Characteristics, accessibility and regional equity evaluation of pediatric medicines through National Drug Price Negotiation of China, 2017–2024

Objectives Since its inception in 2017, China’s National Drug Price Negotiation (NDPN) has served as a crucial mechanism for the strategic procurement of innovative medicines, with pediatric medicines representing a key and prioritized area. This study aims to systematically analyze the inclusion of pediatric medicines in the National Reimbursement Drug List (NRDL) through negotiation from 2017 to 2024, evaluate their current accessibility and regional equity, and provide evidence to support decision-making. Methods Pediatric medicines were classified as either Co-use Medicines for Adults and Children (CMACs) or Child-Specific Medicines (CSMs). Descriptive statistics were used to characterize two types of pediatric medicines. Referring to the WHO/HAI calculation methodology, availability was measured by the Drug Availability Rate (DAR) and the Drug Provision Rate (DPR) of medical institutions and retail pharmacies. Affordability was assessed by Defined Daily Dose cost (DDDc), considering the proportion of China’s household disposable income required to cover annual treatment costs, with a ratio of ≤1 being considered affordable. The Gini coefficient was used to calculate regional equity. Pearson’s correlation test ( p = 0.05) was employed to analyze the relationship between availability and affordability. Results A total of 108 pediatric medicines were identified. Among these, 83 medicines (76.85%) were CMACs and 79 (73.15%) were Child-Appropriate Formulations (CAFs). The average delay between market launch to inclusion in NRDL for pediatric medicines was 4.40 years (SD = 6.76). Regarding availability, Q1-Q2 2025 pediatric medicines demonstrated DAR of 7.89% and DPR of 8.71% in tertiary medical institutions, significantly higher than that in secondary and lower-level institutions ( p 0.05). Regarding affordability, the average DDDc for CSMs (74.01, SD = 132.31) was lower than that for CMACs (272.09, SD = 738.49). Reimbursement increased the number of affordable medicines from 85 (78.70%) to 104 (96.30%), 18 of which were CMACs. Correlation analysis revealed no significant relationship between availability and affordability (Pearson’s r = −0.172, p = 0.187 0.05). After accounting for population factors, regional equity was relatively balanced across provinces, with the Gini coefficient below 0.4. Conclusion Although China’s NDPN policy has successfully improved the affordability and accelerated the inclusion of pediatric medicines, significant “last-mile” barriers persist. Critical gaps remain in the availability of CAFs and access across healthcare institutions and regions.