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Article(id=1207314219373006972, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1207314214872518754, articleNumber=null, orderNo=null, doi=10.14109/j.cnki.xyylc.2025.04.11, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1718812800000, receivedDateStr=2024-06-20, revisedDate=null, revisedDateStr=null, acceptedDate=1734105600000, acceptedDateStr=2024-12-14, onlineDate=1765775740712, onlineDateStr=2025-12-15, pubDate=1745510400000, pubDateStr=2025-04-25, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1765775740712, onlineIssueDateStr=2025-12-15, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1765775740712, creator=13701087609, updateTime=1765775740712, updator=13701087609, issue=Issue{id=1207314214872518754, tenantId=1146029695717560320, journalId=1205117082300743687, year='2025', volume='44', issue='4', pageStart='241', pageEnd='320', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=1, specialIssue=0, createTime=1765775739638, creator=13701087609, updateTime=1765775882010, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1207314812124635584, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1207314214872518754, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1207314812124635585, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1207314214872518754, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=307, endPage=314, ext={EN=ArticleExt(id=1207314219767271559, articleId=1207314219373006972, tenantId=1146029695717560320, journalId=1205117082300743687, language=EN, title=Cost-effectiveness analysis of two kinds of fixed-ratio combination of basal insulin and GLP-1RA for treatment of patients with type 2 diabetes mellitus in China, columnId=1207314218647392369, journalTitle=Chinese Journal of New Drugs and Clinical Remedies, columnName=Original Article, runingTitle=null, highlight=null, articleAbstract=

AIM To evaluate the cost-effectiveness of insulin degludec-liraglutide（iDegLira） versus insulin glargine-lixisenatide （iGlarLixi） in Chinese adult type 2 diabetes mellitus （T2DM） patients. METHODS From the perspective of China’s health system, a Markov model was developed. Quality-adjusted life years （QALY） were used as the health output indicator, and three times 2023 gross domestic product （GDP） per capita of China was used as the willingness-to-pay （WTP） threshold. The model simulates the health output and medical costs over 30 years, evaluates the economics of the two treatment options using the incremental cost-effectiveness ratio （ICER） as an evaluation metric, and performs sensitivity and contextual analyses to test the uncertainty of the results. RESULTS Compared with the iGlarLixi scheme,iDegLira scheme had an incremental cost of 46 142.61 yuan, an incremental utility of 0.014 QALY. The ICER was 3 258 162.70 yuan·QALY-1, which was much larger than the WTP threshold （268 074 yuan·QALY-1） and was not cost-effectiveness. The results of the sensitivity analysis show that the underlying analysis was relatively robust. The results of the contextual analysis showed that the cost-effectiveness of the two schemes was comparable when the price was reduced by 31% at the current WTP threshold. CONCLUSION For Chinese adult T2DM patients with poor glycemic control despite receiving basal insulin in combination with oral hypoglycemic agents, iDegLira scheme has a lower probability of being economical at current prices compared with the iGlarLixi scheme.

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目的 评价德谷胰岛素利拉鲁肽（iDegLira）和甘精胰岛素利司那肽（iGlarLixi）治疗中国成年2型糖尿病（T2DM）患者的经济性。方法 从我国卫生体系角度出发，建立Markov模型，以质量调整生命年（QALY）为健康产出指标，以3倍我国2023年人均国内生产总值作为意愿支付（WTP）阈值，模拟患者使用iDegLira和iGlarLixi治疗30年的健康产出和医疗成本，以增量成本-效果比（ICER）作为评价指标评价两种治疗方案的经济性，并进行敏感性分析和情境分析以检验结果的不确定性。结果 与iGlarLixi方案相比，iDegLira方案的增量成本为46 142.61元，增量效用为0.014 QALY，ICER为3 258 162.70元·QALY-1，远远大于WTP阈值（268 074元·QALY-1），表明iDegLira方案不具有经济性。敏感性分析结果显示，基础分析结果较为稳健；情境分析结果显示，在当前WTP阈值下，iDegLira降价31%时，两种方案的经济性相当。结论 对于接受基础胰岛素联合口服降糖药治疗血糖仍控制不佳的中国成年T2DM患者，与iGlarLixi方案相比，iDegLira方案在当前价格下具有经济性优势的概率较低。

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刘国强
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高宁，女，硕士在读，主要从事药物经济学方面的研究，E-mail: 。

刘国强，男，主任药师，硕士生导师，主要从事药物经济学、卫生技术评估、合理用药方面的研究，E-mail:

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高宁，女，硕士在读，主要从事药物经济学方面的研究，E-mail: 。

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高宁，女，硕士在读，主要从事药物经济学方面的研究，E-mail: 。

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刘国强，男，主任药师，硕士生导师，主要从事药物经济学、卫生技术评估、合理用药方面的研究，E-mail:

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刘国强，男，主任药师，硕士生导师，主要从事药物经济学、卫生技术评估、合理用药方面的研究，E-mail:

