Harmonising relative effectiveness assessments of medicines in Europe

Abstract

The national reimbursement decisions of new medicines in European countries are based on multiple criteria, such as the relative effectiveness, value for money, costs, social and ethical considerations. The relative effectiveness is the extent to which an intervention does more good than harm compared to already available treatment(s). Although reimbursement criteria differ per country, the relative effectiveness is very relevant in many European countries. For this reason, multiple countries simultaneously write their own relative effectiveness assessment (REA) report of the same medicine. There are potential quality and efficiency gains for European countries to collaborate in the production of these REAs. Since more harmonisation is a prerequisite for collaboration, we have studied the possibilities for harmonising REAs in Europe. There is general willingness to cooperate in the development and standardisation of methods for REAs in Europe and it is expected to lead to an increase of quality and expertise throughout Europe. But, the willingness to produce and use joint REAs is not yet shared by all countries, and increases with potential efficiency gains. The potential efficiency gains are highest for smaller/middle-sized European countries and also European countries with less developed HTA systems. We found that important methodological aspects for REAs are approached in a similar way in many European jurisdictions. Nonetheless, there are also differences that should be considered when jointly producing REAs (hereafter referred as joint REAs). In order to cover the needs of multiple jurisdictions joint REAs should be comprehensive in terms of relevant comparators, endpoints, studies included and the uncertainty of the evidence. If there is a lot of variation in treatment patterns between countries or if multiple comparators are available indirect comparisons are likely to play a relevant role in joint REAs, as it is highly unlikely that direct evidence is available for all comparisons. Although available pilot joint REAs seem to cover the needs of multiple jurisdictions from a methodological point of view, the actual use is still limited. Other factors seem to play a relevant role such as timing of the joint REA and not optimal alignment with national procedures. More emphasis needs to be put on these issues in order to realise national use of the reports. Harmonisation of REAs in Europe is feasible, but the production and use of joint REAs follows rather an evolutionary path instead of disruptive introduction. It is driven by jurisdictions that have the highest efficiency gains. Further alignment of methods and procedures is required to enhance harmonisation. The need for alignment of evidence requirements before and after market approval goes beyond national efficiencies and requires a multi-stakeholder debate between regulatory agencies, HTA agencies, and pharmaceutical companies. A common understanding and common policies of evidence requirement for a new medicine will improve the drug development and thus help patients in need for effective, safe and affordable treatments.