This study undertakes a comprehensive examination of the EU’s unified HTA system and draws on its advanced experience to provide reference for drug value assessment and decision-making in China. Initially, we delineate the EU HTA regulatory architecture and its provisions, identifying the HTACG and its constituent subgroups as the pivotal governance entities. Subsequently, we dissect the two core mechanisms of HTAR (EU)—Joint Clinical Assessment (JCA) and Joint Scientific Consultation (JSC). JCA operationalizes the PICO framework as a multi-tiered analytical instrument, systematically quantifying clinical efficacy, stratifying safety outcomes, and executing three-dimensional validity appraisals. Concurrently, JSC furnishes developers with evidence and guidance, aligning evidence plans with both regulatory approval and HTA criteria, thereby fostering therapeutic innovation. Finally, we advance recommendations for enhancing HTA in China: professionalizing and refining the assessment of innovative drugs’ clinical value, constructing a parallel, multi-indication-oriented PICO framework, strengthening data infrastructure and data sharing, establishing communication and consultation platforms and mechanisms, and exploring multi-stakeholder engagement mechanisms.
Key words
European Union /
health technology assessment /
joint clinical assessment /
joint scientific consultation /
recommendation
{{custom_sec.title}}
{{custom_sec.title}}
{{custom_sec.content}}
References
[1] 肖非易,李雪,李睿,等.卫生技术评估在我国医保决策领域应用的挑战与对策[J].中国医疗保险,2025(01):109-116.
[2] 李佳晋,黄天笑,孙育杰,等.HTA在发达国家医保体系中的发展及对我国的启示[J].中国医疗保险,2024(01):100-110.
[3] 叶冬炜,王莉,刘叔文.卫生技术评估在欧洲4国的应用及对我国的启示[J].中国药房,2022,33(01):1-6.
[4] European Commission.Health technology assessment[EB/OL].[2025-06-28].https://health.ec.europa.eu/health-technology-assessment_en.
[5] European Commission. Factsheet-implementing the eu health technology assessment regulation[EB/OL]. (2023-05-16)[2025-06-28]. https://health.ec.europa.eu/publications/factsheet-implementing-eu-health-technology-assessment-regulation_en.
[6] European Commission. Public Health.Implementation of the regulation on health technology assessment[EB/OL].[2025-06-28].https://health.ec.europa.eu/health-technology-assessment/implementation-regulation-health-technology-assessment_en.
[7] European Commission. Scientific specifications of medicinal products subject to joint clinical assessments[EB/OL]. (2024-06-13)[2025-06-25]. https://health.ec.europa.eu/publications/scientific-specifications-medicinal-products-subject-joint-clinical-assessments_en.
[8] RUETHER A, IMAZ-IGLESIA I, BÉLORGEY C, et al. European collaboration on health technology assessment: looking backward and forward[J]. International journal for quality in health care, 2022, 38(1): e34.
[9] SCHÜNEMANN HJ, REINAP M, PIGGOTT T, et al. The ecosystem of health decision making: from fragmentation to synergy[J]. Lancet public health, 2022, 7(4): e378-e390.
[10] VAN BEEKHUIZEN S, CHE M, MONFORT L, et al.Indirect treatment comparisons in EUnetHTA relative effectiveness assessments: learnings and recommendations for the implementation of EU joint clinical assessments[J]. Pharmacoeconomics-open, 2025,9(4):597-609.
[11] European Commission. Directorate-General for Health and Food Safety. Guidance on the scoping process[EB/OL]. (2024-11-28)[2025-06-26]. https://health.ec.europa.eu/publications/guidance-scoping-process_en.
[12] European Commission. PICO exercises[EB/OL]. (2025-02-03)[2025-06-26]. https://health.ec.europa.eu/publications/pico-exercises_en.
[13] European Union. Joint scientific consultation for medicinal products[EB/OL]. (2025-01-10)[2025-06-25]. https://health.ec.europa.eu/publications/factsheet-joint-scientific-consultation-medicinal-products-january-2025_en.
[14] European Union. Briefing document template for Parallel HTACG/EMA Joint Scientific Consultation (JSC) for Medicinal Products (MP)[EB/OL]. (2024-11-21)[2025-06-25]. https://health.ec.europa.eu/system/files/2024-11/hta_jsc_parallel_mp_briefing-document-template_en.docx.
[15] Health Technology Assessment Coordination Group (HTACG). Guidance for the selection of Medicinal Products (MP) for Joint Scientific Consultations (JSC)[S]. Version 3.2. Brussels: European Union, 2024.
[16] European Commission. Commission Implementing Regulation (EU) 2024/3169 of 18 December 2024 laying down rules for the application of Regulation (EU) 2021/2282 with regard to the procedures for joint scientific consultations on medicinal products for human use at Union level[S]. Official journal of the European Union, 2024, L 3169: 1-11.
[17] European Union. Procedural Guidance for Joint Scientific Consultations (JSC) on Medicinal Products (MP)[EB/OL]. (2024-11-21)[2025-06-25]. https://health.ec.europa.eu/system/files/2024-11/hta_jsc_mp_procedural-guidance_en.pdf.
