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两款独家药品未通过医保目录调整形式审查
Bei Ke Cai Jing· 2025-09-03 02:04
Core Points - The National Healthcare Security Administration (NHSA) announced changes to the drug list for basic medical insurance, with six drugs undergoing form review changes, including two drugs that did not pass the review [1][3] - The two drugs that failed the review are injectable risperidone microspheres and injectable triptorelin, both of which are exclusive products from Zhejiang Shengzhao Pharmaceutical Co., Ltd. and Ipsen, respectively [2][3] - The injectable risperidone microspheres have a global market size of $490 million in 2022, with expectations to reach 920 million yuan in China by 2030 [3] Drug Review Changes - Six drugs had their form review results changed, with injectable risperidone microspheres and injectable triptorelin being excluded from the basic medical insurance directory [3][4] - Injectable risperidone microspheres, approved in February 2023, is the first generic version in China for treating mental disorders, while injectable triptorelin was approved in 2023 for treating precocious puberty and prostate cancer [3][4] Commercial Health Insurance Innovations - The newly established commercial health insurance innovative drug directory has gained attention, with 121 drugs passing the form review, including CAR-T and nuclear medicine therapies [5] - CAR-T therapy has faced challenges in entering the insurance directory due to high costs, but five CAR-T products have now passed the form review for the commercial health insurance directory [5] - Nuclear medicine, known for its precision in targeting cancer cells, has also seen several products approved, including technetium-99m and fluorine-18 labeled drugs [6] Future Developments - Negotiations and price discussions for the drug directory adjustments will take place from September to October, with results expected to be announced in November [7]
双目录初审公示:6个药品发生变化 多款创新药、罕见病药引关注
2 1 Shi Ji Jing Ji Bao Dao· 2025-08-28 11:41
Core Insights - The National Healthcare Security Administration (NHSA) has published the preliminary review results for the 2025 medical insurance and commercial insurance innovative drug directory, with significant changes in the approval status of six drugs compared to the previous version [1][2]. Summary by Categories Drug Approval Changes - Six drugs have had their approval status changed, with two drugs (Injectable Risperidone Microspheres and Injectable Triptorelin Acetate) being disapproved, while two others (Levodopa Injection and Calcium Gluconate Sodium Chloride Injection) have been approved [1][3]. - The oral suspension of Ursodeoxycholic Acid remains approved, but the conditions for approval have been adjusted [1][3]. Application Statistics - For the 2025 directory adjustment, the NHSA received 718 applications, involving 633 drug generic names, with 535 passing the preliminary review [1][2]. - The approval rate has increased significantly, reaching 84.52% this year, compared to 68.42% in 2023 and 76.66% in 2024 [2]. Notable Drugs - Levodopa Injection, used for Parkinson's disease, has been approved and is not an exclusive product, indicating its potential for broader market access [4]. - Injectable Ceftriaxone Sodium Sulbactam, another approved drug, is noted for its broad antibacterial spectrum and safety profile [4]. - The oral suspension of Ursodeoxycholic Acid has had its approval conditions modified to include rare disease categories [6]. Innovative Drug Directory - The commercial insurance innovative drug directory has been introduced alongside the basic medical insurance directory, with 141 applications received, of which 121 passed the preliminary review [2]. - A significant number of drugs in both directories are new, with 303 in the basic medical insurance directory meeting specific conditions for approval [7]. Rare Disease Drugs - The directories include a total of 37 rare disease drugs in the basic medical insurance directory and 35 in the commercial insurance innovative drug directory, with 19 drugs approved in both [10][11]. - Notable rare disease drugs include those from Merck and other companies, which have gained attention for their potential market impact [11][12]. Market Trends - The introduction of the commercial insurance innovative drug directory is expected to enhance market access for several high-profile drugs, including CAR-T therapies that have previously struggled to gain approval [9][12]. - The performance of rare disease drug companies has seen significant stock price increases, indicating strong market interest and potential for growth [13].
