Provisionally accepted

Background and objective: Cancer-related venous thromboembolism (CAVTE) is a preventable, life-threatening complication with significant morbidity and mortality. Currently, primary VTE prophylaxis is recommended, but the health and economic benefits have not yet been evaluated and compared in China. The aim of this study was to evaluate and compare the cost-effectiveness of anticoagulants in primary CAVTE prevention in cancer patients in China. Methods: A Markov model with a 5-year horizon was constructed to evaluate the costs and effectiveness of DOACs compared with LMWHs and no prevention in primary prophylaxis of CAVTE in China. The main clinical outcomes were obtained from the available clinical trials comparing DOACs (rivaroxaban, apixaban) with LMWHs or without thromboprophylaxis. Benefits and costs were all extracted from the published literature or local data from public sources. Total costs, quality-adjusted life years (QAYLs), and incremental cost-effectiveness ratios (ICERs) were estimated as the main modal endpoints for each strategy. Uncertainty assessment was performed using deterministic sensitivity analysis and probabilistic sensitivity analysis (PSA). The effects of time horizon, generic price, and individual DOACs were assessed in scenario and subgroup analyses. Results: Primary prophylaxis with DOACs was predicted to yield 1,866 QALYs at a cost of US$3,287,893, resulting in ICERs of US$12,895,851 (DOACs vs. no thromboprophylaxis) and US$43,613,184/QALYs (LMWHs vs. DOACs). Sensitivity analysis showed that ICER was sensitive to VTE and bleeding risk, anticoagulant drug costs, out-of-pocket payment rate, and overall cancer mortality rate. Probabilistic sensitivity analysis showed that DOACs and LMWHs had a probability of 48% and 45% of being cost-effective, respectively, over a 5-year time horizon. Over a 10-year time horizon, DOACs dominated with a cost-effectiveness probability of 43%. Among individual DOACs, apixaban emerged as the preferred strategy for VTE prevention, as it provides incremental health gain at an acceptable cost increase. Conclusion: Primary thromboprophylaxis with DOACs was cost-effective in cancer patients at a willingness-to-pay (WTP) threshold of USD 37,125.24/QALY in China. Cancer mortality rate, VTE and major bleeding risk, and drug costs gained relevance and importance in the decision-making process regarding primary thromboprophylaxis in cancer.