Core Insights - The national medical insurance negotiation for 2025 has introduced a dual-directory system, marking a significant change in the negotiation process for innovative drugs and commercial insurance [1][2][15] - The negotiation process for innovative drugs has seen a price reduction range suggested by the National Medical Insurance Administration (NMIA) of 15% to 50%, with a focus on the CAR-T drugs [3][4] - The introduction of the innovative drug directory is expected to create a more sustainable market payment mechanism for new drugs, with companies needing to reassess their product positioning and market strategies [15] Summary by Sections National Medical Insurance Negotiation - The negotiation took place from October 30 to November 3, 2025, with the first three days dedicated to the national medical insurance directory and the last two days for the commercial insurance innovative drug directory [1] - This year marks the first introduction of an innovative drug directory, which has altered the negotiation dynamics for drug pricing [1][15] Price Negotiation Mechanism - The NMIA has introduced a new price negotiation mechanism for innovative drugs, allowing for price discussions between drug companies and commercial insurance [1][3] - Companies have been advised to consider a price reduction of 15% to 50% during negotiations, with some expressing skepticism about achieving reductions below 15% [3][4] CAR-T Drugs - CAR-T drugs have been a focal point in the negotiations, with successful negotiations reported for some products, such as the CAR-T drug from HeYuan Biotech priced at 999,000 yuan [3][4] - A limited number of CAR-T drugs are expected to be included in the innovative drug directory, with estimates suggesting around 20 drugs may be approved [1][3] Commercial Insurance Dynamics - The dual-directory negotiation allows companies to choose between reporting to the basic medical insurance directory, the innovative drug directory, or both, creating strategic options for different companies [2][10] - The commercial insurance market has shown limited interest in covering rare disease drugs due to their high costs and small patient populations, which may affect their inclusion in the innovative drug directory [14][15] Focus on ADC and Bispecific Antibodies - ADC (Antibody-Drug Conjugates) and bispecific antibodies remain key focus areas in the negotiations, with several innovative drugs vying for inclusion in the directories [8][10] - Companies are adopting varied strategies based on their market positioning, with some prioritizing the basic medical insurance directory for broader market access, while others focus on maintaining high-end product positioning through the innovative drug directory [10][11]

Core Insights - The National Healthcare Security Administration (NHSA) announced the completion of expert review for the 2025 National Basic Medical Insurance (BMI) catalog and the commercial insurance innovative drug catalog adjustments, marking the 8th adjustment since the NHSA's establishment and the first inclusion of a commercial insurance innovative drug catalog [1] Group 1: Drug Approval Process - A total of 644 drugs passed the formal review, with 534 approved for the basic BMI catalog and 121 for the commercial insurance innovative drug catalog, noting that some drugs applied for both [1] - The expert review phase saw less than half of the submitted drugs approved, with low approval rates for both the basic BMI and commercial insurance innovative drug catalogs [2] Group 2: Expert Review Insights - The expert review was conducted by a diverse group including NHSA, insurance companies, universities, and third-party technical firms, with a broad coverage of innovative drugs prioritized for inclusion [2] - Five CAR-T drugs received unanimous approval from experts, despite their high costs, which range around 1 million yuan per injection, and previous unsuccessful attempts to enter the basic BMI catalog [2] Group 3: Future Considerations - The expert review process includes a metric for "expert opinion consensus rate," which increases the likelihood of approval for drugs with broader expert support, while rare disease drugs are approached with more caution [3] - Future payment models for innovative drugs may involve using the commercial insurance innovative drug catalog as a transitional phase before potential inclusion in the basic BMI catalog, allowing for real-world data collection [3] - The NHSA plans to hold a face-to-face communication meeting in Beijing with companies involved in negotiations, bidding, and price discussions [3]

