Assawamakin Anunchai, Upakdee Nilawan, Kongpakwattana Khachen
Department of Pharmacology, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand.
Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand.
J Pharm Policy Pract. 2025 Jul 10;18(1):2526827. doi: 10.1080/20523211.2025.2526827. eCollection 2025.
Biosimilars offer potential for increased access to critical biological therapies in emerging-markets like Thailand. However, making procurement decisions for these complex molecules requires considering multiple factors beyond cost. This study aimed to develop and test a context-specific, value-based procurement framework for biosimilars in Thailand using Multi-Criteria Decision Analysis (MCDA).
This study employed a mixed-methods approach, combining a literature review with expert consensus workshops. The literature review identified existing biosimilar selection criteria, which were mapped onto the Most Economically Advantageous Tender (MEAT) Value-Based Procurement (VBP) framework. Two expert consensus workshops were conducted to develop and refine a Thai-specific MCDA tool. The initial framework underwent a feasibility study in five hospitals across Thailand, with feedback incorporated into the refined version.
The literature review yielded seven relevant studies, predominantly from established markets. The expert workshops produced a tailored MCDA tool with seven key criteria: Quality Assessment, Stability Assessment, Comparability Exercise, Indications and Extrapolation, Pharmacovigilance and Risk Management, Real-World Evidence and Switching Studies, and Other Considerations. Each criterion was weighted based on its perceived importance in the Thai context. The feasibility study resulted in refinements, such as adjusting criterion weights and incorporating flexibility for hospital-specific priorities.
This study presents a comprehensive, context-specific MCDA tool for biosimilar procurement in Thailand. By balancing scientific rigour with practical considerations, this framework has the potential to optimise biosimilar selection, enhancing access to vital biological therapies while ensuring quality and cost-effectiveness. The approach taken to develop this framework could serve as an initiative for other emerging markets seeking to improve their biosimilar procurement strategies.
生物类似药为泰国等新兴市场增加获取关键生物疗法的机会提供了潜力。然而,针对这些复杂分子做出采购决策需要考虑成本以外的多个因素。本研究旨在使用多标准决策分析(MCDA)开发并测试一个针对泰国生物类似药的、基于价值的特定背景采购框架。
本研究采用混合方法,将文献综述与专家共识研讨会相结合。文献综述确定了现有的生物类似药选择标准,并将其映射到最具经济优势投标(MEAT)基于价值的采购(VBP)框架上。举办了两次专家共识研讨会,以开发和完善一个针对泰国的MCDA工具。初始框架在泰国的五家医院进行了可行性研究,并将反馈纳入了完善后的版本。
文献综述产生了七项相关研究,主要来自成熟市场。专家研讨会产生了一个量身定制的MCDA工具,有七个关键标准:质量评估、稳定性评估、可比性研究、适应症和外推、药物警戒和风险管理、真实世界证据和转换研究,以及其他考虑因素。每个标准根据其在泰国背景下的重要性进行加权。可行性研究导致了一些改进,如调整标准权重和纳入针对医院特定优先事项的灵活性。
本研究提出了一个针对泰国生物类似药采购的全面、特定背景的MCDA工具。通过在科学严谨性与实际考虑之间取得平衡,该框架有潜力优化生物类似药的选择,在确保质量和成本效益的同时增加获取重要生物疗法的机会。开发此框架所采用的方法可为其他寻求改进其生物类似药采购策略的新兴市场提供借鉴。