EOPYY,Medicines
EOPYY,Medicines Division.
Int J Technol Assess Health Care. 2017 Jan;33(3):396-401. doi: 10.1017/S0266462317000629. Epub 2017 Jul 31.
The aim of this study was to describe the current regulatory environment in Greece to evaluate the potential introduction of health technology assessment (HTA) for medicinal products for human use.
Data sources consist of national legislation on pricing and reimbursement of health technologies to identify the potential need of establishing HTA and its relevant structure.
The pricing procedure regarding medicinal products for human use is based on an external reference pricing mechanism which considers the average of the three lowest Euorpean Union prices. Currently, a formal HTA procedure has not been applied in Greece, and the only prerequisite used for the reimbursement of medicinal products for human use is their inclusion in the Positive Reimbursement List. To restrict pharmaceutical expenditure, a variety of measures-such as clawback mechanisms, rebates, monthly budget caps per physician, generics penetration targeting-have been imposed, aiming mainly to regulate the price level rather than control the introduction of medicinal products for human use in the Greek pharmaceutical market.
Greece has the opportunity to rapidly build capacity, implement, and take advantage of the application of HTA mechanisms by clearly defining the goals, scope, systems, context, stakeholders, and methods that will be involved in the local HTA processes, taking into account the country's established e-prescription system and the recently adapted legislative framework.
本研究旨在描述希腊当前的监管环境,评估是否有可能引入针对人用药物的卫生技术评估(HTA)。
数据来源包括药品定价和报销的国家立法,以确定建立 HTA 及其相关结构的潜在需求。
人用药品的定价程序基于外部参考定价机制,该机制考虑了欧盟三个最低价格的平均值。目前,希腊尚未正式采用 HTA 程序,人用药品报销的唯一前提条件是将其列入正向补偿清单。为了限制药品支出,已经采取了各种措施,如回扣机制、折扣、每位医生的月度预算上限、针对仿制药的渗透率目标,这些措施主要旨在调节价格水平,而不是控制人用药品在希腊药品市场的引入。
希腊有机会通过明确界定将涉及当地 HTA 流程的目标、范围、系统、背景、利益相关者和方法,快速建立能力、实施并利用 HTA 机制,同时考虑到该国现有的电子处方系统和最近调整的立法框架。