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Article(id=1195741160120565924, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1195741158056964822, articleNumber=1001-2494(2024)04-0363-06, orderNo=null, doi=10.11669/cpj.2024.04.010, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=research-article, receivedDate=1688054400000, receivedDateStr=2023-06-30, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1763016508369, onlineDateStr=2025-11-13, pubDate=1708531200000, pubDateStr=2024-02-22, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1763016508369, onlineIssueDateStr=2025-11-13, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1763016508369, creator=13701087609, updateTime=1763016508369, updator=13701087609, issue=Issue{id=1195741158056964822, tenantId=1146029695717560320, journalId=1190317699101192196, year='2024', volume='59', issue='4', pageStart='285', pageEnd='374', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1763016507876, creator=13701087609, updateTime=1763016622263, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1195741637893730663, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1195741158056964822, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1195741637893730664, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1195741158056964822, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=363, endPage=368, ext={EN=ArticleExt(id=1195741160330281126, articleId=1195741160120565924, tenantId=1146029695717560320, journalId=1190317699101192196, language=EN, title=Cost-Effectiveness Analysis of PEG-rhG-CSF as Primary Prophylaxis to Chemotherapy-Induced Neutropenia in Patients with Epithelial Ovarian Cancer in China: Based on Real-Word Data, columnId=null, journalTitle=Chinese Pharmaceutical Journal, columnName=null, runingTitle=null, highlight=null, articleAbstract=

OBJECTIVE To evaluate the cost-effectiveness of PEG-rhG-CSF versus rhG-CSF in patients with epithelial ovarian cancer in central China for preventing chemotherapy-induced neutropenia. METHODS Two Markov models form healthcare system perspective were developed to evaluate the economics of PEG-rhG-CSF versus rhG-CSF using cost-utility analysis. Cost and probability input data were primarily obtained from a retrospective real-world study conducted in four tertiary hospitals from January 2019 to December 2020. One-way sensitivity analysis,probability sensitivity analysis and scenario analysis were used to verify the robustness of the results. RESULTS The basic analysis showed that, compared with rhG-CSF, PEG-rhG-CSF resulted in higher QALYs and lower cost, gained 0.27 QALYs more while spending 2279.63 yuan less, and the incremental cost-effectiveness ratios were ￥-8393.9/QALY. Sensitivity analysis and scenario analysis revealed robust results. CONCLUSION PEG-rhG-CSF is economically advantageous in Chinese patients with epithelial ovarian cancer for preventing chemotherapy-induced neutropenia.

, correspAuthors=DU Shuzhang, 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=LIANG Yan, ZHAO Jie, LI Jia, LOU Xiaofei, QIAO Gaoxing, ZHANG Rui, HU Wei, LI Junfang, ZUO Xu, DU Shuzhang), CN=ArticleExt(id=1195741374403363105, articleId=1195741160120565924, tenantId=1146029695717560320, journalId=1190317699101192196, language=CN, title=基于真实世界数据的PEG-rhG-CSF用于预防卵巢恶性肿瘤患者化疗引起的中性粒细胞减少症的成本-效用分析, columnId=1190352405612040510, journalTitle=中国药学杂志, columnName=论著, runingTitle=null, highlight=null, articleAbstract=

目的 评价长效聚乙二醇化重组人粒细胞刺激因子(PEG-rhG-CSF)与短效重组人粒细胞集落刺激因子(rhG-CSF)用于预防卵巢恶性肿瘤患者化疗引起的中性粒细胞减少症的经济性。方法 使用真实世界数据,从医疗卫生系统角度出发,构建马尔可夫(Markov)模型,使用成本效用分析对2种药物的经济性进行评价,并通过敏感性分析和情景分析验证模型的稳健性。结果 基础分析结果显示,与rhG-CSF组相比,PEG-rhG-CSF组可节约成本2 279.63元,增加0.27质量调整生命年(QALYs),增量成本效果比(ICER)值为-8 393.90元/QALY,具有绝对经济优势。敏感性分析和情景分析均显示了研究结果的稳健性。结论 PEG-rhG-CSF较rhG-CSF用于预防卵巢恶性肿瘤患者化疗引起的中性粒细胞减少症更具有经济性。