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Diabetes Metab Syndr Obes, 2020,13: 2823-2831., articleTitle=Empagliflozin in type 2 diabetes mellitus patients with high cardiovascular risk: a model-based cost-utility analysis in China, refAbstract=null), Reference(id=1207314232928997954, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1207314219373006972, doi=null, pmid=null, pmcid=null, year=2021, volume=58, issue=3, pageStart=329, pageEnd=339, url=null, language=null, rfNumber=［21］, rfOrder=26, authorNames=LI CY, ZHOU HJ, WANG P, journalName=Acta Diabetol, refType=null, unstructuredReference=LI CY, ZHOU HJ, WANG P. Health utility of type 2 diabetes patients using basal insulin in China: results from the BEYOND Ⅱstudy［J］. Acta Diabetol, 2021, 58（3）: 329-339., articleTitle=Health utility of type 2 diabetes patients using basal insulin in China: results from the BEYOND Ⅱstudy, refAbstract=null), Reference(id=1207314233004495429, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1207314219373006972, doi=null, pmid=null, pmcid=null, year=2023, volume=23, issue=1, pageStart=28, pageEnd=null, url=null, language=null, rfNumber=［22］, rfOrder=27, authorNames=RISOVIC I, DUMANOVIC MS, BOJIC M, journalName=BMC Endocr Disord, refType=null, unstructuredReference=RISOVIC I, DUMANOVIC MS, BOJIC M, et al. Direct comparison two fixed-ratio combination glucagon-like peptide receptor agonist and basal insulin on glycemic and non glycemic parameters in type 2 diabetes［J］. BMC Endocr Disord, 2023, 23（1） :28., articleTitle=Direct comparison two fixed-ratio combination glucagon-like peptide receptor agonist and basal insulin on glycemic and non glycemic parameters in type 2 diabetes, refAbstract=null), Reference(id=1207314233067409991, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1207314219373006972, doi=null, pmid=null, pmcid=null, year=2022, volume=26, issue=8, pageStart=2782, pageEnd=2793, url=null, language=null, rfNumber=［23］, rfOrder=28, authorNames=BILIC-CURCIC I, CIGROVSKI BERKOVIC M, BOZEK T, journalName=Eur Rev Med Pharmacol Sci, refType=null, unstructuredReference=BILIC-CURCIC I, CIGROVSKI BERKOVIC M, BOZEK T, et al.Comparative efficacy and safety of two fixed ratio combinations in type 2 diabetes mellitus patients previously poorly controlled on different insulin regimens: a multi-centric observational study［J］. Eur Rev Med Pharmacol Sci, 2022, 26（8）: 2782-2793., articleTitle=Comparative efficacy and safety of two fixed ratio combinations in type 2 diabetes mellitus patients previously poorly controlled on different insulin regimens: a multi-centric observational study, refAbstract=null), Reference(id=1207314233159684682, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1207314219373006972, doi=null, pmid=null, pmcid=null, year=2024, volume=43, issue=6, pageStart=460, pageEnd=468, url=null, language=null, rfNumber=［24］, rfOrder=29, authorNames=郑彩云, 林妹妹, 戴亨纷, journalName=中国新药与临床杂志, refType=null, unstructuredReference=郑彩云, 林妹妹, 戴亨纷. GLP-1受体激动剂致2型糖尿病患者胃肠道不良反应的网状Meta分析［J］. 中国新药与临床杂志, 2024, 43 （6）: 460-468., articleTitle=GLP-1受体激动剂致2型糖尿病患者胃肠道不良反应的网状Meta分析, refAbstract=null), Reference(id=1207314233214210637, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1207314219373006972, doi=null, pmid=null, pmcid=null, year=2024, volume=43, issue=6, pageStart=460, pageEnd=468, url=null, language=null, rfNumber=［24］, rfOrder=30, authorNames=ZHENG CY, LIN MM, DAI HF, journalName=Chin J New Drugs Clin Rem, refType=null, unstructuredReference=ZHENG CY, LIN MM, DAI HF.GLP-1 receptor agonists cause gastrointestinal adverse reaction in patients with type 2 diabetes mellitus:a network meta-analysis［J］.Chin J New Drugs Clin Rem, 2024, 43（6）: 460-468., articleTitle=GLP-1 receptor agonists cause gastrointestinal adverse reaction in patients with type 2 diabetes mellitus:a network meta-analysis, refAbstract=null), Reference(id=1207314233277125199, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1207314219373006972, doi=null, pmid=null, pmcid=null, year=2019, volume=10, issue=2, pageStart=493, pageEnd=508, url=null, language=null, rfNumber=［25］, rfOrder=31, authorNames=POHLMANN J, RUSSEL-SZYMCZYK M, HOLIK P, journalName=Diabetes Ther, refType=null, unstructuredReference=POHLMANN J, RUSSEL-SZYMCZYK M, HOLIK P, et al. Treating patients with type 2 diabetes mellitus uncontrolled on basal insulin in the czech republic: cost-effectiveness of IDegLira versus iGlarLixi［J］. Diabetes Ther, 2019, 10（2）: 493-508., articleTitle=Treating patients with type 2 diabetes mellitus uncontrolled on basal insulin in the czech republic: cost-effectiveness of IDegLira versus iGlarLixi, refAbstract=null), Reference(id=1207314233352622676, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1207314219373006972, doi=null, pmid=null, pmcid=null, year=2019, volume=11, issue=null, pageStart=605, pageEnd=614, url=null, language=null, rfNumber=［26］, rfOrder=32, authorNames=POHLMANN J, MONTAGNOLI R, LASTORIA G, journalName=Clinicoecon Outcomes Res, refType=null, unstructuredReference=POHLMANN J, MONTAGNOLI R, LASTORIA G, et al. Value for money in the treatment of patients with type 2 diabetes mellitus:assessing the long-term cost-effectiveness of iDegLira versus iGlarLixi in Italy［J］. Clinicoecon Outcomes Res, 2019, 11: 605-614., articleTitle=Value for money in the treatment of patients with type 2 diabetes mellitus:assessing the long-term cost-effectiveness of iDegLira versus iGlarLixi in Italy, refAbstract=null), Reference(id=1207314233423925846, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1207314219373006972, doi=null, pmid=null, pmcid=null, year=2021, volume=12, issue=12, pageStart=3231, pageEnd=3241, url=null, language=null, rfNumber=［27］, rfOrder=33, authorNames=MCCRIMMON RJ, LAMOTTE M, RAMOS M, journalName=Diabetes Ther, refType=null, unstructuredReference=MCCRIMMON RJ, LAMOTTE M, RAMOS M, et al. Cost-Effectiveness of iGlarLixi versus iDegLira in type 2 diabetes mellitus inadequately controlled by GLP-1 receptor agonists and oral antihyperglycemic therapy［J］. Diabetes Ther, 2021, 12（12）:3231-3241., articleTitle=Cost-Effectiveness of iGlarLixi versus iDegLira in type 2 diabetes mellitus inadequately controlled by GLP-1 receptor agonists and oral antihyperglycemic therapy, refAbstract=null), Reference(id=1207314233499423319, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1207314219373006972, doi=null, pmid=null, pmcid=null, year=2021, volume=12, issue=12, pageStart=3217, pageEnd=3230, url=null, language=null, rfNumber=［28］, rfOrder=34, authorNames=MCCRIMMON RJ, FALLA E, SHA JZ, journalName=Diabetes Ther, refType=null, unstructuredReference=MCCRIMMON RJ, FALLA E, SHA JZ, et al. Cost-effectiveness of iGlarLixi in people with type 2 diabetes mellitus suboptimally controlled on basal insulin plus metformin in the UK［J］. Diabetes Ther, 2021,12（12）: 3217-3230., articleTitle=Cost-effectiveness of iGlarLixi in people with type 2 diabetes mellitus suboptimally controlled on basal insulin plus metformin in the UK, refAbstract=null)], funds=[Fund(id=1207314230349500900, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1207314219373006972, awardId=H2021206407, language=CN, fundingSource=河北省自然科学基金项目(H2021206407), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1207314222875250933, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1207314219373006972, xref=1., ext=[AuthorCompanyExt(id=1207314222883639542, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1207314219373006972, companyId=1207314222875250933, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1. 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iDegLira：德谷胰岛素利拉鲁肽, iGlar U100：甘精胰岛素U100, iGlarLixi：甘精胰岛素利司那肽, iDeg：德谷胰岛素

