Workflow
真实世界研究
icon
Search documents
“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]