Cost-Effectiveness Analysis of Recombinant Tumor Necrosis Factor Receptor: Fc Fusion Protein as First-Line Treatment for Active Rheumatoid Arthritis in China.

Background/Objectives: To evaluate the cost-effectiveness of recombinant tumor necrosis factor receptor Fc fusion protein compared with methotrexate as first-line therapy for active rheumatoid arthritis in China using evidence from a Chinese head-to-head randomized trial. Methods: A Markov model with 6 months per cycle was developed to estimate costs and health utilization in the lifetime of patients with RA from the Chinese healthcare system. The analysis data were derived from the randomized clinical trial in China. The primary cost includes drug and other medical costs. The health utilities quality-adjusted life years (QALYs) were derived using EQ-5D-5L mapping from disease-specific health assessment questionnaire (HAQ) scores obtained in clinical trials. The cost-effectiveness analysis was conducted by calculating the incremental cost-effectiveness ratio (ICER) values for rhTNFR:Fc and MTX. One-way and probabilistic sensitivity analyses were conducted to test the robustness of the base-case result. Results: In the base case, rhTNFR:Fc yielded 8.20 QALYs versus 7.46 with methotrexate, resulting in an ICER of CNY 12,783.56 per QALY. Scenario ICERs for bDMARD group combination treatment were 11,776.31 per QALY. Scenario ICERs were CNY 8079.04 per QALY for the patient perspective and CNY 7630.34 per QALY for the medical insurance perspective. One-way analysis highlighted utility inputs as the main drivers, and probabilistic analysis indicated a high probability of cost-effectiveness across common willingness-to-pay thresholds. Conclusions: The fusion protein strategy achieved an incremental cost-effectiveness ratio far below the 2024 China per capita gross domestic product threshold of CNY 95,749 per quality-adjusted life year. As first-line therapy for active rheumatoid arthritis, it is cost-effective relative to methotrexate in the Chinese setting.