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国家医保局详解2025年医保药品目录变化 为何有一类创新药无法通过专家评审?
Yang Guang Wang· 2025-12-10 10:08
Core Insights - The National Healthcare Security Administration (NHSA) has released the 2025 National Medical Insurance Drug List, adding 114 new drugs, including 50 innovative drugs of Class A, and 19 drugs included in the first commercial insurance innovative drug list [1][4] Summary by Sections New Drug Additions - The 2025 National Medical Insurance Drug List primarily adds chemical drugs, with a rapid increase in biological products and some traditional Chinese medicine [1] - Out of the 114 new drugs, 112 were included through negotiation and bidding, while 2 were directly included from national procurement [1] - A total of 111 new drugs were approved in the last five years, with the number of Class A innovative drugs reaching a historical high of 50 [1] Financial Impact - As of October 2023, the NHSA has paid over 460 billion yuan for drugs under agreement, benefiting over 1 billion patients and driving related sales exceeding 670 billion yuan [2] - Basic medical insurance covers approximately 44% of the costs for innovative drugs, while commercial insurance covers about 7% [2] Evaluation and Selection Criteria - The selection process for new drugs has seen a low pass rate during expert reviews, with only 127 out of 311 drugs passing to the negotiation table this year [2] - Some drugs were not favored due to "involutionary innovation," where the clinical value does not significantly improve compared to existing drugs [3][4] - To be included in the list, drugs must meet at least one of three criteria: filling clinical gaps, superior efficacy, or better cost-effectiveness [4] Commercial Insurance Innovations - The newly introduced commercial health insurance innovative drug list emphasizes drug innovation and clinical value, with 19 out of 141 submitted drugs successfully negotiated for inclusion [5] - The drugs in the commercial insurance list include 9 Class A new drugs, addressing gaps in basic medical insurance coverage [5] Future Directions - The NHSA plans to continue annual adjustments to the drug list to meet evolving clinical needs and incorporate advancements in medical technology [6] - The focus will be on supporting domestic and innovative drugs, enhancing collaboration between commercial insurance and innovative pharmaceutical companies [6]
商保怎么落地?医保怎么支持创新?权威解读来了
经济观察报· 2025-12-09 14:25
Core Viewpoint - The introduction of the commercial insurance innovative drug directory will create a win-win situation for patients, insurance companies, and hospitals, allowing patients access to innovative drugs, insurance companies to benefit from discounts, and hospitals to enhance their diagnostic capabilities and influence [1][7]. Summary by Sections Commercial Insurance Directory Release - On December 7, the National Medical Insurance Administration released the adjusted national basic medical insurance directory and the first version of the commercial insurance innovative drug directory, adding 114 new drugs to the basic insurance directory and 19 drugs to the commercial insurance directory [2]. Support for Innovation - The National Medical Insurance Administration aims to clarify the boundaries of basic medical insurance coverage and leave room for the development of commercial insurance, focusing on supporting true and differentiated innovations rather than redundant innovations [3][15]. Drug Selection Criteria - The drugs included in the commercial insurance directory are characterized by high innovation, significant clinical value, non-replaceability by existing basic insurance drugs, and strong insurability [6][11]. Market Dynamics - The commercial insurance directory is expected to provide coverage primarily for high-cost treatments after second and third-line therapies, indicating that it is designed to supplement existing basic insurance rather than simply overlap with it [7][10]. Insurance Product Development - Insurance companies are encouraged to design products that align with the commercial insurance directory, focusing on specific populations and innovative drugs [8][10]. Challenges and Considerations - The main challenges for commercial insurance include improving the efficiency of claims processing, ensuring that products cover truly innovative drugs, and addressing the potential issue of adverse selection if sick individuals are more inclined to purchase insurance [12][13]. Future Outlook - The commercial insurance directory is expected to officially launch on January 1, 2026, with insurance companies likely to introduce corresponding products shortly thereafter [10][12]. Regulatory Support - The National Medical Insurance Administration is committed to supporting true innovation and has implemented stricter evaluation criteria for new drugs, resulting in a lower approval rate for submissions [16][18]. Financial Impact - As of October 2025, the medical insurance fund has paid over 460 billion yuan for negotiated drugs, benefiting over 1 billion patients and driving related sales exceeding 670 billion yuan, demonstrating substantial financial support for the development of innovative drugs [18].
商保怎么落地?医保怎么支持创新?权威解读来了
Jing Ji Guan Cha Wang· 2025-12-09 13:49
Core Insights - The National Healthcare Security Administration (NHSA) has released an updated National Basic Medical Insurance (BMI) catalog, adding 114 new drugs, and a first version of the commercial insurance innovative drug catalog, which includes 19 drugs. This dual catalog aims to clarify the boundaries of basic insurance coverage and create space for the development of commercial insurance, contributing to a diversified medical security system [1][2]. Group 1: Commercial Insurance Catalog Implementation - NHSA emphasizes three considerations for the implementation of the commercial insurance catalog: enhancing communication with local authorities, maintaining drug market prices while providing discounts to insurance companies, and encouraging the design of commercial health insurance products targeting the innovative drug catalog [2][3]. - The commercial insurance catalog includes 19 drugs, with a strict selection process resulting in a less than 20% approval rate for drugs entering the price negotiation phase, indicating a rigorous expert review [3][4]. Group 2: Characteristics of Included Drugs - The drugs in the commercial insurance catalog exhibit four main characteristics: high innovation level, significant clinical value, non-replaceability by existing BMI catalog drugs, and strong insurability [4][5]. - Most drugs included are for second-line and third-line treatments, highlighting the catalog's focus on providing coverage for high-cost treatments of catastrophic diseases beyond existing BMI coverage [5][6]. Group 3: Stakeholder Benefits and Challenges - The commercial insurance catalog is expected to create a win-win situation for patients, insurance companies, and hospitals, allowing access to innovative drugs while providing discounts to insurers and enhancing hospital capabilities [6][7]. - Challenges identified include the need for better integration between commercial insurance and medical institutions, improving claims efficiency, and ensuring that product designs adequately cover truly innovative drugs [6][8]. Group 4: Future Developments and Considerations - The commercial insurance catalog is anticipated to officially launch on January 1, 2026, with insurance companies expected to quickly develop corresponding products. However, the timeline for public access to these products remains uncertain [8][9]. - The potential for insuring individuals with pre-existing conditions is noted, but concerns about adverse selection in the insurance market are raised, emphasizing the need for careful management of pricing and claims data [9][10]. Group 5: Support for True Innovation - The NHSA has increased support for innovative drugs in the BMI catalog, with 50 out of 114 new drugs being classified as first-class innovative drugs, reflecting a significant commitment to fostering true innovation in the pharmaceutical sector [11][12]. - The approval process for drugs has become more stringent, with a lower approval rate for expert reviews, indicating a focus on supporting differentiated innovations rather than redundant ones [12][13].