Critical issues in comparing the use of biologicals across various European countries: TNF inhibitors as case study.

Hoebert, J.M., Mantel-Teeuwisse, A.K., Dijk, L. van, Laing, R.O., Leufkens, H.G.M. Critical issues in comparing the use of biologicals across various European countries: TNF inhibitors as case study. Pharmacoepidemiology and Drug Safety: 2010, 19(Supp. 1) S 184- S 185. Abstract: 26th International conference 'Pharmacoepidemiology & Therapeutic Risk Management', 19-22 augustus 2010, Brighton, UK.
Background: Access to and regulations around new and effective, but highly expensive biologicals offer challenges for policy makers in all European countries. However, due to a number of specific features related to biologicals (e.g. direct delivery to patients, disease based/not population based registries, insurer driven variable access) utilization data may be erratic, incomplete and not be readily available. Objectives: To identify and characterize the critical issues in collecting comparable, reliable and publicly available national utilization data on TNF inhibitors (as case study) in different EU Member States and to compare the use in the countries where these data were available. Methods: TNF inhibitor utilization data were collected in Denmark, Finland, Ireland, the Netherlands, Norway and Portugal (yearly data; 2003–2007). Utilization rates were expressed as defined daily doses/1000 inhabitants/day. Qualitative data on policy measures, guideline preferences and supply side measures were collected by means of a questionnaire filled in by country representatives. Results: TNF utilization was captured by different types of available data; dispensing, wholesalers and claims data. Four sources differentiated between sales to in- or outpatient health care centers. For all countries an increase in use over time was observed. TNF inhibitor utilization varied widely from 0.25 (Portugal) to 1.89 (Norway) DDDs/1000inh/day (2006). Reimbursement restrictions and supply side measures differed among countries. Conclusions: In most European countries, data on national TNF utilization is not easily accessible, if at all. Differences between data sources may hamper direct comparisons of utilization rates. From the available data a large variation in utilization of TNF inhibitors was observed. For optimal decision making on safety and cost effectiveness, access of biologicals in general, innovative methods of data capturing are required.