Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/14419
Title: European drug reimbursement systems' legitimacy : five-country comparison and policy tool
Authors: CLEEMPUT, Irina 
Franken, Margreet
Koopmanschap, Marc
le Polain, Maite
Issue Date: 2012
Publisher: CAMBRIDGE UNIV PRESS
Source: INTERNATIONAL JOURNAL OF TECHNOLOGY ASSESSMENT IN HEALTH CARE, 28 (4), p. 358-366
Abstract: Objectives. In a democratic system, decision makers are accountable for the reasonableness of their decisions. This presumes (i) transparency, (ii) relevance of the decision criteria, (iii) revisability of decisions, and (iv) enforcement/regulation. We aim to (i) evaluate the extent to which drug reimbursement decision-making processes in different contexts meet these conditions and (ii) develop, starting from these findings, a framework for improving the transparency and the relevance of used decision criteria. Methods. We evaluated the Austrian, Belgian, French, Dutch, and Swedish drug reimbursement systems. Based on this evaluation, we developed a framework for improving the transparency of drug reimbursement decision-making processes. It makes explicit the questions often addressed implicitly during decision-making processes as well as criteria for answering each question. Results. Transparency of appraisal processes varies across systems. Justification with explicit criteria is generally limited. Although relevant criteria are similar across systems, their operationalization varies and their role in the appraisal process is not always clear. All systems seem to implicitly address five key questions, relating to (i) the medical, therapeutic, and societal need for treatment; (ii) preparedness to pay for treating the condition as a principle and (iii) for using the treatment under consideration; (iv) preparedness to pay more compared with alternatives; and (v) actual willingness to pay from public resources. Conclusions. Transparency of the appraisal process can be improved by using an explicit decision framework. Systematic use of such a framework enhances consistency across decisions, allows justification of value judgments, and thus enhances legitimacy of societal decision making.
Notes: [Cleemput, Irina] Belgian Hlth Care Knowledge Ctr KCE, Adm Centrum Kruidtuin, Brussels, Belgium. [Cleemput, Irina] Hasselt Univ, Diepenbeek, Belgium. [Franken, Margreet; Koopmanschap, Marc] Erasmus Univ, Inst Hlth Policy & Management BMG, Rotterdam, Netherlands. Irina.Cleemput@kce.fgov.be
Keywords: Drug reimbursement; Decision making; Advisory committees; Pharmaceutical economics;Health Care Sciences & Services; Public, Environmental & Occupational Health; Medical Informatics; drug reimbursement; decision making; advisory committees; pharmaceutical economics
Document URI: http://hdl.handle.net/1942/14419
ISSN: 0266-4623
e-ISSN: 1471-6348
DOI: 10.1017/S0266462312000529
ISI #: 000309929200003
Category: A1
Type: Journal Contribution
Validations: ecoom 2013
Appears in Collections:Research publications

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