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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]
天价药有望报销了
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
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]
68周减重18.34 kg,司美格鲁肽片为何能突破多肽药物的口服易降解、难吸收?
GLP1减重宝典· 2025-08-14 10:33
Core Viewpoint - The successful development of oral semaglutide marks a significant breakthrough in the administration of peptide drugs, overcoming challenges related to stability, absorption, and individual variability in efficacy [4][6][9]. Group 1: Development and Mechanism - Oral semaglutide has successfully addressed multiple barriers, including instability due to gastric acid and digestive enzymes, large molecular size affecting absorption, and individual differences in therapeutic response [4]. - The use of SNAC (sodium N-(8-[2-hydroxybenzoyl] amino) caprylate) enhances the solubility and absorption of the peptide, while also protecting it from degradation [6]. - Pharmacokinetic and pharmacodynamic studies have established optimal dosing methods, ensuring that the semaglutide tablet combined with 300 mg of SNAC achieves maximum bioavailability [6]. Group 2: Clinical Efficacy - Clinical studies have demonstrated that a 14 mg oral semaglutide tablet can significantly reduce HbA1c levels by approximately 2% and promote weight loss [9]. - In the OASIS 1 study, participants with an average baseline weight of 105.4 kg experienced an average weight reduction of 17.4% (18.34 kg) with the 50 mg oral semaglutide group, indicating a more pronounced weight loss effect compared to previous studies [9]. Group 3: Mechanism of Action - Semaglutide acts as a "satiety manager" by directly suppressing appetite through central nervous system activation, particularly in the hypothalamus and brainstem [10]. - It slows gastric emptying, prolonging the feeling of fullness, and stabilizes blood sugar levels, indirectly reducing appetite fluctuations [11][12]. - The drug activates three key pathways: central nervous system pathways that enhance satiety signals, gastrointestinal-vagal pathways that slow gastric emptying, and pancreatic-metabolic pathways that smooth blood sugar levels [13].
“天价抗癌药”冲关医保双目录
Bei Jing Shang Bao· 2025-08-13 16:31
Core Insights - The adjustment of the medical insurance drug catalog in 2025 has seen a significant increase in the number of drugs passing the formal review, with a new commercial insurance innovative drug catalog attracting industry attention [1][3] - The parallel submission of the basic medical insurance catalog and the commercial insurance innovative drug catalog aims to provide comprehensive coverage for different patient groups based on their payment capabilities, enhancing drug accessibility and market competitiveness [1][8] Summary by Sections Basic Medical Insurance Catalog - A total of 718 submissions were received for the basic medical insurance catalog, involving 633 drug generic names, with 534 passing the formal review [3] - The number of drugs passing the formal review from the catalog outside the basic insurance has increased significantly, with 310 out of 472 submissions approved, compared to 249 in 2024 [3] - The approved drugs cover various fields, including oncology, chronic diseases, and rare diseases, with notable entries like monoclonal antibodies and a popular weight-loss drug [3][4] Commercial Insurance Innovative Drug Catalog - The newly established commercial insurance innovative drug catalog received 141 submissions, with 121 passing the initial review, resulting in a pass rate of approximately 85.82% [5] - This catalog also includes drugs for oncology, chronic diseases, and rare diseases, primarily focusing on Western medicine, along with a few traditional Chinese medicines [5][6] - The establishment of this catalog reflects the government's commitment to building a multi-tiered medical insurance system, providing supplementary coverage for high-value drugs not included in the basic insurance [6][8] Dual Submission and Market Strategy - Several drugs have successfully passed the formal review for both the basic medical insurance catalog and the commercial insurance innovative drug catalog, indicating a strategic approach by pharmaceutical companies to expand market coverage [7][8] - The dual submission allows companies to target both broad patient groups through basic insurance and high-value innovative drugs through commercial insurance, enhancing drug accessibility and competitiveness [8]
2025国谈初审名单公布
Guo Ji Jin Rong Bao· 2025-08-13 12:29
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, along with the commercial insurance innovative drug catalog, indicating a significant increase in the number of drugs under review and the introduction of a new commercial insurance category for innovative drugs [1][3]. Group 1: Drug Catalog Submission and Review - A total of 718 submissions were received for the basic medical insurance catalog, involving 633 drug generic names, with 534 passing the preliminary review [3]. - For the commercial insurance innovative drug catalog, 141 submissions were received, involving 141 drug generic names, with 121 passing the preliminary review, including 79 drugs that may be negotiated under both insurance schemes [3][4]. Group 2: Impact on the Pharmaceutical Industry - The introduction of the commercial insurance innovative drug catalog is expected to create new pathways for multi-channel payment for innovative drugs and promote collaboration between commercial insurance and basic medical insurance [3]. - The review process for drugs that have passed the preliminary review does not guarantee inclusion in the final catalog, as they must undergo strict evaluation and successful negotiations [4]. Group 3: Notable Drugs and Categories - The commercial insurance catalog includes 12 monoclonal antibodies, 3 CAR-T therapies, and other innovative drugs, with notable products like CAR-T therapies and PD-1 inhibitors included [5][6]. - There are 42 drugs that only passed the preliminary review for the commercial insurance catalog, primarily from major pharmaceutical companies [6]. Group 4: Future Negotiation Timeline - The NHSA plans to conduct negotiations for the 2025 insurance catalog between September and October, with results expected to be announced between October and November [7].
