丙类目录“沉寂”两月，创新药能纳入“国谈”吗？

Core Viewpoint - The upcoming 2025 National Negotiation (国谈) is causing anxiety among pharmaceutical companies, as the latest signals regarding the Class B drug directory indicate that it may still proceed in sync with the negotiations, with the National Healthcare Security Administration (国家医保局) holding a meeting to discuss the adjustment plan for the drug directories [1][2][3]. Group 1: Changes in Drug Directory - The Class B drug directory will be renamed to the "Commercial Health Insurance Innovative Drug Directory" [2]. - The first version of the directory is expected to be developed in conjunction with the 2025 National Negotiation [2]. - The recent meeting did not invite representatives from the commercial insurance sector, suggesting that these companies may no longer directly participate in the directory formulation [2][7]. Group 2: Implications for Price Negotiation - Analysts indicate that the most significant change in the new directory is the withdrawal of commercial insurance companies from the directory formulation, which may lead to the cancellation of price negotiations [7][9]. - The National Healthcare Security Administration is expected to take the lead in formulating the innovative drug directory, which will have a nature closer to a recommendation list, significantly reducing the constraints on commercial insurance companies [8][10]. - The absence of commercial insurance in the directory formulation raises concerns about the feasibility of price negotiations, as pricing is typically determined collaboratively by payers and pharmaceutical companies [9]. Group 3: Selection Criteria and Market Impact - The selection criteria for the new directory are expected to remain largely unchanged, focusing on filling gaps and enhancing standards, primarily including innovative drugs that cannot be included in the basic medical insurance directory due to their high clinical value [13][14]. - The demand for price reductions in the new innovative drug directory may decrease or even disappear, potentially increasing the chances for high-priced innovative drugs to be included [16][17]. - The mechanism for transitioning drugs from the basic medical insurance directory to the innovative drug directory is anticipated to be established, allowing for a more seamless integration of the two directories [18][19][20].