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Article(id=1200147894247453513, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1200147892095779072, articleNumber=1001-2494(2024)11-1057-08, orderNo=null, doi=10.11669/cpj.2024.11.013, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1701014400000, receivedDateStr=2023-11-27, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1764067155658, onlineDateStr=2025-11-25, pubDate=1717776000000, pubDateStr=2024-06-08, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1764067155658, onlineIssueDateStr=2025-11-25, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1764067155658, creator=13701087609, updateTime=1764067155658, updator=13701087609, issue=Issue{id=1200147892095779072, tenantId=1146029695717560320, journalId=1190317699101192196, year='2024', volume='59', issue='11', pageStart='953', pageEnd='1064', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1764067155144, creator=13701087609, updateTime=1764067375019, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1200148814364508515, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1200147892095779072, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1200148814364508516, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1200147892095779072, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=1057, endPage=1064, ext={EN=ArticleExt(id=1200147894507500372, articleId=1200147894247453513, tenantId=1146029695717560320, journalId=1190317699101192196, language=EN, title=Cost-Effectiveness Analysis of Denosumab in the Treatment of Chinese Postmenopausal Women and Men with Osteoporosis, columnId=null, journalTitle=Chinese Pharmaceutical Journal, columnName=null, runingTitle=null, highlight=null, articleAbstract=

OBJECTIVE To evaluate the economic value of denosumab compared with alendronate and zoledronate in the treatment of postmenopausal women and men with osteoporosis (OP) from the perspective of Chinese health system. METHODS Markov model was built and the treatment period was set to 5 years. The clinical efficacy, health utilities and cost data were obtained from published literature. Lifetime health outcomes and costs were calculated for each intervention with the consideration of adherence and treatment residual effect. With the incremental cost-effectiveness ratio as the index, the threshold of a willingness-to-pay was set as 3 times GDP per capita. Scenario analysis and sensitivity analysis were conducted to test the result's robustness. RESULTS Denosumab was dominant compared with alendronate or zoledronate in postmenopausal women with OP, associated with higher QALY by 0.06 and 0.03 and lower costs by CNY1 471 and CNY3 327 respectively. Denosumab was also dominant compared with alendronate or zoledronate in men with OP, associated with higher QALY by 0.07 and 0.03 and lower CNY2 costs by 158 and CNY3 526 respectively. Sensitivity analyses verified the robustness of study results. CONCLUSION In the treatment of postmenopausal women and men with OP, denosumab has absolute advantages over alendronate and zoledronate, and should be a preferred or long-term treatment in clinical practice.

, correspAuthors=Xiaoning HE, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, authorCompany=null, fund=null, authors=null, authorsList=Mengqian ZHANG, Xiaobing JIANG, Xiaoning HE), CN=ArticleExt(id=1200147896411714441, articleId=1200147894247453513, tenantId=1146029695717560320, journalId=1190317699101192196, language=CN, title=地舒单抗治疗中国男性与绝经后女性骨质疏松症患者的成本-效果分析, columnId=1190352405612040510, journalTitle=中国药学杂志, columnName=论著, runingTitle=null, highlight=null, articleAbstract=

目的 从中国卫生体系角度,评价地舒单抗与阿仑膦酸钠、唑来膦酸治疗男性与绝经后女性骨质疏松症的经济性。方法 构建Markov模型,设定骨质疏松症治疗药物的治疗周期时长为5年,通过已发表文献获取临床疗效、健康效用及成本数据,在考虑治疗依从性与断药后疗效残余效应的基础上,计算各干预方案下患者终身疾病转归的健康产出及成本。以增量成本-效果比为指标,在3倍人均GDP阈值下评价各干预方案的经济性。采用情境分析、敏感性分析检验结果的稳健性。结果 治疗绝经后女性骨质疏松症患者,地舒单抗相较阿仑膦酸钠、唑来膦酸分别增加质量调整生命年(quality-adjusted life year,QALY)0.06、0.03,节约总成本1 471、3 327元,具有绝对优势;治疗男性骨质疏松症患者,地舒单抗相较阿仑膦酸钠、唑来膦酸分别增加QALY 0.07、0.03,节约总成本2 158、3 526元,具有绝对优势。敏感性分析证明了结果的稳健性。结论 在治疗男性与绝经后女性骨质疏松症中,地舒单抗相较阿仑膦酸钠、唑来膦酸均具有较大优势,可成为临床优先或长期治疗选择。

, correspAuthors=贺小宁, authorNote=null, correspAuthorsNote=
*贺小宁,女,博士,副教授 研究方向:卫生经济学与药物经济学 Tel:(022)87401830
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张梦倩,女,博士,讲师 研究方向:卫生事业与药事管理

