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自费创新药械“进院”再迎利好,国家医保局发文完善“特例单议”
Di Yi Cai Jing· 2025-08-15 13:08
Core Viewpoint - The recent reforms in medical insurance payment methods, particularly the special single negotiation mechanism, aim to support the use of innovative drugs and medical devices, addressing concerns about high costs in medical institutions [1][3][4]. Group 1: Special Single Negotiation Mechanism - The special single negotiation mechanism is designed to provide reasonable compensation for medical services when the costs exceed three times the payment standard [2][4]. - The mechanism will be refined in conjunction with national policies supporting the development of innovative drugs and medical devices, indicating a commitment to support medical institutions in treating complex and critical patients [3][4]. - The number of cases eligible for special single negotiation should not exceed 5% of the total discharged cases under the DRG or DIP payment systems [4]. Group 2: Impact on Innovative Drugs - The reforms are expected to benefit drugs listed in the commercial health insurance innovative drug directory, particularly those with high clinical value and patient benefits [5][6]. - The introduction of the commercial health insurance innovative drug directory is anticipated to provide a framework for local authorities to evaluate and implement the special single negotiation policy effectively [5][7]. - Local governments, such as those in Hainan and Guangzhou, are developing their own innovative drug directories to enhance the support for innovative drugs and medical devices [8][9]. Group 3: Regional Initiatives - Regions with relatively abundant medical insurance funds, like Shanghai and Zhejiang, have already launched local supportive directories for innovative drugs and devices [8][10]. - The Zhejiang Medical Security Bureau has established a list of innovative medical technologies eligible for payment incentives, focusing on drugs that have recently entered the basic medical insurance directory [11][12]. - Shanghai has implemented a strategy to adjust payment standards for cases involving new technologies, allowing for full payment without a control ratio for high-cost cases [12].
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].
多款百万一针抗癌药,入围商保创新药目录初审名单
21世纪经济报道· 2025-08-13 07:18
Core Insights - The article discusses the announcement by the National Medical Insurance Administration regarding the preliminary review of 534 drugs for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance drug catalog, along with 121 drugs included in the commercial insurance innovative drug catalog [1][2]. Group 1: Drug Catalog Adjustments - The 2025 drug catalog adjustments implement a "dual-track system," focusing on basic insurance for essential drugs while providing supplementary coverage for "exclusive new drugs" or "rare disease medications" through the commercial insurance innovative drug catalog [1][2]. - A total of 718 applications were received for the basic medical insurance catalog, with 534 approved, while 141 applications were received for the commercial insurance innovative drug catalog, with 121 approved [1][2]. Group 2: CAR-T Therapies - CAR-T therapies, which are personalized cancer treatments, have gained attention due to their high costs, with prices exceeding 1 million yuan per injection for several products [1][2]. - The article highlights that CAR-T therapies are among the first specialty drugs to be included in commercial insurance coverage, with various regions like Jiangsu and Shanghai incorporating them into their insurance plans [2]. Group 3: Drug Composition and Approval Process - The approved drugs are predominantly Western medicines, with over 98% of the list, and only two traditional Chinese medicines included [3]. - The approval of drugs through preliminary review does not guarantee inclusion in the basic medical insurance or commercial insurance catalogs, as further expert evaluations and price negotiations are required [3]. Group 4: Pricing and Negotiation - Approximately 80 drug varieties passed the preliminary review for both the basic medical insurance and commercial insurance catalogs, indicating potential for simultaneous negotiations [3]. - Drugs that exceed the basic insurance pricing limits may still qualify for the next evaluation stage, but their final inclusion depends on successful negotiations [3].
121种药通过初审 国家医保局将首次制定商保创新药目录
Yang Shi Xin Wen· 2025-08-13 06:09
2025年国家医保药品目录调整工作日前启动。今年目录调整中增设了商保创新药目录,这也是国家医保局将首次制定商业健康保险创新药品目录。 首版商保创新药目录 通过初审名单公布 昨天,国家医保局公示了通过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。 国家医保局共收到商保创新药目录申报信息141份,涉及药品通用名141个,经初步审核,121个药品通用名通过形式审查。其中,5款细胞疗法高值创新药进 入商保创新药目录。 形式审查是目录调整程序中的第一步,代表该药品具备了参与目录调整后续工作流程的资格,不代表其已经纳入了目录。 满足多元用药需求 助商业健康保险发展 基本医保和商业健康保险都是我国多层次医疗保障体系的重要组成部分。2024年,基本医保参保13.26亿人,参保率巩固在95%。当年基金总支出达到2.97万 亿元,为广大人民群众看病就医提供了坚实保障。 但基本医保总体筹资水平不高,人均筹资仅1070元,其中约2/3还是来自各级财政补助,因此必须牢牢把握"保基本"定位。 随着医药技术创新发展和医疗服务水平提升,确有一小部分临床效果显著、创新程度高的药品因超出 ...
