Core Viewpoint - The article discusses the introduction of the commercial insurance innovative drug directory in China, which supplements the basic medical insurance directory and aims to include high-priced innovative drugs that provide significant clinical value and patient benefits [2][10]. Summary by Sections Introduction of the Commercial Insurance Innovative Drug Directory - The National Healthcare Security Administration announced a list of drugs that passed the initial review for the commercial insurance innovative drug directory, with a total of 121 drugs, over half of which are cancer or rare disease medications [2][5]. - The directory is expected to include high-priced drugs, such as CAR-T therapies costing over 1 million yuan per injection and gene therapies priced around 98,000 yuan per injection [2][4]. Drug Approval and Characteristics - To qualify for the commercial insurance innovative drug directory, drugs must either be newly approved from January 1, 2020, to June 30, 2025, or have indications included in the national rare disease directory by June 30, 2025 [5]. - Among the 121 drugs, 57 are imported, accounting for 47%, with notable entries from companies like Pfizer and Johnson & Johnson [5]. Focus on Cancer and Rare Diseases - The majority of drugs that passed the initial review are cancer treatments, with over 40 entries, followed by 35 for rare diseases [5][6]. - The article highlights the potential for the directory to alleviate payment challenges for rare disease medications, with companies actively submitting applications [6]. Pricing and Negotiation Challenges - The pricing negotiation process for drugs in the commercial insurance directory remains uncertain, as it involves collaboration between the National Healthcare Security Administration, commercial insurers, and pharmaceutical companies [12][13]. - The article notes that the commercial insurance directory may serve as a "double insurance" for companies, allowing them to apply for both the basic medical insurance and the commercial insurance directories simultaneously [9]. Future Considerations and Recommendations - The article suggests that the implementation of the commercial insurance innovative drug directory requires further exploration and refinement, with recommendations for pilot programs in specific insurance products [14]. - It emphasizes the need for insurance companies to develop reasonable pricing mechanisms and improve data integration with basic medical insurance to enhance their pricing strategies [13][14].

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].

Core Viewpoint - The National Healthcare Security Administration (NHSA) has released a work plan for the adjustment of the National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance drug catalog and the Commercial Health Insurance Innovative Drug Catalog, allowing eligible companies to apply for inclusion starting July 11, 2023 [1][3]. Group 1: Work Plan Details - The work plan allows for the application of new generic names or exclusive drugs for rare diseases approved for marketing within the last five years to be included in the Commercial Health Insurance Innovative Drug Catalog [1]. - The application process includes preparation, submission, initial review, public announcement, re-examination, and final announcement of the drug list [2]. - The timeline for the application process spans from July to November 2023, with specific phases for expert review and negotiation for pricing [2]. Group 2: Benefits for Innovative Drugs - Inclusion in the Commercial Health Insurance Innovative Drug Catalog can enhance sales for innovative drugs by leveraging the scale of basic medical insurance or commercial insurance [4]. - Drugs in the commercial insurance catalog are exempt from being counted in the basic medical insurance self-pay rate indicators and the monitoring of selected alternative products [4]. - The arrangement allows for innovative drugs to be excluded from the Diagnosis-Related Group (DRG) payment system, addressing the issue of high costs associated with innovative treatments [5]. Group 3: Application Choices for Companies - Companies can choose to apply for either the basic medical insurance catalog, the commercial health insurance innovative drug catalog, or both [6]. - The selection criteria for the commercial health insurance catalog focus on high innovation, significant clinical value, and substantial patient benefits, making it unlikely for the same drug to be included in both catalogs simultaneously [6][7]. - For products priced above the set standard, inclusion in the commercial insurance catalog is seen as more favorable compared to the basic medical insurance catalog [8].