Department of Quantitative Methods, Management, University of Las Palmas de Gran Canaria, Las Palmas, Spain.
Int J Technol Assess Health Care. 2023 Jul 5;39(1):e50. doi: 10.1017/S0266462323000387.
Spain incorporated in 2020 changes in its health technology assessment (HTA), pricing, and reimbursement system for medicines including publishing reports, development of networks of experts, or consultation with stakeholders. Despite these changes, it is unclear how deliberative frameworks are applied and the process has been criticized for not being sufficiently transparent. This study analyses the level of implementation of deliberative processes in HTA for medicines in Spain.
We review the grey literature and summarize the Spanish HTA, pricing, and reimbursement process of medicines. We apply the deliberative processes for HTA checklist, developed to assess the overall context of the deliberative process, and identify the stakeholders involved and type of involvement following the framework for evidence-informed deliberative processes, a framework for benefit package design that aims to optimize the legitimacy of decision making.
In the Spanish HTA, pricing, and reimbursement process deliberation takes place in order to exchange viewpoints and reach common ground, mainly during the prioritization, assessment, and appraisal steps. It is closed to the public, not clearly summarized in published documents and limited to the Ministry of Health, the regulatory agency, other Ministries, and experts with mostly clinical and/or pharmaceutical background. The views of stakeholders are only represented through consultation. Communication is the most commonly used form of stakeholder engagement.
Despite improvements in transparency of the Spanish HTA process for evaluating medicines, aspects related to stakeholder involvement and implementation of deliberative frameworks need further attention in order to achieve further legitimacy of the process.
西班牙于 2020 年对其药品的卫生技术评估（HTA）、定价和报销系统进行了改革，包括发布报告、建立专家网络或与利益相关者协商。尽管进行了这些改革，但尚不清楚如何应用审议框架，而且该过程因不够透明而受到批评。本研究分析了西班牙药品 HTA 中审议过程的实施程度。
我们回顾了灰色文献并总结了西班牙的药品 HTA、定价和报销流程。我们应用了 HTA 审议流程检查表，该检查表用于评估审议过程的整体背景，并根据循证审议流程框架确定所涉及的利益相关者及其参与类型，该框架是利益包设计框架，旨在优化决策的合法性。
在西班牙的 HTA、定价和报销流程审议中，主要是在优先级设置、评估和评估步骤中，进行观点交流并达成共识。它对公众关闭，未在已发布的文件中明确总结，仅限于卫生部、监管机构、其他部委以及主要具有临床和/或制药背景的专家。利益相关者的观点仅通过协商来代表。沟通是利益相关者参与的最常用形式。
尽管西班牙药品 HTA 评估过程的透明度有所提高，但在利益相关者参与和实施审议框架方面仍需要进一步关注，以实现该过程的进一步合法性。
