Pharmaco-economic Evaluation Of Sintilimab For First-line Treatment Of Advanced Non-small Cell Lung Cancer

Objective:In recent years,with the deepening of tumor immunotherapy research,the treatment mode of immune checkpoint inhibitor combined with chemotherapy has been proved to significantly improve the efficacy of patients with advanced non-small cell lung cancer.As a kind of monoclonal antibody against programmed cell death receptor-1(PD-1),Sintilimab combined with chemotherapy has a significant effect on advanced squamous non-small cell lung cancer,but its price is relatively expensive,which brings a certain economic burden to patients.From the point of view of China’s health service system,this study uses the partitioned survival model in the pharmacoeconomic evaluation,consider different situations to conduct cost-effectiveness analysis of the first-line treatment scheme of Sintilimab combined with chemotherapy for advanced squamous non-small cell lung cancer,in order to evaluate the economy of Sintilimab combined with chemotherapy compared with standard chemotherapy.In order to reduce the economic burden of patients and promote rational clinical medication.Methods:1.Based on a large phase III clinical trial(ORIENT-12)carried out in the patient population of China,the health status of advanced non-small cell lung cancer disease progression was simulated.The Excel software was used to establish a partition survival model with three states of disease progression,progression and death.The total survival curve and progression-free survival curve of the two groups of treatment schemes reported in the trial were re-fitted by R software.2.The cycle of the model is consistent with the administration period of Sintilimab in the follow-up test,which is set at 21 days,and the cycle period of the model is 10 years.3.Combined with the treatment cost,utility value,incidence of adverse reactions,discount rate and other parameters,the total cost and output of the two groups of treatment schemes are calculated through the fitting function,and the incremental cost-utility ratio(ICER)is obtained.This value is compared with the willingness to pay value(WTP)recommended by the pharmacoeconomics evaluation guide in China,Therefore,we can judge the economy of Sintilimab combined with chemotherapy in the treatment of advanced squamous non-small cell lung cancer compared with standard first-line chemotherapy.4.Finally,the stability of the model results is evaluated through sensitivity analysis and situational analysis.Results:1.The basic analysis results showed that the Sintilimab group obtained 0.79 qualityadjusted life years(QALYs)at a cost of 168866 yuan.The chemotherapy group obtained0.61 QALYs at a cost of 158880 yuan.Compared with the control chemotherapy group,the patients in the treatment group received 0.18 more QALYs,but at the same time increased the cost of 9986 yuan.The incremental cost-effectiveness ratio ICER was56183 yuan/QALY,lower than WTP.2.The result of sensitivity analysis shows that the utility value of the non-progress state,the utility value of the progress state and the price of Sintilimab are the three factors that have the greatest impact on the evaluation result of the model.However,the change of ICUR value with all uncertain parameters within the set range does not exceed WTP,indicating that the basic analysis results are robust.When the WTP is 3 times the per capita gross domestic product(GDP),the economic probability of the combination chemotherapy of Sintilimab compared with the chemotherapy alone is close to 93.8%.3.The result of scenario analysis shows that the combination of Sintilimab and chemotherapy can bring more health outcomes in all scenarios,but the cost is high.When the price of Sintilimab is the price before medical insurance,the ICUR is 307323yuan/QALY,higher than 3 times the per capita GDP;When Sintilimab ’s price is reduced by 60% to enter the price after medical insurance,the ICUR is 121699 yuan/QALY,between 1 and 3 times the per capita GDP;When the European population utility value is adopted,the ICUR is 73356 yuan/QALY,which is less than one time of the per capita GDP.Conclusion:Based on the national medical insurance negotiation in 2021,Sintilimab was successfully left in the medical insurance catalogue after another price reduction.The first-line treatment of advanced squamous non-small cell lung cancer with Sintilimab combined with chemotherapy is more cost-effective.