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百万抗癌药首次通过商保创新药目录初审
第一财经·2025-08-14 05:04

Core Viewpoint - The article discusses the recent approval of high-priced innovative drugs for commercial insurance innovation drug directory, highlighting the ongoing negotiations for inclusion in the basic medical insurance directory, which remains the primary goal for most innovative drug companies [3][4][8]. Summary by Sections Approval Process - The National Medical Insurance Administration announced that 121 innovative drugs passed the preliminary formal review for the commercial insurance innovation drug directory, with a significant number also applying for the basic medical insurance directory [3][7]. - The review process assesses whether the drugs meet the criteria for inclusion in the insurance directories and the completeness of their information [7]. Drug Categories - Less than 40% of the drugs approved only for the commercial insurance innovation drug directory fall into five main categories: rare disease medications, newly approved drugs with limited real-world evidence, globally priced drugs that still do not meet basic insurance thresholds, high-priced new drugs for existing treatments, and preventive biological agents restricted by legal regulations [4][5]. Dual Directory Applications - Approximately 80 drugs, or about 60% of those in the commercial insurance innovation drug directory, applied for both directories, indicating a transitional strategy for many innovative drug companies [8]. - Many high-priced innovative drugs that exceed the acceptable value threshold for basic medical insurance are opting for single directory applications [8][10]. Market Dynamics - The competition in the market for cancer drugs and other treatment areas is intensifying, with a focus on "true innovation" and "differentiated innovation" as encouraged by the National Medical Insurance Administration [10]. - The article notes that some innovative drugs are being submitted for commercial insurance first, with the expectation that they may later be evaluated for inclusion in the basic medical insurance directory once sufficient real-world data is available [11]. Insurance Considerations - The decision to include innovative drugs in the commercial insurance directory is influenced by factors such as the drug's appeal to insurance products, potential premium increases, and the risk of excessive claims [14][15]. - The article highlights the differences in coverage and reimbursement capabilities across various regions, which may affect the sales pathways for innovative drugs [15].