Department of Health Care Management, Technische Universität Berlin, Berlin, Germany.
Health Policy. 2013 Mar;109(3):263-9. doi: 10.1016/j.healthpol.2012.12.005. Epub 2013 Jan 20.
In the past, free price setting mechanisms in Germany led to high prices of patented pharmaceuticals and to increasing expenditures in the pharmaceutical sector. In order to control patented pharmaceutical prices and to curb increasing pharmaceutical spending, the Act for Restructuring the Pharmaceutical Market in Statutory Health Insurance (AMNOG) came into effect on 1st January 2011. In a structured dossier, pharmaceutical manufacturers have to demonstrate the additional therapeutic benefit of the newly approved pharmaceutical compared to its appropriate comparator. According to the level of additional benefit, pharmaceuticals will be subject to price negotiations between the Federal Association of Statutory Health Insurance Funds and the pharmaceutical company concerned (or assigned to a reference price group in case of no additional benefit). Therefore, the health care reform is a first step to decision making based on "value for money". The process of price setting based on early benefit evaluation has an impact on the German as well as the European pharmaceutical markets. Therefore, these structural changes in Germany are of importance for pricing decisions in many European countries both from a political point of view and for strategic planning for pharmaceutical manufacturers, which may have an effect on insured patients' access to pharmaceuticals.
在过去，德国自由定价机制导致专利药品价格高昂，制药行业支出不断增加。为了控制专利药品价格并抑制医药支出的增长，《法定健康保险药品市场结构调整法》（AMNOG）于 2011 年 1 月 1 日生效。制药商必须在结构化档案中证明新批准的药品与适当的比较药物相比具有额外的治疗益处。根据额外益处的水平，药品将受到联邦法定健康保险基金协会与相关制药公司之间的价格谈判的约束（或者在没有额外益处的情况下分配给参考价格组）。因此，医疗保健改革是基于“物有所值”的决策的第一步。基于早期效益评估的定价过程对德国乃至欧洲药品市场都有影响。因此，德国的这些结构性变化对于许多欧洲国家的定价决策具有重要意义，无论是从政治角度还是从制药商的战略规划角度来看，这可能会影响参保患者获得药品的机会。
