Core Viewpoint - The annual adjustment of the national basic medical insurance (BMI) drug list has begun, with a significant increase in the number of drugs passing the preliminary review, indicating intensified competition for inclusion in the insurance coverage [3][5]. Summary by Sections Drug Approval and Competition - A total of 310 drug names passed the preliminary review this year, up from 249 in 2024, reflecting a growing number of innovative drugs approved [3][5]. - The number of first-class innovative drugs approved in China has shown a clear upward trend, with 48 approved in 2024, more than five times the number in 2018 [5]. Impact on Patients and Accessibility - The inclusion of innovative drugs in the BMI list significantly improves patient access, with over 70 anti-tumor drugs added from 2018 to 2024, addressing the issue of patients lacking available treatments [5][6]. - The pricing of new drugs is crucial for patient affordability, as high costs can limit access despite the availability of innovative treatments [7][8]. Pricing Negotiations and Challenges - The negotiation process for drug pricing involves expert evaluations and discussions with companies to establish mutually acceptable reimbursement standards [7][10]. - Balancing the need for affordable pricing with the necessity for companies to recoup R&D costs presents a significant challenge in the negotiation process [8][11]. Policy Directions and Innovation Support - The 2025 adjustment plan emphasizes maintaining fund security while encouraging innovation and optimizing the drug list structure [10][11]. - The focus is on supporting genuine innovation and ensuring that new drugs provide real clinical benefits, with a comprehensive evaluation of their value [10][12]. Real-World Data and Evaluation - The importance of real-world data in assessing drug effectiveness and safety is highlighted, as it provides insights beyond controlled clinical trials [14][15]. - The need for a robust drug value assessment system is increasingly urgent, as it informs decisions on funding and resource allocation [13][16].

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].

Core Viewpoint - The article discusses the challenges and limitations of using alternative data for training large models in the context of artificial intelligence, particularly in robotics, emphasizing that while alternative data can reduce costs, it often compromises the model's generalization capabilities [6][30][40]. Group 1: Challenges in Training Large Models - Training large models, especially in robotics, requires vast amounts of real-world interaction data, which is costly to obtain [2][4]. - Researchers are exploring alternative data sources to balance cost and training effectiveness, but achieving this balance is complex [5][8]. Group 2: Alternative Data Strategies - Various methods for obtaining alternative data include simulation, human videos, and handheld gripper devices, each with its own strengths and weaknesses [10][12][13]. - While these methods have produced significant research outcomes, they represent compromises that may weaken the inherent capabilities of large-scale learning models [14]. Group 3: Limitations of Alternative Data - The reliance on alternative data can lead to a disconnect between the training environment and real-world applications, limiting the model's ability to generalize effectively [26][28]. - The design decisions made when creating alternative data can significantly impact the overlap between successful strategies in real-world scenarios and those learned from alternative data [23][24]. Group 4: Importance of Real-World Data - Real-world data is essential for developing models with broad generalization capabilities, as it allows models to learn the true mechanisms of the world [36]. - Alternative data should be viewed as a supplementary source of knowledge rather than a replacement for real-world experience [37][38]. Group 5: The Concept of "Sporks" - The term "sporks" is used to describe alternative data approaches that attempt to combine the benefits of large-scale training with the cost-effectiveness of alternative data [39][40]. - Other "spork" methods include hybrid systems that combine manual design with learning components, aiming to mitigate the high data demands of machine learning [41][42].

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]