, correspAuthors=杜书章, authorNote=null, correspAuthorsNote=
*杜书章,男,主任药师 研究方向:药物经济学与医院药学 Tel:(0371)66913134
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梁艳,女,硕士,主管药师 研究方向:药物经济学与医院药学

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梁艳,女,硕士,主管药师 研究方向:药物经济学与医院药学

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梁艳,女,硕士,主管药师 研究方向:药物经济学与医院药学

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参数列表 聚乙二醇化重组人粒细胞刺激因子
(PEG-rhG-CSF)		 重组人粒细胞集落刺激因子
(rhG-CSF)		 分布 数据来源
转移概率
化疗后预防性使用粒细胞集落刺激因子状态
至中性粒细胞减少伴发热状态 0.007 0.036 5 Beta 真实世界
至死亡 0.001 0.001 Beta [18]
中性粒细胞减少伴发热状态
至中性粒细胞减少伴发热合并感染状态 0.547 0.547 Beta [19-20]
至死亡 0.084 0.084 Beta [21]
中性粒细胞减少伴发热合并感染状态至死亡 0.092 0.092 Beta [19-20]
中性粒细胞减少伴发热状态至化疗药物相对剂量强度<85% 0.677 0.677 Beta [22]
未发生中性粒细胞减少伴发热至化疗药物相对剂量强度<85% 0.417 0.417 Beta [22]
成本参数/元
聚乙二醇化重组人粒细胞刺激因子/周期 3 390 Gamma 真实世界
重组人粒细胞刺激因子针/周期 792 Gamma 真实世界
单周期化疗费用(n=171) 2 795.25±499.97 Gamma 真实世界
单次人均住院费用(n=171) 13 481.55±5 286.40 Gamma 真实世界
中性粒细胞减少伴发热治疗费用 25 000 Gamma 专家意见
中性粒细胞减少伴发热合并感染治疗费用 50 000 Gamma 专家意见
化疗药物相对剂量强度<85%成本/d(n=171) 1 723.17±682.86 Gamma 真实世界
效用参数
化疗后预防性使用粒细胞集落刺激因子状态 0.81 Beta [16]
中性粒细胞减少伴发热状态 0.56 Beta [16]
中性粒细胞减少伴发热合并感染状态 0.56 Beta [16]
卵巢癌全化疗周期结束后 0.84 Beta [17]
贴现(成本/效用) 0.05 [23]
), ArticleFig(id=1197101795483894769, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195741160120565924, language=CN, label=表1, caption=

马尔可夫(Markov)模型相关参数汇总

, figureFileSmall=null, figureFileBig=null, tableContent=
参数列表 聚乙二醇化重组人粒细胞刺激因子
(PEG-rhG-CSF)		 重组人粒细胞集落刺激因子
(rhG-CSF)		 分布 数据来源
转移概率
化疗后预防性使用粒细胞集落刺激因子状态
至中性粒细胞减少伴发热状态 0.007 0.036 5 Beta 真实世界
至死亡 0.001 0.001 Beta [18]
中性粒细胞减少伴发热状态
至中性粒细胞减少伴发热合并感染状态 0.547 0.547 Beta [19-20]
至死亡 0.084 0.084 Beta [21]
中性粒细胞减少伴发热合并感染状态至死亡 0.092 0.092 Beta [19-20]
中性粒细胞减少伴发热状态至化疗药物相对剂量强度<85% 0.677 0.677 Beta [22]
未发生中性粒细胞减少伴发热至化疗药物相对剂量强度<85% 0.417 0.417 Beta [22]
成本参数/元
聚乙二醇化重组人粒细胞刺激因子/周期 3 390 Gamma 真实世界
重组人粒细胞刺激因子针/周期 792 Gamma 真实世界
单周期化疗费用(n=171) 2 795.25±499.97 Gamma 真实世界
单次人均住院费用(n=171) 13 481.55±5 286.40 Gamma 真实世界
中性粒细胞减少伴发热治疗费用 25 000 Gamma 专家意见
中性粒细胞减少伴发热合并感染治疗费用 50 000 Gamma 专家意见
化疗药物相对剂量强度<85%成本/d(n=171) 1 723.17±682.86 Gamma 真实世界
效用参数
化疗后预防性使用粒细胞集落刺激因子状态 0.81 Beta [16]
中性粒细胞减少伴发热状态 0.56 Beta [16]
中性粒细胞减少伴发热合并感染状态 0.56 Beta [16]
卵巢癌全化疗周期结束后 0.84 Beta [17]
贴现(成本/效用) 0.05 [23]
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基于真实世界数据的PEG-rhG-CSF用于预防卵巢恶性肿瘤患者化疗引起的中性粒细胞减少症的成本-效用分析
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梁艳 1 , 赵杰 1 , 李嘉 1 , 娄小飞 1 , 乔高星 1 , 张瑞 1 , 胡伟 2 , 李军芳 3 , 左旭 4 , 杜书章 1, *
中国药学杂志 | 论著 2024,59(4): 363-368
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中国药学杂志 | 论著 2024, 59(4): 363-368
基于真实世界数据的PEG-rhG-CSF用于预防卵巢恶性肿瘤患者化疗引起的中性粒细胞减少症的成本-效用分析
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梁艳1, 赵杰1, 李嘉1, 娄小飞1, 乔高星1, 张瑞1, 胡伟2, 李军芳3, 左旭4, 杜书章1, *
作者信息
  • 1 郑州大学第一附属医院药学部, 郑州 450001
  • 2 信阳市中心医院药学部, 河南 信阳 464099
  • 3 河南科技大学第一附属医院药学部, 河南 洛阳 471003
  • 4 新乡市中心医院药学部, 河南 新乡 453099

