Tenecteplase for ischemic stroke at 4.5 to 24 hours without thrombectomy: a cost-utility analysis from the perspective of Chinese healthcare system.

Background: Tenecteplase improves functional outcomes in acute ischemic stroke (AIS) patients treated 4.5 to 24 h after symptom onset who do not undergo thrombectomy. However, its cost-utility remains unexamined. Methods: A hybrid model combining a short-term decision tree and a long-term Markov model was developed to simulate the costs and quality-adjusted life years (QALYs) for Chinese patients with AIS at 4.5 to 24 h, who did not undergo thrombectomy. Clinical data were sourced from the TRACE-III trial, while cost data were obtained from the China National Stroke Registry and the Thrombolysis Implementation and Monitor of Acute Ischemic Stroke in China database. The primary outcome was the incremental cost-effectiveness ratio (ICER). Secondary outcomes included total costs, total QALYs and remaining life expectancy, as well as the incremental cost, incremental QALYs, and incremental remaining life expectancy. One-way sensitivity analysis, probabilistic sensitivity analysis (PSA), and scenario analysis were conducted to test the robustness of the results. Results: For a Chinese patient with AIS treated within 4.5 to 24 h after symptom onset without thrombectomy, adding tenecteplase to standard care resulted in an incremental cost of 2,536 Chinese Yuan (CNY) and an increase of 0.40 QALYs, yielding an ICER of 6,386 CNY per QALY. One-way sensitivity analysis revealed that the most significant factors influencing the ICER were the efficacy and cost of tenecteplase. PSA and scenario analyses confirmed the robustness of these results. Conclusion: Compared to standard medical treatment alone, administering intravenous tenecteplase between 4.5 and 24 h after onset for Chinese patients with AIS who did not undergo thrombectomy, is highly cost-effective.