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Coverage with evidence development schemes for medical devices in Europe: characteristics and challenges

Author

Listed:
  • Carlo Federici

    (Bocconi University
    Warwick University)

  • Vivian Reckers-Droog

    (Erasmus University Rotterdam)

  • Oriana Ciani

    (Bocconi University
    University of Exeter)

  • Florian Dams

    (University of Bern
    Swiss Institute of Translational and Entrepreneurial Medicine (Sitem-Insel AG))

  • Bogdan Grigore

    (University of Exeter)

  • Zoltán Kaló

    (Syreon Research Institute)

  • Sándor Kovács

    (Syreon Research Institute)

  • Kosta Shatrov

    (University of Bern
    Swiss Institute of Translational and Entrepreneurial Medicine (Sitem-Insel AG))

  • Werner Brouwer

    (Erasmus University Rotterdam
    Erasmus University Rotterdam)

  • Michael Drummond

    (University of York)

Abstract

Objectives Medical devices are potentially good candidates for coverage with evidence development (CED) schemes, as clinical data at market entry are often sparse and (cost-)effectiveness depends on real-world use. The objective of this research was to explore the diffusion of CED schemes for devices in Europe, and the factors that favour or hamper their utilization. Methods We conducted structured interviews with 25 decision-makers from 22 European countries to explore the characteristics of existing CED programmes for devices, and how decision makers perceived 13 pre-identified challenges associated with initiating and operating CED schemes for devices. We also collected data on individual schemes that were either initiated or still ongoing in the last 5 years. Results We identified seven countries with CED programmes for devices and 78 ongoing schemes. The characteristics of CED programmes varied across countries, including eligibility criteria, roles and responsibilities of stakeholders, funding arrangements, and type of decisions being contemplated at the outset of each scheme. We observed a high variability in how decision makers perceived CED-related challenges possibly reflecting country-specific arrangements and different experiences with CED. One general finding across all countries was that relatively little attention was paid to the evaluation of schemes, both during and at their completion. Conclusions CED programmes for devices with different characteristics exist in Europe. Decision-makers’ perceptions differ on the challenges associated with these schemes. More exchange of knowledge and experience will help decision makers anticipate the likely challenges in CED schemes for devices, and to learn from good practices existing elsewhere.

Suggested Citation

  • Carlo Federici & Vivian Reckers-Droog & Oriana Ciani & Florian Dams & Bogdan Grigore & Zoltán Kaló & Sándor Kovács & Kosta Shatrov & Werner Brouwer & Michael Drummond, 2021. "Coverage with evidence development schemes for medical devices in Europe: characteristics and challenges," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 22(8), pages 1253-1273, November.
  • Handle: RePEc:spr:eujhec:v:22:y:2021:i:8:d:10.1007_s10198-021-01334-9
    DOI: 10.1007/s10198-021-01334-9
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    References listed on IDEAS

    as
    1. Josh J. Carlson & Shuxian Chen & Louis P. Garrison, 2017. "Performance-Based Risk-Sharing Arrangements: An Updated International Review," PharmacoEconomics, Springer, vol. 35(10), pages 1063-1072, October.
    2. 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, pages 109-123, February.
    3. 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.
    4. Michael Drummond & Rosanna Tarricone & Aleksandra Torbica, 2016. "Incentivizing research into the effectiveness of medical devices," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 17(9), pages 1055-1058, December.
    5. Panos Kanavos & Olivier Wouters & Panos Kanavos & Alessandra Ferrario & Giovanni Tafuri & Paolo Siviero, 2017. "Managing Risk and Uncertainty in Health Technology Introduction: The Role of Managed Entry Agreements," Global Policy, London School of Economics and Political Science, vol. 8, pages 84-92, March.
    6. repec:bla:glopol:v:8:y:2017:i:s2:p:84-92 is not listed on IDEAS
    7. Trevor Jozef Piatkiewicz & Janine Marie Traulsen & Tove Holm-Larsen, 2018. "Risk-Sharing Agreements in the EU: A Systematic Review of Major Trends," PharmacoEconomics - Open, Springer, vol. 2(2), pages 109-123, June.
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    Cited by:

    1. Carlo Federici & Leandro Pecchia, 2022. "Exploring the misalignment on the value of further research between payers and manufacturers. A case study on a novel total artificial heart," Health Economics, John Wiley & Sons, Ltd., vol. 31(S1), pages 98-115, September.
    2. 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.
    3. 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.
    4. 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.

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    More about this item

    Keywords

    Coverage with evidence development; Medical devices; European HTA policies; Value of information; Adoption and reimbursement of medical devices;
    All these keywords.

    JEL classification:

    • I18 - Health, Education, and Welfare - - Health - - - Government Policy; Regulation; Public Health

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