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EUROPEAN DRUG REIMBURSEMENT SYSTEMS' LEGITIMACY: FIVE-COUNTRY COMPARISON AND POLICY TOOL

Published online by Cambridge University Press:  17 September 2012

Irina Cleemput ,
Margreet Franken ,
Marc Koopmanschap  and
Maïté le Polain
Irina Cleemput
Affiliation:
Belgian Health Care Knowledge Centre (KCE), Brussels, Belgium, and Hasselt University, Diepenbeek, Belgium e-mail: Irina.Cleemput@kce.fgov.be
Margreet Franken
Affiliation:
Institute of Health Policy and Management (BMG), Erasmus University Rotterdam, the Netherlands
Marc Koopmanschap
Affiliation:
Institute of Health Policy and Management (BMG), Erasmus University Rotterdam, the Netherlands
Maïté le Polain
Affiliation:
Belgian Health Care Knowledge Centre (KCE), Brussels, Belgium
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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.

Keywords

Drug reimbursementDecision makingAdvisory committeesPharmaceutical economics
Type
POLICIES
Information
International Journal of Technology Assessment in Health Care , Volume 28 , Issue 4 , October 2012 , pp. 358 - 366
Copyright
Copyright © Cambridge University Press 2012

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