ABSTRACT

Background

Healthcare payers are increasingly adopting managed entry agreements (MEAs) between themselves and manufacturers, to overcome the challenge of sustaining access in an era of innovative and high-cost medicines. This study aims to investigate current MEA activity in Saudi Arabia and explore the challenges encountered when implementing such agreements.

Methods

An explanatory sequential mixed-methods approach was used. Quantitative data on MEAs were collected, followed by qualitative semi-structured interviews with different stakeholders.

Results

Our questionnaire garnered responses from 18 pharmaceutical companies from 3 different continents and identified 25 agreements in Saudi Arabia since 2010. Financial-based agreements were more prevalent than outcomes-based agreements at 44% versus 32%, respectively. Stakeholders showed positive attitudes toward MEAs, valuing their benefits in facilitating market access for both costly and innovative medicines. The main challenges included data availability, administrative and financial burden, lack of expertise, confidentiality, and lack of clear regulations.

Conclusions

Despite clear implementation challenges, a growing tendency toward MEAs exists in Saudi Arabia because of the potential benefits they bring to patients, healthcare providers, payers, and manufacturers. It is believed that the newly established health technology assessment center in Saudi Arabia will bring more clarity and shape the concept of MEAs in the country.

中文翻译：

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探索沙特阿拉伯管理进入协议的现状和观点：混合方法

摘要

背景

医疗保健支付者越来越多地在自己和制造商之间采用管理准入协议 (MEA)，以克服在创新和高成本药物时代维持可及性的挑战。本研究旨在调查沙特阿拉伯当前的 MEA 活动，并探讨在实施此类协议时遇到的挑战。

方法

使用了解释性顺序混合方法。收集了关于多边环境协定的定量数据，然后对不同的利益相关者进行了定性的半结构化访谈。

结果

我们的问卷收集了来自 3 个不同大陆的 18 家制药公司的回复，并确定了自 2010 年以来沙特阿拉伯的 25 项协议。基于财务的协议比基于结果的协议更为普遍，分别为 44% 和 32%。利益相关者对多边环境协定表现出积极态度，重视其在促进昂贵和创新药物市场准入方面的好处。主要挑战包括数据可用性、行政和财务负担、缺乏专业知识、保密以及缺乏明确的法规。

结论

尽管存在明显的实施挑战，但由于 MEA 给患者、医疗保健提供者、付款人和制造商带来的潜在好处，沙特阿拉伯存在越来越多的趋势。相信沙特阿拉伯新成立的卫生技术评估中心将为该国的多边环境协定的概念带来更多的清晰和塑造。