Managing new premium-priced medicines in Europe

An issue of growing concern for health policy-makers in Europe is the continuing rise in spending on pharmaceuticals. In OECD countries pharmaceutical expenditure rose by 3.5% per year between 2000 and 2009, and averages 18-19% of total health expenditure [1]. Similar averages are seen across Europe, with pharmaceutical spending representing the largest component of ambulatory care [2]. Spending in some countries has dropped since 2009 on account of specific policy decisions taken due to the financial crisis, but in others this growth has remained constant [1,3]. Contributing to this is the continual introduction of new premium-priced medicines, particularly for biologicals given the appreciable number in development and their envisaged high prices [3-6]. And while the introduction of new therapies and current rapid pace of therapeutic innovation, particularly for noncommunicable diseases, is extremely positive from a patient perspective, managing their entry and longer term affordability especially under health insurance schemes and vis-à-vis existing lower-cost therapies poses a series of challenges to policy-makers regarding therapeutic complexity and higher costs [7]. To mitigate such pressures and to balance the demand for new medicines and the financial impact of their introduction, further development of systems and processes to optimize the entry of new medicines is necessary across Europe; this applies to countries with welldeveloped medicine policies and regulation traditions and those with less mature systems. And while many European countries have not traditionally required active priority-setting for access to medicines, appraising new medicines using pharmacoeconomics is increasingly seen as critical to improve efficient spending while maintaining an appropriate balance between access and cost-effectiveness. Indeed, policy-makers are in need of wider guidance on how to optimise the entry of new medicines to ensure the financial sustainability of their health care systems while encouraging the development of new treatments to address areas of unmet clinical need. Although not an exhaustive list, areas in which the challenges around the sustainable management of new medicines are especially acute include: