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医保、商保药品双目录公布,新目录支持真创新
Ren Min Ri Bao· 2025-12-12 12:56
Core Viewpoint - The recent adjustment of the National Medical Insurance Drug List and the Commercial Health Insurance Innovative Drug List signifies the successful completion of the annual national medical insurance drug negotiation process, emphasizing the goals of "filling gaps, encouraging innovation, and optimizing structure" [1][10]. Group 1: Drug List Adjustments - A total of 114 new drugs were added to the list, with 111 being newly launched within the last five years, representing 97.3% of the additions, including 50 first-class innovative drugs [2][11]. - The total number of drugs in the directory has increased to 3,253, with 1,857 Western medicines and 1,396 traditional Chinese medicines, significantly enhancing the coverage for critical areas such as cancer, chronic diseases, and rare diseases [2][11]. - The new directory includes drugs that address gaps in basic medical insurance, such as treatments for triple-negative breast cancer, pancreatic cancer, and lung cancer, as well as medications for rare diseases and chronic conditions [2][11]. Group 2: Support for Innovation - The negotiation success rate for this year reached 88.19%, the highest in recent years, with 127 drugs participating and 112 achieving success, indicating a strong support for genuine innovation [4][13]. - The selection process for drugs involved strict evaluations, with only 41.48% of the 331 drugs reviewed passing the expert assessment, reflecting a focus on high-quality submissions [5][14]. - The pricing assessment for drugs is based on their clinical value, with a higher willingness to pay for drugs that demonstrate significant clinical benefits, aligning with the principle of "paying more for quality life" [6][14]. Group 3: Commercial Health Insurance - The first version of the commercial health insurance innovative drug directory includes 19 high-priced innovative drugs, aimed at establishing a multi-tiered insurance system [8][16]. - The directory is designed to enhance the attractiveness of insurance products, potentially increasing the insurance uptake and improving the profitability structure of insurance companies [9][17]. - The commercial insurance directory complements the basic medical insurance list, facilitating a clearer distinction in coverage and promoting the development of a multi-layered medical insurance system [9][17].
关乎13亿人!现场直击最新医保药品目录解读会:“双目录”背后有这四大细节
Mei Ri Jing Ji Xin Wen· 2025-12-10 14:08
Core Insights - The National Healthcare Security Administration (NHSA) held a conference on December 9, 2023, to discuss the 2025 Medical Insurance Drug List, attracting significant interest from various stakeholders, including over 23,000 online viewers [1][6]. Group 1: Drug List Adjustments - The basic medical insurance fund, exceeding 3 trillion yuan, is directly linked to the annual release of the National Medical Insurance Drug List [6]. - In 2025, 114 new drugs were added to the basic medical insurance list, with 111 being new drugs launched within the last five years, marking a record high in both proportion and quantity [7]. - The adjustment process for the drug list has become clearer, with specific phases for preparation, application, review, and negotiation [7]. Group 2: Misunderstandings in Drug Pricing - There are misconceptions regarding the negotiation process, particularly the belief that all drugs must reduce prices upon renewal; only 30 out of 178 drugs negotiated for renewal experienced an average price drop of 13.8% [8]. - The average price reduction for the 15 drugs that were renewed was only 8.4% [8]. Group 3: Commercial Health Insurance Innovations - The NHSA introduced the first Commercial Health Insurance Innovative Drug List, which involves a more complex review process, including a re-evaluation by a specialized expert group [9]. - Certain drugs, while deemed valuable by basic medical insurance experts, were not included in the commercial insurance list due to concerns over their insurability and management difficulties [10]. Group 4: Challenges in Implementation - The NHSA aims to leverage the "three exclusions" policy to facilitate drug inclusion in hospitals and encourage the design of insurance products targeting the innovative drug list [11]. - There are significant challenges in aligning commercial insurance products with the innovative drug list, including low efficiency in claims processing and insufficient coverage [12]. Group 5: Differentiated Innovation in Pharmaceuticals - The NHSA emphasizes the need for differentiated innovation in pharmaceuticals, urging companies to provide robust evidence, such as head-to-head clinical trial data, to support claims of being "best in class" [15][16]. - The selection of reference drugs for economic evaluation is crucial, requiring a comprehensive approach that considers multiple dimensions of comparison [16][17].