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张梦倩,女,博士,讲师 研究方向:卫生事业与药事管理

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张梦倩,女,博士,讲师 研究方向:卫生事业与药事管理

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J China Pharm(中国药房), 2022, 33(14): 1742-1747., articleTitle=Cost-utility analysis of denosumab and zoledronic acid in the treatment of postmenopausal osteoporosis, refAbstract=null), Reference(id=1200147906998137096, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1200147894247453513, doi=null, pmid=null, pmcid=null, year=2021, volume=29, issue=2, pageStart=210, pageEnd=218, url=null, language=null, rfNumber=[46], rfOrder=45, authorNames=YOU R, MORI T, KE L, journalName=Menopause, refType=null, unstructuredReference=YOU R, MORI T, KE L, et al. Which injected antiosteoporotic medication is worth paying for? A cost-effectiveness analysis of teriparatide, zoledronate, ibandronate, and denosumab for postmenopausal osteoporotic women in China[J]. Menopause, 2021, 29(2): 210-218., articleTitle=Which injected antiosteoporotic medication is worth paying for? 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QALY-质量调整生命年;ICER-增量成本效果比;A-绝经后女性;B-男性。

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QALY-质量调整生命年;ICER-增量成本效果比;A-绝经后女性;B-男性。

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QALY-质量调整生命年;A-绝经后女性;B-男性。

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QALY-质量调整生命年;A-绝经后女性;B-男性。

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参数 数值
男性 女性
一般人群各年龄组不同骨折发生率/次·1 000人年-1
髋部骨折[20]
75~79岁组 2.37 4.08
80~84岁组 5.19 6.44
85~89岁组 5.71 6.59
≥90岁组 8.35 8.67
椎体骨折[21]
75~79岁组 4.50 12.05
80~84岁组 5.94 21.19
85~89岁组 9.54 26.89
≥90岁组 9.54 26.89
腕部骨折[22-23]1)
75~79岁组 - 13.87
80~84岁组 - 15.01
85~89岁组 - 15.10
≥90岁组 - 13.97
其他骨折[24]
75~79岁组 14.31 17.32
80~84岁组 45.70 17.32
85~89岁组 52.78 17.32
≥90岁组 52.78 17.32
各干预方案减少不同骨折发生率的相对危险比 [RR2)(95% CI)3)][19]
地舒单抗
髋部骨折 0.56 (0.35-0.90)
椎体骨折 0.32 (0.22-0.45)
腕部骨折 0.80 (0.67-0.96)
其他骨折 0.80 (0.67-0.96)
阿仑膦酸钠
髋部骨折 0.61 (0.42-0.90)
椎体骨折 0.57 (0.45-0.71)
腕部骨折 0.84 (0.74-0.94)
其他骨折 0.84 (0.74-0.94)
唑来膦酸
髋部骨折 0.60 (0.45-0.81)
椎体骨折 0.38 (0.25-0.58)
腕部骨折 0.79 (0.67-0.94)
其他骨折 0.79 (0.67-0.94)
各干预方案不同治疗时间点的治疗依从性[% (95% CI)][29]
地舒单抗
6个月 100
12个月 63.9 (60.8-66.7)
18个月 57.00 (53.8-60.1)
24个月 50.00 (46.3-53.5)
36个月 41.50 (36.9-46.1)
60个月 16.10 (1.9-42.9)
阿仑膦酸钠
6个月 39.70 (39.4-39.9)
12个月 28.30 (28.1-28.6)
18个月 22.80 (22.6-23.0)
24个月 19.00 (18.8-19.2)
36个月 13.90 (13.7-14.1)
60个月 7.80 (7.5-8.0)
唑来膦酸
6个月 100
12个月 100
18个月 22.70 (13.5-33.4)
24个月 22.70 (13.5-33.4)
36个月 15.20 (7.5-25.3)
60个月 2.70 (0.2-11.6)
), ArticleFig(id=1200147900555685971, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1200147894247453513, language=CN, label=表1, caption=

地舒单抗、阿仑膦酸钠、唑来膦酸治疗中国男性与绝经后女性骨质疏松症的Markov模型各项转移概率输入参数

, figureFileSmall=null, figureFileBig=null, tableContent=
参数 数值
男性 女性
一般人群各年龄组不同骨折发生率/次·1 000人年-1
髋部骨折[20]
75~79岁组 2.37 4.08
80~84岁组 5.19 6.44
85~89岁组 5.71 6.59
≥90岁组 8.35 8.67
椎体骨折[21]
75~79岁组 4.50 12.05
80~84岁组 5.94 21.19
85~89岁组 9.54 26.89
≥90岁组 9.54 26.89
腕部骨折[22-23]1)
75~79岁组 - 13.87
80~84岁组 - 15.01
85~89岁组 - 15.10
≥90岁组 - 13.97
其他骨折[24]
75~79岁组 14.31 17.32
80~84岁组 45.70 17.32
85~89岁组 52.78 17.32
≥90岁组 52.78 17.32
各干预方案减少不同骨折发生率的相对危险比 [RR2)(95% CI)3)][19]
地舒单抗
髋部骨折 0.56 (0.35-0.90)
椎体骨折 0.32 (0.22-0.45)
腕部骨折 0.80 (0.67-0.96)
其他骨折 0.80 (0.67-0.96)
阿仑膦酸钠
髋部骨折 0.61 (0.42-0.90)
椎体骨折 0.57 (0.45-0.71)
腕部骨折 0.84 (0.74-0.94)
其他骨折 0.84 (0.74-0.94)
唑来膦酸
髋部骨折 0.60 (0.45-0.81)
椎体骨折 0.38 (0.25-0.58)
腕部骨折 0.79 (0.67-0.94)
其他骨折 0.79 (0.67-0.94)
各干预方案不同治疗时间点的治疗依从性[% (95% CI)][29]
地舒单抗
6个月 100
12个月 63.9 (60.8-66.7)
18个月 57.00 (53.8-60.1)
24个月 50.00 (46.3-53.5)
36个月 41.50 (36.9-46.1)
60个月 16.10 (1.9-42.9)
阿仑膦酸钠
6个月 39.70 (39.4-39.9)
12个月 28.30 (28.1-28.6)
18个月 22.80 (22.6-23.0)
24个月 19.00 (18.8-19.2)
36个月 13.90 (13.7-14.1)
60个月 7.80 (7.5-8.0)
唑来膦酸
6个月 100
12个月 100
18个月 22.70 (13.5-33.4)
24个月 22.70 (13.5-33.4)
36个月 15.20 (7.5-25.3)
60个月 2.70 (0.2-11.6)
), ArticleFig(id=1200147900752818267, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1200147894247453513, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
参数 数值
药品成本/元·年-1[30]
地舒单抗 1 247.06
阿仑膦酸钠 3 039.92
唑来膦酸 2 750.40
注射成本/元·次-1[31-35]
皮下注射 3.75
静脉注射 5.96
疾病管理成本/元·次-1[31-35]
BMD检查1) 127.43
门诊诊疗费 20.18
骨折成本/元[36-37]
髋部骨折后第1年成本 28 834.83
椎体骨折后第1年成本 21 689.72
腕部骨折/其他骨折后第1年成本 9 116.91
髋部骨折后第2年及以后成本 8 131.58
椎体骨折后第2年及以后成本2) 6 116.62
), ArticleFig(id=1200147900912201822, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1200147894247453513, language=CN, label=表2, caption=

