Presentation (CTI)

OBJECTIVES: The National Healthcare Security Administration has established a value-based drug evaluation mechanism to assess candidate drugs for NRDL. This study reviews the latest NRDL updates and highlights key factors in setting payment standards.
METHODS: We reviewed academic literature and government documents to identify relevant studies. We conducted desk research and quantitative analyses, using the best available prices and product data before and after NRDL negotiations from 2017 to 2024.
RESULTS: A total of 871 drug were added to the NRDL through 2017-2024. In 2024, among 249 unlisted candidates, 117(47%) participated in the price negotiation, with 89(76%) successfully listed. These 89 drugs had an average price reduction of 63% and were listed within a median time of 1.1 years after approval. The negotiation success rate for innovative drugs (first launched globally in China) was over 90%. Key factors influencing payment standards were analyzed. Budget impact: payment standards decrease with more targeted patients. Linear regression based on 12 medicines for rare diseases showed that annual costs (range: 15,505CNY to 292,365CNY) were estimated to reduce by 7,074CNY for every 1,000 additional new cases per year. Analysis of 50 cancer drugs indicated that annual costs (range: 11,796CNY to 297,200CNY) were estimated to reduce by 1,369CNY for every 1,000 additional new cases yearly. Clinical value: later-generation products tend to achieve higher payment standards. Nineteen targeted therapies across three generations for treating NSCLC were analyzed. With each generational upgrade, annual costs for EGFR and ALK TKIs were estimated to increase by 8,995CNY and 16,394CNY, respectively. Furthermore, the analysis suggested that key factors also include cost-effectiveness evidence and the price of NRDL substitution.
CONCLUSIONS: Payment standard decisions of NRDL in China are complex, comprehensively considering factors such as clinical value, budget impact, and market competition, and showing an increasing trend of support for innovative drugs while ensuring affordability.