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T2DM：2型糖尿病

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iDegLira：德谷胰岛素利拉鲁肽，iGlarLixi：甘精胰岛素利司那肽，ICER：增量成本-效果比

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WTP：意愿支付，ICER：增量成本-效果比

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WTP：意愿支付，iDegLira：德谷胰岛素利拉鲁肽，iGlarLixi：甘精胰岛素利司那肽

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iDegLira：德谷胰岛素利拉鲁肽，iGlarLixi：甘精胰岛素利司那肽

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事件iDegLira组iGlarLixi组来源
发生风险（P1）年发生率（r）转移概率及取值范围*（P2）发生风险（P1）年发生率（r）转移概率及取值
范围*（P2）
心肌梗死0.034 000.008 650.008 61（0.007 75~0.009 47）0.027 000.006 840.006 82（0.006 14~0.007 50）文献［15］
心力衰竭0.107 000.028 290.027 90（0.025 11~0.030 69）0.084 000.021 930.021 70（0.019 53~0.023 87）文献［15］
卒中0.039 000.009 950.009 90（0.008 91~0.010 89）0.036 000.009 170.009 12（0.008 21~0.010 04）文献［15］
T2DM无并发症死亡率0.045 380.009 290.009 25（0.008 32~0.010 17）0.050 000.010 260.010 21（0.009 19~0.011 23）文献［16,17］
心肌梗死死亡率0.051 730.010 620.010 57（0.009 51~0.011 62）0.057 000.011 740.011 67（0.010 50~0.012 84）文献［16,17］
心力衰竭死亡率0.051 730.010 620.010 57（0.009 51~0.011 62）0.057 000.011 740.011 67（0.010 50~0.012 84）文献［16,17］
卒中死亡率0.051 730.010 620.010 57（0.009 51~0.011 62）0.057 000.011 740.011 67（0.010 50~0.012 84）文献［16,17］
), ArticleFig(id=1207314228684362194, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1207314219373006972, language=CN, label=表1, caption=

使用两种治疗方案的患者各状态间的转移概率

, figureFileSmall=null, figureFileBig=null, tableContent=
事件iDegLira组iGlarLixi组来源
发生风险（P1）年发生率（r）转移概率及取值范围*（P2）发生风险（P1）年发生率（r）转移概率及取值
范围*（P2）
心肌梗死0.034 000.008 650.008 61（0.007 75~0.009 47）0.027 000.006 840.006 82（0.006 14~0.007 50）文献［15］
心力衰竭0.107 000.028 290.027 90（0.025 11~0.030 69）0.084 000.021 930.021 70（0.019 53~0.023 87）文献［15］
卒中0.039 000.009 950.009 90（0.008 91~0.010 89）0.036 000.009 170.009 12（0.008 21~0.010 04）文献［15］
T2DM无并发症死亡率0.045 380.009 290.009 25（0.008 32~0.010 17）0.050 000.010 260.010 21（0.009 19~0.011 23）文献［16,17］
心肌梗死死亡率0.051 730.010 620.010 57（0.009 51~0.011 62）0.057 000.011 740.011 67（0.010 50~0.012 84）文献［16,17］
心力衰竭死亡率0.051 730.010 620.010 57（0.009 51~0.011 62）0.057 000.011 740.011 67（0.010 50~0.012 84）文献［16,17］
卒中死亡率0.051 730.010 620.010 57（0.009 51~0.011 62）0.057 000.011 740.011 67（0.010 50~0.012 84）文献［16,17］
), ArticleFig(id=1207314228789219798, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1207314219373006972, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
项目基础值下限上限分布类型来源
药物治疗成本
日均注射剂量/U·d-1
iDegLira34.3010.0050.00Gamma文献［9］
iGlarLixi37.9010.0040.00Gamma文献［9,10］
平均注射次数/次·d-1
iDegLira1文献［9］
iGlarLixi1文献［10］
药品单价/元
iDegLira217.60174.08261.12Gamma药智网
iGlarLixi160.00128.00192.00Gamma
年药品成本/元
iDegLira9 080.81由用法用量及药品价格计算
iGlarLixi7 377.87
检查化验年成本/元1 535.191 228.161 842.23文献［19］
心肌梗死年治疗成本/元42 274.9833 819.9850 729.98Gamma文献［20］
心力衰竭年治疗成本/元24 189.5119 351.6129 027.41Gamma文献［20］
卒中年治疗成本/元24 615.7119 692.5729 538.85Gamma文献［20］
效用值
T2DM无并发症0.9360.9340.938Beta文献［21］
心肌梗死0.8860.8830.889Beta文献［21］
心力衰竭0.7500.7460.754Beta文献［21］
卒中0.8300.8270.833Beta文献［21］
死亡0文献［21］
), ArticleFig(id=1207314228885688793, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1207314219373006972, language=CN, label=表2, caption=

