罕见病用药
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打通高价创新药与患者之间“最后一公里”
经济观察报· 2025-12-10 10:54
Core Viewpoint - The release of the commercial health insurance innovative drug directory addresses the issue of "can it be used" at the hospital level, but the "last mile" between high-priced innovative drugs and patients remains unconnected. To achieve seamless transformation from "policy text" to "patient benefit," three key barriers must be crossed [1][3]. Group 1: Release of the Directory - On December 7, 2025, the National Healthcare Security Administration officially released the first version of the "Commercial Health Insurance Innovative Drug Directory," incorporating 19 high-clinical-value, high-cost innovative drugs into the commercial health insurance payment framework for the first time at the national level [2]. - The directory includes 14 anti-tumor drugs (including all 5 CAR-T therapies available in China), 2 rare disease drugs, and 2 Alzheimer's disease new drugs, aligning with the current claims data of commercial health insurance, where malignant tumors are the most prevalent and costly disease area [2]. Group 2: Policy Support and Challenges - The commercial health insurance innovative drug directory is supported by policies that exempt the listed drugs from self-payment rate assessments, collection of alternative monitored varieties, and DRG payment scope, addressing the challenges hospitals face in using innovative drugs under cost control pressures [3]. - Despite the directory solving the "can it be used" issue, the connection between high-priced innovative drugs and patients still needs to be established, requiring standardization and universalization of the directory [3][4]. Group 3: Standardization and Payment Collaboration - The current directory serves as a guiding list rather than a mandatory coverage requirement for commercial insurance products, necessitating the promotion of core drugs in the directory as standard configurations in commercial health insurance, especially in inclusive "benefit insurance" products [4]. - The basic medical insurance market can leverage its large insured population to negotiate lower drug prices, but the fragmented nature of the commercial health insurance market poses challenges in forming a cohesive payment force to negotiate with pharmaceutical companies [4]. Group 4: Service Integration and Patient Experience - An ideal multi-tiered payment system should achieve seamless integration and instant settlement among basic medical insurance, commercial insurance, and patient out-of-pocket expenses, which currently requires patients to prepay and navigate complex claims processes [5]. - Commercial insurance accounts for only 7.7% of the overall payment for innovative drugs, indicating significant growth potential. Bridging the "last mile" between the 19 innovative drugs in the directory and patients requires coordinated efforts from government and market forces [5].
打通高价创新药与患者之间“最后一公里”
Jing Ji Guan Cha Wang· 2025-12-10 10:28
Core Insights - The National Healthcare Security Administration (NHSA) has officially released the first version of the "Commercial Health Insurance Innovative Drug Directory," incorporating 19 high-value, expensive innovative drugs into the commercial health insurance payment framework for the first time [1][2] - The introduction of this directory marks a significant step in improving China's multi-tiered medical security system and transforming the role of commercial insurance [1] Group 1: Directory Overview - The directory includes 19 drugs, of which 14 are anti-tumor drugs (including all 5 CAR-T therapies available in China), 2 are rare disease medications, and 2 are new drugs for Alzheimer's disease [1] - The structure of the directory aligns closely with current claims data from commercial health insurance, as malignant tumors are the most prevalent and costly disease area in China [1] Group 2: Policy Support - The drugs listed in the commercial health insurance innovative drug directory are exempt from self-payment rate assessments, do not fall under centralized procurement monitoring, and are not included in the Diagnosis-Related Group (DRG) payment scope, referred to as the "three exclusions" policy [2] - This policy alleviates the challenges hospitals face in using innovative drugs amid pressures from centralized procurement and DRG payment reforms [2] Group 3: Implementation Challenges - The transition from policy text to patient benefits requires overcoming three key barriers: standardization and inclusivity of the directory, payment coordination and bargaining power, and service fluidity and one-stop experience [2][3][4] - The current directory serves as a guiding list rather than a mandatory coverage requirement for commercial insurance products, necessitating efforts to make core drugs standard features in commercial health insurance, especially in inclusive "benefit insurance" products [3] Group 4: Payment and Service Integration - The commercial health insurance market is fragmented, with varying funding levels and coverage across different regions, which raises uncertainties about its ability to negotiate effectively with pharmaceutical companies [3] - Establishing a regional or national commercial insurance procurement coordination mechanism is essential for negotiating better drug prices and conditions, ensuring financial sustainability of coverage plans [3][4] - The ideal multi-tiered payment system should enable seamless integration and immediate settlement among basic medical insurance, commercial insurance, and out-of-pocket expenses, which currently requires patients to prepay and navigate complex claims processes [4]
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].
