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310个目录外药品拟角逐进入医保 面临价格博弈与“真创新”的考量
Di Yi Cai Jing· 2025-08-23 08:55
Core Points - The annual adjustment of the national basic medical insurance catalog has begun, with the National Medical Insurance Administration announcing a list of drugs that have passed preliminary review, indicating increased competition for drug inclusion in the insurance catalog this year [1][3] - A total of 310 generic drugs passed the preliminary review, significantly up from 249 in 2024, reflecting a substantial increase in the number of innovative drugs approved [1][3] - The adjustment process involves expert evaluation, negotiation, and price consultation, with a focus on balancing drug pricing and patient accessibility [1][6] Group 1: Drug Approval and Inclusion - The National Medical Insurance Administration has been adjusting the drug catalog since its establishment in 2018, with 530 drugs added through negotiations, enhancing the accessibility of innovative drugs [3] - Over 70 anti-tumor drugs have entered the insurance catalog from 2018 to 2024, addressing the needs of patients with various cancers [3] - The approval of innovative drugs has surged, with 48 first-class innovative drugs approved in 2024, more than five times the number in 2018 [3] Group 2: Pricing and Negotiation - The negotiation process for drug pricing is crucial, as it determines the reimbursement standards and affects the financial viability of innovative drugs [6][7] - The challenge lies in finding a balance between drug pricing and patient accessibility, as high prices can limit patient access while low prices may hinder the return on investment for pharmaceutical companies [6][9] - The adjustment of the insurance catalog is seen as a way to optimize the use of limited medical resources and improve the efficiency of the insurance fund [4][6] Group 3: Innovation and Evaluation - The 2025 adjustment plan emphasizes supporting true innovation and optimizing the structure of the drug catalog while ensuring fund security [8][9] - The need for a comprehensive drug value assessment system is highlighted, focusing on real-world data to evaluate the effectiveness and safety of drugs post-approval [10][12] - The integration of health technology assessments (HTA) in drug pricing negotiations is noted as a practice that could enhance transparency and fairness in the process [13]
310个目录外药品拟角逐进入医保,面临价格博弈与“真创新”的考量
Di Yi Cai Jing· 2025-08-23 08:37
Core Insights - The competition for access to the national medical insurance (NMI) directory is expected to intensify this year, with a significant increase in the number of drugs passing the preliminary review [2][4]. Group 1: NMI Directory Adjustments - The annual adjustment of the national basic medical insurance directory has commenced, with 310 drug names passing the preliminary review, up from 249 in 2024, indicating a more competitive environment for drug access [2][4]. - Since the establishment of the National Medical Insurance Administration in 2018, there have been eight rounds of adjustments to the NMI drug directory, with 530 drugs added through negotiations, enhancing the accessibility of innovative drugs [4]. - The approval of innovative drugs has surged, with the number of first-class innovative drugs approved reaching 48 in 2024, over five times that of 2018, and nearly 40 approved in the first half of this year alone [4][5]. Group 2: Pricing and Negotiation - The negotiation process for drug pricing involves expert evaluations and discussions with companies to establish mutually acceptable reimbursement standards, referred to as "soul bargaining" [7]. - The pricing of newly approved drugs is often high due to substantial R&D investments, making affordability a critical factor for patients [7][8]. - The balance between low reimbursement prices, which may hinder innovation returns, and high prices, which could strain the insurance fund, is a significant challenge in the NMI directory adjustments [7][11]. Group 3: Innovation and Evaluation - The NMI adjustments emphasize supporting true innovation and optimizing the structure of the drug directory, with a focus on filling clinical gaps and encouraging differentiated innovations [9][10]. - The establishment of a comprehensive drug value assessment system is increasingly urgent, with a need for scientific methods to guide financial decisions in the NMI [12]. - Real-world data is crucial for evaluating the effectiveness and safety of drugs post-approval, and it is essential for adjusting reimbursement standards based on actual clinical outcomes [13][14].
