Financial Studies, vol. 29(3), pages 523-564.
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    Cited by:

    1. Hampson, G. & Mott, D. & Devlin, N. & Shah, K., 2019. "Public Preferences for Health Gains and Cures: A Discrete Choice Experiment," Consulting Reports 002108, Office of Health Economics.
    2. Bengt Jönsson & Grace Hampson & Jonathan Michaels & Adrian Towse & J.-Matthias Graf Schulenburg & Olivier Wong, 2019. "Advanced therapy medicinal products and health technology assessment principles and practices for value-based and sustainable healthcare," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 20(3), pages 427-438, April.

    More about this item


    Judging value for money and improving decision making;

    JEL classification:

    • I1 - Health, Education, and Welfare - - Health

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