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Characterising Uncertainty in the Assessment of Medical Devices and Determining Future Research Needs


  • Claire Rothery
  • Karl Claxton
  • Stephen Palmer
  • David Epstein
  • Rosanna Tarricone
  • Mark Sculpher


Decisions about the adoption of medical interventions are informed by evidence on their costs and effects. For a range of reasons, evidence relating to medical devices may be limited. The decision to adopt a device early in its life cycle when the evidence base is least mature may impact on the prospects of acquiring further evidence to reduce uncertainties. Equally, rejecting a device will result in no uptake in practice and hence no chance to learn about performance. Decision options such as ‘only in research’ or ‘approval with research’ can overcome these issues by allowing patients early access to promising new technologies while limiting the risks associated with making incorrect decisions until more evidence or learning is established. In this paper, we set out the issues relating to uncertainty and the value of research specific to devices: learning curve effects, incremental device innovation, investment and irrecoverable costs, and dynamic pricing. We show the circumstances under which an only in research or approval with research scheme may be an appropriate policy choice. We also consider how the value of additional research might be shared between the manufacturer and health sector to help inform who might reasonably be expected to conduct the research needed. © 2017 The Authors. Health Economics published by John Wiley & Sons, Ltd.

Suggested Citation

  • Claire Rothery & Karl Claxton & Stephen Palmer & David Epstein & Rosanna Tarricone & Mark Sculpher, 2017. "Characterising Uncertainty in the Assessment of Medical Devices and Determining Future Research Needs," Health Economics, John Wiley & Sons, Ltd., vol. 26(S1), pages 109-123, February.
  • Handle: RePEc:wly:hlthec:v:26:y:2017:i:s1:p:109-123
    DOI: 10.1002/hec.3467

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    References listed on IDEAS

    1. Simon Walker & Mark Sculpher & Karl Claxton & Steve Palmer, 2012. "Coverage with evidence development, only in research, risk sharing or patient access scheme? A framework for coverage decisions," Working Papers 077cherp, Centre for Health Economics, University of York.
    2. Briggs, Andrew & Sculpher, Mark & Claxton, Karl, 2006. "Decision Modelling for Health Economic Evaluation," OUP Catalogue, Oxford University Press, number 9780198526629, Decembrie.
    3. Claire McKenna & Karl Claxton, 2011. "Addressing Adoption and Research Design Decisions Simultaneously," Medical Decision Making, , vol. 31(6), pages 853-865, November.
    4. Drummond, Michael F. & Sculpher, Mark J. & Claxton, Karl & Stoddart, Greg L. & Torrance, George W., 2015. "Methods for the Economic Evaluation of Health Care Programmes," OUP Catalogue, Oxford University Press, edition 4, number 9780199665884, Decembrie.
    5. Martelli, Nicolas & van den Brink, Hélène, 2014. "Special funding schemes for innovative medical devices in French hospitals: The pros and cons of two different approaches," Health Policy, Elsevier, vol. 117(1), pages 1-5.
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    Cited by:

    1. Tarricone, Rosanna & Amatucci, Fabio & Armeni, Patrizio & Banks, Helen & Borsoi, Ludovica & Callea, Giuditta & Ciani, Oriana & Costa, Francesco & Federici, Carlo & Torbica, Aleksandra & Marletta, Marc, 2021. "Establishing a national HTA program for medical devices in Italy: Overhauling a fragmented system to ensure value and equal access to new medical technologies," Health Policy, Elsevier, vol. 125(5), pages 602-608.
    2. Aleksandra Torbica & Rosanna Tarricone & Jonas Schreyögg & Mike Drummond, 2022. "Pushing the boundaries of evaluation, diffusion, and use of medical devices in Europe: Insights from the COMED project," Health Economics, John Wiley & Sons, Ltd., vol. 31(S1), pages 1-9, September.
    3. Michael Drummond & Carlo Federici & Vivian Reckers‐Droog & Aleksandra Torbica & Carl Rudolf Blankart & Oriana Ciani & Zoltán Kaló & Sándor Kovács & Werner Brouwer, 2022. "Coverage with evidence development for medical devices in Europe: Can practice meet theory?," Health Economics, John Wiley & Sons, Ltd., vol. 31(S1), pages 179-194, September.
    4. Rosanna Tarricone & Aleksandra Torbica & Michael Drummond & for the MedtecHTA Project Group, 2017. "Key Recommendations from the MedtecHTA Project," Health Economics, John Wiley & Sons, Ltd., vol. 26(S1), pages 145-152, February.
    5. Sandor Kovács & Zoltán Kaló & Rita Daubner‐Bendes & Katarzyna Kolasa & Rok Hren & Tomas Tesar & Vivian Reckers‐Droog & Werner Brouwer & Carlo Federici & Mike Drummond & Antal Tamás Zemplényi, 2022. "Implementation of coverage with evidence development schemes for medical devices: A decision tool for late technology adopter countries," Health Economics, John Wiley & Sons, Ltd., vol. 31(S1), pages 195-206, September.
    6. Rosanna Tarricone & Aleksandra Torbica & Michael Drummond, 2017. "Challenges in the Assessment of Medical Devices: The MedtecHTA Project," Health Economics, John Wiley & Sons, Ltd., vol. 26(S1), pages 5-12, February.

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