上海:聚焦药品医疗器械重点领域和产品,建立在研重点品种服务清单
Xin Lang Cai Jing· 2025-11-24 09:55
Core Viewpoint - The Shanghai Municipal Government has issued measures to deepen the reform of drug and medical device regulation, aiming to promote high-quality development in the pharmaceutical industry, focusing on key areas such as cell and gene therapy, rare diseases, and pediatric medications [1] Group 1: Key Areas of Focus - The measures emphasize the importance of specific fields and products, including cell and gene therapy, rare diseases, pediatric medications, high-quality first generic drugs, artificial intelligence medical devices, medical robots, brain-machine interfaces, particle therapy equipment, and innovative traditional Chinese medicine diagnostic and treatment devices [1] Group 2: Regulatory Support - A service list for key varieties under research will be established, providing proactive guidance in clinical trials, registration and listing, inspections, and production licensing [1]
让“罕见”都被看见 我国已有约100种罕见病用药被纳入医保
Yang Shi Wang· 2025-09-22 02:10
Core Insights - The 2025 China Rare Disease Conference was held in Beijing from September 20 to 21, highlighting the growing focus on rare diseases in the country [1] - Currently, there are 419 hospitals in the national rare disease diagnosis and treatment collaboration network, with the list of rare diseases expanded to 207 types [1] - Approximately 100 rare disease medications have been included in the national medical insurance drug list, indicating increased accessibility for patients [1] - In 2024, the medical insurance fund will allocate 8.6 billion yuan for rare disease medications, accounting for 7.7% of the total payment for drugs during the agreement period [1]
新华鲜报 | 约100种罕见病用药进医保!生命与希望在集结
Xin Hua She· 2025-09-21 14:59
新华社北京9月21日电 题:约100种罕见病用药进医保!生命与希望在集结 新华社记者李恒、彭韵佳 这是一场关乎生命与希望的对话,一次科学与温情的交融。 9月20日至21日,2025年中国罕见病大会在京举行。大会传递的数据温暖且令人振奋:目前全国罕见病 诊疗协作网医院达419家,罕见病直报系统现有626家医院参加登记,罕见病目录扩展至207种病种,已 有约100种罕见病用药被纳入国家医保药品目录。 医者与患者、科研人员与药企代表……这不仅仅是一场探讨罕见病诊疗与关爱的会议,更如同一束光, 穿透"罕见"的迷雾,照亮一个国家正以制度之善、科技之新、人文之暖守护"罕见病群体"。 保障更全!多层次保障体系为患者点亮生命之光—— 最新数据显示,国家医保药品目录内罕见病用药覆盖42个罕见疾病种类。2024年医保基金为协议期内罕 见病药品支付86亿元,约占协议期药品总支付的7.7%。 "医保基金坚持'尽力而为、量力而行',但罕见病用药保障不能仅靠基本医保。"国家医保局医药服务管 理司司长黄心宇说,我国正构建基本医保、大病保险、医疗救助三重保障体系,并积极探索商业健康保 险、社会慈善等多元保障路径。 从药物研发、快速审评、纳入 ...
