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首版商保创新药目录完成专家评审 5款“天价”CAR-T过评
Jing Ji Guan Cha Wang· 2025-09-20 14:41
一位参与本次商保创新药目录评审的专家向经济观察报介绍,本次专家评审由医保局主持召集,其中包 括医保局、保司、高校、第三方技术公司等不同领域人士。总体来说,经专家评审筛选出来的药品比例 不高,但覆盖面较广,有几类创新药会被优先考虑纳入商保创新药目录,例如已纳入地方惠民保和商业 健康险的药品、一类创新药、创新程度高且患者获得感较强的药品等。 多位专家告诉经济观察报,5款CAR-T药物均通过了专家评审。CAR-T药物以"天价"闻名,每针的价格 在100万元左右,即便叠加各种优惠,每针价格也在50万元左右。此前,CAR-T药物曾多次尝试进入基 本医保目录,均失败。 商保创新药目录需要经过多轮专家评审。一位专家透露,他参与评审时,拿到的名单里共有55个药品, 已不足通过形式审查名单的一半,这些药品还需要继续被筛选。他估计,创新药目录专家评审环节,最 终通过的药品会在30个以下。 9月20日,国家医保局公告,2025年国家基本医保目录及商保创新药目录调整专家评审工作已结束。 2025年是国家医保局成立以来第8次进行医保目录调整,也是首次在基本医保目录之外增设商保创新药 目录。 据8月12日国家医保局公布的名单,2025年 ...
多款救命药有望商保报销 保费怎么定是关键
经济观察报· 2025-08-16 13:32
Core Viewpoint - The article discusses the introduction of the commercial insurance innovative drug directory in China, which supplements the basic medical insurance directory and aims to include high-priced innovative drugs that provide significant clinical value and patient benefits [2][10]. Summary by Sections Introduction of the Commercial Insurance Innovative Drug Directory - The National Healthcare Security Administration announced a list of drugs that passed the initial review for the commercial insurance innovative drug directory, with a total of 121 drugs, over half of which are cancer or rare disease medications [2][5]. - The directory is expected to include high-priced drugs, such as CAR-T therapies costing over 1 million yuan per injection and gene therapies priced around 98,000 yuan per injection [2][4]. Drug Approval and Characteristics - To qualify for the commercial insurance innovative drug directory, drugs must either be newly approved from January 1, 2020, to June 30, 2025, or have indications included in the national rare disease directory by June 30, 2025 [5]. - Among the 121 drugs, 57 are imported, accounting for 47%, with notable entries from companies like Pfizer and Johnson & Johnson [5]. Focus on Cancer and Rare Diseases - The majority of drugs that passed the initial review are cancer treatments, with over 40 entries, followed by 35 for rare diseases [5][6]. - The article highlights the potential for the directory to alleviate payment challenges for rare disease medications, with companies actively submitting applications [6]. Pricing and Negotiation Challenges - The pricing negotiation process for drugs in the commercial insurance directory remains uncertain, as it involves collaboration between the National Healthcare Security Administration, commercial insurers, and pharmaceutical companies [12][13]. - The article notes that the commercial insurance directory may serve as a "double insurance" for companies, allowing them to apply for both the basic medical insurance and the commercial insurance directories simultaneously [9]. Future Considerations and Recommendations - The article suggests that the implementation of the commercial insurance innovative drug directory requires further exploration and refinement, with recommendations for pilot programs in specific insurance products [14]. - It emphasizes the need for insurance companies to develop reasonable pricing mechanisms and improve data integration with basic medical insurance to enhance their pricing strategies [13][14].
百万抗癌药首次通过商保创新药目录初审
Di Yi Cai Jing Zi Xun· 2025-08-14 05:16
Core Insights - The article discusses the recent approval of several high-priced innovative drugs for the commercial insurance innovation drug directory, which were previously excluded from the basic medical insurance directory due to high costs [2][5] - Over 60% of the drugs included in the commercial insurance innovation drug directory have also applied for the basic medical insurance directory, indicating a dual strategy by pharmaceutical companies [2][5] - The National Healthcare Security Administration (NHSA) has initiated a new phase of expert reviews for these drugs, which will determine their final inclusion in the insurance directories [10] Group 1: Drug Approval and Market Dynamics - A total of 121 innovative drugs passed the preliminary review for the commercial insurance innovation drug directory, with 141 applications submitted [5] - Approximately 80 drugs applied for both the basic medical insurance and commercial insurance directories, highlighting a trend towards dual applications [5][9] - The article identifies five categories of drugs that were only submitted for the commercial insurance directory, including rare disease treatments and newly approved drugs with limited clinical data [3][4] Group 2: Pricing and Economic Considerations - Some high-priced rare disease treatments have annual costs exceeding 1 million yuan, which have previously failed to meet the basic medical insurance criteria [6] - The NHSA emphasizes that the approval for the basic medical insurance directory does not guarantee inclusion, as drugs must pass rigorous evaluations and negotiations [9] - The article notes that the commercial insurance directory may serve as a transitional option for innovative drugs that exceed the acceptable pricing thresholds for basic medical insurance [5][10] Group 3: Industry Perspectives and Future Implications - Industry experts suggest that the commercial insurance innovation drug directory should focus on new drugs that fill clinical gaps and provide differentiated treatment options [7] - There is a concern among pharmaceutical companies regarding the potential impact of drug inclusion on insurance premiums and patient access [10][11] - The article highlights the need for real-world evidence to support the clinical efficacy of some newly approved drugs, which may influence their acceptance in the basic medical insurance directory in the future [8][9]
