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一粒药从实验室到临床应用有多远 十六条新措施助力创新药加速跑(政策解读)
Ren Min Ri Bao· 2025-07-01 21:53
Core Viewpoint - The article discusses the recent measures introduced by the National Healthcare Security Administration and the National Health Commission to support the high-quality development of innovative drugs in China, emphasizing the acceleration of innovative drugs from laboratories to hospitals and ensuring affordability for the public [1][2]. Group 1: Policy Measures - The new policy includes 16 measures aimed at invigorating the development of innovative drugs, marking a significant governmental push for the biopharmaceutical industry [1][2]. - The measures focus on encouraging "true innovation" in drug development and avoiding homogenization and insufficient clinical value in certain areas [2]. Group 2: Drug Approval and Market Dynamics - In 2024, the number of approved Class 1 innovative drugs reached 48, more than five times the number in 2018, indicating a significant increase in drug approvals [2]. - As of mid-2023, nearly 40 Class 1 innovative drugs were approved in the first half of the year alone, showcasing a clear "explosion effect" in the market [2]. Group 3: Affordability and Accessibility - The measures aim to enhance the multi-channel payment capabilities for innovative drugs, encouraging commercial health insurance and mutual medical assistance to include these drugs in their coverage [3][4]. - Since 2018, 149 innovative drugs have been included in the medical insurance directory, accounting for 17% of new drug approvals, with medical insurance fund expenditures reaching 4.1 trillion yuan, driving sales over 6 trillion yuan [3]. Group 4: Integration of Insurance Systems - The establishment of a commercial health insurance directory for innovative drugs is proposed to better align with basic medical insurance, enhancing overall coverage [4]. - The measures also suggest synchronizing settlements between basic medical insurance and commercial health insurance to streamline processes for patients [5]. Group 5: Drug Availability in Medical Institutions - The policy emphasizes the need to expedite the entry of innovative drugs into designated medical institutions and encourages timely meetings to address drug supply based on clinical needs [6]. - The ongoing reforms in medical insurance payment systems aim to support the reasonable use of innovative drugs, allowing medical institutions to apply for special cases when standard payment methods are not suitable [6]. Group 6: Global Market Expansion - The article highlights that Chinese pharmaceutical companies are increasingly engaging in overseas transactions, with over 90 deals completed in 2024, totaling more than 50 billion dollars [6]. - The measures propose to facilitate the global market development of innovative drugs by providing platforms and price support for companies looking to expand internationally [6].
国务院研究优化集采:第11批药品集采将至,报价机制调整在即
Core Viewpoint - The Chinese government is optimizing the centralized procurement policy for drugs and medical supplies to ensure quality and affordability for the public, indicating potential issues with the quality of some procured drugs and the need for further exploration of the policy [1][2][3]. Group 1: Policy Optimization - The State Council is focusing on enhancing the evaluation of drug procurement policies and ensuring the quality of drugs and medical supplies [1][2]. - The 11th batch of drug procurement is expected to take place in 2025, with a target of 700 varieties to be procured [1]. - The introduction of a new pricing mechanism aims to prevent extreme low pricing that could harm consumer confidence and the survival of companies [3][4]. Group 2: Pricing Mechanism Adjustments - The new draft policy suggests a price difference limit of 1.8 times the lowest bid for the same drug, with a focus on avoiding abnormal low pricing [4]. - The extreme low prices observed in recent procurements have raised concerns about their sustainability and potential negative impacts on the pharmaceutical industry [3][7]. - The rapid increase in B-license companies, which do not produce drugs themselves, has led to concerns about quality and market stability [7][8]. Group 3: Quality Assurance - Discussions around the relationship between low prices and drug quality have intensified, especially following the disqualification of a company for failing to meet quality standards [6][7]. - The government emphasizes the need for a transparent regulatory mechanism to ensure drug quality while maintaining competitive pricing [5][6]. - The focus on quality is crucial as low prices could lead to reduced profit margins for manufacturers, potentially impacting their ability to maintain quality and innovate [7][8]. Group 4: Future Directions - The upcoming 11th batch of procurement is seen as a significant reform, reflecting lessons learned from previous rounds and aiming for a more balanced approach to pricing and quality [10][11]. - There is a call for a unified and transparent procurement platform to ensure fair pricing and quality assurance in drug procurement [10][11]. - The need to balance innovation and quality in drug procurement is highlighted, with suggestions to incorporate clinical benefits into the procurement evaluation criteria [11].
人工耳蜗植入进医保 6月1日起,四川参保患者单例治疗费用将从20余万元降至3万元左右
Si Chuan Ri Bao· 2025-05-07 02:32
Group 1 - The Sichuan Provincial Medical Security Bureau has officially included cochlear implantation surgery and cochlear implants in the basic medical insurance payment scope starting from June 1 [1][2] - The cost for patients undergoing cochlear implantation will significantly decrease from over 200,000 yuan to around 30,000 yuan, alleviating the financial burden on families of hearing-impaired patients [1][2] - The policy applies to insured individuals diagnosed with bilateral severe or profound hearing loss who cannot improve their hearing and speech understanding through hearing aids or other devices [1] Group 2 - The fifth batch of national centralized procurement for high-value medical consumables will include cochlear implants and peripheral vascular stents, with the average price for a set of cochlear implants dropping from over 200,000 yuan to approximately 50,000 yuan [2] - The Sichuan Medical Security Bureau aims to further reduce the medical expenses for insured individuals by incorporating cochlear implantation surgery and cochlear implants into the insurance payment scope [2]
2025年政府工作:支持创新药发展,注重药品集采质量,鼓励中医药发展
Lian He Zi Xin· 2025-03-18 11:34
Investment Rating - The report indicates a positive outlook for the pharmaceutical industry, particularly for innovative drug development, with a focus on quality and regulatory improvements [1][10]. Core Insights - The government emphasizes the importance of supporting innovative drug development, optimizing drug procurement policies, and enhancing quality assessments and regulations [1][3][10]. - The report highlights the expected improvement in the competitive landscape of the pharmaceutical industry due to policy support, which will shorten the return period on R&D investments for innovative drug companies [1][4][10]. - The increasing aging population and enhanced medical insurance payment capabilities are projected to sustain growth in downstream demand for the pharmaceutical industry [1][10]. Summary by Sections Encouragement of Innovative Drug Development - The 2025 government report reiterates support for innovative drugs, including the establishment of a pricing mechanism and a directory for innovative drugs [3][4]. - Policies introduced in 2024 aim to protect innovative drug companies from early price reductions due to procurement [3][4]. Focus on Quality in Drug Procurement - The report states that drug procurement policies will be optimized to emphasize quality assessments and regulations, transitioning from merely promoting procurement to optimizing it [5][6]. - Historical data shows that the average price reduction in drug procurement has been between 52% and 59%, with the most competitive procurement round in 2024 seeing reductions exceeding 70% [5][7]. Enhancement of Medical Insurance Payment Capabilities - The government plans to increase per capita financial subsidies for medical insurance and improve the overall payment capabilities of the medical insurance fund [7][8]. - The expansion of the medical insurance coverage to include innovative drugs is anticipated as the new drug directory is implemented [7][8]. Encouragement of Traditional Chinese Medicine Development - The report outlines ongoing support for the development of Traditional Chinese Medicine (TCM), including the establishment of innovation centers and the integration of digital technologies [9][10]. - Policies aimed at modernizing and industrializing TCM are expected to enhance the operational efficiency of TCM enterprises [9][10]. Conclusion - The report concludes that the pharmaceutical industry is poised for recovery in growth rates, with improved external environments for innovative drugs and TCM enterprises [10][11].