OBJECTIVE To assess the cost-effectiveness of recombinant human TNK tissue-type plasminogen activator(rhTNK-tPA) compared to alteplase(rt-PA) for intravenous thrombolysis in acute ischemic stroke(AIS) patients within 4.5 h of symptom onset, from the perspective of healthcare system of China.

METHODS Based on the data from a multi-center randomized controlled trial(TRACE-2) in China, a decision tree-Markov model was developed with a cycle length of three months. The model estimated the short-term and lifetime direct medical costs and total quality-adjusted life years(QALYs) for AIS patients receiving 2 thrombolytic agents. The incremental cost-effectiveness ratio of rhTNK-tPA relative to rt-PA was calculated. One-way sensitivity analysis and probabilistic sensitivity analysis were conducted to assess the robustness of the model results.

RESULTS The cost-effectiveness analysis demonstrated that the lifetime costs for patients in the rhTNK-tPA and rt-PA groups were ¥136 076 and ¥148 355, respectively, with corresponding QALYs of 6.01 and 5.95. The rhTNK-tPA group not only incurred lower treatment costs but also achieved higher QALYs, suggesting that rhTNK-tPA was a dominant therapeutic option compared to rt-PA. The deterministic and probabilistic sensitivity analyses showed the base-case results to be robust.

CONCLUSION  Compared with rt-PA, rhTNK-tPA is more cost-effective for AIS patients requiring intravenous thrombolysis within 4.5 h of onset.