| ObjectiveData from the latest phase III clinical trial show that the hepatic arterial infusion oxaliplatin,leucovorin and fluorouracil(FOLFOX)combined with sorafenib(Sora HAIC)treatment strategy compared to sorafenib monotherapy.Sora HAIC has been shown to be more effective in patients with hepatocellular carcinoma(HCC)with portal vein invasion.However,considering the high cost of hepatic arterial infusion chemotherapy(HAIC),this study evaluated the cost-effectiveness of hepatic arterial infusion chemotherapy in combination with sorafenib for the first-line treatment of HCC patients from the perspective of the Chinese healthcare system.This study provides a reference for the rational allocation of limited health resources in China.Methods1.To construct multi-state Markov models of disease-free survival,disease-free recurrence survival,disease progression and death,and to simulate the disease course of HAIC combined with sorafenib versus sorafenib alone in the first-line treatment of advanced HCC.2.Using cost-effectiveness analysis,the probability of transfer between disease states was calculated based on survival data from clinical trials;the national uniform prices were used to measure the prices of major drugs;the costs of adverse reaction management,medical service costs and health utility values were obtained from published literature.3.The primary outcomes include Life Years(LYs),Quality-adjusted Life Years(QALYs),and Incremental Cost-effectiveness Ratios(ICERs).4.The robustness of the model was verified by one-way sensitivity analysis and probabilistic sensitivity analysis(PSA).The entire life cycle of the patient was used as the study time horizon.Results1.In the treatment of advanced HCC,the Sora HAIC regimen had a survival benefit of1.18 QALYs(1.68 LYs)and a cost of $65,254,compared with a survival benefit and total cost of $0.52 QALYs(0.79 LYs)and $14,280,respectively,for the sorafenib regimen alone.2.The ICER of Sora HAIC vs sorafenib was $77,132/QALY($57,153/LY).Parameter that most influenced the ICER was utility of PFS state.3.In China,PSA results showed that Sora HAIC regimen was not economical compared to the sorafenib,using the 3* Gross Domestic Product(GDP)per capita of $30,492/QALY as the willingness to pay(WTP)threshold.But about 38.8% of the simulations were favorable to Sora HAIC at the WTP threshold of 3*GDP per capita of Beijing($72,000/QALY).When3*GDP per capita of Fujian($47,285/QALY)and Gansu Province($14,595/QALY)were used as WTP threshold,the acceptability of Sora HAIC was 0.3% and 0%,respectively.ConclusionsFrom the Chinese health system perspective,Sora HAIC is not cost-effective overall.In low-and middle-income areas,the Sora HAIC regimen was completely uneconomic,but in high-income areas,represented by Beijing,the probability of Sora HAIC being cost-effective increased to 38.8%. |