Variable Access to Clopidogrel in a Harmonized EU Market

Abstract

Objectives This study focuses on the different national coverage and reimbursement strategies and their consequences for access to clopidogrel, a drug with a central European Union (EU) registration. Our objectives are 1) to assess whether changes in reimbursement policies in EU member states influenced clopidogrel prescribing; and 2) to determine whether clopidogrel-specific policy characteristics, general characteristics of the health system, or indicators for the amount of cardiovascular care delivered were associated with the level of clopidogrel prescribing. Methods Data were collected in Austria, Belgium, Denmark, Germany, Hungary, Portugal, Slovenia, The Netherlands, and the United Kingdom (England). Utilization rates were expressed as defined daily doses (DDDs)/1000 persons/day. To determine whether changes in reimbursement policies influenced clopidogrel utilization, a segmented linear regression approach was used. Results Clopidogrel prescribing varied widely in the studied countries, from 2.76 (The Netherlands) to 6.83 (Belgium) DDDs/1000 persons/day (March 2005). Six countries had therapeutic indication restrictions to clopidogrel use. Health system characteristics did not explain variation in clopidogrel prescribing. Conclusion A disconnect will be indicated in this study between the concept of a harmonized EU pharmaceuticals market and the reality in an individual member state. Although clopidogrel was centrally registered in the EU, policy measures at the national level result in different roles in clinical practice for this drug.