地舒单抗、阿仑膦酸钠、唑来膦酸治疗中国男性与绝经后女性骨质疏松症的Markov模型各项成本输入参数

, figureFileSmall=null, figureFileBig=null, tableContent=
参数 数值
药品成本/元·年-1[30]
地舒单抗 1 247.06
阿仑膦酸钠 3 039.92
唑来膦酸 2 750.40
注射成本/元·次-1[31-35]
皮下注射 3.75
静脉注射 5.96
疾病管理成本/元·次-1[31-35]
BMD检查1) 127.43
门诊诊疗费 20.18
骨折成本/元[36-37]
髋部骨折后第1年成本 28 834.83
椎体骨折后第1年成本 21 689.72
腕部骨折/其他骨折后第1年成本 9 116.91
髋部骨折后第2年及以后成本 8 131.58
椎体骨折后第2年及以后成本2) 6 116.62
), ArticleFig(id=1200147901038030949, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1200147894247453513, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
变量 主分析 下限 上限 变动区间1)
基线年龄(男性)/岁 78 50 80 [研究纳入人群年龄起始值, 模型输入上限]2)
基线年龄(女性)/岁 77 55 80 [研究纳入人群年龄起始值, 模型输入上限]
基线椎体骨折患病率(男性)/% 52.65 42.65 62.65 ±10
基线椎体骨折患病率(女性)/% 61.70 51.70 71.70 ±10
地舒单抗年药品费用/元 1 247.06 997.65 1 496.47 ±20%
阿仑膦酸钠年药品费用/元 3 039.92 2 431.94 3 647.90 ±20%
唑来膦酸年药品费用/元 2 750.40 2 200.32 3 300.48 ±20%
髋部骨折后第1年成本/元 28 834.83 23 068.00 34 602.00 ±20%
椎体骨折后第1年成本/元 21 689.72 17 352.00 26 028.00 ±20%
其他骨折后第1年成本/元 9 116.91 7 293.60 10 940.40 ±20%
髋部骨折第2年及以后成本/元 8 131.58 6 505.60 9 758.40 ±20%
椎体骨折第2年及以后成本/元 6 116.62 4 893.60 7 340.40 ±20%
髋部骨折效用系数 0.55 0.53 0.57 CI上下界3)
椎体骨折效用系数 0.68 0.65 0.70 CI上下界
其他骨折效用系数 0.83 0.82 0.84 CI上下界
髋部骨折后效用系数 0.86 0.84 0.89 CI上下界
椎体骨折后效用系数 0.85 0.82 0.87 CI上下界
阿仑膦酸钠髋部骨折疗效(RR)4) 0.61 0.42 0.9 CI上下界
阿仑膦酸钠椎体骨折疗效(RR) 0.57 0.45 0.71 CI上下界
阿仑膦酸钠腕部/其他骨折疗效(RR) 0.84 0.74 0.94 CI上下界
唑来膦酸髋部骨折疗效(RR) 0.6 0.45 0.81 CI上下界
唑来膦酸椎体骨折疗效(RR) 0.38 0.25 0.58 CI上下界
唑来膦酸腕部/其他骨折疗效(RR) 0.79 0.67 0.94 CI上下界
地舒单抗髋部骨折疗效(RR) 0.56 0.35 0.9 CI上下界
地舒单抗椎体骨折疗效(RR) 0.32 0.22 0.45 CI上下界
地舒单抗腕部/其他骨折疗效(RR) 0.8 0.67 0.96 CI上下界
骨折相关死亡风险占比/% 30 20 40 ±10
贴现率/% 5 3 8 [3,8]5)
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地舒单抗、阿仑膦酸钠、唑来膦酸治疗中国男性与绝经后女性骨质疏松症成本-效果分析的单因素敏感性分析关键变量取值上、下限及变动区间