成本及效用值参数

, figureFileSmall=null, figureFileBig=null, tableContent=
项目基础值下限上限分布类型来源
药物治疗成本
日均注射剂量/U·d-1
iDegLira34.3010.0050.00Gamma文献［9］
iGlarLixi37.9010.0040.00Gamma文献［9,10］
平均注射次数/次·d-1
iDegLira1文献［9］
iGlarLixi1文献［10］
药品单价/元
iDegLira217.60174.08261.12Gamma药智网
iGlarLixi160.00128.00192.00Gamma
年药品成本/元
iDegLira9 080.81由用法用量及药品价格计算
iGlarLixi7 377.87
检查化验年成本/元1 535.191 228.161 842.23文献［19］
心肌梗死年治疗成本/元42 274.9833 819.9850 729.98Gamma文献［20］
心力衰竭年治疗成本/元24 189.5119 351.6129 027.41Gamma文献［20］
卒中年治疗成本/元24 615.7119 692.5729 538.85Gamma文献［20］
效用值
T2DM无并发症0.9360.9340.938Beta文献［21］
心肌梗死0.8860.8830.889Beta文献［21］
心力衰竭0.7500.7460.754Beta文献［21］
卒中0.8300.8270.833Beta文献［21］
死亡0文献［21］
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治疗方案成本/元增量成本/元效果/QALY增量效果/QALYICER/元·QALY-1
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两种治疗方案的成本-效果分析结果

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两种基础胰岛素与GLP-1RA复方制剂治疗中国2型糖尿病患者的成本-效果分析
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高宁 1 , 冯冰 1 , 高胜男 2 , 张羽曦 1 , 张冉冉 1 , 刘国强 1
中国新药与临床杂志 | 论著 2025,44(4): 307-314
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中国新药与临床杂志 | 论著 2025, 44(4): 307-314
两种基础胰岛素与GLP-1RA复方制剂治疗中国2型糖尿病患者的成本-效果分析
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高宁1 , 冯冰1, 高胜男2, 张羽曦1, 张冉冉1, 刘国强1
作者信息
  • 1.河北医科大学第三医院　临床药学部，河北　石家庄　050051
  • 2.河北省药物与卫生技术综合评估学会，河北　石家庄　050051

    • 高宁，女，硕士在读，主要从事药物经济学方面的研究，E-mail: 。

    刘国强，男，主任药师，硕士生导师，主要从事药物经济学、卫生技术评估、合理用药方面的研究，E-mail:

通讯作者:

刘国强
Cost-effectiveness analysis of two kinds of fixed-ratio combination of basal insulin and GLP-1RA for treatment of patients with type 2 diabetes mellitus in China
Ning GAO1 , Bing FENG1, Sheng-nan GAO2, Yu-xi ZHANG1, Ran-ran ZHANG1, Guo-qiang LIU1
Affiliations
  • 1. Department of Clinical Pharmacy, Hebei Medical University Third Hospital, Shijiazhuang HEBEI 050051, China
  • 2. Hebei Society for Integrated Drug and Health Technology Assessment, Shijiazhuang HEBEI 050051, China
出版时间: 2025-04-25 doi: 10.14109/j.cnki.xyylc.2025.04.11
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目的 评价德谷胰岛素利拉鲁肽（iDegLira）和甘精胰岛素利司那肽（iGlarLixi）治疗中国成年2型糖尿病（T2DM）患者的经济性。方法 从我国卫生体系角度出发，建立Markov模型，以质量调整生命年（QALY）为健康产出指标，以3倍我国2023年人均国内生产总值作为意愿支付（WTP）阈值，模拟患者使用iDegLira和iGlarLixi治疗30年的健康产出和医疗成本，以增量成本-效果比（ICER）作为评价指标评价两种治疗方案的经济性，并进行敏感性分析和情境分析以检验结果的不确定性。结果 与iGlarLixi方案相比，iDegLira方案的增量成本为46 142.61元，增量效用为0.014 QALY，ICER为3 258 162.70元·QALY-1，远远大于WTP阈值（268 074元·QALY-1），表明iDegLira方案不具有经济性。敏感性分析结果显示，基础分析结果较为稳健；情境分析结果显示，在当前WTP阈值下，iDegLira降价31%时，两种方案的经济性相当。结论 对于接受基础胰岛素联合口服降糖药治疗血糖仍控制不佳的中国成年T2DM患者，与iGlarLixi方案相比，iDegLira方案在当前价格下具有经济性优势的概率较低。

