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罗马尼亚卫生技术评估的发展。

DEVELOPMENT OF HEALTH TECHNOLOGY ASSESSMENT IN ROMANIA.

机构信息

Scoala Nationala de Sanatate Publica Management si Perfectionare in Domeniul

Scoala Nationala de Sanatate Publica Management si Perfectionare in Domeniul Sanitar.

出版信息

Int J Technol Assess Health Care. 2017 Jan;33(3):371-375. doi: 10.1017/S0266462317000095. Epub 2017 Apr 24.

DOI:10.1017/S0266462317000095
PMID:28436346
Abstract

OBJECTIVES

The aim of this study was to describe and analyze the introduction of health technology (HTA) in Romania.

METHODS

Based on a review of the literature and legislative documents and personal experiences and observations, the authors describe, evaluate, and explain the background and evolution of the HTA system.

RESULTS

Initiatives to introduce HTA in Romania date from the early 1990s, but real steps were taken only in 2012 when the European Union Directive 2011/24/ on the application of patients' rights in cross-border health care had to be passed into Romanian law. The main developments consist of: the establishment of a national competent authority, the development of a methodology for the rapid assessment of drugs, setting HTA as the main tool for compiling the list of medicines to be covered by the NHIF, and capacity building initiatives. One early result of HTA implementation was an updated list of reimbursed drugs, allowing Romanian patients access to new, innovative medicines.

CONCLUSIONS

In Romania, HTA become an issue for all stakeholders: decision makers are interested in cost-containment, patients in obtaining the best care, and producers in receiving acceptable reimbursement remains on the health policy agenda. Further steps are envisaged, especially for international collaboration, which is considered an important factor for HTA development in Romania.

摘要

目的

本研究旨在描述和分析罗马尼亚卫生技术评估(HTA)的引入情况。

方法

基于文献回顾、立法文件以及个人经验和观察,作者对 HTA 系统的背景和演变进行了描述、评估和解释。

结果

罗马尼亚早在 20 世纪 90 年代初就有引入 HTA 的举措,但直到 2012 年,当欧盟指令 2011/24/关于在跨境医疗保健中实施患者权利必须转化为罗马尼亚法律时,才采取了真正的步骤。主要进展包括:建立了一个国家主管部门,制定了一种快速评估药物的方法,将 HTA 作为编制 NHIF 覆盖药品清单的主要工具,并开展了能力建设举措。HTA 实施的早期成果之一是更新了报销药品清单,使罗马尼亚患者能够获得新的创新药物。

结论

在罗马尼亚,HTA 成为所有利益相关者关注的问题:决策者关注成本控制,患者关注获得最佳护理,生产者关注获得可接受的报销,这些都仍然是卫生政策议程上的议题。预计还将采取进一步措施,特别是考虑到国际合作,这被认为是罗马尼亚 HTA 发展的一个重要因素。

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