, figureFileSmall=null, figureFileBig=null, tableContent=
变量 主分析 下限 上限 变动区间1)
基线年龄(男性)/岁 78 50 80 [研究纳入人群年龄起始值, 模型输入上限]2)
基线年龄(女性)/岁 77 55 80 [研究纳入人群年龄起始值, 模型输入上限]
基线椎体骨折患病率(男性)/% 52.65 42.65 62.65 ±10
基线椎体骨折患病率(女性)/% 61.70 51.70 71.70 ±10
地舒单抗年药品费用/元 1 247.06 997.65 1 496.47 ±20%
阿仑膦酸钠年药品费用/元 3 039.92 2 431.94 3 647.90 ±20%
唑来膦酸年药品费用/元 2 750.40 2 200.32 3 300.48 ±20%
髋部骨折后第1年成本/元 28 834.83 23 068.00 34 602.00 ±20%
椎体骨折后第1年成本/元 21 689.72 17 352.00 26 028.00 ±20%
其他骨折后第1年成本/元 9 116.91 7 293.60 10 940.40 ±20%
髋部骨折第2年及以后成本/元 8 131.58 6 505.60 9 758.40 ±20%
椎体骨折第2年及以后成本/元 6 116.62 4 893.60 7 340.40 ±20%
髋部骨折效用系数 0.55 0.53 0.57 CI上下界3)
椎体骨折效用系数 0.68 0.65 0.70 CI上下界
其他骨折效用系数 0.83 0.82 0.84 CI上下界
髋部骨折后效用系数 0.86 0.84 0.89 CI上下界
椎体骨折后效用系数 0.85 0.82 0.87 CI上下界
阿仑膦酸钠髋部骨折疗效(RR)4) 0.61 0.42 0.9 CI上下界
阿仑膦酸钠椎体骨折疗效(RR) 0.57 0.45 0.71 CI上下界
阿仑膦酸钠腕部/其他骨折疗效(RR) 0.84 0.74 0.94 CI上下界
唑来膦酸髋部骨折疗效(RR) 0.6 0.45 0.81 CI上下界
唑来膦酸椎体骨折疗效(RR) 0.38 0.25 0.58 CI上下界
唑来膦酸腕部/其他骨折疗效(RR) 0.79 0.67 0.94 CI上下界
地舒单抗髋部骨折疗效(RR) 0.56 0.35 0.9 CI上下界
地舒单抗椎体骨折疗效(RR) 0.32 0.22 0.45 CI上下界
地舒单抗腕部/其他骨折疗效(RR) 0.8 0.67 0.96 CI上下界
骨折相关死亡风险占比/% 30 20 40 ±10
贴现率/% 5 3 8 [3,8]5)
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结果指标 绝经后女性 男性
地舒
单抗		 阿仑
膦酸钠		 唑来
膦酸		 地舒单抗vs
阿仑膦酸钠		 地舒单抗vs
唑来膦酸		 地舒
单抗		 阿仑
膦酸钠		 唑来
膦酸		 地舒单抗vs
阿仑膦酸钠		 地舒单抗vs
唑来膦酸
总成本/元 19 677 21 148 23 004 -1 471 -3 327 26 205 28 363 29 731 -2 158 -3 526
干预方案成本/元 2 505 2 637 5 002 -133 -2 497 2 416 2 536 4 898 -119 -2 481
疾病管理成本/元 192 72 159 119 33 177 70 160 107 17
髋部骨折成本/元 5 891 6 299 6 186 -408 -295 6 294 6 793 6 601 -499 -307
椎体骨折成本/元 7 619 8 616 8 171 -997 -552 10 616 12 082 11 281 -1 466 -665
腕部骨折成本/元 2 302 2 319 2 306 -17 -3
其他骨折成本/元 1 168 1 204 1 180 -37 -12 6 701 6 882 6 701 -181 -89
QALY 6.61 6.55 6.58 0.06 0.03 6.16 6.08 6.13 0.07 0.03
ICER/元·QALY-1 - 绝对优势 绝对优势 - 绝对优势 绝对优势
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地舒单抗、阿仑膦酸钠、唑来膦酸治疗中国男性与绝经后女性骨质疏松症成本-效果分析的主分析结果

