Objective:In recent years,with the continuous innovation and development of medicine,molecular targeted drugs have played a great role in anti-tumor therapy,which is more targeted and less side effects,and easier to be accepted by patients.Ensartinib,as a newly marketed AlK-positive tyrosine kinase inhibitor,has a good clinical effect,but due to the short marketing time,there is a lack of economic reference data.From the perspective of health system,this study compared the cost-effectiveness of ensartinib and crizotinib in the treatment of AlK-positive non-small cell lung cancer by using the zonal survival model,evaluated the economy of ensartinib,and provided certain reference for clinical rational drug use in patients.Methods:The clinical data of this study were based on a high-quality,multicenter Phase III randomized clinical trial(eXalt3),with three state partitioned survival models(progression-free survival,disease progression,and death)established according to the disease progression process,and survival data at the later stage of the trial were extrapolated using parameter method.The utility value came from the published literature,the drug cost came from the provincial drug procurement platform,and other medical costs came from the literature.The duration of the study was the full life cycle of patients,and the reference drug administration scheme of the model cycle was set as 1 month.Cost-effectiveness analysis was conducted according to the cost and utility data after model simulation,and single factor sensitivity analysis,probability sensitivity analysis and scenario analysis were conducted on the results of model analysis.Results by comparing the Ratio of Incremental Cost and incremental effectiveness,namely the incremental cost-effectiveness ratio(ICER)and the value of willing to pay,the economics of Enshatinib treatment was evaluated.Result:Under the whole life cycle,the average annual cost of ensartinib was 491486.07 yuan,and the average utility value of ensartinib was 5.55QALYs.The average annual cost of crizotinib was 209649.16 yuan,and the average utility value of crizotinib was 3.315QALYs.The incremental cost-utility ratio is 126,101.53 yuan/QALYs.In 2021,the per capita GDP is 80,976 yuan,and the incremental cost utility is 242,928 yuan(three times the per capita GDP)lower than the threshold of willingness to pay.Univariate sensitivity analysis showed that the drug cost and the utility value of ensartinib PFS had the greatest influence on the results,while other parameters had little influence.No matter how the parameter changes,the ICER value is always lower than the willing payment value,and the model is relatively stable.In probability sensitivity analysis,Monte Carlo simulation was used to obtain ICER’s scatter diagram of distribution.All points were distributed in the first quadrant and below the line of willing to pay value.Ensartinib had absolute economic advantages over crizotinib,which was consistent with the results of cost-utility analysis.Scenario analysis results Although the total cost and incremental cost-utility ratio of ensartinib increased,but the increased incremental cost-utility ratio was lower than the willing value of payment,ensartinib has economic advantages.Conclusion:The results of cost-utility analysis and sensitivity analysis show that ensartinib has absolute economic advantages over crizotinib.From the perspective of health system,ensartinib is a reasonable and economical treatment for AlK-positive non-small cell lung cancer. |