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EUROPEAN DRUG REIMBURSEMENT SYSTEMS' LEGITIMACY: FIVE-COUNTRY COMPARISON AND POLICY TOOL.
MedLine Citation:
PMID:  22980497     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
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.
Authors:
Irina Cleemput; Margreet Franken; Marc Koopmanschap; Maïté le Polain
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-9-17
Journal Detail:
Title:  International journal of technology assessment in health care     Volume:  -     ISSN:  1471-6348     ISO Abbreviation:  Int J Technol Assess Health Care     Publication Date:  2012 Sep 
Date Detail:
Created Date:  2012-9-17     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8508113     Medline TA:  Int J Technol Assess Health Care     Country:  -    
Other Details:
Languages:  ENG     Pagination:  1-9     Citation Subset:  -    
Affiliation:
Belgian Health Care Knowledge Centre (KCE), Brussels, Belgium, and Hasselt University, Diepenbeek, Belgium e-mail: Irina.Cleemput@kce.fgov.be.
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