, figureFileSmall=null, figureFileBig=null, tableContent=
结果指标 绝经后女性 男性
地舒
单抗		 阿仑
膦酸钠		 唑来
膦酸		 地舒单抗vs
阿仑膦酸钠		 地舒单抗vs
唑来膦酸		 地舒
单抗		 阿仑
膦酸钠		 唑来
膦酸		 地舒单抗vs
阿仑膦酸钠		 地舒单抗vs
唑来膦酸
总成本/元 19 677 21 148 23 004 -1 471 -3 327 26 205 28 363 29 731 -2 158 -3 526
干预方案成本/元 2 505 2 637 5 002 -133 -2 497 2 416 2 536 4 898 -119 -2 481
疾病管理成本/元 192 72 159 119 33 177 70 160 107 17
髋部骨折成本/元 5 891 6 299 6 186 -408 -295 6 294 6 793 6 601 -499 -307
椎体骨折成本/元 7 619 8 616 8 171 -997 -552 10 616 12 082 11 281 -1 466 -665
腕部骨折成本/元 2 302 2 319 2 306 -17 -3
其他骨折成本/元 1 168 1 204 1 180 -37 -12 6 701 6 882 6 701 -181 -89
QALY 6.61 6.55 6.58 0.06 0.03 6.16 6.08 6.13 0.07 0.03
ICER/元·QALY-1 - 绝对优势 绝对优势 - 绝对优势 绝对优势
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结果指标 地舒单抗 阿仑膦酸钠 唑来膦酸 地舒单抗vs阿仑膦酸钠 地舒单抗vs唑来膦酸
总成本/元 25 998 28 031 29 702 -2 033 -3 703
干预方案成本/元 2 417 2 536 4 898 -120 -2 481
疾病管理成本/元 177 70 160 107 17
髋部骨折成本/元 6 299 6 802 6 602 -5 503 -303
椎体骨折成本/元 10 403 11 738 11 251 -1 335 -848
其他骨折成本/元 6 703 6 885 6 791 -182 -88
QALY 6.16 6.09 6.12 0.07 0.04
ICER/元·QALY-1 - 绝对优势 绝对优势
), ArticleFig(id=1200147901679759476, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1200147894247453513, language=CN, label=表5, caption=

地舒单抗、阿仑膦酸钠、唑来膦酸治疗中国男性骨质疏松症成本-效果分析的情境分析结果

, figureFileSmall=null, figureFileBig=null, tableContent=
结果指标 地舒单抗 阿仑膦酸钠 唑来膦酸 地舒单抗vs阿仑膦酸钠 地舒单抗vs唑来膦酸
总成本/元 25 998 28 031 29 702 -2 033 -3 703
干预方案成本/元 2 417 2 536 4 898 -120 -2 481
疾病管理成本/元 177 70 160 107 17
髋部骨折成本/元 6 299 6 802 6 602 -5 503 -303
椎体骨折成本/元 10 403 11 738 11 251 -1 335 -848
其他骨折成本/元 6 703 6 885 6 791 -182 -88
QALY 6.16 6.09 6.12 0.07 0.04
ICER/元·QALY-1 - 绝对优势 绝对优势
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地舒单抗治疗中国男性与绝经后女性骨质疏松症患者的成本-效果分析
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张梦倩 1 , 江晓兵 2 , 贺小宁 3, *
中国药学杂志 | 论著 2024,59(11): 1057-1064
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中国药学杂志 | 论著 2024, 59(11): 1057-1064
地舒单抗治疗中国男性与绝经后女性骨质疏松症患者的成本-效果分析
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张梦倩1, 江晓兵2, 贺小宁3, *
作者信息
  • 1 兰州大学药学院, 兰州 730000
  • 2 广州医科大学附属第二医院, 广州 510260
  • 3 天津大学药物科学与技术学院, 天津 300072

    • 张梦倩,女,博士,讲师 研究方向:卫生事业与药事管理

通讯作者:

*贺小宁,女,博士,副教授 研究方向:卫生经济学与药物经济学 Tel:(022)87401830
Cost-Effectiveness Analysis of Denosumab in the Treatment of Chinese Postmenopausal Women and Men with Osteoporosis
Mengqian ZHANG1, Xiaobing JIANG2, Xiaoning HE3, *
Affiliations
  • 1 School of Pharmacy, Lanzhou University, Lanzhou 730000, China
  • 2 The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou 510260, China
  • 3 School of Pharmaceutical Science and Technology, Tianjin University, Tianjin 300072, China
出版时间: 2024-06-08 doi: 10.11669/cpj.2024.11.013
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目的 从中国卫生体系角度,评价地舒单抗与阿仑膦酸钠、唑来膦酸治疗男性与绝经后女性骨质疏松症的经济性。方法 构建Markov模型,设定骨质疏松症治疗药物的治疗周期时长为5年,通过已发表文献获取临床疗效、健康效用及成本数据,在考虑治疗依从性与断药后疗效残余效应的基础上,计算各干预方案下患者终身疾病转归的健康产出及成本。以增量成本-效果比为指标,在3倍人均GDP阈值下评价各干预方案的经济性。采用情境分析、敏感性分析检验结果的稳健性。结果 治疗绝经后女性骨质疏松症患者,地舒单抗相较阿仑膦酸钠、唑来膦酸分别增加质量调整生命年(quality-adjusted life year,QALY)0.06、0.03,节约总成本1 471、3 327元,具有绝对优势;治疗男性骨质疏松症患者,地舒单抗相较阿仑膦酸钠、唑来膦酸分别增加QALY 0.07、0.03,节约总成本2 158、3 526元,具有绝对优势。敏感性分析证明了结果的稳健性。结论 在治疗男性与绝经后女性骨质疏松症中,地舒单抗相较阿仑膦酸钠、唑来膦酸均具有较大优势,可成为临床优先或长期治疗选择。

