Core Viewpoint - The article discusses the launch of the 11th batch of national drug centralized procurement in China, highlighting significant changes aimed at improving transparency, quality, and clinical relevance in the procurement process [1][3]. Group 1: Key Changes in Drug Procurement - The 11th batch of centralized procurement introduces eight major changes, including the abandonment of the "lowest price" anchor, allowing doctors to report quantities by brand, raising bidding qualification thresholds, and enhancing quality supervision [3][4]. - For the first time, the selection process for procurement drugs has been made public, respecting the opinions of clinical doctors and ensuring a more transparent procedure [4][6]. - The selection criteria now include a requirement that at least seven companies must have passed the consistency evaluation for generics, with 122 products meeting this criterion, of which 55 have been selected for procurement [6][10]. Group 2: Clinical Considerations and Expert Opinions - The selection process emphasizes the importance of clinical and pharmaceutical expert opinions, with consultations held to assess the suitability of drugs for procurement [7][8]. - High-risk drugs, such as certain antibiotics and those with narrow therapeutic indices, have been excluded from this batch to ensure patient safety and effective clinical use [8][10]. Group 3: Market Dynamics and Pricing Strategies - New drugs and those under negotiation for national insurance are excluded from procurement, ensuring that only established generics are considered, which helps maintain innovation in the pharmaceutical industry [10][11]. - A new market scale condition has been introduced, where drugs with a procurement amount of less than 100 million yuan in 2024 will not be included, enhancing the scale effect of procurement [11][12]. - The procurement process will now allow medical institutions to report quantities based on specific drug brands, aligning procurement outcomes more closely with clinical needs [12][14]. Group 4: Quality Control and Bidding Requirements - The procurement strategy will no longer use the lowest bid as a reference point, aiming to prevent excessive price competition and ensure rational bidding [15][16]. - A "low-price declaration" will be required from the lowest bidding company to justify their pricing, addressing concerns about unsustainable low bids [18][19]. - The threshold for bidding qualifications has been raised, requiring companies to have at least two years of experience in producing similar formulations, thereby enhancing the quality of generics [19][20].
不再锚定“最低价”,国家药品集采迎八大变化
第一财经·2025-07-16 16:04