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 Insights - The article discusses the recent approval of several high-priced innovative drugs for the commercial insurance innovation drug directory, which were previously excluded from the basic medical insurance directory due to high costs [2][5] - Over 60% of the drugs included in the commercial insurance innovation drug directory have also applied for the basic medical insurance directory, indicating a dual strategy by pharmaceutical companies [2][5] - The National Healthcare Security Administration (NHSA) has initiated a new phase of expert reviews for these drugs, which will determine their final inclusion in the insurance directories [10] Group 1: Drug Approval and Market Dynamics - A total of 121 innovative drugs passed the preliminary review for the commercial insurance innovation drug directory, with 141 applications submitted [5] - Approximately 80 drugs applied for both the basic medical insurance and commercial insurance directories, highlighting a trend towards dual applications [5][9] - The article identifies five categories of drugs that were only submitted for the commercial insurance directory, including rare disease treatments and newly approved drugs with limited clinical data [3][4] Group 2: Pricing and Economic Considerations - Some high-priced rare disease treatments have annual costs exceeding 1 million yuan, which have previously failed to meet the basic medical insurance criteria [6] - The NHSA emphasizes that the approval for the basic medical insurance directory does not guarantee inclusion, as drugs must pass rigorous evaluations and negotiations [9] - The article notes that the commercial insurance directory may serve as a transitional option for innovative drugs that exceed the acceptable pricing thresholds for basic medical insurance [5][10] Group 3: Industry Perspectives and Future Implications - Industry experts suggest that the commercial insurance innovation drug directory should focus on new drugs that fill clinical gaps and provide differentiated treatment options [7] - There is a concern among pharmaceutical companies regarding the potential impact of drug inclusion on insurance premiums and patient access [10][11] - The article highlights the need for real-world evidence to support the clinical efficacy of some newly approved drugs, which may influence their acceptance in the basic medical insurance directory in the future [8][9]

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 Insights - This year, several high-priced innovative drugs that were previously excluded from the basic medical insurance directory due to the "invisible threshold" have passed the preliminary review for the commercial insurance innovative drug directory [1][2] - Over 60% of the drugs included in the preliminary review for the commercial insurance innovative drug directory are also applying for the basic medical insurance directory, indicating a dual strategy among pharmaceutical companies [1][4] - The National Medical Insurance Administration has published a list of 121 innovative drugs that passed the preliminary review for the commercial insurance innovative drug directory, reflecting a significant interest from pharmaceutical companies in gaining access to broader insurance coverage [3][8] Summary by Categories Innovative Drug Directory - A total of 141 applications were received for the commercial insurance innovative drug directory, with 121 passing the preliminary review, marking the first year this directory has been included in the adjustment process [3] - Approximately 40% of the drugs that only applied for the commercial insurance innovative drug directory are primarily rare disease medications, newly approved drugs with limited clinical data, and high-priced innovative drugs that do not meet the basic insurance entry threshold [2][4] Dual Directory Applications - About 80 drugs, or roughly 60% of those in the commercial insurance innovative drug directory, have also applied for the basic medical insurance directory, suggesting that the commercial directory serves as a transitional option for many innovative drug companies [4][9] - The drugs that opted for "single directory" applications are often those with high innovation and clinical value but priced significantly above the acceptable threshold for basic medical insurance [4][5] Pricing and Market Dynamics - The pricing of innovative drugs is a critical factor, with some drugs being priced at levels that are already the lowest globally, yet still not qualifying for basic medical insurance [6][8] - The competitive landscape for oncology drugs is intensifying, with companies considering the potential for inclusion in the commercial insurance directory as a means to enhance product attractiveness without significantly raising premiums [9][10] Future Considerations - The expert review phase for the drugs that passed the preliminary review will begin soon, with a focus on whether these drugs can be included in the commercial insurance directory and the basic medical insurance directory [9] - There is a growing sentiment in the industry that innovative drugs with uncertain clinical benefits may initially enter the commercial insurance directory before being reassessed for basic medical insurance inclusion based on real-world data [7][10]

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].