Core Insights - The success rate of negotiations for the National Essential Medicines List reached 88% in 2025, a significant increase from 76% the previous year, marking a seven-year high [1] - A total of 114 new drugs were added to the list, including 50 innovative first-class drugs, indicating a record number both in terms of proportion and quantity [2] - Nearly 100 drugs (98) were rejected during the formal review stage, with over 60% failing to pass expert evaluation, reflecting a continuous decline in the approval rate [1][4] Group 1: Negotiation Process and Outcomes - The negotiation process has matured over the past eight years, involving self-application by pharmaceutical companies, expert evaluations, and price negotiations, resulting in 718 submissions and 535 passing the formal review [2] - The expert evaluation phase saw a pass rate of 41.48%, with 129 drugs proceeding to negotiations, of which 112 were successfully included in the National Essential Medicines List [2] - The total number of drugs in the list increased to 3,253, with 1,857 Western medicines and 1,396 traditional Chinese medicines [8] Group 2: Reasons for Rejection - The decline in approval rates for drugs in the expert evaluation phase is attributed to increased clarity in application processes and heightened competition among similar drugs [4] - Several rejected drugs included first-class innovative drugs, with reasons such as lack of significant clinical value compared to existing treatments [5] - Four main reasons for rejection were identified: lack of innovation, high prices, and insufficient clinical necessity [6] Group 3: Support for True Innovation - The focus on "true innovation" emphasizes filling clinical gaps, offering superior alternatives, and providing better cost-effectiveness [7] - Successful new entries into the list included innovative treatments for various cancers and chronic diseases, reflecting a commitment to enhancing healthcare coverage [8] - The National Healthcare Security Administration aims to maintain a dynamic adjustment of the drug list to meet evolving clinical needs [8] Group 4: Value-Based Purchasing - The negotiation process incorporates a systematic value assessment, including expert evaluations and price calculations, to ensure fair pricing [9] - Recent improvements in price calculation methods aim to enhance fairness and scientific rigor in the evaluation process [10] - The emphasis on differentiated innovation requires pharmaceutical companies to provide substantial clinical evidence to support claims of added value [11]
“国谈”过评率仅约40％ 国家医保局解释了五大原因
Di Yi Cai Jing·2025-12-10 08:49