商保创新药目录药品初审名单公布,多款百万抗癌药在列
Core Insights - The National Healthcare Security Administration (NHSA) announced the preliminary review results for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance drug catalog, revealing 534 drugs passed the review, with 121 drugs included in the commercial insurance innovative drug catalog [1][2] Group 1: Drug Catalog Adjustments - The 2025 adjustments mark the first implementation of a "dual-track system," focusing on basic insurance for essential drugs while providing supplementary coverage for "exclusive new drugs" or "rare disease medications" through the commercial insurance innovative drug catalog [1][2] - A total of 718 submissions were received for the basic insurance catalog, with 534 approved, while 141 submissions were made for the commercial insurance catalog, with 121 approved [1][2] - The number of drug names excluded from the catalog increased from 249 in 2024 to 310 [1] Group 2: CAR-T Therapies - CAR-T therapies, which are personalized cancer treatments, have gained attention due to their high costs, with prices exceeding 1 million yuan per injection for several products [1][2] - The commercial insurance catalog will include CAR-T therapies in upgraded coverage plans in various regions, with Shanghai's "Huibao" covering up to 500,000 yuan for patients [2] - Over the past three years, more than 80 lymphoma patients have received treatment through this channel, with total reimbursements exceeding 40 million yuan [2] Group 3: Drug Composition and Approval Process - The approved drugs are predominantly Western medicines, with over 98% representation, and only two traditional Chinese medicines included [3] - Notable cancer drugs include those from major pharmaceutical companies, alongside innovative domestic products like gene therapy for hemophilia B and PD-1 monoclonal antibodies [3] - Passing the preliminary review does not guarantee inclusion in the final catalog, as further expert evaluations and price negotiations are required [3][4] Group 4: Submission Conditions - Unique drugs meeting specific criteria can apply for both the commercial insurance innovative drug catalog and the basic catalog simultaneously [4]
121个药品通用名通过商保创新药目录初步形式审查
国家医保局介绍,形式审查是对申报药品是否符合当年基本医保目录和商保创新药目录调整申报条件以 及药品信息完整性进行的审核。根据《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业 健康保险创新药品目录调整工作方案》,形式审查分为初审、初审结果公示、复审、复审结果公告四个 步骤。本次公示的内容即为今年的初审结果。 国家医保局表示,通过对药品申报资料进行形式审查,一方面,可以确保申报的药品符合申报条件;另 一方面,对申报资料的完整性、规范性进行审核,有利于后续评审、测算阶段相关信息的全面、真实、 准确。同时,为确保目录调整公开透明,国家医保局对通过初审的药品名单和主要信息进行公示,本身 也是主动接受监督的一种方式。 形式审查仅为第一步 国家医保局称,按照《基本医疗保险用药管理暂行办法》和《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业健康保险创新药品目录调整工作方案》,目录调整分为企业申报、形式审查、专 家评审、谈判竞价/价格协商等环节,形式审查只是企业申报后目录调整所有程序中的第一步。一个药 品通过初步形式审查,只代表初审符合相应申报条件,还需要通过公示接受社会监督,即使药品最终确 定通 ...
“国谈”价格保密进入第七年,引入创新药目录后将有哪些变化
Di Yi Cai Jing· 2025-08-05 12:21
"就在不久之前,香港卫生署给我们发来邮件,希望引入我们的一款CAR-T(嵌合抗原受体T细胞免疫 疗法)产品,对当地药品目录进行优化。相较于该区域市场上的另一款CAR-T产品,我们产品定价相当 于打了对折,单价低了100多万港币。" 张妍(化名)是国内某头部CAR-T企业市场准入相关负责人。谈及这次邀约时,她表示,一方面,企业 对于"打开境外市场销路"乐见其成;但另一方面,企业也存在一层担忧:考虑到医保支付端的承受能 力、患者可及性及市场竞争现况,CAR-T疗法在境内市场已给出了较低的定价,但企业在全球市场的投 入回报率可能因国际比价和价格联动而变得不确定。 "百万抗癌药"CAR-T药品所面临的商业化困境具有一定的典型性。整体来看,我国目前创新药价格在全 球范围内属较低水平,同一款药国内外销售价格相差二三十倍的案例屡有发生,一定程度制约了我国创 新药生态链发展。 业界担忧的还有两个趋势:一些本土创新药企将销售重心转向海外市场或将早期成果"卖青苗"出售;一 些跨国药企在考虑到全球价格体系后,可能对中国市场的产品引入和销售预期进行调整。长期来看,这 两个趋势可能会影响到中国创新药产业的国际竞争优势和国内患者获益。 ...
