2025.08. 23 本文字数：3329，阅读时长大约5分钟 作者 | 第 一财经 林 志吟 一年一度的国家基本医保目录调整已拉开序幕。 近日，国家医保局公布了通过初步形式审查的药品名单，通过初步形式审查的药品，并不代表着已进 入医保目录，还需要经过专家评审、谈判/竞价/价格协商、公布结果这些环节，最终才能被纳入医 保报销目录。 这次目录外通过初审的通用名有310个，较2024年249个通过形式审查明显增加，意味着今年的医 保准入竞争将更加激烈。 如何在定价跟患者用药可及性之间找到平衡点，如何在药品定价上体现"真创新"，是创新药进入医 保目录面临的考验。 比如今年4月份，乳腺癌药物卡匹色替片在国内获批上市，这是首个且唯一在华获批、用于任意特定 生物标志物（PIK3CA、AKT1或PTEN）改变的乳腺癌患者的AKT抑制剂。 这次国家医保局公布的通过初步形式审查的药品名单中，卡匹色替片亦现身其中。 角逐医保目录 一直以来，医保基金是我国药品费用最大的支付方。 今年是国家医保局自2018年成立以来第八年开展医保药品目录调整。 对于申请进入基本目录的药品，独家品种采用谈判方式、非独家品种采用竞价方式确认医保支付标准 ...

Core Insights - The Chinese innovative drug market has experienced a significant transformation over the past decade, evolving from a focus on "virtual innovation" to "real research and development" due to policy reforms and market demands [5][6][7] - As of now, China accounts for 52.5% of the global innovative drug transaction volume, marking it as the largest market for new drug transactions [4][5] - The shift in transaction types from License-in to License-out indicates a growing global influence of Chinese pharmaceutical companies, with License-out transactions expected to reach 44% by 2024 [5][6] Industry Trends - The number of global pharmaceutical transactions has increased from 358 in 2015 to 743 in 2024, with a compound annual growth rate of 8%, while China's transactions surged from 55 to 213, with total transaction value rising from $3.1 billion to $57.1 billion [5][6] - The Chinese pharmaceutical industry is transitioning from being a "follower" to a "contributor" in global innovation, driven by both market demand and capital [6][7] Challenges and Solutions - The current state of the industry is marked by excessive internal competition, or "involution," which hinders true innovation [7][8] - To combat this, the industry must focus on protecting innovators and addressing market entry barriers, as well as improving data availability for clinical needs [8][9] - The lack of comprehensive epidemiological and disease burden data is a significant barrier to effective drug development, necessitating improvements in data collection and analysis [10][11] Future Directions - In the era of precision medicine, the development of detailed epidemiological data will be crucial for assessing market potential and guiding drug development decisions [11] - Companies need to understand the clinical pathways and unmet needs of patients to drive innovation and improve drug offerings [11]

Group 1 - The establishment of a commercial insurance innovation drug directory indicates that China's pharmaceutical industry has welcomed a second major buyer, alongside basic medical insurance [1][6] - The National Healthcare Security Administration (NHSA) has introduced new measures to support the high-quality development of innovative drugs, including the opening of medical insurance data and the establishment of a commercial insurance innovation drug directory [1][6] - Since 2018, the medical insurance fund has spent 410 billion yuan on negotiated drugs, highlighting the significant financial impact of medical insurance on the pharmaceutical sector [1] Group 2 - The transition from the 1.0 version of medical insurance (1998-2019) to the 2.0 version (2020 onwards) emphasizes the importance of establishing mechanisms that ensure accessible, safe, and affordable basic healthcare [2][3] - The NHSA aims to create a collaborative platform between social insurance and commercial insurance, addressing the challenges of data sharing and payment efficiency [3][4] - The integration of basic medical insurance and commercial insurance is crucial for building a multi-tiered medical security system, which includes addressing legal and theoretical barriers [3] Group 3 - The sharing of medical data between commercial insurance and medical insurance is expected to enhance risk management and improve pricing strategies in the commercial insurance market [4][5] - The introduction of a one-stop payment system could significantly reduce the financial burden on patients, particularly in corporate supplementary medical insurance [4] - Long-term changes in the commercial health insurance model are anticipated, integrating various services such as patient management and community support [5] Group 4 - The NHSA is focusing on utilizing real-world data to evaluate the comprehensive value of drugs and medical devices, which will influence their inclusion in both basic medical insurance and commercial insurance directories [6][9] - Real-world data is essential for understanding the effectiveness and safety of innovative drugs in diverse patient populations, which can lead to more informed purchasing decisions by medical insurance [7][9] - The establishment of a management platform for clinical data quality is necessary to support the transition from volume-based to value-based payment mechanisms [7] Group 5 - The Hainan Boao Lecheng International Medical Tourism Pilot Zone has initiated a project to support the entry of innovative drugs into medical insurance using real-world data, aiming to address key decision-making issues in medical insurance [8][9] - The project categorizes unlisted innovative drugs by disease type and explores multi-channel payment pathways, enhancing the accessibility of innovative treatments [9]

