如何支持真创新？国家医保局详解“双目录”

Core Insights - The National Healthcare Security Administration (NHSA) has introduced 114 new drugs to the basic medical insurance catalog for 2025, with a significant focus on innovative treatments and a record number of new drugs added [1][5][6] Summary by Sections New Drug Additions - A total of 114 drugs were added to the basic medical insurance catalog, including 105 through negotiation, 7 through competitive bidding, and 2 directly from national procurement [1] - Among the new additions, 111 are new products launched within the last five years, representing nearly 98% of the total, with 50 classified as Category 1 new drugs, marking a historical high in both proportion and quantity [1][5] Therapeutic Areas - The newly added drugs cover critical therapeutic areas such as oncology, anti-infection, chronic diseases, rare diseases, and mental health, addressing diverse clinical needs [1][5][6] Directory Adjustment Process - The adjustment process involved four main stages: application, review, negotiation/bidding, and results. A total of 718 applications were received, with 535 passing the initial review, resulting in an 85% approval rate [3] - In the expert review phase, 311 drugs were evaluated, with 129 passing, leading to a 41.48% approval rate [3][4] Negotiation Success Rates - The negotiation and bidding phase saw 127 drugs participate, with 112 successfully negotiated, achieving a success rate of 88.19%, the highest since 2018 [4][5] Commercial Insurance Innovation - The first commercial insurance innovative drug catalog was released alongside the basic insurance adjustments, featuring 19 innovative drugs from 18 companies, with 9 being Category 1 new drugs [2][7] - The commercial insurance catalog aims to complement the basic insurance, providing additional support for high-cost innovative drugs while ensuring basic medication needs are met [2][8] Future Considerations - The NHSA emphasizes the importance of a multi-layered medical insurance system, encouraging the integration of commercial health insurance and innovative drug catalogs to enhance patient access to diverse treatment options [8][10] - Key challenges include aligning the different execution cycles of basic insurance and commercial products, as well as improving communication between insurance companies and pharmaceutical firms [9][10]