全国性“医保+商保”清分结算中心落地北京 医保商保数据互通
Core Insights - The establishment of a national "medical insurance + commercial insurance" clearing and settlement center in Beijing aims to enhance the efficiency of patient reimbursement and reduce the financial burden of medical expenses [1][4] - The acceleration of data sharing between medical insurance and commercial insurance is supported by recent government policies, which emphasize improving the quality of health insurance services and facilitating quick medical expense settlements [2][3] Group 1: Policy Support and Development - Multiple policies since last year have promoted the integration of medical insurance and commercial insurance, with a focus on enhancing service levels and expanding coverage [2] - The National Medical Insurance Administration has outlined key tasks for 2025, with several initiatives aimed at improving data sharing and collaboration between commercial health insurance and basic medical insurance [3][6] Group 2: Operational Changes and Patient Experience - The new clearing center offers two options for patients: "fast compensation" and "direct compensation," significantly reducing the time required for claims processing [4][5] - The center utilizes encrypted medical insurance data to streamline the claims process, allowing for quicker reimbursements without requiring patients to submit additional documents [4][5] Group 3: Market Implications and Future Outlook - Experts predict that 2025 will mark a pivotal year for the development of commercial health insurance, driven by enhanced data sharing and the introduction of a commercial health insurance innovation drug directory [6][7] - The commercial health insurance sector currently represents a small portion of the overall medical insurance framework, indicating significant growth potential as policies evolve [7][8]
三大机遇!我国这一市场最新展望
券商中国· 2025-08-03 23:41
近日,瑞士再保险在"全球与中国寿险与健康险市场"媒体圆桌会上,提出了上述观点。在瑞士再保险看来,中 国寿险和健康险市场虽有压力但前景仍乐观,并有望在未来十年实现较高增速。 未来十年在全球份额有望继续提升 人口结构变化趋势,医保支付方式改革及增设商保健康险创新药目录,中国医疗行业进一步对外开放—— 这是未来几年中国寿险和健康险行业的三大重点机遇。 瑞士再保险寿险与健康险再保险首席执行官沐睿柏(PaulMurray)表示,中国的寿险和健康险市场目前存在着消 费需求低迷、利率下降的两大压力,但展望未来,他对中国寿险和健康险的前景依然非常乐观。 "我们预计在未来十年,寿险和健康险保费的增长将超过GDP的增长。"他表示,这主要受益于中等收入群体规 模持续扩大、风险意识稳步提升,以及寿险与健康险在社会保障体系中的作用日益增强——尤其在应对人口老 龄化挑战中,保险作为"第三支柱"的支撑作用将进一步凸显。 同时,中国市场在世界保险业中的重要性也将继续提升。2024年,中国寿险和健康险保费达到5840亿美元,占 全球市场的份额为15%。他表示,预计未来十年,中国在全球寿险与健康险市场中的份额将增长至17%。 (来源:瑞士再保险 ...
暴涨120%,医药股集体大爆发
Zheng Quan Shi Bao· 2025-07-25 02:50
Market Overview - On July 25, A-shares and Hong Kong stocks opened lower, with the Hang Seng Tech Index dropping over 1% [1] - The three major A-share indices briefly turned positive during the day but fell back into negative territory by the time of reporting [1] A-share Index Performance - Shanghai Composite Index: 3598.56, down 0.20% [2] - Shenzhen Component Index: 11178.86, down 0.13% [2] - ChiNext Index: 2342.28, down 0.13% [2] Hong Kong Stock Performance - Hang Seng Index: 25507.24, down 0.62% [2] - Hang Seng Tech Index: 5679.27, down 1.11% [2] Pharmaceutical Sector Activity - Pharmaceutical stocks showed renewed strength, with the innovative drug sector becoming active again [2] - Zhendong Pharmaceutical surged over 10%, with a cumulative increase of over 40% in three days [2] - Other notable performers included Sanming Gene, which rose over 8%, and several other companies in the sector [2] CRO Concept Stocks - CRO concept stocks experienced a rally, with Boten Co. rising over 8% [3] - Other companies such as Kanglong Huacheng, Medisi, and Zhaoyan New Drug also saw gains [3] Hong Kong CXO Concept Stocks - CXO concept stocks in Hong Kong collectively rose, with Kanglong Huacheng increasing over 10% and Zhaoyan New Drug up over 6% [4] - The stock of Weili Zhibo-B opened on its first day of trading with an increase of over 120%, currently priced at 76.6 HKD per share [4] Medical Device Sector - The medical device sector continued to rise, with A-share companies Zhengchuan Co. and Kangtai Medical hitting the daily limit, and Nanwei Medical increasing over 10% [5] Policy Changes in Pharmaceutical Procurement - The National Medical Insurance Administration announced adjustments to the drug procurement rules, indicating a shift towards a "quality-price balance" in China's drug procurement [7] - This change is expected to positively influence the healthy development of the pharmaceutical industry [7] Investment Opportunities - The introduction of the commercial insurance innovative drug directory is anticipated to benefit related companies, enhancing their valuation [8] - Investment themes include innovative drugs and medical devices, commercial insurance service providers, and differentiated medical terminals [8]