Center for Health Economics, Department of Public Health, Ghent University Ghent, Belgium.
Front Pharmacol. 2011 Oct 11;2:57. doi: 10.3389/fphar.2011.00057. eCollection 2011.
This Perspective describes (a) the current situation, (b) challenges and initiatives, (c) and formulates recommendations to valorize and create access to innovative medicines in the EU. We are currently still far away from optimal assessment of value for money in the EU. On the one hand, valorizing innovative medicines involves a local appraisal by health technology assessment (HTA) bodies and competent authorities about the value for money, the budget impact, and the local medical need that can be filled with new medicines. Therefore, local priorities and national health care policy environments should be reflected in the processes and criteria used for assessing value for money and ultimately for reimbursement decisions. On the other hand, a pan-European assessment of both relative effectiveness and medical need (including general ethical and social considerations) should be envisaged in order to feed part of the data needed for the local decisions in an efficient way. This could be the task of the European Medicines Agency, HTA bodies, and competent authorities together.
本观点描述了（a）现状、（b）挑战和举措、（c）以及制定建议，旨在在欧盟中重视和创造创新药物的可及性。我们目前在评估欧盟的性价比方面仍远不理想。一方面，评估创新药物涉及卫生技术评估（HTA）机构和主管当局对性价比、预算影响以及新药物可以满足的当地医疗需求的本地评估。因此，本地的优先事项和国家医疗保健政策环境应反映在用于评估性价比和最终报销决策的流程和标准中。另一方面，应设想对相对有效性和医疗需求（包括一般伦理和社会考虑）进行泛欧评估，以便以有效的方式为本地决策所需的数据提供一部分。这可能是欧洲药品管理局、HTA 机构和主管当局共同的任务。