双目录初审公示:6个药品发生变化,多款创新药、罕见病药引关注
2 1 Shi Ji Jing Ji Bao Dao· 2025-08-28 11:19
Core Viewpoint - The National Healthcare Security Administration (NHSA) has officially announced the preliminary review results for the adjustment of the 2025 medical insurance and commercial insurance innovative drug catalog, indicating an increase in the number of drugs passing the review and the overall approval rate compared to previous years [1][2]. Summary by Relevant Sections Drug Review Changes - Six drugs underwent changes in their review status, with two drugs, injectable risperidone microspheres and injectable triptorelin, being disapproved, while injectable levodopa and calcium gluconate sodium injection were approved [1][5][6]. - The injectable risperidone microspheres, an exclusive product of Shengzhao Pharmaceuticals, was first launched in mainland China in February 2025 for treating mental disorders [6][7]. - The injectable triptorelin, also an exclusive product, was launched in 2023 for treating prostate cancer and precocious puberty [7]. Approval Statistics - A total of 718 applications were received for the 2025 catalog adjustment, involving 633 drug generic names, with 535 passing the preliminary review, resulting in an approval rate of 84.52% [1][2]. - The approval rates have shown a significant increase over the past three years, with 68.42% in 2023, 76.66% in 2024, and 84.52% in 2025 [2]. Innovative Drug Catalog - The commercial insurance innovative drug catalog was introduced for the first time, with 141 applications received, involving 141 drug generic names, and 121 passing the review [3]. - Among the drugs, 79 were submitted for both the basic medical insurance catalog and the commercial insurance innovative drug catalog [3]. Notable Products - Several notable products are highlighted, including CAR-T products that have previously failed to enter the medical insurance catalog but are now included in the commercial insurance innovative drug catalog [11][12]. - Unique products such as the first and only AKT inhibitor and the only Trop-2 ADC for breast cancer treatment are also included in the catalogs, indicating a focus on innovative therapies [13][14]. Rare Disease Medications - The review process has also included rare disease medications, with 37 drugs in the basic medical insurance catalog and 35 in the commercial insurance innovative drug catalog, of which 19 are approved in both [15][16]. - The approval of rare disease drugs is seen as a significant development, with companies like Beihai Kangcheng gaining attention for their innovative products [20].
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]
百利天恒朱义:冲医保还是商保,是一种“赌博”
Jing Ji Guan Cha Wang· 2025-08-20 10:18
经济观察报 见习记者 刘晓诺 对于尚未完成商业化的创新药企来说,国家医保局正在制定的商保创新药目录,既是一次良机,也将让他们面临重要抉择。 8月18日,在2025年西普会"健康产业资本峰会"上,百利天恒(688506.SH)创始人、董事长朱义说,百利天恒明年实现创新药商业化是大概率事件,届时百 利天恒将有两种选择:第一种是尝试进入基本医保,第二种则是走"自费药市场+商业医保"的路线。 目前,百利天恒还没有商业化的创新药产品。其核心管线是一款全球首创的新概念EGFR×HER3双抗ADC药物,目前处在III期临床阶段。 "我们的药涉及十几个适应证。如果进入基本医保,以后该怎么处理,我们现在非常头疼。"朱义说,他有种迫切感,急需与商业保险公司谈谈:"如果我们 明年走商保的话,能保多少、覆盖多少,有哪些重点的服务,未来企业发展前景究竟会怎样?" 关于两种路线的选择,朱义认为:"作为企业来讲,这叫做'赌博'。" 他表示,需要进行深度的调研才能做决定。"国家政策对商业医保发展的基础设施,还需要进一步构建。以后商业医保怎样和公立医院有效地执行保险契 约,怎样和基本医保协同,商保产品怎样卖出去,这些问题我们都需要去搞清楚。" ...