卫光生物: 关于竞得土地使用权并签署成交确认书的公告
Zheng Quan Zhi Xing· 2025-09-07 09:15
Core Viewpoint - Shenzhen Wego Biological Products Co., Ltd. successfully won the bidding for state-owned construction land use rights in Guangming District, Shenzhen, for a price of RMB 60.4 million, which aligns with the company's strategic development plan for establishing an intelligent industrial base [1] Group 1: Land Acquisition Details - The company participated in the bidding for the land use rights of plot A628-0045, covering an area of 69,986.43 square meters, with a usage period of 30 years [1] - The funding for this land acquisition will come from the company's own or self-raised funds, and it does not constitute a related party transaction or a major asset restructuring as per regulations [1] Group 2: Strategic Implications - The acquisition of the land is intended to support the company's intelligent industrial base project, which is crucial for the company's high-quality development [1] - Upon completion of the new industrial base, the company plans to relocate its operations and will cooperate with the Guangming District government to facilitate the recovery of the existing factory site [1]
软骨发育不全等86个罕见病病种诊疗指南发布
Xin Hua She· 2025-07-10 07:55
Core Viewpoint - The National Health Commission of China has released the "Guidelines for the Diagnosis and Treatment of 86 Rare Diseases (2025 Edition)" to enhance the standardization of rare disease treatment and ensure medical quality and safety [1][2]. Group 1: Rare Disease Guidelines - The guidelines provide clear instructions on clinical manifestations, diagnostic methods, and medical interventions for the 86 rare diseases included in the second batch of the rare disease directory [1][2]. - The guidelines reflect the era's demand for comprehensive health care throughout an individual's life cycle, emphasizing the importance of early screening and treatment for rare diseases [1]. Group 2: Specific Rare Diseases - Achondroplasia (ACH) is highlighted as a genetic disorder leading to disproportionate short stature, with typical clinical features including shortened proximal long bones, macrocephaly, and distinctive facial characteristics [2]. - Currently, there is only one approved treatment for ACH abroad, while no specific drug has been approved in China, and treatment mainly focuses on symptom management and complications [2]. Group 3: Government Initiatives and Statistics - The Chinese government has shown increasing attention to rare diseases, with the first batch of rare disease directory published in 2018, which included 121 diseases and corresponding treatment guidelines [2]. - Approximately 20 million people in China are affected by rare diseases, with over 200,000 new patients each year [2]. - As of January 1, 2025, the new national medical insurance drug list will include 13 new medications for rare diseases, significantly reducing the financial burden on patients [2].
与健康“童”行!京东健康联合多方推动儿童用药安全与科学育儿普及
Zhong Jin Zai Xian· 2025-05-31 03:28
Core Viewpoint - The "Healthy Childhood: Nurturing the Future" 2025 Children's Health Science Popularization Initiative was launched by JD Health, aiming to enhance children's health education and support families in scientific parenting [1][3]. Group 1: Initiative Launch and Objectives - The initiative was launched on May 29, ahead of Children's Day, with participation from pediatric experts and representatives from various pharmaceutical companies [1]. - JD Health plans to collaborate with leading medical institutions to conduct a series of educational live streams focusing on children's health topics such as flu prevention, nutrition, and psychological growth [1][3]. Group 2: Industry Collaboration and Expert Insights - The initiative addresses the increasing demand from parents for children's health management due to changing lifestyles and environments [3]. - Experts emphasized the importance of integrating various resources through internet medical platforms to enhance health education dissemination [3]. - Pharmaceutical representatives highlighted their commitment to responsible branding and innovation in children's medication [3][4]. Group 3: Comprehensive Health Service Framework - JD Health has established a comprehensive pediatric medication supply chain covering various health needs, including nutrition, respiratory medications, and rare disease treatments [4]. - The "China Children's Care Program" will provide parents with 24/7 consultation services via the JD app, facilitating experience sharing among parents [5]. Group 4: Future Plans and Innovations - JD Health aims to focus on clinical pain points in children's medication, leveraging its supply chain and AI capabilities to enhance service delivery [7]. - The company plans to expand its pediatric medication offerings, including inhalants and innovative drugs, to improve accessibility for families across the country [7]. - JD Health will utilize its proprietary AI model to assist healthcare institutions in building comprehensive management platforms for children's health [7][8]. Group 5: Commitment to Holistic Health Solutions - The initiative underscores the belief that safeguarding children's health is foundational to overall public health [8]. - JD Health seeks to collaborate with partners in various fields to meet children's health needs comprehensively, ensuring reliable and accessible health services for families [8].