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Implementation of coverage with evidence development schemes for medical devices: A decision tool for late technology adopter countries

Author

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  • 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

Abstract

Experiences with coverage with evidence development (CED) schemes are fairly limited in Central and Eastern European (CEE) countries, which are usually late adopters of new health technologies. Our aim was to put forward recommendations on how CEE health technology assessment bodies and payer organizations can apply CED to reduce decision uncertainty on reimbursement of medical devices, with a particular focus on transferring the structure and data from CED schemes in early technology adopter countries in Western Europe. Structured interviews on the practices and feasibility of transferring CED schemes were conducted and subsequently, a draft tool for the systematic classification of decision alternatives and recommendations was developed. The decision tool was reviewed in a focus group discussion and validated within a wider group of CEE experts in a virtual workshop. Transferability assessment is needed in case of (1) joint implementation of a CED scheme; (2) transferring the structure of an existing CED scheme to a CEE country; (3) reimbursement decisions that are linked to outcomes of an ongoing CED scheme in another country and (4) real‐world evidence transferred from completed CED schemes. Efficient use of available resources may be improved by adequately transferring evidence and policy tools from early technology adopter countries.

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  • 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.
  • Handle: RePEc:wly:hlthec:v:31:y:2022:i:s1:p:195-206
    DOI: 10.1002/hec.4504
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    References listed on IDEAS

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    1. 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.
    2. 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.
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