医保药品目录“双轨制”调整在即 商业健康保险发挥补位价值
Jin Rong Shi Bao· 2025-08-20 03:17
Core Viewpoint - The National Healthcare Security Administration (NHSA) has introduced a dual-track system for drug listings, which includes a new commercial health insurance innovative drug directory, highlighting the critical role of commercial health insurance in the medical security system [1][2]. Group 1: Drug Directory Dual-Track System - The new dual-track system allows for basic medical insurance to focus on essential coverage while the commercial health insurance innovative drug directory provides supplementary coverage for high-priced drugs that do not qualify for the basic insurance directory [2]. - A total of 534 drugs were approved for the basic medical insurance directory, while 121 drugs made it to the commercial health insurance innovative drug directory, with a significant majority being Western medicines [2][3]. - Approximately 80 drugs applied for both directories, accounting for about 60% of the commercial health insurance innovative drug directory, indicating a strategic approach to drug approval [2]. Group 2: Role of Commercial Health Insurance - Commercial health insurance is positioned as a "second payment layer" to address the challenges of high-cost innovative drugs and to enhance the multi-tiered medical security system [4][5]. - The increasing demand for innovative drugs due to aging populations and rising medical costs necessitates the involvement of commercial health insurance to cover expenses beyond the basic insurance scope [4][5]. - Local governments are actively promoting commercial health insurance to support the development of innovative drugs, with measures to encourage the integration of innovative drug costs into group health insurance products [6]. Group 3: Challenges and Opportunities - Despite the potential of commercial health insurance, its current contribution to innovative drug payments remains low, with only 7.7% of the market share, indicating a heavy financial burden on patients [7]. - To enhance the payment capacity of commercial health insurance, collaboration among insurance companies, pharmaceutical firms, and healthcare providers is essential, focusing on innovative service models [7]. - The NHSA has introduced supportive policies for the commercial health insurance innovative drug directory, which may help expand coverage and optimize services for high-cost drugs [7][8].
天价药有望报销了
2 1 Shi Ji Jing Ji Bao Dao· 2025-08-18 13:40
Core Insights - The National Healthcare Security Administration (NHSA) has announced the preliminary review results for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance drug catalog, with 534 drugs passing the initial review for basic insurance and 121 innovative drugs for commercial health insurance [1][5][17] - The commercial health insurance innovative drug catalog aims to cover high-value innovative drugs that are not included in the basic insurance, focusing on areas such as oncology and rare diseases [6][18] - The process for drugs to be included in the commercial health insurance catalog involves multiple steps, including expert review and price negotiations, making the final inclusion uncertain [3][8][11] Summary by Sections Drug Catalog and Review Process - A total of 534 drugs have passed the initial review for the basic medical insurance catalog, while 121 innovative drugs have been preliminarily approved for the commercial health insurance catalog [1][5] - The review process includes company applications, formal reviews, expert evaluations, and price negotiations, with the initial review only indicating eligibility for further steps [8][12] Market Dynamics and Challenges - The commercial health insurance catalog operates on a voluntary basis, meaning that both pharmaceutical companies and insurers must agree on terms, which introduces uncertainty in market uptake [3][11] - Insurers are concerned about the cost savings from drug pricing and the actual market impact of the new catalog, as well as the compliance issues related to high-priced drugs [3][12] Focus on Innovative Drugs - The new catalog emphasizes innovative drugs that provide significant clinical benefits but are not covered by basic insurance, particularly in oncology and rare diseases [6][18] - The inclusion of CAR-T therapies and rare disease medications indicates a shift towards addressing unmet medical needs in the market [6][19] Implications for Insurance Companies - The commercial health insurance sector is expected to adapt its product offerings based on the new catalog, potentially leading to a more standardized approach across the industry [7][13] - Insurers are encouraged to develop specialized products that cater to high-net-worth individuals seeking coverage for innovative drugs, enhancing their competitive edge [13][19] Future Outlook - The NHSA's initiatives are seen as a critical step towards reforming the payment system for innovative drugs, aiming to alleviate the financial burden on patients and improve access to high-cost treatments [17][18] - The projected growth of the innovative drug market in China suggests a significant opportunity for commercial health insurance to expand its role in covering these therapies [16][19]
