| Objective:Type Ⅱ diabetes(T2DM)is one of the important chronic diseases threatening human health,which has brought heavy disease burden to society.iGlarLixi is an innovative drug for T2DM treatment,which is an injectable compound preparation composed of insulin glargine 100 U/mL and lixisenatide in a fixed proportion.The hypoglycemic efficacy and safety of iGlarLixi have been confirmed through a series of clinical trials,and it is expected to enter the diabetes drug market in China soon.IDegAsp is the world’s first soluble dual-insulin preparation that composed of insulin degludec and insulin aspart.It has been widely used in the clinical treatment of T2DM and has been included in the National Reimbursement Drug List(NRDL)in China.So far,there is no evidence of pharmacoeconomic evaluation related to iGlarLixi in China.Therefore,the main objective of this study is to evaluate the long-term health and economic value of iGlarLixi compared with IDegAsp in adults with T2DM inadequately controlled by oral antidiabetic drugs with or without basic insulin treatment,from the perspective of healthcare system in China;then according to the cost-utility analysis,the appropriate drug price of iGlarLixi was back calculated to support its drug pricing after its listing in China.Method:The United Kingdom Prospective Diabetes Study Outcome Model 2(UKPDS OM2)diabetes model was used to simulate the long-term health outcomes and economic benefits of the two treatment strategies.As no head-to-head comparison data of the two therapeutic drugs are currently available,the baseline characteristics of the study population and the efficacy data of iGlarLixi were sourced from the LixiLan-LChina clinical trial.The relative efficacy of IDegAsp was derived from a published indirect treatment comparison study,and its absolute efficacy was calculated according to Bucher’s indirect comparative method.Due to the unavailability of iGlarLixi pricing data in China,the annual medication cost of iGlarLixi was assumed to be equal to that of IDegAsp at the beginning of the study.Afterwards,the comparator drug price and the willingness-to-pay(WTP)threshold(1xGDP and 3xGDP)was uesed to back calculate the appropriate drug price of iGlarLixi.Ultimately,one-way sensitivity analysis,probability sensitivity analysis and scenario analysis were carried out to verify the robustness of the model.Results:Based on the initial assumption of equal annual medication cost of iGlarLixi and IDegAsp,the incremental cost-utility ratio(ICUR)value of iGlarLixi compared with IDegAsp was far below the WTP threshold,indicating that iGlarLixi was a costeffective strategy.Based on the cost-utility analysis,the result of back calculations showed that when the annual medication cost of iGlarLixi was $656.96 and $1075.96,the ICUR would be close to the WTP threshold of 1xGDP and 3xGDP,respectively.The one-way sensitivity analysis based on the above drug price showed that the most sensitive parameter to the model results was the increase of the discount rate from the baseline value to 8%.Therefore,in order to calculate a more robust drug price of iGlarLixi,the study conducted the drug price exploration again at a discount rate of 8%.The results showed that the annual medication cost of iGlarLixi needs to be reduced to$590.41 and $865.03 to obtain an IUCR value of iGlarLixi compared with IDegAsp closed to 1xGDP and 3xGDP,respectively.After adjusting all model parameters back to the baseline value,the model results based on the above drug price were robust to the one-way sensitivity analysis,probability sensitivity analysis and scenario analysis.Conclusion:The long-term cost-utility analysis of T2DM patients in China shows that iGlarLixi is cost-effective compared with IDegAsp when the annual medication cost of iGlarLixi is equal to that of IDegAsp.Through price exploration,the study back calculates that iGlarLixi will be a cost-effective treatment strategy when the annual medication cost of iGlarLixi is between $590.41 to $865.03. |
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