德谷胰岛素利拉鲁肽  /  甘精胰岛素利司那肽  /  2型糖尿病  /  Markov模型  /  成本-效果分析

AIM To evaluate the cost-effectiveness of insulin degludec-liraglutide（iDegLira） versus insulin glargine-lixisenatide （iGlarLixi） in Chinese adult type 2 diabetes mellitus （T2DM） patients. METHODS From the perspective of China’s health system, a Markov model was developed. Quality-adjusted life years （QALY） were used as the health output indicator, and three times 2023 gross domestic product （GDP） per capita of China was used as the willingness-to-pay （WTP） threshold. The model simulates the health output and medical costs over 30 years, evaluates the economics of the two treatment options using the incremental cost-effectiveness ratio （ICER） as an evaluation metric, and performs sensitivity and contextual analyses to test the uncertainty of the results. RESULTS Compared with the iGlarLixi scheme,iDegLira scheme had an incremental cost of 46 142.61 yuan, an incremental utility of 0.014 QALY. The ICER was 3 258 162.70 yuan·QALY-1, which was much larger than the WTP threshold （268 074 yuan·QALY-1） and was not cost-effectiveness. The results of the sensitivity analysis show that the underlying analysis was relatively robust. The results of the contextual analysis showed that the cost-effectiveness of the two schemes was comparable when the price was reduced by 31% at the current WTP threshold. CONCLUSION For Chinese adult T2DM patients with poor glycemic control despite receiving basal insulin in combination with oral hypoglycemic agents, iDegLira scheme has a lower probability of being economical at current prices compared with the iGlarLixi scheme.

