Radic D, Haugk S, Radic M
Wirtschaftswissenschaftliche Fakultät, Universität Leipzig, Leipzig.
Fraunhofer-Zentrum für Internationales Management und Wissensökonomie, Preis- und Dienstleistungsmanagement, Leipzig.
Gesundheitswesen. 2018 Jun;80(6):573-579. doi: 10.1055/s-0042-113600. Epub 2016 Sep 16.
Ever since the introduction of the Market Restructuring Act, the evaluation and price negotiations of drugs have been controversial. While the Federal Joint Committee considers that the process is transparent and in accordance with clear evidence-based criteria, representatives of pharmaceutical companies are particularly critical of the fact that the central association of statutory health insurance is involved in both the determination of added therapeutic benefit of drugs as well as in the subsequent price negotiation. In this study, we investigate these 2 contradictory assessments empirically. For this purpose, we model the benefit assessment and price negotiation processes under AMNOG and analyze their relationship. We show that the number of patients in the target population, and the annual cost of therapy for the appropriate comparator therapy have a negative influence on the determination of the added benefit of the new therapy. The added value itself has a positive (negative) effect on the mark-up for the appropriate comparator therapy (price discount), while the annual treatment costs of the new therapy (which appropriate comparator therapy) have a positive (negative) influence. We find clues, but no significant evidence for the hypothesis that the decisions on the added value of new medicines and the subsequent price negotiations are interdependent.
自《市场结构调整法案》出台以来，药品评估和价格谈判一直存在争议。虽然联邦联合委员会认为该过程是透明的，且符合明确的循证标准，但制药公司代表对法定医疗保险中央协会参与药品额外治疗效益的确定以及随后的价格谈判这一事实尤为不满。在本研究中，我们通过实证研究来探讨这两种相互矛盾的评估。为此，我们对加速审批程序下的效益评估和价格谈判过程进行建模，并分析它们之间的关系。我们表明，目标人群中的患者数量以及适当对照疗法的年度治疗成本对新疗法额外效益的确定有负面影响。新增价值本身对适当对照疗法的加价（价格折扣）有正向（负向）影响，而新疗法（适当对照疗法）的年度治疗成本有正向（负向）影响。我们找到了一些线索，但没有显著证据支持关于新药新增价值决策与后续价格谈判相互依存的假设。
