Core Insights - The approval rate for drugs outside the national essential drug list has reached a four-year low during the expert review phase, indicating increasing scrutiny and higher standards for innovation [1][4] - The success rate for negotiations in the upcoming 2025 national essential drug list has improved to 88%, up from 76% the previous year, marking a seven-year high [1] - A total of 114 new drugs will be added to the national essential drug list, including 50 innovative first-class drugs, reflecting a significant increase in both quantity and quality [2][8] Group 1: Approval Rates and Trends - The approval rate for drugs in the expert review phase has declined for two consecutive years, with only 41.48% of drugs passing this stage this year [2][3] - In the past three years, the number of drugs passing the formal review has increased, but the expert review approval rate has decreased from 74.2% to 47.0% [3] - Nearly 60% of drugs outside the essential list failed to pass the expert review, highlighting a trend towards stricter evaluation criteria [1][4] Group 2: Reasons for Non-Approval - Several drugs, including first-class innovative drugs, were not approved due to lack of significant clinical value compared to existing treatments [5][6] - The "Four No Changes" principle (no change in active ingredient, indication, administration route, or clinical value) has been identified as a key reason for low approval rates [6] - High prices and mismatched value with existing treatments have also contributed to the rejection of certain drugs, with examples of significant price discrepancies noted [6] Group 3: Support for True Innovation - The national healthcare authority emphasizes support for "true innovation" and "differentiated innovation," aiming to exclude drugs that do not significantly advance clinical outcomes [5][7] - Successful drugs entering the essential list share common characteristics such as filling therapeutic gaps and offering superior alternatives [7] - The overall speed and quantity of innovative drugs entering the national essential drug list have increased, addressing various medical needs including major diseases and rare conditions [8] Group 4: Value-Based Pricing and Evaluation - The negotiation process for the national essential drug list has evolved to include a more systematic and scientific value assessment, enhancing fairness and rigor in price evaluations [10] - The approach to pricing has shifted to support higher payment thresholds for drugs with greater innovation, reflecting a value-based pricing model [10][11] - The importance of robust clinical evidence in supporting claims of additional benefits for new drugs has been highlighted, particularly in competitive therapeutic areas [11][12]

Core Points - The release of the "dual directory" system for basic medical insurance and commercial health insurance marks a new phase in China's healthcare reform, emphasizing precision, differentiation, and collaboration in the medical insurance system [1][15][16] - The updated basic medical insurance directory will be implemented nationwide starting January 1, 2026, adding 114 new drugs, including 50 innovative drugs, while removing 29 drugs that are clinically unavailable or can be better replaced [1][15][16] - The first edition of the commercial health insurance innovative drug directory focuses on 19 high-innovation, high-clinical-value drugs that exceed the basic insurance coverage, including CAR-T cell therapy and treatments for rare diseases [1][15][16] Group 1: Key Signals - Signal 1: Balancing "Basic Protection" and "Promoting Innovation" - The adjustment of the medical insurance drug directory reflects a dual consideration of the sustainability of the insurance fund and fairness in drug access for patients, with a focus on encouraging innovation and optimizing the structure [4][17][19] - The overall success rate of the newly added innovative drugs is 88%, an increase from 76% in 2024, indicating a shift towards strategic purchasing and value-based purchasing in medical insurance [4][17][19] Group 2: Commercial Health Insurance Directory - Signal 2: Addressing the "Beyond Insurance" Drug Dilemma - The commercial health insurance innovative drug directory serves as an upgrade package to meet higher-level medical needs, filling the gap left by basic insurance, which cannot cover all high-value innovative drugs [6][9][20] - The establishment of this directory provides a systematic recommendation of innovative drugs for commercial insurance companies, avoiding confusion and inconsistency in standards [6][9][20] Group 3: Implementation and Coordination - Signal 3: Strengthening System Coordination and Clinical Connection - The implementation of the dual directory requires a comprehensive approach involving information system transitions, hospital management, payment mechanism restructuring, and patient awareness [10][23][24] - The policy mandates a nationwide switch to the new directory by January 1, 2026, with a six-month transition period for drugs removed from the directory to ensure continuity of patient care [10][24][26] - The commercial health insurance directory's drugs will follow similar procurement and usage guidelines as those under basic insurance, facilitating access to innovative treatments [10][27][28]