insulin degludec-liraglutide  /  insulin glargine-lixisenatide  /  type 2 diabetes mellitus  /  Markov model  /  cost-effectiveness analysis
高宁, 冯冰, 高胜男, 张羽曦, 张冉冉, 刘国强. 两种基础胰岛素与GLP-1RA复方制剂治疗中国2型糖尿病患者的成本-效果分析. 中国新药与临床杂志, 2025 , 44 (4) : 307 -314 . DOI: 10.14109/j.cnki.xyylc.2025.04.11
Ning GAO, Bing FENG, Sheng-nan GAO, Yu-xi ZHANG, Ran-ran ZHANG, Guo-qiang LIU. Cost-effectiveness analysis of two kinds of fixed-ratio combination of basal insulin and GLP-1RA for treatment of patients with type 2 diabetes mellitus in China[J]. Chinese Journal of New Drugs and Clinical Remedies, 2025 , 44 (4) : 307 -314 . DOI: 10.14109/j.cnki.xyylc.2025.04.11
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糖尿病根据发病机制分为1型糖尿病和2型糖尿病（type 2 diabetes mellitus, T2DM）, 我国糖尿病主要以T2DM为主[1]。T2DM会随着疾病进程的发展, 引发多种并发症, 如心脑血管并发症、微血管和神经系统病变、肾病、糖尿病足等, 严重降低患者的生命质量。一项预测2020—2030年糖尿病疾病负担的研究表明, 预计到2030年, 我国20~79岁成年人的糖尿病患病率将从8.2%上升到9.7%, 糖尿病的治疗总成本将从2 502亿美元增加到4 604亿美元, 人均治疗成本将从231美元增加到414美元[2]。因此, 选择安全、经济、有效的药物来控制患者血糖水平、减少并发症的发生非常重要。
胰高血糖素样肽-1受体激动剂（glucagon-like peptide-1 receptor agonist, GLP-1RA）和基础胰岛素作用于不同靶器官, 能针对T2DM的病理生理缺陷发挥机制互补的作用, 在增强疗效的同时还可以减少单独使用基础胰岛素或GLP-1RA相关的不良反应[3]。我国《2型糖尿病短期胰岛素强化治疗专家共识（2021年版）》[4]指出, 基础胰岛素联合GLP-1RA治疗是短期胰岛素强化治疗的后续转换方案之一, 两者联合可以更好地控制血糖, 还可以减少胰岛素的剂量；2024年美国糖尿病协会在发布的《糖尿病护理标准》[5]中强调, 成人T2DM患者考虑早期使用联合方案治疗时, 如已使用胰岛素, 推荐其联合GLP-1RA进行治疗, 以尽快达到个体化治疗目标。但患者在使用胰岛素与GLP-1RA的联合方案时, 需分别在睡前注射基础胰岛素和早餐前注射GLP-1RA[6]，给患者操作带来了一定的不便, 同时临床医生在调整剂量时也需格外谨慎。为解决这一临床困扰, 近年来有多个基础胰岛素与GLP-1RA的固定比例复方制剂陆续上市,成为临床治疗的新选择。例如，德谷胰岛素利拉鲁肽（insulin degludec-liraglutide, iDegLira）和甘精胰岛素利司那肽（insulin glargine-lixisenatide, iGlarLixi）先后在我国上市, 两者都适用于血糖控制不佳的成人T2DM患者。DUAL系列研究和LixiLan系列研究分别证实了iDegLira和iGlarLixi在不同T2DM人群中的疗效和安全性, 即在胰岛素使用剂量相同或更低的情况下, 与使用基础胰岛素或GLP-1RA单药治疗的患者相比, iDegLira和iGlarLixi组患者的糖化血红蛋白（glycosylated hemoglobin, HbA1c）降幅更大、达标率更高, 且能减少低血糖的发生风险, 避免胰岛素治疗带来的体重增加等不良反应[7, 8]。
目前, iDegLira和iGlarLixi均已通过医保谈判被纳入我国国家医保目录。除这两种药物外, 医保目录中还有预混胰岛素和徳谷门冬双胰岛素两类胰岛素类复方制剂, 但这两类复方制剂在组成成分、作用机制与适用人群等方面均与基础胰岛素-GLP-1RA复方制剂存在差异；加之迄今针对iDegLira和iGlarLixi直接对比的药物经济学研究较少, 且都来源于国外视角,尚无基于中国人群开展的相关药物经济学评价。基于此, 本研究以基础胰岛素联合口服降糖药控制不佳的中国T2DM患者为目标人群, 对iDegLira和iGlarLixi开展药物经济学评价, 以期为完善我国T2DM治疗策略提供参考。
资料与方法
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资料来源
本研究中iDegLira的临床数据来源于DUAL Ⅱ中国研究[9], 该研究是一项为期26周的随机、双盲、多中心、平行组、治疗达标Ⅲ期临床试验, 研究对象为接受基础胰岛素联合口服降糖药治疗后血糖仍控制不佳的中国成年T2DM患者。研究共纳入患者453例, 并将患者按照2：1的比例随机分配为iDegLira和德谷胰岛素两个治疗组。
由于缺少iDegLira和iGlarLixi头对头比较的临床试验, 因此本研究利用EVANS等[10]的一项间接治疗比较（indirect treatment comparison, ITC）研究获取iGlarLixi的相关临床数据。该ITC研究通过德谷胰岛素的SWITCH 2研究、iDegLira的DUAL Ⅱ和DUAL Ⅴ研究与iGlarLixi的LixiLan-L研究的临床试验数据将两者相关联, 建立了一个间接比较网络（图1）, 评估了经基础胰岛素治疗血糖仍控制不佳的T2DM患者使用iDegLira与iGlarLixi治疗的相对治疗效果。
模型建立
本研究基于已公开发表的文献[11, 12], 结合疾病发展特点和各状态间转移概率的可获得性, 采用TreeAge Pro 2022软件建立Markov模型。根据T2DM患者的疾病发展过程, 现有研究通常采用三状态的Markov模型, 即T2DM无并发症、T2DM有并发症、死亡；本研究还考虑了T2DM心血管并发症的发生情况, 最终设立的模型状态为5种, 分别为T2DM无并发症、心肌梗死、心力衰竭、卒中、死亡, 其中死亡状态为吸收态, 并假设在患者死亡状态下不产生额外成本。状态间的相互转移关系见图2。
T2DM为长期进展性疾病, 较长的研究时限能更好地反映治疗方案对患者健康支出与健康产出的综合影响。DUAL Ⅱ中国研究中, 患者人群的平均年龄为54.5岁。国家卫健委公布的最新数据显示, 2023年我国居民人均预期寿命为78.6岁[13], 随着医疗卫生服务水平与生活质量的提升, 人们的寿命会不断延长,因此本研究将模拟时限设定为30年, 模型循环周期设定为1年。根据TreeAge Pro 2022软件自带的半周期校正公式对两种治疗方案的模拟成本和健康产出进行半周期循环校正。贴现率采用《中国药物经济学评价指南2020》[14]的推荐值, 设为5%。