Core Insights - The introduction of the commercial insurance innovative drug directory has opened up possibilities for innovative pharmaceutical companies to access high-value and high-innovation drugs in national negotiations and multi-layered payment systems [1][2] - Real-world data (RWD) is expected to play a larger role in the pricing of new drugs and their entire lifecycle, enhancing value-based purchasing in medical insurance and innovative payment in commercial insurance [1][2] - The National Medical Insurance Administration has been actively seeking public opinions on how RWD can support the comprehensive value assessment of drugs and medical devices [1][2] Group 1: Policy Developments - The recent rapid policy advancements in the pharmaceutical industry have surprised stakeholders, particularly with the release of measures supporting high-quality development of innovative drugs [1][2] - The establishment of a comprehensive value assessment system based on RWD is a key focus in recent discussions, aiming to optimize its role in the dual directory access and post-access re-evaluation [1][2][3] Group 2: Real-World Data Application - RWD has matured as auxiliary evidence in the evaluation and approval of innovative drugs, but its application in medical insurance value purchasing is relatively new [2][3] - The need for RWD in assessing the clinical effectiveness of newly listed drugs has become critical, especially as some drugs fail to meet expected value post-market entry [2][3][10] - RWD can fill evidence gaps left by traditional clinical trials, thus reducing uncertainty in medical insurance decision-making and improving fund utilization efficiency [5][10] Group 3: Dynamic Evaluation and Pricing - The evaluation of the clinical added value of innovative drugs should be dynamic, with RWD being used to balance clinical benefits and fund affordability [5][6] - The potential for RWD to support dynamic management of the medical insurance directory and drug exit mechanisms is recognized, allowing for timely removal of low-value drugs [6][8] Group 4: Integration of Insurance Systems - The introduction of the commercial insurance innovative drug directory allows for parallel applications with the basic medical insurance directory, with over 100 drugs already applying for the innovative drug directory [7][8] - RWD is anticipated to become a crucial element in connecting the dual directories, enabling a phased approach to drug access and evaluation [8][9] Group 5: Data Quality and Governance - The quality of RWD is essential for high-quality research, with current challenges including data inconsistency and lack of standardized collection methods [11][13] - Establishing a comprehensive system for RWD collection, application, and evaluation is crucial for enhancing the negotiation process for drug pricing and ensuring proper clinical use [13][14] Group 6: Collaborative Governance - The establishment of a unified medical insurance information platform has facilitated the collection of high-quality RWD, which can support regulatory decision-making [12][14] - The recent implementation of management measures for RWD usage in Hainan province highlights the potential for RWD to inform dynamic adjustments in the medical insurance directory and improve healthcare services [14]

Core Viewpoint - The article emphasizes the importance of implementing a comprehensive value assessment for innovative drugs and medical devices as a new policy tool under the "Measures to Support the High-Quality Development of Innovative Drugs" [1] Group 1: Policy Implementation - The National Healthcare Security Administration (NHSA) held a seminar focusing on the comprehensive value assessment of innovative drugs and devices, indicating a shift towards evaluating real-world effectiveness rather than solely relying on laboratory data [1] - Future value-based purchasing in healthcare will prioritize real-world data to enhance the effectiveness of insurance coverage decisions [1][2] Group 2: Research Directions - The research will focus on two main areas: comprehensive value assessment for basic medical insurance drug catalog management and for commercial health insurance innovative drug catalog management [2] - Specific topics include evaluating drugs not yet on the market within certain regions, proposed new inclusions in the catalog, and mechanisms for drug exit from the catalog [2] Group 3: Evaluation Framework - A systematic and comprehensive evaluation framework is needed to assess the value of medical products, addressing questions like "where to allocate funds" and "is the spending worthwhile" [2] - The evaluation process will occur in three stages: pre-market assessment, post-market but pre-insurance assessment, and post-insurance entry re-evaluation [3] Group 4: Expert Insights - Experts believe that the establishment of a comprehensive value assessment system will help avoid competitive internalization among innovative drugs and guide the rational allocation of medical resources [4] - The NHSA's initiative is seen as a significant step away from merely reducing drug prices to a more structured approach in determining insurance payment standards for innovative drugs [4]