骨质疏松症  /  成本-效果分析  /  地舒单抗  /  阿仑膦酸钠  /  唑来膦酸

OBJECTIVE To evaluate the economic value of denosumab compared with alendronate and zoledronate in the treatment of postmenopausal women and men with osteoporosis (OP) from the perspective of Chinese health system. METHODS Markov model was built and the treatment period was set to 5 years. The clinical efficacy, health utilities and cost data were obtained from published literature. Lifetime health outcomes and costs were calculated for each intervention with the consideration of adherence and treatment residual effect. With the incremental cost-effectiveness ratio as the index, the threshold of a willingness-to-pay was set as 3 times GDP per capita. Scenario analysis and sensitivity analysis were conducted to test the result's robustness. RESULTS Denosumab was dominant compared with alendronate or zoledronate in postmenopausal women with OP, associated with higher QALY by 0.06 and 0.03 and lower costs by CNY1 471 and CNY3 327 respectively. Denosumab was also dominant compared with alendronate or zoledronate in men with OP, associated with higher QALY by 0.07 and 0.03 and lower CNY2 costs by 158 and CNY3 526 respectively. Sensitivity analyses verified the robustness of study results. CONCLUSION In the treatment of postmenopausal women and men with OP, denosumab has absolute advantages over alendronate and zoledronate, and should be a preferred or long-term treatment in clinical practice.

