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Qualitative Analysis of Introducing, Using and Changing Cost-effectiveness Thresholds for Development of Pharmaceutical Benefit Package in Thailand

นิธิเจน กิตติรัชกุล; Nitichen Kittiratchakool; ยศ ตีระวัฒนานนท์; Yot Teerawattananon; ปฤษฐพร กิ่งแก้ว; Pritaporn Kingkaew; Botwright, Siobhan; บุสดี โสบุญ; Budsadee Soboon; พรอุมา ราศรี; Pornuma Rasri; นภดล พิมสาร; Nopphadol Pimsarn; อธิพร เรืองทวีป; Atiporn Rueangthaweep; พิชญ์สินี ศุภผล; Pitsinee Supapol; วรรณฤดี อิสรานุวัฒน์ชัย; Wanrudee Isaranuwatchai;
Date: 2568-08
Abstract
Background and Rationale The cost-effectiveness threshold (CET) is a policy-level decision-making tool used as a benchmark for interpreting health economic evaluations. In Thailand, this approach has been integrated into the consideration of benefit package inclusion under the Universal Health Coverage (UHC) and the development of the National List of Essential Medicines (NLEM). However, there has been no qualitative study on the use and evolution of CET in Thailand. Objectives This study aims to explore the origins, utilisation, challenges, and limitations of CET, as well as the monitoring and evaluation processes associated with CET-based policies. Additionally, it examines the characteristics of medicines subjected to cost-effectiveness analysis during different CET periods, the changes in CET, and the resulting impacts within the scope of the development of Thailand’s NLEM. Methods This study employed qualitative research methods to review events related to the use and evolution of CET in policy decision-making, focusing on explanatory insights. Data collection methods included literature and document review, focus-group discussions, in-depth interviews and stakeholder meetings. The data analysis consisted of: 1) Categorisation – Organising information from meeting minutes using content analysis. 2) Thematic analysis – Identifying key themes from focus-group discussions and in-depth interviews with stakeholders both within and outside the NLEM Subcommittee and relevant working groups. 3) Triangulation – Cross-validating information obtained from meeting minutes, focus-group discussions, and in-depth interviews, supplemented by literature and other relevant documents. 4) Chronological and comparative analysis – Sequencing events and comparing data across different processes. In addition, preliminary findings were presented in the stakeholder meetings to gather feedback and refine policy recommendations. Findings The official use of CET in Thailand began in 2008, with an initial reference range of 1–3 times the gross domestic product (GDP) per capita, following the widely understood recommendation of the World Health Organization. In 2009, research indicated that the Thai population's willingness to pay (WTP) for healthcare was approximately 100,000 THB per quality-adjusted life year (QALY), equivalent to 1 GDP per capita. In 2011, the GDP-based reference for CET was replaced with gross national income (GNI) per capita, which amounted to 117,442 THB. Subsequently, in 2012, the NLEM Subcommittee approved a CET of 120,000 THB per QALY, as proposed by the health economics working group. This was later revised to 160,000 THB per QALY in 2013, based on 1.2 GNI per capita (Atlas Method) and aligned with WTP research findings, which estimated 156,000 THB per QALY. Thailand has primarily determined CET using two key approaches: referencing macroeconomic indicators (GDP/GNI per capita) and assessing the population’s willingness to pay. The practical application of CET generally aligns with its nature as a single numerical value with a clear threshold for categorisation (costeffective or not cost-effective). This has provided a standardised benchmark for medicine evaluation. However, its limitations and challenges depend on contextual factors, such as the stringency of decisionmakers, the quality of cost-effectiveness studies, and the management of different health funds. Despite CET being one of the criteria used in NLEM decision-making, no formal or routine monitoring and evaluation processes for its application have been established. Previous assessments have focused on access to Category E(2) medicines and appropriate prescribing practices according to prescribing guidelines. In 2 0 2 1 and 2 0 2 3, impact assessments of CET adjustments were conducted, revealing that CET changes had no influence on medicine pricing proposed for cost-effectiveness evaluation. This was due to marketdriven pricing strategies determined at a global level. Likewise, changes in CET did not affect the NLEM Subcommittee’s decision-making, as multiple factors, including technical, ethical, and political considerations, were taken into account. Discussions within the Subcommittee have also explored the development of an affordability threshold or a budget impact ceiling. However, such efforts have not been successfully implemented due to various challenges, including the lack of academic research on appropriate threshold-setting methods and differences in budget allocation mechanisms across Thailand’s public health insurance schemes. Since 2 0 2 1, cost-effectiveness evaluations have increasingly focused on specific medicine categories, such as treatments for rare diseases and personalised medicines, which present both methodological and political challenges. As NLEM development is expected to become more complex, the Subcommittee has discussed a new CET of 5 0 0,0 0 0 THB per QALY for high-cost, life-saving medicines with no alternative treatments. However, this CET has not yet been formally adopted and remains an issue requiring further monitoring and evaluation. Conclusion and Discussion Findings from this study indicate that the concepts and processes of NLEM development have evolved over time. However, the use of scientific evidence, cost-effectiveness considerations, and financial feasibility— practices that have been in place for over a decade—are likely to remain fundamental principles. This is especially relevant in the current era, where pharmaceutical technologies and innovations are becoming increasingly complex.
Copyright ผลงานวิชาการเหล่านี้เป็นลิขสิทธิ์ของสถาบันวิจัยระบบสาธารณสุข หากมีการนำไปใช้อ้างอิง โปรดอ้างถึงสถาบันวิจัยระบบสาธารณสุข ในฐานะเจ้าของลิขสิทธิ์ตามพระราชบัญญัติสงวนลิขสิทธิ์สำหรับการนำงานวิจัยไปใช้ประโยชน์ในเชิงพาณิชย์
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