Core Viewpoint - The future value-based purchasing of medical insurance will focus on the real-world effectiveness of innovative drugs and devices rather than solely on laboratory data provided at the time of market entry [1][2]. Group 1: Policy and Evaluation Framework - The National Healthcare Security Administration (NHSA) is implementing a comprehensive value evaluation for innovative drugs and devices as part of new policies to support high-quality development [1][3]. - The NHSA is conducting a series of discussions to gather insights on how real-world data can serve the comprehensive value evaluation of drugs and devices [1][2]. - A systematic and complete evaluation framework is needed to scientifically assess the comprehensive value of medical products, addressing issues such as where funds are allocated and whether expenditures are justified [2][3]. Group 2: Stages of Value Evaluation - The comprehensive value evaluation of drugs will occur in three stages: pre-market, post-market before insurance entry, and post-insurance entry [2][3]. - Pre-market evaluation will involve collecting clinical data for drugs not yet available in the domestic market but used in specific regions, serving as a basis for market entry and insurance inclusion [2]. - Post-market evaluation will assess drugs based on safety, efficacy, economic viability, equity, accessibility, and innovation, comparing them with similar products to determine insurance inclusion [3]. Group 3: Implications for the Industry - The establishment of a comprehensive value evaluation system is expected to avoid internal competition among innovations and guide the rational allocation of medical resources [4][5]. - The NHSA's initiative signals a shift from a low-price strategy to a more value-based approach in determining insurance payment standards for innovative drugs [3][5]. - Collaboration opportunities may arise for commercial health insurance companies in areas such as innovative drug directories and one-stop settlement with basic medical insurance [5].

机器之心报道 机器之心编辑部 我们知道，训练大模型本就极具挑战，而随着模型规模的扩大与应用领域的拓展，难度也在不断增加，所需的数据更是海量。 大型语言模型（LLM）主要依赖大量文本数据，视觉语言模型（VLM）则需要同时包含文本与图像的数据，而在机器人领域，视觉 - 语言 - 行动模型（VLA）则 要求大量真实世界中机器人执行任务的数据。 目前而言，Agent 是我们走向通用人工智能（AGI）的重要过渡。训练 Agent 则需要带有行动标签的真实交互数据，而获取这类数据的成本远比从网页上获取文本 与图像的成本高昂得多。 因此，研究者一直在尝试寻找一种替代方案，来实现鱼和熊掌兼得的效果：既能够降低数据获取成本，又能够保证大模型训练成果，保持基础模型训练中常见的 大规模数据带来的优势。 加州大学伯克利分校副教授，Physical Intelligence 的联合创始人，强化学习领域大牛 Sergey Levine 为此撰写了一篇文章，分析了训练大模型的数据组合，但他却 认为，鱼和熊掌不可兼得，叉子和勺子组合成的「叉勺」确实很难在通用场景称得上好用。 替代数据 尽管在视觉感知和自然语言处理任务中，真实世界数据一直被视 ...

Core Insights - The adjustment of the national medical insurance drug catalog for 2025 has officially begun, highlighting the urgent need to establish a comprehensive drug value evaluation system [1][2] - The core functions of medical insurance involve scientifically and reasonably managing funds, which necessitates a systematic evaluation framework to assess the comprehensive value of medical products [1][2] Group 1: Importance of Real-World Data - Real-world data (RWD) is crucial for evaluating the safety, effectiveness, economic viability, fairness, accessibility, and innovation of medical products purchased by medical insurance [2][3] - The establishment of a unified medical insurance information platform has enabled the collection of extensive data, which is essential for transforming this data into actionable evidence [2][3] Group 2: Evaluation Framework - A structured real-world database should be created, along with technical guidelines to standardize and structure real-world data at the smallest granularity [3][4] - A unified evaluation system, standards, and methods should be developed to assess the comprehensive value of drugs at different stages: pre-market, pre-insurance entry, and post-insurance entry [3][4][5] Group 3: Dynamic Management of Drug Evaluation - Post-market drugs require ongoing evaluation to ensure their clinical effectiveness, utilizing real-world data for comprehensive re-evaluation [5] - New products should be compared with existing ones to determine their relative value, ensuring that only those with high comprehensive value remain in the insurance catalog [5]