Core Viewpoint - The National Healthcare Security Administration (NHSA) of China has announced a pilot program for a "Real-World Comprehensive Value Assessment" of healthcare, which will be linked to adjustments in both public and commercial insurance directories, aiming to establish a value-oriented assessment system based on real-world research by the end of 2027 [1][2][3]. Group 1: Pilot Program Details - Eleven provinces, including Beijing, Hainan, and Jiangsu, have been included in the pilot program, which will undergo dynamic management to ensure effective implementation [2][9]. - The assessment system is expected to influence pricing and payment guarantees for innovative drugs, generic drugs, medical consumables, and healthcare services across 21 specific scenarios [2][4]. - The NHSA will collaborate with relevant parties to address concerns regarding the evidence submitted for drug approval and its real-world clinical benefits [2][4]. Group 2: Real-World Research Significance - Real-world research (RWS) is recognized for providing evidence that complements traditional randomized controlled trials (RCTs), particularly regarding the actual efficacy and clinical benefits of drugs in practice [3][4]. - The NHSA has previously emphasized the importance of RWS in supporting the comprehensive value assessment of innovative drugs and has initiated discussions to establish a scientific methodology for RWS [3][4]. Group 3: Application Scenarios - The assessment system will be applied in seven scenarios within the pharmaceutical sector, including pre-market research, price governance, and post-market value reassessment [5][6]. - In the medical consumables sector, five application scenarios include adjustments to the insurance directory and price governance [5][6]. - The healthcare services sector will see five application scenarios, focusing on price management and dynamic adjustments [5][6]. Group 4: Implementation Phases - The pilot program will be executed in three phases: a startup phase by the end of 2023, a practical phase in 2026, and an application phase in 2027 [10][14][16]. - The startup phase will focus on establishing norms and building a talent pool in pilot regions [10][14]. - The practical phase aims to complete the construction of databases and produce preliminary evaluation results [14][15]. - The application phase will support healthcare decision-making and establish a comprehensive operational mechanism for the assessment system [16].
事关创新药械全生命周期价值评估，年底前11省份启动这项试点
Di Yi Cai Jing·2025-09-23 07:53