创建一个多标准决策分析工具,以提高基于价值的购买在沙特阿拉伯的仿制药和生物相似药物:一个试点研究
Yazed Alruthia1,2, Horiyah Alhajri1, Omar A Almohammed1
1Department of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.
ClinicoEconomics and outcomes research : CEOR
|January 13, 2026
概括
沙特阿拉伯为非专利制药 (OPP) 开发了一个基于价值的采购框架,优先考虑有效性和药物稳定性. 这旨在提高医疗保健支出效率,同时解决治疗等效问题.
科学领域:
- 卫生经济学 卫生经济学
- 制药政策 制药政策
- 决策分析 决策分析
背景情况:
- 沙特阿拉伯的医疗保健改革侧重于仿制药和生物相似药物,以提高效率.
- 对非专利制药 (OPP) 治疗等价性的担忧仍然存在.
- 需要一个由利益相关者驱动的框架,以价值为基础的OPP采购.
研究的目的:
- 在沙特阿拉伯建立一个以利益相关者为导向的,基于价值的采购框架,用于非专利药品 (OPP).
- 通过多标准决策分析 (MCDA) 定义基本的采购标准.
主要方法:
- 通过沙特ISPOR章节召集了包括药剂师和监管机构在内的利益相关者.
- 举办了一次研讨会,审查29个潜在的采购标准.
- 使用多标准决策分析 (MCDA) 和联合分析来确定标准权重.
主要成果:
- 确定了16个关键标准,其中公布的疗效数据 (11.56%) 和药物稳定性获得了最高的重要性.
- 其他重要的标准包括生物等价性,现实数据,药物安全性和质量保证.
- 药监部门获得了最低的权重 (3.23%).
结论:
- 本试点研究介绍了沙特阿拉伯OPP采购的第一个基于共识的MCDA标准.
- 该框架将科学有效性 (有效性,稳定性) 优先于成本.
- 它为国家基于价值的采购系统提供了基础,需要在招标中进行进一步的测试.
相关概念视频
Structure-Activity Relationships and Drug Design
1.7K
Drug design is a dynamic field that involves discovering and developing new medications based on specific biological targets. This process heavily relies on structure-activity relationships (SAR) and quantitative structure-activity relationships (QSAR) to guide the design and optimization of efficient drugs.
SAR studies the intricate relationship between a drug's chemical structure and biological activity. It focuses on understanding how modifications to a drug's structure can influence...
SAR studies the intricate relationship between a drug's chemical structure and biological activity. It focuses on understanding how modifications to a drug's structure can influence...
1.7K
Drug Products: Biologics, Biosimilars and Interchangeables
229
Body:Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
229
Bioequivalence of Drugs: Drugs with Multiple Indications
147
The concept of therapeutic equivalence (TE) in drugs with multiple indications is complex. A generic drug may be therapeutically equivalent to a brand-name product for one specific indication, but this doesn't necessarily mean it's equivalent for all other indications. Evidence of TE in one patient group and bioequivalence shown in healthy volunteers can support—but not confirm—TE for other indications. However, definitive proof requires individual clinical studies for each...
147
Bioequivalence studies: Biowaivers
218
Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
218
Pharmacokinetic Models: Comparison and Selection Criterion
328
Physiological and compartmental models are valuable tools used in studying biological systems. These models rely on differential equations to maintain mass balance within the system, ensuring an accurate representation of the dynamic processes at play.
Physiological models take a detailed approach by considering specific molecular processes. They can predict drug distribution, metabolism, and elimination changes, providing a comprehensive understanding of how drugs interact with the body.
Physiological models take a detailed approach by considering specific molecular processes. They can predict drug distribution, metabolism, and elimination changes, providing a comprehensive understanding of how drugs interact with the body.
328
Decision Making: P-value Method
6.8K
The process of hypothesis testing based on the P-value method includes calculating the P- value using the sample data and interpreting it.
First, a specific claim about the population parameter is proposed. The claim is based on the research question and is stated in a simple form. Further, an opposing statement to the claim is also stated. These statements can act as null and alternative hypotheses: a null hypothesis would be a neutral statement while the alternative hypothesis can...
First, a specific claim about the population parameter is proposed. The claim is based on the research question and is stated in a simple form. Further, an opposing statement to the claim is also stated. These statements can act as null and alternative hypotheses: a null hypothesis would be a neutral statement while the alternative hypothesis can...
6.8K