海南博鳌乐城加速建设国际医疗旅游目的地
Zhong Guo Xin Wen Wang· 2025-08-21 20:00
Core Insights - The introduction of the Koli Ear Nexa system has enabled 100 hearing-impaired patients in China to regain their hearing since its launch in the Boao Lecheng International Medical Tourism Pilot Zone [1] - The Lecheng Pilot Zone has established itself as a key channel for international innovative medical devices and drugs to enter the Chinese market, having introduced 504 types of urgently needed foreign medical products that are not yet available domestically [1] - The Pilot Zone has launched 31 medical tourism products across various fields, supported by favorable policies such as "zero tariff" for imported medical devices, which injects new momentum into the medical tourism industry [2] Group 1 - The Lecheng Pilot Zone has become a major hub for international innovative medical products, achieving synchronization with international standards in medical technology, equipment, and pharmaceuticals since its establishment in 2013 [1] - The zone has over 30 operational medical institutions, creating a medical industry landscape led by top public hospitals and specialized international and domestic brands [1] - The Pilot Zone's policies allow for faster access to international advanced medical devices for patients with urgent clinical needs, significantly reducing the traditional clinical verification cycle [1] Group 2 - The Boao Yiling Life Care Center has launched various medical tourism products that have gained popularity among international tourists, offering services that combine traditional Chinese medicine with cultural experiences [2] - The center has attracted patients from countries such as the United States, Russia, and Canada, providing a diverse range of health management services that integrate both Eastern and Western medical practices [2] - The Lecheng Pilot Zone is actively expanding its international market presence by hosting promotional events in countries like Indonesia and establishing connections with local travel agencies and insurance companies [3] Group 3 - Future promotional efforts will extend to Southeast Asia, Europe, America, and Australia, enhancing the zone's international outreach [3] - The Pilot Zone is also working on partnerships with overseas insurance companies to facilitate cross-border insurance payments, improving the medical service experience for international visitors [3]
乐城海南眼视光眼科医院招募眼疾患者开展真实世界研究
Hai Nan Ri Bao· 2025-08-05 01:40
Core Insights - The Hainan Eye Hospital has introduced the 0.19 fluocinolone acetonide intravitreal implant, a unique FDA-approved drug for treating diabetic macular edema (DME), leveraging the "pilot" policy of the Boao Lecheng International Medical Tourism Pilot Zone [1] - The hospital is recruiting 121 DME patients nationwide for a real-world effectiveness study, with the first patient already injected on August 1 [2] Group 1 - The 0.19 fluocinolone acetonide implant is a non-biodegradable injectable corticosteroid that provides sustained release for up to three years, specifically for DME treatment [1] - DME is a common complication of diabetes, often affecting both eyes, leading to significant treatment and economic burdens for patients [1] - The new implant aims to help DME patients manage macular edema over the long term, maintain vision, and reduce the frequency of medical visits [1]
“真实世界数据”挂钩医保商保“双目录”,对创新药影响几何
Di Yi Cai Jing· 2025-08-04 12:55
Core Insights - The introduction of the commercial insurance innovative drug directory has opened up possibilities for innovative pharmaceutical companies to access high-value and high-innovation drugs in national negotiations and multi-layered payment systems [1][2] - Real-world data (RWD) is expected to play a larger role in the pricing of new drugs and their entire lifecycle, enhancing value-based purchasing in medical insurance and innovative payment in commercial insurance [1][2] - The National Medical Insurance Administration has been actively seeking public opinions on how RWD can support the comprehensive value assessment of drugs and medical devices [1][2] Group 1: Policy Developments - The recent rapid policy advancements in the pharmaceutical industry have surprised stakeholders, particularly with the release of measures supporting high-quality development of innovative drugs [1][2] - The establishment of a comprehensive value assessment system based on RWD is a key focus in recent discussions, aiming to optimize its role in the dual directory access and post-access re-evaluation [1][2][3] Group 2: Real-World Data Application - RWD has matured as auxiliary evidence in the evaluation and approval of innovative drugs, but its application in medical insurance value purchasing is relatively new [2][3] - The need for RWD in assessing the clinical effectiveness of newly listed drugs has become critical, especially as some drugs fail to meet expected value post-market entry [2][3][10] - RWD can fill evidence gaps left by traditional clinical trials, thus reducing uncertainty in medical insurance decision-making and improving fund utilization efficiency [5][10] Group 3: Dynamic Evaluation and Pricing - The evaluation of the clinical added value of innovative drugs should be dynamic, with RWD being used to balance clinical benefits and fund affordability [5][6] - The potential for RWD to support dynamic management of the medical insurance directory and drug exit mechanisms is recognized, allowing for timely removal of low-value drugs [6][8] Group 4: Integration of Insurance Systems - The introduction