多款“明星药”亮相!医保“双目录”初审名单公布,“天价抗癌药”等双赛道冲关
Bei Jing Shang Bao· 2025-08-13 11:53
Core Insights - The adjustment of the medical insurance drug catalog for 2025 has seen a significant increase in the number of drugs passing the formal review, with a new commercial insurance innovative drug catalog introduced, attracting high industry attention [1][3][5] Summary by Sections Medical Insurance Drug Catalog - The National Healthcare Security Administration (NHSA) received 718 applications for the basic medical insurance catalog, with 534 passing the initial review, including 472 applications from outside the catalog, marking a notable increase from 249 in 2024 [3] - The approved drugs cover various fields such as oncology, chronic diseases, and rare diseases, with a significant number of monoclonal antibody injections passing the review [3][4] Commercial Insurance Innovative Drug Catalog - The newly established commercial insurance innovative drug catalog received 141 applications, with 121 passing the initial review, resulting in a pass rate of approximately 85.82% [5] - This catalog also includes drugs for oncology, chronic diseases, and rare diseases, primarily focusing on Western medicine, with some traditional Chinese medicine included [5][6] Dual Track Submission - Several drugs have simultaneously passed the reviews for both the basic medical insurance catalog and the commercial insurance innovative drug catalog, indicating a strategy to cater to different patient payment capabilities [7][8] - The dual submission approach allows for broader market coverage and addresses the needs of high-value innovative drugs that may not be included in the basic insurance catalog [8] Industry Implications - The increase in the number of drugs passing the reviews reflects the growing investment in innovative drug research and development in China, with a focus on enhancing patient access to essential medications [4][6] - The establishment of the commercial insurance innovative drug catalog signifies the government's commitment to building a multi-tiered medical security system, providing supplementary coverage for high-value drugs not included in the basic insurance [6][8]
创新药再度领涨市场!创新药ETF富国(159748)盘中涨幅达3.85%
Mei Ri Jing Ji Xin Wen· 2025-08-13 05:25
Group 1 - The core viewpoint of the articles highlights the strong performance of innovative drugs, biomedicine, and AI healthcare sectors, leading the market gains [1] - As of the report, the innovative drug ETF (159748) saw an intraday increase of 3.85%, with key stocks like Haikang rising over 10% and others like Innovent and Kelun increasing over 7% [1] - The Hong Kong Stock Connect medical ETF (159506) also experienced a rise of 3.20%, with stocks such as CanSino Biologics increasing over 8% and WuXi AppTec rising over 6% [1] Group 2 - On August 12, the National Healthcare Security Administration announced the preliminary review of 121 innovative drugs for inclusion in the commercial insurance innovative drug directory, which includes several PD-1 drugs and five domestically approved CAR-T therapies [1] - The announcement from the healthcare authority is expected to enhance the accessibility of payments and improve commercialization expectations for these "star products," potentially raising the valuation center for innovative drugs in the Hong Kong market [1] - Recent clarifications on brain-computer interface implementation and industrial goals are expected to boost expectations in high-end medical equipment, neuroregulation, and surgical robotics sectors [1] Group 3 - The innovative drug ETF (159748) closely tracks the SHS Innovative Drug Index (CSI: 931409), which selects listed companies engaged in the research, production, and sales of innovative drugs, focusing on high-quality securities in the pharmaceutical sector [1] - The Hong Kong Stock Connect medical ETF (159506) tracks the Hang Seng Hong Kong Stock Connect Healthcare Index (HSSCHI), which excludes companies with the lowest average R&D to revenue rankings over the past two years, emphasizing high R&D spending and innovative drug business proportions [2]