| Objective:To assess the long-term cost-effectiveness of dapagliflozin and saxagliptin separately or together in patients with type 2 diabetes mellitus inadequately controlled by metformin from the perspective of Chinese healthcare service providers.Method:(1)Meta-analysis:Randomized controlled trials of the efficacy and safety of dapagliflozin and saxagliptin in type 2 diabetes mellitus patients were found by searching PubMed,CNKI and other Chinese and English databases.Documents that meet the criteria for inclusion and exclusion were screened and their efficacy and safety indicators were meta-analyzed by Revman5.3 software.(2)Cost-utility analysis:A cost-utility analysis of the three therapeutic groups was conducted based on the UKPDS OM2 model by simulating the long-term health outcome and costs.The clinical efficacy and safety data entered into the model were sourced from the clinical trials finally included in the meta-analysis,and the relevant costs,utility values,and other parameters were collected from databases.(3)Sensitivity analysis:① In the univariate sensitivity analysis,the model parameters included baseline demographics,costs,utilities,discount rate,treatment time and time horizon,and the analysis result is reported as a tornado chart.② Varied acquisition costs of dapagliflozin and saxagliptin(20%,40%and 60%discount off the official government bid price in China in 2019)were evaluated in a scenario analysis.③ In the probabilistic sensitivity analysis,second-order uncertainty was addressed by setting the number of bootstraps from fixed probability distributionsResults:(1)Meta-analysis:5 head-to-head randomized controlled trials with a total of 2665 patients were finally included.The analysis results showed that there was no statistical difference in the baseline HbAlc of the three groups of patients.The combination group was significantly better than the dapagliflozin group and saxagliptin group in reducing HbAlc and FPG.In terms of weight reduction,there was no statistical difference between the combination group and the dapagliflozin group,while the combination group was significantly better than the saxagliptin group.In terms of adverse reactions,the overall incidence of hypoglycemia and urinary tract infections in the combination group was not statistically different from that of the dapagliflozin group and saxagliptin group.In terms of the incidence of genital infections,the combination group was significantly lower than that of the dapagliflozin group,and significantly higher than that of the saxagliptin group.(2)Cost-utility analysis:After 50 years of simulation,the quality-adjusted life years(QALY)obtained by the combination group,dapagliflozin group,and saxagliptin group were 11.28 years,11.45 years,and 11.26,respectively;the total costs spent from the three groups were ￥190092.91,￥174137.73 and ￥158130.33,respectively;the absolute net monetary benefits(NMB)of the three groups were￥2208892.21,￥2261002.31and ￥2236601.26,respectively.The incremental cost-utility ratio(ICUR)of the combination group compared to the saxagliptin group was ￥1479204.68,which is more than 3 times of the per capita GDP,indicating that the combination group was not cost effective.Compared to the combination group,the dapagliflozin group was dominant with higher QALYs and lower total costs.The ICUR of the dapagliflozin group versus the saxagliptin group was ￥82905.40 per QALY(ICUR<3 times of the per capita GDP),indicating that the dapagliflozin group was favorable.(3)The pharmacoeconomic results were robust to univariate,scenario and probabilistic sensitivity analyses.Conclusion:Compared with combination of dapagliflozin and saxagliptin or saxagliptin,dapagliflozin appears to be a cost-effective therapy as add-on to metformin for Chinese patients whose type 2 diabetes is insufficiently controlled by metformin.Even though,combination therapy of dapagliflozin and saxagliptin performed a good clinical efficacy in short-term clinical trials. |
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