“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
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]
创新药打开支付新路径 药企还有哪些考量?
智通财经网· 2025-08-24 11:25
Core Insights - The first version of the commercial insurance innovative drug directory has been officially released, listing 121 drugs, marking the approach of a "dual directory" era [1] - The inclusion of commercial health insurance in the directory system by the National Medical Insurance Administration breaks the previous single payment model, providing a new pathway for innovative drugs to overcome payment bottlenecks in clinical applications [1] - The "first commercial insurance, then basic medical insurance" model allows innovative drugs to accumulate real-world data before considering inclusion in the basic medical insurance directory [1] Industry Perspective - The past decade has seen transformative changes in China's innovative drug sector, driven significantly by government policies, yet there are still notable gaps in the commercial logic of the industry [2] - Even innovative drug companies with a market value of 10 billion yuan may struggle to achieve profitability, indicating deficiencies in the payment system [2] - The development of commercial insurance in the payment sector is crucial for establishing a complete commercial loop for innovative drugs, which is essential for sustainable industry growth [2] Company Strategies - Companies like Fosun Pharma have multiple products listed in the initial review of the commercial insurance innovative drug directory, including the CAR-T therapy, which has faced challenges in entering the basic medical insurance negotiations [2][3] - The uncertainty surrounding the commercial insurance system includes issues related to fairness, price negotiation, and the lack of mature operational experience [3] - Companies are exploring differentiated pricing strategies based on pharmacoeconomic evaluations to ensure that patients have access to medications while maintaining profitability [5][6] Regulatory Environment - The "Support Measures for High-Quality Development of Innovative Drugs" outlines how to reasonably determine the medical insurance payment standards for innovative drugs, emphasizing the use of pharmacoeconomic methods [7] - This policy direction aims to balance the demands of the medical insurance fund's sustainability with the recognition of the research and clinical contributions of innovative drugs [7]
创新药打开支付新路径 药企还有哪些考量?
Xin Lang Cai Jing· 2025-08-24 09:07
Core Insights - The introduction of the first commercial insurance innovative drug directory marks a significant shift in China's healthcare payment landscape, allowing for a dual-directory system that includes both basic medical insurance and commercial health insurance [2][3] - This new model aims to alleviate the financial burden on patients for high-priced innovative drugs and provides pharmaceutical companies with more flexible pricing strategies and market coverage options [2][3] - The concept of "first commercial insurance, then basic insurance" is proposed for innovative drugs that are not yet covered by basic medical insurance, allowing for the accumulation of real-world data before negotiating for inclusion in the basic insurance directory [2][3] Industry Dynamics - The commercial insurance sector's involvement in innovative drug payments is seen as crucial for creating a complete commercial loop in the Chinese innovative drug market, which has undergone significant transformation over the past decade [3][4] - Despite the potential benefits, uncertainties remain regarding the implementation of commercial insurance policies, including fairness, price negotiation, and the lack of mature operational experience [4][5] - The current commercial insurance innovative drug directory serves as a guideline, with local execution and detailed implementation still needing observation and refinement [4][5] Pricing and Economic Evaluation - Drug economic evaluation is becoming an essential tool for drug reimbursement and payment decisions, focusing on the effectiveness, safety, economic viability, and patient benefits of drugs [6][8] - Companies are exploring differentiated pricing strategies based on economic evaluations to achieve a balance between patient access, corporate returns, and manageable healthcare costs [6][8] - The recent policy direction emphasizes the use of drug economic evaluation in determining reimbursement standards, aiming to align with China's national conditions and market status while recognizing the value of innovative drug development [8]