osteoporosis  /  cost-effectiveness analysis  /  denosumab  /  alendronate  /  zoledronate
张梦倩, 江晓兵, 贺小宁. 地舒单抗治疗中国男性与绝经后女性骨质疏松症患者的成本-效果分析. 中国药学杂志, 2024 , 59 (11) : 1057 -1064 . DOI: 10.11669/cpj.2024.11.013
Mengqian ZHANG, Xiaobing JIANG, Xiaoning HE. Cost-Effectiveness Analysis of Denosumab in the Treatment of Chinese Postmenopausal Women and Men with Osteoporosis[J]. Chinese Pharmaceutical Journal, 2024 , 59 (11) : 1057 -1064 . DOI: 10.11669/cpj.2024.11.013
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骨质疏松症(osteoporosis,OP)是一种因骨量减低、骨组织微结构损坏,导致骨脆性增加、易发生骨折的全身性骨病[1]。骨质疏松性骨折是骨质疏松症的严重后果,会引发多种手术及医疗并发症,甚至致残、致死,给患者及其家庭和社会带来沉重的疾病负担。绝经后女性是骨质疏松症的高风险人群,超过50%的女性在绝经后至少发生1次骨质疏松性骨折[2]。相较女性患者,男性骨质疏松症患者受到的关注较少,但我国50岁以上男性人群中骨质疏松症的患病率达6%[3],其中1/5会发生骨质疏松性骨折[4],且骨折的致残率和致死率均明显高于女性[5-6]。临床实践中加强对男性与绝经后女性骨质疏松症的预防、治疗和管理,对减少骨折的发生至关重要。
有效的抗骨质疏松症药物治疗可显著降低骨质疏松症患者的骨折风险。《原发性骨质疏松症诊疗指南(2022)》建议,对于骨折高风险的骨质疏松症患者,推荐使用口服双膦酸盐(如阿仑膦酸钠等)、唑来膦酸或地舒单抗[7]。其中,阿仑膦酸钠与唑来膦酸临床应用较为广泛,但由于存在胃肠道反应、一过性“类流感样”症状、肾功能损伤等不良反应,用药依从性不理想且需要进入“药物假期”,临床使用受限[8]。地舒单抗是一种核因子κB受体活化因子配体(receptor activator of nuclear factor-κB ligand,RANKL)抑制剂,能够抑制RANKL与其受体结合,减少破骨细胞形成、存活,从而降低骨吸收、增加骨量,改善皮质骨或松质骨的强度,总体安全性良好,不存在“药物假期”。本研究旨在基于我国医疗卫生体系角度,探究地舒单抗治疗男性与绝经后女性骨质疏松症的经济性,为相关医疗政策决策制定提供建议。
1 资料与方法
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1.1 模型结构
本研究采用Markov模型模拟骨质疏松症患者的疾病转归,模型结构包括8个状态分布[9],分别为非骨折、髋部骨折、椎体骨折、腕部骨折、其他骨折、髋部骨折后、椎体骨折后和死亡(图1)。患者进入Markov队列时处于非骨折状态,每个周期后,患者可能停留在非骨折状态、发生骨折或死亡。发生骨折后,患者后续健康状态转移情况随本次骨折发生部位而异。在发生某一部位骨折一年后,患者可能再次发生新的骨折、转移至骨折后状态(针对髋部骨折和椎体骨折)、重回健康状态(针对腕部骨折和其他骨折)或死亡。模型循环周期设定为6个月,模拟至患者死亡或年龄达到100岁。
1.2 模型设定
本研究基于中国卫生体系角度,分别对中国男性与绝经后女性骨质疏松症患者展开模拟研究。根据骨质疏松症诊断标准,均设定男性与绝经后女性人群的骨密度(bone mineral density,BMD)T值≤-2.5[10]。参考中国台湾骨质疏松症真实世界研究[11],设定绝经后女性人群的起始平均年龄为77岁(研究纳入患者年龄≥55岁),基线椎体骨折患病率为61.70%;男性人群的起始平均年龄为78岁(研究纳入患者年龄≥50岁),基线椎体骨折患病率为52.65%。由于骨质疏松症药物治疗周期时长一般为5年,因此假设药物治疗周期时长均为5年[9],且治疗停止后,干预方案疗效存在残余效应,持续2年后逐渐消失[12]。治疗干预方案为地舒单抗(普罗力®),对照方案为阿仑膦酸钠(福善美®)、唑来膦酸(密固达®)。治疗频次参考说明书推荐用法用量,地舒单抗为皮下注射,每6个月一次;阿仑膦酸钠为口服,每周70 mg;唑来膦酸为静脉滴注,每年1次。患者在治疗期间每年进行1次常规门诊随访,每2年接受1次BMD检查。研究采用5%的贴现率对成本和效用值贴现。
1.3 数据来源
1.3.1 转移概率
本研究涉及的转移概率包括模拟人群的骨折发生率、干预方案的依从性以及各健康状态的死亡率。骨折发生率(F)基于一般人群骨折发生率(Fgen)、BMD水平和既往骨折史等基线特征对骨折发生率的影响(RRm)及干预方案疗效对骨折发生率的影响(RRdrug)计算(F=Fgen×RRm×RRdrug)。其中,BMD每下降一个标准差的相对骨折风险、有椎体骨折病史的相对骨折风险及干预方案降低骨折风险的程度均来自已发表的Meta分析,男性与绝经后女性人群参数相同[13-19]。一般人群各类型骨折发生率来自已发表的流行病学研究,男性与绝经后女性人群髋部骨折、椎体骨折发生率均来自中国人群研究[20-21],绝经后女性人群腕部骨折与其他骨折分别来自挪威人群与国际多中心研究[22-23],男性人群其他骨折发生率来自瑞典人群研究,且由于该发生率包含腕部骨折,腕部骨折发生率未单独计算[24]。男性与绝经后女性人群的治疗依从性数据均来源于真实世界观察性研究(表1)。
各健康状态的死亡率(D)基于一般人群死亡率(Dgen)和骨折死亡相对风险比(RRd-fx/gen)按公式1计算死亡率。
D=Dgen×RRd-fx/gen
其中,一般人群死亡率均来自中国人口与就业统计年鉴,根据性别数值不同[25]。男性与绝经后女性人群髋部骨折和椎体骨折死亡相对风险比均来自瑞典人群的观察性研究[24,26],且骨折和骨折后状态的死亡相对风险比分别参考该研究中骨折第1年、第2~5年的死亡风险比;其他骨折的死亡相对风险比分别来自美国与瑞典人群的观察性研究[26-27]。另外,根据已发表的流行病学研究,髋部及椎体骨折患者随访8年内死亡风险逐渐接近一般人群,因此假设髋部、椎体骨折相对死亡风险的影响持续至骨折发生后8年[9,26,28],其他骨折仅在1年内增加死亡风险,且骨折后死亡风险增量的30%归因于骨折事件本身[9]。进一步调整各状态死亡相对风险后用公式2计算死亡率。
D=Dgen×[(RRd-fx/gen-1)×30%+1]
1.3.2 成本
在卫生体系视角下,本研究纳入直接医疗成本,包括干预方案成本(药品及注射费)、疾病管理成本(BMD检查和门诊随访费用)和骨折相关成本(表2)。药品成本来自药品价格公开数据[30]。注射及疾病管理成本来自中国东、中、西部五个城市(广州、上海、天津、北京、成都)相应医疗服务项目价格均值[31-35]。考虑到不同骨折类型的严重程度及实际康复需求不同,本研究结合已发表文献及临床专家建议,假设腕部和其他骨折仅在1年内产生成本,髋部及椎体骨折在第2年及以后仍有成本[9]。其中,髋部、椎体、腕部骨折后第1年的成本来自一项分析——成都、西安3所医院骨折患者经济负担的问卷随访研究,其他骨折成本参考腕部骨折成本[36];髋部骨折第2年及以后成本来自北京髋部骨折患者康复成本回顾性问卷调查研究[37];椎体骨折第2年及以后成本根据椎体骨折第1年成本、髋部骨折第1年与第2年成本推算。各成本均根据中国医疗保健服务消费价格指数进行调整[38]。