百万抗癌药首次通过商保创新药目录初审
第一财经· 2025-08-14 05:04
Core Viewpoint - The article discusses the recent approval of high-priced innovative drugs for commercial insurance innovation drug directory, highlighting the ongoing negotiations for inclusion in the basic medical insurance directory, which remains the primary goal for most innovative drug companies [3][4][8]. Summary by Sections Approval Process - The National Medical Insurance Administration announced that 121 innovative drugs passed the preliminary formal review for the commercial insurance innovation drug directory, with a significant number also applying for the basic medical insurance directory [3][7]. - The review process assesses whether the drugs meet the criteria for inclusion in the insurance directories and the completeness of their information [7]. Drug Categories - Less than 40% of the drugs approved only for the commercial insurance innovation drug directory fall into five main categories: rare disease medications, newly approved drugs with limited real-world evidence, globally priced drugs that still do not meet basic insurance thresholds, high-priced new drugs for existing treatments, and preventive biological agents restricted by legal regulations [4][5]. Dual Directory Applications - Approximately 80 drugs, or about 60% of those in the commercial insurance innovation drug directory, applied for both directories, indicating a transitional strategy for many innovative drug companies [8]. - Many high-priced innovative drugs that exceed the acceptable value threshold for basic medical insurance are opting for single directory applications [8][10]. Market Dynamics - The competition in the market for cancer drugs and other treatment areas is intensifying, with a focus on "true innovation" and "differentiated innovation" as encouraged by the National Medical Insurance Administration [10]. - The article notes that some innovative drugs are being submitted for commercial insurance first, with the expectation that they may later be evaluated for inclusion in the basic medical insurance directory once sufficient real-world data is available [11]. Insurance Considerations - The decision to include innovative drugs in the commercial insurance directory is influenced by factors such as the drug's appeal to insurance products, potential premium increases, and the risk of excessive claims [14][15]. - The article highlights the differences in coverage and reimbursement capabilities across various regions, which may affect the sales pathways for innovative drugs [15].
商保“单目录”申报仅约四成,药企抉择背后有何考量
Di Yi Cai Jing Zi Xun· 2025-08-13 13:15
今年,曾在历年"国谈"中或因不符合"70万不谈,50万不入"隐形门槛而被基本医保目录谈判拒之门外的 多款高价创新药通过了商保创新药目录初审。 与此同时,超六成纳入商保创新药目录初审名单的药品同时申报并进入基本目录谈判的初审名单,包括 2款阿尔茨海默症治疗药物、3款CAR-T药物等,这些高价"明星药物"能否通过专家评审、进入"谈判 桌"并最终获得医保支付,仍待揭晓。 8月12日,国家医保局发布《关于公示通过2025年国家基本医疗保险、生育保险和工伤保险药品目录及 商保创新药目录调整初步形式审查的药品及相关信息》的公告(下称"形式审查公示"),121款创新药 通过商保创新药目录初步形式审查,第一财经记者梳理得出上述信息。这与记者此前和多家申报企业方 交流情况基本一致,鉴于基本医保目录覆盖人群广、支付和"进院"政策确定性更强,仍是多数创新药企 的首选或最终目的。 此外,根据国家医保局公示的"入围"药品信息,第一财经还发现,在占比不到四成(40余款)的仅申报 并通过商保创新药目录的药品中,主要包含五类:一是适应证人群少但价格高昂的罕见病用药;二是以 海外临床数据或替代终点上市,真实世界证据尚待积累的刚获批新药;三是药 ...
商保创新药目录今起申报!业内:纳入商保并对创新药实施DRG除外支付,将极大推动创新药入院使用
Mei Ri Jing Ji Xin Wen· 2025-07-11 06:31
Core Viewpoint - The National Healthcare Security Administration (NHSA) has released a work plan for the adjustment of the National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance drug catalog and the Commercial Health Insurance Innovative Drug Catalog, allowing eligible companies to apply for inclusion starting July 11, 2023 [1][3]. Group 1: Work Plan Details - The work plan allows for the application of new generic names or exclusive drugs for rare diseases approved for marketing within the last five years to be included in the Commercial Health Insurance Innovative Drug Catalog [1]. - The application process includes preparation, submission, initial review, public announcement, re-examination, and final announcement of the drug list [2]. - The timeline for the application process spans from July to November 2023, with specific phases for expert review and negotiation for pricing [2]. Group 2: Benefits for Innovative Drugs - Inclusion in the Commercial Health Insurance Innovative Drug Catalog can enhance sales for innovative drugs by leveraging the scale of basic medical insurance or commercial insurance [4]. - Drugs in the commercial insurance catalog are exempt from being counted in the basic medical insurance self-pay rate indicators and the monitoring of selected alternative products [4]. - The arrangement allows for innovative drugs to be excluded from the Diagnosis-Related Group (DRG) payment system, addressing the issue of high costs associated with innovative treatments [5]. Group 3: Application Choices for Companies - Companies can choose to apply for either the basic medical insurance catalog, the commercial health insurance innovative drug catalog, or both [6]. - The selection criteria for the commercial health insurance catalog focus on high innovation, significant clinical value, and substantial patient benefits, making it unlikely for the same drug to be included in both catalogs simultaneously [6][7]. - For products priced above the set standard, inclusion in the commercial insurance catalog is seen as more favorable compared to the basic medical insurance catalog [8].