模型参数
1　状态转移概率
本研究中两组治疗方案的心血管并发症发生率来源于一项真实世界队列研究[15], 该研究比较了使用iDegLira与iGlarLixi的9 130例患者在治疗4年间的心血管和微血管事件的发生风险。由于未收集到iDegLira组相关并发症的死亡率, 本研究通过HbA1c的降低值和iGlarLixi组相关并发症死亡率计算得出。iGlarLixi组T2DM心血管并发症死亡率来自一项模拟研究[16], 患者使用iGlarLixi 5年后T2DM心血管并发症死亡率为5.70%。一项来自英国的前瞻性糖尿病研究结果显示, HbA1c下降1%, 糖尿病相关死亡风险下降21%[17]。由ITC研究可知, iDegLira组和iGlarLixi组HbA1c差异为-0.44%［95%置信区间（CI）为-0.71%~-0.17%］, 因此iDegLira组相对于iGlarLixi组的糖尿病相关死亡风险下降9.24%，由此算得iDegLira组T2DM心血管并发症死亡率。限于数据的可获得性, 本研究假设心肌梗死、心力衰竭、卒中3种心血管并发症死亡率相同。
各状态间的转移概率按下述方法计算：先将以上各时间段内的事件发生率通过公式r=1-［ln（1-P1）］/t1转化为年发生率, 式中r为瞬时发生率, P1为一段时限下发生某事件的概率，t1为观察的时间长度；再通过公式P2=1-exp（-rt2）计算事件的转移概率, 式中P2为一个循环周期下的转移概率, t2为单个循环周期的时间[18]。使用两种治疗方案的患者各状态间的转移概率见表1。
2　成本参数
本研究基于我国卫生体系角度, 仅测算直接医疗成本, 包括药物治疗成本、检查化验等背景成本和并发症治疗成本。两种药品均采用2023年国家医保谈判价格。由ITC研究可知, iDegLira和iGlarLixi的日均注射剂量差异为-3.60（95%CI为-10.30 ~3.30）U[10],结合DUAL Ⅱ中国研究中iDegLira的剂量[9]计算得到iGlarLixi的日均注射剂量为37.90 U。我国目前上市的iGlarLixi有两种规格, 甘精胰岛素利司那肽注射液（Ⅰ）（3 mL：300 U甘精胰岛素+300 μg利司那肽）说明书中规定的日注射剂量范围为5~20 U,甘精胰岛素利司那肽注射液（Ⅱ）（3 mL：300 U甘精胰岛素+150 μg利司那肽）为10~40 U。本研究根据文献计算得出iGlarLixi的日均注射剂量为37.90 U,位于10~40 U, 因此本研究选择甘精胰岛素利司那肽注射液（Ⅱ）的价格来计算药品成本。iDegLira规格为3 mL（德谷胰岛素300 U：利拉鲁肽10.8 mg）, iGlarLixi规格为3 mL（甘精胰岛素300 U：利司那肽150 μg）。
为避免成本的重复计算, 发生心血管并发症的患者抗高血压药物、调脂药物以及抗血栓药物等心血管疾病管理成本、相关检查费用以及住院费用已包括在相关心血管事件治疗成本中。所有成本均已通过中国医疗消费价格指数调整到2023年水平。相关成本参数见表2。
3　健康产出
本研究采用质量调整生命年（quality-adjusted life years, QALY）作为健康产出。基于Markov模型, 对每周期的疾病状态进行效用赋值, 累积计算各状态的时间长度, 最终加权得到患者总的QALY。本研究采用的健康效用值来源于一项使用胰岛素治疗的中国T2DM患者的健康效用值研究[21], 该研究纳入了78家医疗卫生中心的12 583例中国患者, 采用欧洲五维健康量表三水平版本（EuroQol 5 dimensions 3 levels, EQ-5D-3L）对不同并发症（包括心肌梗死、心力衰竭、卒中等）的T2DM患者进行评分, 并使用中国积分体系进行效用值的测算。各健康状态的效用值见表2。
成本-效果分析
将上述参数输入所构建的Markov模型中, 对两种治疗方案进行为期30年的模拟。采用QALY作为产出指标, 计算iDegLira方案相对于iGlarLixi方案的增量成本-效果比（incremental cost-effective ratio, ICER）。药物经济学评价通常采用人均国内生产总值（gross domestic product, GDP）作为意愿支付（willingness-to-pay, WTP）阈值标准。根据世界卫生组织的推荐：ICER低于1倍人均GDP, 表明方案增加的成本为完全值得；ICER在1~3倍人均GDP之间, 表明方案增加的成本可以接受；ICER高于3倍人均GDP,表明方案增加的成本不值得接受。本研究将WTP阈值确定为2023年全国人均GDP的3倍。国家统计局网站显示, 2023年我国人均GDP为89 358元, 即本研究的WTP阈值为268 074元·QALY-1。
不确定性分析
1　敏感性分析
为验证研究结果的稳健性, 本研究进行了单因素敏感性分析和概率敏感性分析。参考《中国药物经济学评价指南2020》[14]以及多数同类文献, 本研究设置单因素敏感性分析范围：iDegLira和iGlarLixi胰岛素用量采用说明书中规定的最大和最小日注射剂量为取值范围, 成本范围设定为基础值的±20%, 健康效用值范围设定为基础值的95%CI, 转移概率范围设定为基础值±10%, 贴现率取0~8%，详见表2。单因素敏感性分析结果以龙卷风图展示。概率敏感性分析中的参数分布类型设置为：胰岛素用量及成本参数服从Gamma分布, 健康效用值及转移概率参数服从Beta分布, 贴现率服从Normal分布。根据各参数的分布情况进行蒙特卡罗模拟1 000次, 分析结果通过绘制成本-效果散点图和成本-效果可接受曲线展示。
2　情境分析
采用情境分析考虑iDegLira降价对研究结果的影响, 以5%作为iDegLira单价变化幅度, 以每次变化后的价格进行蒙特卡罗模拟, 根据模拟结果绘制对应价格下两种治疗方案具有经济性优势的概率曲线图, 分析iDegLira降价一定比例后与iGlarLixi相比治疗T2DM患者具有经济性优势的概率。
结果
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基础分析结果
经Markov模型模拟30年后, iGlarLixi方案的累计成本为237 239.29元, 累计健康效用值为12.496 QALY；iDegLira方案的累计成本为283 381.90元, 累计健康效用值为12.510 QALY。iDegLira方案相对于iGlarLixi方案的ICER为3 258 162.70元·QALY-1, 远远大于本研究设定的WTP阈值（268 074元·QALY-1）,表明与iGlarLixi方案相比, iDegLira方案治疗我国经基础胰岛素联合口服降糖药治疗血糖仍控制不佳的T2DM患者不具有经济性。见表3。
不确定性分析结果
1　单因素敏感性分析
单因素敏感性分析结果见图3。
龙卷风图显示，对ICER影响较大的因素为iDegLira和iGlarLixi的日均注射剂量、iGlarLixi组T2DM无并发症到卒中的转移概率及卒中到死亡的转移概率等。
2　概率敏感性分析