1.3.3 健康效用值
各状态的健康效用值根据一般人群效用值和骨折事件的影响计算。一般人群健康效用值数据来自中国人群EQ-5D-5L量表健康效用值常模,根据性别数值不同[39]。骨折状态的效用系数来自国际骨质疏松症基金会发起的骨质疏松症骨折效用研究[40],其中,髋部、椎体和其他骨折状态的效用系数分别为0.55(95% CI:0.53~0.57)、0.68(95% CI:0.65~0.70)和0.83(95% CI:0.82~0.84),髋部骨折后和椎体骨折后状态的效用系数分别为0.86(95% CI:0.84~0.89)和0.85(95% CI:0.82~0.87)。
1.4 评价指标、情境分析和敏感性分析
本研究中,健康产出的评价指标为质量调整生命年(quality-adjusted life year,QALY);经济性结果的评价指标为增量成本-效果比(incremental cost-effectiveness ratio,ICER)。本研究采用情境分析、单因素敏感性分析和概率敏感性分析检验结果的稳健性。情境一考虑原研和仿制药使用情况,阿仑膦酸钠使用市场份额加权价格(1 771 元·年-1),唑来膦酸使用集采最高中标价格(436 元·年-1)。男性人群中,情境二替换不同干预方案降低男性患者椎体骨折风险程度的数据,该数据来自已发表的Meta分析[41]。单因素敏感性分析参数及其变动范围见表3。假设健康效用值、骨折成本和干预方案疗效分别服从β、正态和对数正态分布,通过蒙特卡洛模拟迭代1 000次进行概率敏感性分析[42]。
2 结果
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2.1 主分析结果
根据《中国药物经济学评价指南(2020版)》推荐,将3倍人均GDP(2023年,268 074元)作为意愿支付阈值[43]。治疗绝经后女性患者,地舒单抗相较阿仑膦酸钠、唑来膦酸的增量QALY分别为0.06、0.03,分别节约总成本1 471、3 327元,具有绝对优势。治疗男性患者,地舒单抗相较阿仑膦酸钠、唑来膦酸的增量QALY分别为0.07、0.03,节约总成本2 158、3 526元,具有绝对优势(表4)。两个人群中地舒单抗总成本的节约主要体现在干预方案成本与治疗骨折成本方面,即地舒单抗存在价格优势与临床疗效优势。
2.2 情境分析和敏感性分析结果
情境一,治疗绝经后女性骨质疏松症患者,地舒单抗相较阿仑膦酸钠节约总成本378元,仍具有绝对优势,相较唑来膦酸的增量总成本为882元,ICER为30 466 元·QALY-1,远低于1倍人均GDP;治疗男性骨质疏松症患者,地舒单抗相较阿仑膦酸钠节约总成本1 170元,仍具有绝对优势,相较唑来膦酸的增量总成本为595元,ICER为19 088 元·QALY-1,远低于1倍人均GDP。情境二,治疗男性骨质疏松症患者,地舒单抗相较阿仑膦酸钠和唑来膦酸,均具有绝对优势(表5)。
单因素敏感性分析表明(图2、3,呈现对结果影响较大的前15位参数),相关参数在指定范围内变动时,治疗男性与绝经后女性骨质疏松症患者,地舒单抗相较于阿仑膦酸钠与唑来膦酸均具有绝对优势,说明主分析结果稳健。概率敏感性分析表明(图4、5),在研究设定阈值范围内,地舒单抗与阿仑膦酸钠、唑来膦酸相比均更具经济性。
3 讨论
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本研究基于中国卫生体系角度,对地舒单抗、阿仑膦酸钠与唑来膦酸治疗男性与绝经后女性骨质疏松症的经济性进行了评价。结果显示,与阿仑膦酸钠、唑来膦酸相比,地舒单抗成本更低、QALY更高,具有绝对优势。
本研究与其他基于中国绝经后女性评价地舒单抗与唑来膦酸治疗骨质疏松症经济性的研究结果一致[44-46]。但You等[46]的研究表明地舒单抗相较唑来膦酸具有绝对优势,而文献[44-45]的研究表明在1~3倍人均GDP阈值下,地舒单抗较唑来膦酸更具经济性。可能的原因在于研究[44-45]考虑了唑来膦酸“药物假期”的问题,设置用药方案为用药3年、停药2年,且停药期间药物疗效维持不变,高估了唑来膦酸的治疗效果,低估了其治疗成本,最终结果表现为地舒单抗在有增量QALY的同时也有增量成本。
本研究是首个基于中国男性骨质疏松症患者进行地舒单抗经济性评价的研究,且首次同时纳入中国绝经后女性骨质疏松症患者。本研究根据中国骨质疏松症真实世界研究,设定了人群的基线年龄与椎体骨折患病率,符合中国骨质疏松症患者特征。此外,本研究更符合真实临床实践及实际医药市场环境。首先,考虑了不同干预方案停止治疗的疗效残余效应及用药依从性;其次,针对实际医药市场,在情境分析中考虑了原研和仿制药使用情况及是否纳入国家集中采购。研究结论具有一定参考价值。
本研究也存在一定的局限性:①由于缺乏与研究人群完全一致的流行病学数据,模型转移概率疗效参数涉及一系列假设和校正,可能与真实疾病转归存在一定差距。②由于缺乏中国一般人群数据,模型所需腕部和其他骨折发生率来自其他国家流行病学研究或临床试验,并假设其他骨折与腕部骨折成本一致,在骨折发生率和成本预估方面可能存在偏倚。③所需成本参数来自基于特定区域骨折人群的医疗费用研究,由于医疗卫生发展水平及医保政策的地区差异,该参数在全国代表性方面存在一定局限。④未考虑对照方案与干预方案的不良反应、骨折患者的看护及康复等产生的成本。
文献
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2024年第59卷第11期
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doi: 10.11669/cpj.2024.11.013
  • 接收时间：2023-11-27
  • 首发时间：2025-11-25
  • 出版时间：2024-06-08
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  • 收稿日期：2023-11-27
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    1 兰州大学药学院, 兰州 730000
    2 广州医科大学附属第二医院, 广州 510260
    3 天津大学药物科学与技术学院, 天津 300072

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*贺小宁,女,博士,副教授 研究方向:卫生经济学与药物经济学 Tel:(022)87401830
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2种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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