Differentiated Access under China’s National Reimbursement Drug Negotiation: A Comparative Case Study of Three Innovative Pharmaceuticals

Abstract

China’s National Reimbursement Drug Negotiation (NRDN) mechanism is the primary pathway for innovative drugs to enter the national reimbursement list. However, different drug categories may follow distinct institutional pathways and yield different pricing outcomes. This study preliminarily explores how three categories of innovative pharmaceuticals—competitive biologics, breakthrough high-cost therapies, and rare disease drugs—navigate China’s reimbursement system, and examines differentiated pricing dynamics and affordability outcomes. A multiple-case comparative design was used, focusing on sintilimab (PD-1 inhibitor), axicabtagene ciloleucel (CAR-T therapy), and risdiplam (SMA oral drug). Data were collected from Drugdataexpy, corporate annual reports, and policy documents (through April 2026). Sintilimab followed conventional negotiation with tiered price reductions (86% cumulative reduction). Axicabtagene ciloleucel (1.2 million CNY) has not entered basic insurance but gained early access via the newly established Commercial Health Insurance Innovative Drug Catalog (December 2025). Risdiplam took a rare disease priority pathway with a pre-negotiation voluntary price cut (94% cumulative reduction). These three cases suggest a possible trend toward stratified governance within China’s drug access system. However, the commercial catalog’s effectiveness remains unverified due to short implementation time. Causal inferences are limited by data availability and case study design.