Setting the annual treatment cost negotiation threshold for high-value innovative drugs from an opportunity cost perspective: A case study in high-value innovative oncology drugs

Given that the current annual treatment cost threshold in China restricts price negotiations for some high-value innovative drugs, patients with related conditions often experience limited treatment options, leading to significant equity concerns. This study adopts the opportunity cost perspective and applies the equity-weighted coefficient method. By incorporating both population-level health gains and fairness, the study evaluates the feasibility of improving the current threshold-setting mechanism for high-value innovative drugs and proposes a recommended threshold range for policymaking. This study also constructs a database of innovative oncology drugs excluded during the comprehensive review stage between 2021 and 2023. A combination of analytical methods, including scenario analysis, scatter plots, probabilistic sensitivity analysis (PSA), and subgroup analysis, was used to assess whether the current annual treatment cost negotiation threshold can be optimized and to estimate a recommended threshold range. The analysis further examined how different threshold levels influence the equity weight coefficient ( θ ) and net health benefit (NHB), and whether the current threshold exerts differential effects across various drug categories. The results revealed that the existing threshold of RMB 500,000 corresponds to the θ of 12.7, indicating a relatively high opportunity cost. This finding suggests that the threshold could be adjusted to improve equity. Considering both population-level health benefits and fairness, the recommended range for the annual treatment cost negotiation threshold was estimated to lie between RMB 718,475 and 766,373. However, the current first-stage threshold applied in China's National Reimbursement Drug List (NRDL) process may insufficiently account for equity considerations, thereby restricting access to high-value innovative drugs. We recommend a moderate adjustment to the thresholds by integrating opportunity costs, θ , and NHBs to promote greater fairness and improve access to high-value drugs. • The use of annual treatment cost thresholds is uncommon in international practices. • The equity weight coefficient is 12.71 under threshold, above levels in previous studies. • The suggested threshold range is RMB 718,475–766,373 for equity considerations.