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国家医保局已制定“新上市药品首发价格机制”,中国创新药或迈向定价新周期
Zhong Jin Zai Xian· 2025-08-01 03:22
Group 1 - The National Healthcare Security Administration (NHSA) has established a "first launch price mechanism" for new drugs to encourage innovation in drug development, marking a shift from a cost-control approach to one that promotes high-quality innovation [1][2][3] - The NHSA aims to support high-level innovative drugs by ensuring that their initial pricing reflects the high investment and risk associated with their development, and proposes a price stability period for these drugs [1][3] - The NHSA is facilitating the approval process for innovative drugs through a "joint review and approval" model, which allows for quicker clinical access to new drugs [1][5] Group 2 - The introduction of the first launch price mechanism addresses the previous ambiguity surrounding the pricing of innovative drugs in China, which often led to challenges in market entry and pricing for companies [2][3] - The NHSA's new pricing guidelines include over 100 new pricing projects for innovative products and devices, establishing a parallel structure for pricing and technological innovation [2] - The proposed pricing mechanism allows companies to self-assess their drugs based on clinical value and evidence, which can influence their initial pricing and market entry strategy [4][5] Group 3 - The NHSA's approach is seen as a structural response to enhance the incentive mechanisms for drug development, potentially establishing a "real market price" for innovative drugs before they enter negotiations for inclusion in the healthcare insurance catalog [3][4] - The new pricing model includes a five-year price stability period for high-scoring drugs, which will not be subject to centralized procurement during this time, allowing companies to recover their investments more effectively [5] - Industry experts express optimism about the evolving policy environment for innovative drugs, anticipating that these changes will enhance investment returns and strengthen the position of Chinese markets in global pharmaceutical strategies [6]