    • 梁艳,女,硕士,主管药师 研究方向:药物经济学与医院药学

通讯作者:

*杜书章,男,主任药师 研究方向:药物经济学与医院药学 Tel:(0371)66913134
Cost-Effectiveness Analysis of PEG-rhG-CSF as Primary Prophylaxis to Chemotherapy-Induced Neutropenia in Patients with Epithelial Ovarian Cancer in China: Based on Real-Word Data
LIANG Yan1, ZHAO Jie1, LI Jia1, LOU Xiaofei1, QIAO Gaoxing1, ZHANG Rui1, HU Wei2, LI Junfang3, ZUO Xu4, DU Shuzhang1, *
Affiliations
  • 1 Department of Pharmacy, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450001, China
  • 2 Department of Pharmacy, Xinyang Central Hospital, Xinyang, 464099, China
  • 3 Department of Pharmacy, The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, 471003, China
  • 4 Department of Pharmacy, Xinxiang Central Hospital, Xinxiang, 453099, China
出版时间: 2024-02-22 doi: 10.11669/cpj.2024.04.010
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摘要
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目的 评价长效聚乙二醇化重组人粒细胞刺激因子(PEG-rhG-CSF)与短效重组人粒细胞集落刺激因子(rhG-CSF)用于预防卵巢恶性肿瘤患者化疗引起的中性粒细胞减少症的经济性。方法 使用真实世界数据,从医疗卫生系统角度出发,构建马尔可夫(Markov)模型,使用成本效用分析对2种药物的经济性进行评价,并通过敏感性分析和情景分析验证模型的稳健性。结果 基础分析结果显示,与rhG-CSF组相比,PEG-rhG-CSF组可节约成本2 279.63元,增加0.27质量调整生命年(QALYs),增量成本效果比(ICER)值为-8 393.90元/QALY,具有绝对经济优势。敏感性分析和情景分析均显示了研究结果的稳健性。结论 PEG-rhG-CSF较rhG-CSF用于预防卵巢恶性肿瘤患者化疗引起的中性粒细胞减少症更具有经济性。

聚乙二醇化重组人粒细胞刺激因子  /  重组人粒细胞集落刺激因子  /  真实世界  /  中性粒细胞减少  /  成本效用分析

OBJECTIVE To evaluate the cost-effectiveness of PEG-rhG-CSF versus rhG-CSF in patients with epithelial ovarian cancer in central China for preventing chemotherapy-induced neutropenia. METHODS Two Markov models form healthcare system perspective were developed to evaluate the economics of PEG-rhG-CSF versus rhG-CSF using cost-utility analysis. Cost and probability input data were primarily obtained from a retrospective real-world study conducted in four tertiary hospitals from January 2019 to December 2020. One-way sensitivity analysis,probability sensitivity analysis and scenario analysis were used to verify the robustness of the results. RESULTS The basic analysis showed that, compared with rhG-CSF, PEG-rhG-CSF resulted in higher QALYs and lower cost, gained 0.27 QALYs more while spending 2279.63 yuan less, and the incremental cost-effectiveness ratios were ￥-8393.9/QALY. Sensitivity analysis and scenario analysis revealed robust results. CONCLUSION PEG-rhG-CSF is economically advantageous in Chinese patients with epithelial ovarian cancer for preventing chemotherapy-induced neutropenia.

