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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探索沙特阿拉伯有管理进入协议的现状和观点：混合方法

背景

医疗保健支付者越来越多地采用他们与制造商之间的管理进入协议（MEA），以克服在创新和高成本药品时代维持获取的挑战。这项研究旨在调查目前在沙特阿拉伯的多边环境协定活动，并探讨在执行此类协定时遇到的挑战。

方法

使用了一种解释性的顺序混合方法方法。收集有关多边环境协定的定量数据，然后与不同的利益相关者进行定性的半结构化访谈。

结果

自2010年以来，我们的问卷调查获得了来自3个不同大洲的18家制药公司的反馈，并确定了沙特阿拉伯的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，对其在促进昂贵和创新药物的市场准入方面的价值进行了评估。主要挑战包括数据可用性，管理和财务负担，缺乏专业知识，机密性以及缺乏明确的法规。

结论

尽管实施中存在明显的挑战，但由于多边环境协定带给患者，医疗服务提供者，付款人和制造商的潜在利益，因此在中东，非洲和非洲存在越来越多的MEA。据信，在沙特阿拉伯新建立的卫生技术评估中心将使该国的多边环境协定的概念更加清晰明了。