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

Mike Drummond, Sandor Kovacs, Zoltan Kalo, Rita Daubner-Bendes, Katarzyna Kolasa, Rok Hren, Tomas Tesar, Vivian. Reckers-Droog, Werner B. F. Brouwer, Carlo. Federici, Antal Zemplenyi

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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.
Original languageEnglish
Pages (from-to)195-206
JournalHealth Economics
Issue numberS1
Early online date23 Mar 2022
Publication statusPublished - Sept 2022

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