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Early benefit assessment of innovative pharmaceuticals according to AMNOG in Germany: empirical analysis of the decision-making process

德国AMNOG创新药物早期效益评估：决策过程的实证分析

基本信息

批准号：
255711605
负责人：
Professorin Dr. Katharina Blankart
金额：
--
依托单位：
Lehrstuhl Health Care Management
依托单位国家：
德国
项目类别：
Research Grants
财政年份：
2014
资助国家：
德国
起止时间：
2013-12-31 至 2016-12-31
项目状态：
已结题

来源：
https://gepris.dfg.de/gepris/projekt/255711605?language=en
关键词：
Early benefit assessment innovative pharmaceuticals

项目摘要

Across many industrialized countries, decision processes have established that determine reimbursement of new health technologies. By introducing the Act on the Reform of the Market for Medicinal Products (Arzneimittelmarktneuordnungsgesetz, short: AMNOG) in 2010, the regulatory framework for patented pharmaceuticals has changed substantially for Germany. Manufacturers are to submit a dossier to demonstrate additional health benefit of the new pharmaceutical. In turn, a so-called early benefit assessment (EBA) is then conducted by the Institute for Quality and Efficiency in Health Care (IQWiG) before the Federal Joint Committee (G-BA) makes a decision. As coverage decision-making is highly relevant for health policy, sound empirical analysis is necessary to understand the functioning of in order to assess the consequences of AMNOG. Currently, no empirical evidence exists that analyses what influences the appraisal.It is thus the aim of this project to identify factors that determine the degree of the additional benefit (remarkable, considerable, minor, not quantifiable, no evidence of benefit, less benefit than comparator). We also examine factors that explain the effect on the level of rebate granted by the manufacturer in the subsequent price negotiations. Doing so, we differentiate between (a) the quality of evidence presented to demonstrate additional benefit, (b) its presentation, (c) technological characteristics of the appraised pharmaceuticals, (d) process related criteria for decision-making, and (e) the pharmaceutical s budget impact. For this purpose, regression analysis such as binomial and multinomial logistic regression models will be used. In a pilot study that has preceded this project, we already defined the variables to be collected. The pilot study also confirmed the feasibility of the project.The project uses the documentation of the EBAs as data source from the G-BA s website and the Lauer-Taxe database to calculate the rebate granted. To ensure the validity of the data, all variables are to be extracted by two independent reviewers and compared afterwards. The results provide evidence about the roles of the participating institutions (especially G-BA and IQWiG) and, the decision processes.

在许多工业化国家，已经建立了决定新卫生技术报销的决策程序。 2010 年出台的《药品市场改革法案》（Arzneimittelmarktneuordnungsgesetz，简称：AMNOG）使德国专利药品的监管框架发生了重大变化。制造商将提交一份档案来证明新药的额外健康益处。反过来，在联邦联合委员会 (G-BA) 做出决定之前，医疗保健质量与效率研究所 (IQWiG) 会进行所谓的早期效益评估 (EBA)。由于承保决策与卫生政策高度相关，因此需要进行合理的实证分析来了解其功能，从而评估 AMNOG 的后果。目前，还没有经验证据来分析影响评估的因素。因此，该项目的目的是确定决定额外效益程度的因素（显着、相当大、次要、不可量化、没有效益证据、效益低于比较者）。我们还研究了解释对制造商在随后的价格谈判中给予的回扣水平的影响的因素。这样做，我们区分（a）用于证明额外益处的证据质量，（b）其表述，（c）评估药品的技术特征，（d）与决策过程相关的标准，以及（e）药品的预算影响。为此，将使用回归分析，例如二项式和多项式逻辑回归模型。在该项目之前的一项试点研究中，我们已经定义了要收集的变量。试点研究也证实了该项目的可行性。该项目使用EBA文件作为来自G-BA网站和Lauer-Taxe数据库的数据源来计算授予的退税。为了确保数据的有效性，所有变量均由两名独立评审员提取并随后进行比较。结果提供了有关参与机构（尤其是 G-BA 和 IQWiG）的作用以及决策过程的证据。