ANALYSIS OF AFFORDABILITY OF NEGOTIATED PEDIATRIC DRUGS BY CATEGORY IN CHINA’S NATIONAL REIMBURSEMENT DRUG LIST
Author(s)
Xinyue Yuan, Bachelor, Zhihao Zhao, Master, Yangyang Fan, Bachelor, MING HU, PhD.
West China School of Pharmacy, Sichuan University, Chengdu, China.
West China School of Pharmacy, Sichuan University, Chengdu, China.
OBJECTIVES: The National Drug Price Negotiation (NDPN) policy has reshaped China's drug market access rules, while its impact on pediatric medicines is understudied. This study aims to analyze the affordability of pediatric medicines in the National Reimbursement Drug List (NRDL) through negotiation from 2017 to 2024, and provide evidence to support decision-making.
METHODS: Based on our previous inclusion/exclusion criteria, we screened pediatric medicines in the NRDL and categorized them by ATC class, negotiation year, and launch-to-NRDL delay. Referring to the WHO/HAI calculation methodology, we calculated the average DDDc (cost per defined daily dose) for each category separately, using negotiated prices from the Yaozhi Database and DDD values from the WHO ATC/DDD Index or drug package inserts. We then assessed the statistical relationship between each categorical variable and DDDc (p<0.05). Affordability was assessed by DDDc, considering the proportion of Chinas household disposable income required to cover annual treatment costs, with a ratio of ≤1 being considered affordable.
RESULTS: A total of 108 pediatric medicines were included, covering 12 ATC classes except classes G and P. Class L accounted for the largest proportion (n=21), while class S had the smallest (n=1), nine traditional Chinese patent medicines were also included. Mean DDDc varied significantly by ATC class (F=2.043, p=0.029), with class B highest (1045.09, SD=1653.67) and class S lowest (9.90, SD=0.00). Before reimbursement, 23 medicines were unaffordable, mainly in class L (n=11). After reimbursement, 4 remained unaffordable (class L:2, B:1, M:1), with a mean launch-to-NRDL delay of 2.03 years (SD=0.87). Mean DDDc also differed significantly by negotiation year (F=32.122, p=0.000), peaking in 2021 (310.54) and bottoming in 2019 (37.36). No correlation was found between launch-to-NRDL delay and DDDc (p=0.852>0.05).
CONCLUSIONS: NDPN enhances pediatric drug affordability, yet targeted strategies are needed to address inequities across therapeutic categories and negotiation cycles.
METHODS: Based on our previous inclusion/exclusion criteria, we screened pediatric medicines in the NRDL and categorized them by ATC class, negotiation year, and launch-to-NRDL delay. Referring to the WHO/HAI calculation methodology, we calculated the average DDDc (cost per defined daily dose) for each category separately, using negotiated prices from the Yaozhi Database and DDD values from the WHO ATC/DDD Index or drug package inserts. We then assessed the statistical relationship between each categorical variable and DDDc (p<0.05). Affordability was assessed by DDDc, considering the proportion of Chinas household disposable income required to cover annual treatment costs, with a ratio of ≤1 being considered affordable.
RESULTS: A total of 108 pediatric medicines were included, covering 12 ATC classes except classes G and P. Class L accounted for the largest proportion (n=21), while class S had the smallest (n=1), nine traditional Chinese patent medicines were also included. Mean DDDc varied significantly by ATC class (F=2.043, p=0.029), with class B highest (1045.09, SD=1653.67) and class S lowest (9.90, SD=0.00). Before reimbursement, 23 medicines were unaffordable, mainly in class L (n=11). After reimbursement, 4 remained unaffordable (class L:2, B:1, M:1), with a mean launch-to-NRDL delay of 2.03 years (SD=0.87). Mean DDDc also differed significantly by negotiation year (F=32.122, p=0.000), peaking in 2021 (310.54) and bottoming in 2019 (37.36). No correlation was found between launch-to-NRDL delay and DDDc (p=0.852>0.05).
CONCLUSIONS: NDPN enhances pediatric drug affordability, yet targeted strategies are needed to address inequities across therapeutic categories and negotiation cycles.
Conference/Value in Health Info
2026-09, ISPOR Asia Pacific 2026, Bangkok, Thailand
Value in Health, Volume 55, Issue S1
Code
HPR25
Topic
Health Policy & Regulatory
Topic Subcategory
Coverage with Evidence Development & Adaptive Pathways, Insurance Systems & National Health Care, Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Pediatrics