Price trend, clinical benefit and within-class competition of drugs for metastatic Non-small cell lung cancer in China: a retrospective cohort study.

Background: The affordability and clinical benefit of novel anticancer drugs are critical determinants of equitable access to cancer care in China and globally. In China, a recent influx of innovative drugs for metastatic non-small cell lung cancer (NSCLC) has occurred alongside major pricing policy reforms. However, it remains unclear whether this expanded availability has reduced prices and aligned costs with clinical benefit. This study aims to assess the price trends of metastatic NSCLC drugs in China, evaluate how within-class competition influences these trends, and determine the relationship between drug pricing and clinical benefit. Methods: This retrospective cohort study included all domestic and imported targeted agents for metastatic NSCLC approved in China between January 1, 2005, and March 15, 2026 based on approval data from the National Medical Products Administration (NMPA). Pivotal trial characteristics were identified from drug labels, regulatory review reports, and published literature. Price information at launch and post-approval was collected from the provincial medical insurance bureau procurement platforms. Clinical benefit was assessed using the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) v2.0. We included drug prices from 2019 to 2026 to calculate monthly treatment costs, and to estimate the average annual reduction rate (AARR) and total treatment reduction rate (TTRR). The primary outcomes were monthly treatment cost, AARR, and TTRR; secondary outcomes included the association between price reduction magnitude, competition index, National Reimbursement Drug List (NRDL) status, and the correlation between ESMO-MCBS scores and monthly treatment costs. Spearman correlation analyses were used to evaluate the associations between monthly treatment costs (both initial and latest) and ESMO-MCBS scores, and between the competition index and AARR or TTRR. Univariable and multivariable regression analyses were performed to assess the effects of NRDL status and the competition index on the magnitude of price reduction. Findings: A total of 51 targeted drugs for metastatic NSCLC were included, comprising 16 EGFR inhibitors, 11 PD-1/PD-L1 inhibitors, 8 ALK inhibitors, 5 MET inhibitors, 4 ROS1 inhibitors, 3 KRAS inhibitors, 2 RET inhibitors, and 2 HER2 inhibitors. The median monthly treatment price decreased substantially from launch to the latest prices, with NRDL drugs showing the largest reductions (median $7058.9 to $2547.2) compared with non-NRDL drugs (median $1,2173.2 to $1,1526.0). The AARR was largest during NRDL negotiation (median -54.8%; IQR, -68.1% to -38.1%), followed by post-inclusion declines (median -3.6%; IQR, -16.0% to -0.6%), whereas pre-NRDL reductions were minimal (median -0.05%; IQR, -1.08% to 0.2%). The median Spearman correlation coefficient values were 0.997 (IQR, 0.775-1.000) for EGFR inhibitors, 0.942 (IQR, 0.765-1.000) for PD-1/PD-L1 inhibitors, 0.689 (IQR, 0.456-0.787) for ALK inhibitors, and 1.000 (IQR, 0.507-1.000) for MET inhibitors. Spearman correlation analyses showed that the competition index was not significantly correlated with the magnitude of price reductions either before or after NRDL inclusion. Univariate and multivariate regression analyses indicated that NRDL inclusion significantly reduced prices, whereas within-class competition had no significant impact on the extent of price reductions. There was no significant association between either launch prices ( Interpretation: Our findings demonstrate that NRDL negotiations are the primary driver of price reductions for targeted lung cancer drugs in China, whereas market competition alone has a limited effect on lowering prices. Neither launch prices nor current prices of NSCLC drugs correlate strongly with clinical benefit. Incorporating value-oriented clinical benefit assessment into reimbursement decisions may help prioritize drugs with substantial clinical benefit and ensure that drug pricing more closely reflects therapeutic value. Funding: This work was supported by the National Natural Science Foundation of China (72374115) and Tsinghua University Initiative Scientific Research Program (20257020014).