埃及新药申请报销和采购的药物经济评估报告国家建议》。

Global journal on quality and safety in healthcare Pub Date : 2024-08-01 eCollection Date: 2024-11-01 DOI:10.36401/JQSH-24-12
Mary Gamal, Amal Samir Sedrak, Gihan Hamdy Elsisi, Ahmed Elagamy, Ahmed Seyam, Mariam Eldebeiky, Randa Eldessoki
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引用次数: 0

摘要

导言:为改善我国医疗系统的资源分配,埃及统一采购、医疗供应和医疗技术管理局(UPA)与全民健康保险管理局(UHIA)建立了联合经济评估程序,以支持全民健康保险管理局的报销决策和 UPA 的采购决策。本研究的主要目的是介绍埃及制定的国家药物经济学指南,尤其是用于新药报销和采购的指南:方法:作为埃及政府当局的一项全国性倡议活动,成立了一个焦点小组。方法:作为埃及政府当局的一项全国性倡议活动,成立了一个焦点小组,其目的是为评估创新和高预算药品制定国家药物经济学指南。该小组由具有卫生经济学、结果研究、公共卫生和药学实践经验的各利益相关方组成。为了制定国家药物经济学指南,我们采取了三个步骤。首先,焦点小组回顾了欧洲卫生技术评估网络 (EUnetHTA) 对新药品进行卫生经济学评估的方法,以及加拿大药品和卫生技术局 (CADTH) 的指导方针和管理保健药剂学学会 (AMCP) 的处方集提交格式。其次,重点小组将 EUnetHTA 指南作为参考,并根据本地情况进行了调整。焦点小组利用 CADTH 和 AMCP 指南增加了价值评估部分。第三,焦点小组采用准德尔菲小组方法,通过焦点小组收集主要利益相关者的意见和反馈:焦点小组的成果是用于评估创新和高预算药品的国家药物经济学指南的主要结构,包括七个主要议题:经济评估是卫生技术评估(HTA)的核心要素;因此,鼓励 UHIA 和 UPA 为创新产品制定统一的联合药物经济学指南,作为其承诺在决策中使用 HTA 的第一步。准则的标准化不仅确保了透明度,还保证了支持循证决策的过程准确、透明。预计这些准则将帮助决策者改进其程序,并为埃及患者带来更好的保健成果。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
National Recommendations for Pharmacoeconomic Evaluations Reporting for Reimbursement and Procurement of New Pharmaceutical Applications in Egypt.

Introduction: To improve resource allocation within our healthcare system, the Egyptian Authority for Unified Procurement, Medical Supply and the Management of Medical Technology (UPA) and Universal Health Insurance Authority (UHIA) established a joint economic evaluation process to support UHIA reimbursement decisions and UPA procurement decisions. The main objective of this study is to describe the developed national pharmacoeconomic guidelines in Egypt, especially for reimbursement and procurement for new pharmaceuticals.

Methods: A focus group was formed as a national initiative activity by governmental authorities in Egypt. The aim of this focus group was to develop national pharmacoeconomic guidelines for the evaluation of innovative and high-budget pharmaceutical products. This group consisted of various stakeholders with experience in health economics, outcomes research, public health, and pharmacy practice. To develop our national pharmacoeconomic guidelines, three steps were taken. First, the focus group reviewed the European Network for Health Technology Assessment (EUnetHTA) methods for health economic evaluations for new pharmaceuticals as well as the Canadian Agency for Drugs and Technologies in Health (CADTH) guidelines and the Academy of Managed Care Pharmacy (AMCP) Format for Formulary Submissions. Second, the focus group used the EUnetHTA guideline as a reference and adapted it to our local context. The focus group added the value assessment component, using the CADTH and AMCP guidelines. Third, the focus group collected input and feedback from key stakeholders through a focus group by using the quasi-Delphi panel approach.

Results: The results of the focus group are a main structure of national pharmacoeconomic guidelines for the evaluation of innovative and high-budget pharmaceutical products, consisting of seven main topics.

Conclusion: Economic evaluation is a core element of Health Technology Assessment, (HTA); therefore, the UHIA and UPA were encouraged to produce unified joint pharmacoeconomic guidelines for innovative products as an initial step in their commitment to implement the use of HTA in decision-making. This standardization of guidelines not only ensures transparency but also guarantees an accurate and transparent process to support evidence-based decision-making. These guidelines are expected to help decision-makers improve their process and attain better health outcomes for Egyptian patients.

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