PEG-rhG-CSF  /  rhG-CSF  /  real-world  /  neutropenia  /  cost-utility analysis
梁艳, 赵杰, 李嘉, 娄小飞, 乔高星, 张瑞, 胡伟, 李军芳, 左旭, 杜书章. 基于真实世界数据的PEG-rhG-CSF用于预防卵巢恶性肿瘤患者化疗引起的中性粒细胞减少症的成本-效用分析. 中国药学杂志, 2024 , 59 (4) : 363 -368 . DOI: 10.11669/cpj.2024.04.010
LIANG Yan, ZHAO Jie, LI Jia, LOU Xiaofei, QIAO Gaoxing, ZHANG Rui, HU Wei, LI Junfang, ZUO Xu, DU Shuzhang. Cost-Effectiveness Analysis of PEG-rhG-CSF as Primary Prophylaxis to Chemotherapy-Induced Neutropenia in Patients with Epithelial Ovarian Cancer in China: Based on Real-Word Data[J]. Chinese Pharmaceutical Journal, 2024 , 59 (4) : 363 -368 . DOI: 10.11669/cpj.2024.04.010
正文
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2020年全球恶性肿瘤报告指出,卵巢癌在全球妇科常见恶性肿瘤的发病率和死亡率均位居第8位。在我国,卵巢癌年发病率和病死率分别居女性生殖系统肿瘤第3位和第2位,是严重威胁妇女健康的恶性肿瘤[1-3]。卵巢癌病因尚不明确,目前尚未找到早期发现卵巢癌的有效方法,临床确诊时多为晚期。根据组织病理学特征,卵巢癌主要分为上皮性卵巢癌、生殖细胞肿瘤以及性索-间质肿瘤三大类,其中上皮性卵巢癌最为常见,占80%~90%。手术联合化疗是卵巢恶性肿瘤的主要治疗方式,铂类联合紫杉类药物是初始治疗的首选方案[2]。
中性粒细胞减少症(chemotherapy-induced neutropenia, CIN)是骨髓抑制性化疗最严重的血液学毒性,中性粒细胞减少伴发热(febrile neutropenia, FN)是其最主要的临床并发症。中性粒细胞减少的程度、持续时间与感染,甚至死亡风险直接相关,严重影响了化疗药物相对剂量强度(relative dose intensity, RDI)与既定周期,临床上不得不降低药物剂量、延迟治疗时间或更改方案,最终难以达到预期的疗效。因此,预防或治疗中性粒细胞减少症是保证足剂量化疗或剂量密集化疗的根本[4]。重组人粒细胞集落刺激因子(recombinant human granulocyte-colony stimulating factor, rhG-CSF)与聚乙二醇化重组人粒细胞刺激因子(pegylated recombinant human granulocyte-colony stimulating factor, PEG-rhG-CSF)是目前临床上防治肿瘤放化疗引起的中性粒细胞减少症的有效药物。前者价格便宜,但半衰期较短,仅为3.5 h,每个化疗周期需连续多日给药;后者是rhG-CSF经聚乙二醇化修饰后的长效剂型,半衰期可达47 h,每个化疗周期仅需单次给药,但价格较高。《中国临床肿瘤学会肿瘤放化疗相关中性粒细胞减少症规范化管理指南》指出对妇科肿瘤患者预防性给予G-CSF(包括PEG-rhG-CSF和rhG-CSF)可以降低化疗相关中性粒细胞减少症的发生率、持续时间和严重程度[5]。国内现有针对两者用于妇科肿瘤化疗患者的临床研究主要集中在有效性与安全性,经济性还未有研究[6-8]。为了更直观地比较PEG-rhG-CSF与rhG-CSF用于预防卵巢恶性肿瘤患者化疗引起的中性粒细胞减少症的经济性,本研究从医疗卫生系统角度出发,基于真实世界数据,构建马尔可夫模型,评估两种方案的成本-效用,以期为临床合理经济用药提供参考依据。