成本-效果散点图显示, 当WTP阈值为268 074元·QALY-1时, iDegLira与iGlarLixi相比具有经济性的概率为27.4%，见图4。成本-效果可接受曲线显示, 当WTP阈值在0~1 000 000元·QALY-1之间变化时, iDegLira方案具有经济性优势的概率低于iGlarLixi方案, 但随着WTP阈值的升高, iDegLira方案具有经济性优势的概率也在逐渐增大，见图5。
3　情境分析
当iDegLira降价31%, 即药品单价为每支150.14元时, iDegLira具有经济性优势的概率为50.5%, 两种方案在268 074元·QALY-1的WTP阈值下具有经济性的概率相近，见图6。
讨论
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本研究从我国卫生体系角度出发, 以基础胰岛素联合口服降糖药治疗血糖仍控制不佳的中国成年T2DM患者为目标人群, 建立Markov模型, 对iDegLira和iGlarLixi方案进行成本-效果分析。研究结果显示, 两种方案的长期健康产出相近但iDegLira方案成本较高, iDegLira方案相对于iGlarLixi方案的ICER为3 258 162.70元·QALY-1, 远远大于本研究设定的WTP阈值, 表明在当前价格下iDegLira方案不具有经济性。敏感性分析结果与基础分析结果一致, 表明基础分析结果较稳健。情境分析结果显示, 当iDegLira降价31%, 即药品单价为每支150.14元时, 两者具有经济性的概率相当。
一项真实世界研究回顾了186例使用二甲双胍和基础胰岛素治疗血糖控制不佳的T2DM患者改为iDegLira和iGlarLixi治疗后对血糖及其他疗效参数的影响。结果表明, iDegLira和iGlarLixi平均HbA1c下降幅度相似（-1.2% vs. -1.1%）, 但iDegLira组患者6个月后HbA1c<7%的比例显著更高（22.0% vs.18.2%, P<0.05）[22]。BILIC-CURCIC等[23]开展的一项多中心观察性研究纳入了376例使用胰岛素控制不佳的T2DM患者, 评价iDegLira和iGlarLixi的疗效与安全性。结果显示, 与iDegLira组相比, iGlarLixi组患者需要明显更高的平均胰岛素剂量才能达到血糖目标。这与本研究结果相似。本研究结果显示, 较低剂量的iDegLira即可使患者获得更低的HbA1c, 降低T2DM相关并发症的死亡风险, 增加患者的健康获益；但使用iDegLira方案的患者心血管并发症发生风险略高, 需要花费更多的成本来治疗并发症, 从而使得该方案最终总成本较高。其次, 由本研究结果可知, 药物剂量是对ICER影响较大的一个因素。基础胰岛素和GLP-1RA在临床治疗中最常见的不良反应分别为低血糖和剂量依赖性的胃肠道反应, 会降低患者依从性, 影响药物疗效[24], 因此在临床应用中应该重点关注不同患者对于两种复方制剂的剂量调整与转换。《基础胰岛素/胰升糖素样肽-1受体激动剂复方制剂用于治疗2型糖尿病的临床专家建议》[3]对于iDegLira和iGlarLixi的起始剂量及剂量调整在不同人群中均有明确的推荐，临床医生和药师应该遵循个体化治疗原则, 根据患者临床情况及时调整最优剂量, 使患者获得最佳的治疗效果, 避免给患者造成不必要的经济负担。
目前将iDegLira与iGlarLixi进行经济学比较的研究还较少，且由于不同国家的人群、医疗政策、药品成本及评价模型等均有所差异,评价结果也不尽相同。POHLMANN等[25, 26]采用IQVIA CORE模型分别从捷克医保支付者角度和意大利卫生体系角度评价了iDegLira对比iGlarLixi在基础胰岛素控制不佳的患者中的经济性, 研究结果均显示iDegLira方案能获得较高的生存获益且成本也较高, 但ICER小于其设定的WTP阈值（1 200 000捷克克朗·QALY-1和30 000欧元·QALY-1）, 具有经济性。这与本研究得到的成本和效果值结果类似, 可能是因为本研究与这两项研究所评价的目标人群相似, 且利用同一ITC研究结果数据有关。但由于我国WTP阈值通常低于西方国家, 因此最终得到的经济性评价结果相反。而MCCRIMMON等[27, 28]采用CORE模型从英国卫生体系角度对GLP-1RA控制不佳的T2DM患者开展的经济学评价结果显示, 与iDegLira相比,iGlarLixi方案获得的QALY更多且成本更低, 为绝对优势方案, 这与本研究结果有所不同。可见, 药物经济学评价结果受多种因素的影响, 有必要利用更丰富的临床循证证据基于决策环境从不同研究角度针对不同目标人群对iDegLira和iGlarLixi开展更全面的经济学研究, 促进临床合理安全用药, 为患者减少经济负担。
本研究也具有一定的局限性：（1）本研究采用的某些临床数据来源于ITC研究, 可能会与头对头比较的研究结果存在差异, 导致评价结果出现偏倚；（2）T2DM并发症较多, 常见的微血管及大血管并发症有十余种, 本研究所构建的Markov模型仅考虑了3种心血管并发症状态, 无法完全模拟T2DM及其并发症之间的复杂转移及疾病进展过程, 也未考虑Markov模型状态转移概率随时间的变化情况, 可能对研究结果的精确性造成一定程度的影响；（3）本研究模型中的状态间转移概率基于事件发生率计算而来, 由于缺乏中国或亚洲人群的研究, 采用的事件发生率主要是来自于欧美人群的研究结果, 这会给研究结果带来一定的偏倚；（4）本研究的成本数据仅纳入了直接医疗成本,未考虑间接成本和隐性成本, 使其不能全面体现方案的经济性。
综上所述, 对于接受基础胰岛素联合口服降糖药治疗血糖仍控制不佳的中国成年T2DM患者, 与iGlarLixi方案相比, iDegLira方案在当前价格下具有经济性优势的概率较低。随着未来我国医保谈判工作对药品价格的调整, iDegLira适当降价后, 可能会提高其具有经济性优势的概率。
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  • 河北省自然科学基金项目(H2021206407)
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参考文献 引证文献
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doi: 10.14109/j.cnki.xyylc.2025.04.11
  • 接收时间：2024-06-20
  • 首发时间：2025-12-15
  • 出版时间：2025-04-25
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  • 收稿日期：2024-06-20
  • 录用日期：2024-12-14
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河北省自然科学基金项目(H2021206407)
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    1.河北医科大学第三医院　临床药学部，河北　石家庄　050051
    2.河北省药物与卫生技术综合评估学会，河北　石家庄　050051

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