天价药有望报销了
21世纪经济报道· 2025-08-18 12:58
Core Viewpoint - The National Healthcare Security Administration (NHSA) has announced the preliminary review results for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance drug catalog, with 534 drugs passing the initial review for basic insurance and 121 innovative drugs for commercial health insurance [1][2] Summary by Sections Commercial Health Insurance Innovative Drug Directory - The commercial health insurance innovative drug directory is voluntary for pharmaceutical companies and insurance firms, meaning that the success of negotiations remains uncertain [3][4] - The directory aims to include innovative drugs that exceed the basic insurance coverage, focusing on high clinical value and significant patient benefits [5][6] Market Dynamics and Drug Coverage - The directory primarily covers unmet needs in areas such as oncology, rare diseases, and chronic conditions, with several CAR-T therapies included [6][7] - The inclusion of domestic pharmaceutical products has increased, enhancing the controllability of the drug supply chain [6][7] Challenges in Implementation - The process from preliminary review to final inclusion in the directory involves multiple steps, including expert evaluation and price negotiations, which introduces uncertainty [9][11] - Concerns exist regarding the balance between patient accessibility and the sustainability of insurance companies, particularly regarding the definition of coverage limits and risk management [10][11] Impact on Insurance Products - The innovative drug directory is expected to stimulate discussions on product innovation within the insurance industry, encouraging companies to optimize their product strategies based on the directory [13][14] - Insurance companies are advised to design products that cater to different consumer capabilities, enhancing the appeal of high-end medical insurance [14][15] Future Market Potential - The innovative drug market in China is projected to reach 1 trillion yuan by 2035, with commercial health insurance expected to cover a significant portion of this market [16][17] - The NHSA's recent measures aim to establish a multi-layered payment system for innovative drugs, enhancing their accessibility and reducing the financial burden on patients [17][18]
天价药有望报销了!医保、商保、药企三方仍需寻求平衡打通堵点
2 1 Shi Ji Jing Ji Bao Dao· 2025-08-18 10:49
Core Insights - The National Healthcare Security Administration (NHSA) has announced the preliminary review results for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance drug catalog, with 534 drugs passing the initial review for basic insurance and 121 innovative drugs for commercial health insurance [1][3] - The commercial health insurance innovative drug catalog aims to include high-value innovative drugs that are not covered by basic insurance, focusing on areas such as oncology and rare diseases [4][15] - The process for drugs to be included in the commercial health insurance catalog involves multiple steps, including expert review and price negotiations, which introduces uncertainty regarding the final inclusion of these drugs [7][10] Industry Dynamics - The NHSA's new policies are seen as a significant step towards creating a multi-layered payment system for innovative drugs, addressing the historical challenges of insufficient insurance coverage and high out-of-pocket costs for patients [15][16] - The commercial health insurance sector is expected to play a crucial role in expanding access to innovative drugs, with the potential to cover a larger patient base and enhance the financial viability of drug companies [17] - The introduction of the commercial health insurance innovative drug catalog is anticipated to stimulate product innovation within the insurance industry, as companies adapt their offerings to meet the needs of patients seeking coverage for high-cost medications [11][12] Market Opportunities - The innovative drug market in China is projected to reach 1 trillion yuan by 2035, with commercial health insurance expected to cover 44% of this market, translating to approximately 440 billion yuan [14][15] - The inclusion of domestic drug companies in the innovative drug catalog is increasing, which may enhance the stability of the drug supply chain and improve pricing negotiations [4][16] - The potential for specialized insurance products targeting high-net-worth individuals seeking coverage for innovative drugs is growing, as insurers look to differentiate their offerings in a competitive market [12][13]