1 资料与方法
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1.1 研究资料
本研究基于真实世界研究,采用回顾性分析方法,收集河南省四所三甲医院,2019年1月至2020年12月使用PEG-rhG-CSF(新瑞白)或rhG-CSF(立生素)预防化疗所致中性粒细胞减少症发生的上皮性卵巢癌的女性出院患者病例。所纳入的四所医院,其住院服务质量与范围均位于当地前列,故样本一定程度可以代表中国中部地区卵巢癌患者情况。纳入标准为年龄18~75岁,病理组织学诊断为上皮性卵巢癌,采用新辅助或辅助化疗且连续住院次数≥6次,化疗方案为紫杉醇+卡铂,21 d为一个化疗周期。排除同时患有其他肿瘤疾病,长效与短效CSF合用或未连续用药患者。根据预防CIN的药物选择将患者分为PEG-rhG-CSF组和rhG-CSF组。本研究获得郑州大学第一附属医院伦理委员会的批准(批号:2020-KY-543)。
1.2 模型构建
根据限定的纳、排标准,最终共有171例患者纳入本次研究,其中PEG-rhG-CSF组65人,平均年龄(51.3±18.87)岁,rhG-CSF组106人,平均年龄(51.08±14.05)岁。两组患者在年龄、民族、婚姻、职业、医保类型等方面差异均无统计学意义(P>0.05),病例情况基线一致。
本研究从医疗卫生系统角度,基于真实世界临床诊疗数据及国内外中性粒细胞减少相关药物经济学文献[9-12],使用EXCEL2021构建Markov模型,模拟PEG-rhG-CSF与rhG-CSF用于预防卵巢恶性肿瘤患者化疗引起的中性粒细胞减少症的成本与产出,并进行成本效用分析。该模型包括短期和长期两个Markov模型。其中短期模型A用于模拟上皮性卵巢癌患者在化疗周期内的生存状态,分为化疗后预防性使用粒细胞集落刺激因子(CSF)、FN、FN合并感染和死亡4个健康状态,见图1。假设所有患者从CSF状态进入模型,模型的单次模拟周期为21 d,共计6个周期。长期模型B模拟上皮性卵巢癌患者全部化疗周期结束后的生存情况,分为RDI<85%(RDI)、RDI≥85%(无RDI)和死亡3个健康状态,见图2。长期模型中,假设发生过RDI<85%的患者进入RDI状态,未发生过RDI<85%的患者进入无RDI状态,两个状态的死亡风险转移概率不同,循环周期设定为1年,模型长度为患者终身,根据《2022年中国人口和就业统计年鉴》我国女性平均预期寿命为80岁[13],本研究基线年龄为51岁,模型长度设定为29年。
1.3 模型参数及来源
1.3.1 模型A转移概率
根据真实世界数据中患者入院时及经化疗后48 h预防性使用粒细胞集落刺激因子后病情变化情况进行状态分类,计算各状态患者的百分比,获得患者在不同状态间的转移概率。具体数值参见表1。
1.3.2 模型B转移概率
柳叶刀全球癌症生存趋势监测研究显示我国卵巢癌患者化疗后5年生存率为41.8%[14]。当RDI<85%时,卵巢癌患者死亡风险比(HR)为1.71[15],通过转移概率计算公式1和2计算可得出无RDI患者的每年死亡率[12]。假设卵巢癌患者化疗5年后疾病治愈,则5年后患者的死亡率以我国女性人群全因死亡率计算,数据来源于《2022年中国人口和就业统计年鉴》[13]。
$ r=\frac{\ln \left(1-P_{0}\right)}{t_{0}}$
$ P=1-e^{-\mathrm{rt}}$
P为一个循环周期的转移概率,t为循环周期的时间,P0和t0为原临床试验中的发生概率和时间周期,r为常数。
1.3.3 效用参数
本研究的健康效用数据来源于已发表的相关文献,具体数据见表1[16-17]。
1.3.4 成本参数
本研究从医疗卫生系统角度出发,成本仅考虑直接医疗成本,包括PEG-rhG-CSF(新瑞白)、rhG-CSF(立生素)成本、化疗药品成本、发生RDI<85%成本、FN治疗成本及合并感染的治疗成本、因住院治疗产生的其他成本(表1)。在防治上皮性卵巢癌化疗引起的中性粒细胞减少Ⅲ期临床试验中PEG-rhG-CSF组与rhG-CSF组不良事件发生率比较差异无统计学意义,与真实世界观察一致,因此在本模型中不考虑相关药物不良反应处置成本[7]。