of the commercial insurance innovative drug directory allows for parallel applications with the basic medical insurance directory, with over 100 drugs already applying for the innovative drug directory [7][8] - RWD is anticipated to become a crucial element in connecting the dual directories, enabling a phased approach to drug access and evaluation [8][9] Group 5: Data Quality and Governance - The quality of RWD is essential for high-quality research, with current challenges including data inconsistency and lack of standardized collection methods [11][13] - Establishing a comprehensive system for RWD collection, application, and evaluation is crucial for enhancing the negotiation process for drug pricing and ensuring proper clinical use [13][14] Group 6: Collaborative Governance - The establishment of a unified medical insurance information platform has facilitated the collection of high-quality RWD, which can support regulatory decision-making [12][14] - The recent implementation of management measures for RWD usage in Hainan province highlights the potential for RWD to inform dynamic adjustments in the medical insurance directory and improve healthcare services [14]
郭广昌:复星坚定看好海南自贸港 将加大文旅等优势产业在琼布局
Zhong Guo Jing Ji Wang· 2025-07-29 16:48
Core Viewpoint - Fosun International is optimistic about the Hainan Free Trade Port, which will officially start its full island closure operation on December 18, 2025, marking a new beginning for the company and the region [3][4]. Group 1: Investment and Development in Hainan - Fosun has been deeply engaged in Hainan for nearly 20 years, creating over 6,000 jobs and contributing more than 10 billion yuan in taxes [3]. - The company has established significant projects in the tourism sector, such as the Atlantis Hotel in Sanya, which has received over 32 million visitors since its opening [3]. - In the health sector, Fosun is leveraging the policy advantages of the Boao Lecheng Pilot Zone to promote the application of global biomedical innovations, with several products already manufactured in Hainan [3][4]. Group 2: Strategic Initiatives and Future Projects - Fosun is accelerating its green technology transformation through its subsidiary Hainan Mining, which has made acquisitions in lithium and oil resources globally and is establishing a lithium hydroxide production line in Hainan [4]. - The company plans to launch the "Hainan Super Mediterranean" project in October 2024, which will feature the world's first AI-themed resort and aims to create a super tourism destination in Hainan [5][6]. - The lithium hydroxide project in Yangpu, with an investment of 1.056 billion yuan, is expected to generate an annual output value exceeding 2 billion yuan, enhancing the competitiveness of Hainan's green low-carbon industry [6]. Group 3: Community Engagement and Social Responsibility - Fosun has been actively involved in community support initiatives in Hainan, including the establishment of the Fosun Guangcai Education Fund to support underprivileged students [7]. - The company has invested over 12 million yuan in healthcare projects aimed at improving local medical services in Hainan [7].
(经济观察)海南自贸港扩大开放促医药产业发展
Zhong Guo Xin Wen Wang· 2025-05-07 05:42
Group 1 - The "zero tariff" policy for medical devices and drugs in Hainan is enhancing the competitiveness and attractiveness of the Boao Lecheng International Medical Tourism Pilot Zone by allowing hospitals to import foreign drugs and devices that are not yet available in China while reducing operational costs for hospitals and patients [1] - Since the implementation of the "zero tariff" policy on December 25, 2024, the Haikou Customs has supervised a total declared value of 60.239 million yuan for "zero tariff" medical devices and drugs, resulting in a tax exemption of 8.187 million yuan [1] - The Lecheng International Medical Tourism Pilot Zone is becoming a major channel for international innovative medical devices and drugs to enter China, supported by policies for licensed medical practices, research, and international medical exchanges [1] Group 2 - Hainan's efforts to attract international innovative medical device and drug companies reflect a broader initiative to promote high-quality development in the pharmaceutical industry through regulatory reforms and increased openness [2] - The Hainan Provincial Drug Administration has proposed five measures to enhance regulatory innovation, including creating a high ground for real-world research applications and facilitating product imports [2] - Over the next three years, Hainan aims to accelerate the application of real-world research, expand local production of innovative medical devices and drugs, and enhance international collaboration in medical technology projects [2] Group 3 - The "Lecheng research and application + Haikou production" model has enabled the successful import and local production of the drug "Kexaira" by First Voice Pharmaceutical, which was approved for full market entry in China through the real-world research green channel [3] - The Haikou National High-tech Zone is becoming a core area for Hainan's biopharmaceutical industry, with the pharmaceutical industry expected to account for nearly 80% of the province's total output value in 2024 [3] - The establishment of the Lecheng Medical Engineering Transformation Platform by the end of this year will serve as Hainan's first technology transfer and incubation platform in the field of innovative medical devices and drugs, promoting the transformation and incubation of innovative products [3]