A Comparison of Reimbursement Recommendations by European HTA Agencies: Is There Opportunity for Further Alignment?
A Comparison of Reimbursement Recommendations by European HTA Agencies: Is There Opportunity for Further Alignment?
复制标题
DOI：
10.3389/fphar.2017.00384
复制
发表时间：
2017-06-30
影响因子：
5.6
通讯作者：
Salek, Sam
中科院分区：
文献类型：
--
作者：
Allen, Nicola;Liberti, Lawrence;Salek, Sam
简介：在欧洲及其他地区，医疗保健成本不断上涨且医疗保健资源有限，导致实施卫生技术评估 (HTA) 来为医疗政策和报销决策提供信息。欧洲立法为欧洲药品管理局的监管流程提供了统一的途径，但报销决策仍然由每个国家负责。人们认识到需要为欧洲的新药建立一个更加客观和协作的报销环境。因此，本研究的目的是根据欧洲药品管理局（EMA）关于集中营销授权的建议，客观评估和比较9个欧洲司法管辖区的国家报销建议。 方法：利用公开数据和新开发的分类工具，本研究通过评估HTA流程以及监管机构、HTA和决策组织之间的关系，对9个欧洲报销系统进行评估。每个国家 HTA 机构均根据两种新颖的分类法进行分类。系统分类根据监管机构、HTA 执行机构和报销决策覆盖机构之间的关系，重点关注 HTA 机构在国家报销系统中的地位。 HTA 流程分类法区分了各个 HTA 机构的经济和治疗评估方法以及独立评估步骤的内容。随后将分类组与国家 HTA 建议进行比较。结果：本研究确定了 EMA 2008 年至 2012 年批准的 102 种新活性物质 (NAS) 的欧洲国家报销建议。使用新颖的分类工具对这些报销建议进行了比较，并确定了报销系统的组织结构（系统分类）与 HTA 建议之间的一致性。然而，HTA 流程和建议之间的一致性较差。结论：为了在欧洲内部建立更加协调的 HTA 环境，首先有必要了解欧洲内部 HTA 实践的差异。这项研究确定了 HTA 建议和系统分类之间的一致性，这项研究的主要意义之一是这种一致性可以支持欧洲更具协作性的 HTA 环境。
Introduction: In Europe and beyond, the rising costs of healthcare and limited healthcare resources have resulted in the implementation of health technology assessment (HTA) to inform health policy and reimbursement decision-making. European legislation has provided a harmonized route for the regulatory process with the European Medicines Agency, but reimbursement decision-making still remains the responsibility of each country. There is a recognized need to move toward a more objective and collaborative reimbursement environment for new medicines in Europe. Therefore, the aim of this study was to objectively assess and compare the national reimbursement recommendations of 9 European jurisdictions following European Medicines Agency (EMA) recommendation for centralized marketing authorization.Methods: Using publicly available data and newly developed classification tools, this study appraised 9 European reimbursement systems by assessing HTA processes and the relationship between the regulatory, HTA and decision-making organizations. Each national HTA agency was classified according to two novel taxonomies. The System taxonomy, focuses on the position of the HTA agency within the national reimbursement system according to the relationship between the regulator, the HTA-performing agency, and the reimbursement decision-making coverage body. The HTA Process taxonomy distinguishes between the individual HTA agency's approach to economic and therapeutic evaluation and the inclusion of an independent appraisal step. The taxonomic groups were subsequently compared with national HTA recommendations.Results: This study identified European national reimbursement recommendations for 102 new active substances (NASs) approved by the EMA from 2008 to 2012. These reimbursement recommendations were compared using a novel classification tool and identified alignment between the organizational structure of reimbursement systems (System taxonomy) and HTA recommendations. However, there was less alignment between the HTA processes and recommendations.Conclusions: In order to move forward to a more harmonized HTA environment within Europe, it is first necessary to understand the variation in HTA practices within Europe. This study has identified alignment between HTA recommendations and the System taxonomy and one of the major implications of this study is that such alignment could support a more collaborative HTA environment in Europe.