1.4 不确定性分析
1.4.1 敏感性分析
本研究应用单因素敏感性分析和概率敏感性分析来验证模型的稳健性。单因素敏感性分析是指固定其他参数不变,估算改变单个变量对结果的影响,变化范围设定参见图3,结果通过龙卷风图表示。概率敏感性分析从相应的参数分布中随机抽取数值,运用二阶蒙特卡罗模拟迭代1 000次得到,结果通过成本-效用可接受曲线及增量成本-效用比散点图表示[24]。
1.4.2 情景分析
受集采政策影响,国内部分省份相关研究药品价格在2023年上半年又有一定程度的调整,因此本研究在原模型的基础上,使用新调整的价格,即在新价格基础上再降价50%,进行情景分析,以评估研究药物的经济性。
2 结果
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2.1 基础分析结果
基于构建的短、长期Markov模型,基础分析结果显示:PEG-rhG-CSF组和rhG-CSF组的治疗总成本和产出分别为199 122.21元、6.17 QALYs和201 401.84元、5.90 QALYs。相较于rhG-CSF组,PEG-rhG-CSF组患者多获得0.27 QALYs,成本减少2 279.63元,ICER值为-8 393.90元/QALY。根据《中国药物经济学评价指南2020》[23],PEG-rhG-CSF较rhG-CSF用于预防卵巢恶性肿瘤患者化疗引起的中性粒细胞减少具有绝对经济学优势。
2.2 敏感性分析结果
单因素敏感性分析结果显示FN合并感染治疗费用、FN治疗费用、贴现、FN至FN合并感染状态转移概率和PEG-rhG-CSF价格对ICER影响最大,提示决策时要关注这些变量在具体情境下的取值。
概率敏感性分析结果以散点图展示见图4。散点主要位于第1、4象限,大部分散点位于1倍人均国内生产总值(GDP)线以下,绝大部分散点位于3倍人均GDP线以下。且在不同意愿支付阈值绘制的成本-效果可接受曲线(图5)中,当意愿支付阈值为1倍人均GDP(85 698元)[25]时,PEG-rhG-CSF更具有经济性的概率为88.9%,当阈值为3倍人均GDP时,PEG-rhG-CSF更具有经济性的概率达98.1%。
2.3 情景分析结果
受集采政策影响,2023年上半年部分省份研究药物PEG-rhG-CSF(新瑞白)和rhG-CSF(立生素)价格大幅度下降,分别从单支1 695元、132元降至697元、38.46元。因此在建立的模型上使用2023集采新价格及再降价50%进行情景分析,以评估PEG-rhG-CSF的经济性。模拟结果见图6,随着药品价格的降低, PEG-rhG-CSF经济学优势进一步增大,且降价越多,PEG-rhG-CSF经济学优势增大越明显,这与单因素敏感性分析结果一致。
3 讨论
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紫杉醇和卡铂联合化疗方案成为大多数卵巢癌一线化疗方案中的首选方案,其最主要的不良反应为血液学毒性反应,其导致3/4 级中性粒细胞减少发生率高达50%~88%,可能导致化疗减量及化疗延迟,为FN中危化疗方案[26]。临床研究表明,预防性使用PEG-rhG-CSF可有效降低妇科恶性肿瘤患者化疗期间中性粒细胞减少症的发生率、FN 发生率,疗效与 rhG-CSF相当或更具优势,但操作更为简便,仅需1次注射即可维持有效血药浓度,且安全性良好[6-7,26]。但PEG-rhG-CSF单支价格远高于rhG-CSF,多达十几倍,给患者造成一定负担。真实世界数据来源于现实的医疗环境,较随机对照试验(RCTs)数据,基于真实世界数据开展的药物经济学评价能够反映更加接近实际的情况,为医疗决策者提供更加真实的证据作为参考依据[27]。因此,本研究基于真实世界数据,从中国临床出发评估PEG-rhG-CSF与rhG-CSF的成本效用。
本研究从医疗卫生系统角度,考虑直接医疗成本,基于收集的卵巢癌患者资料,构建了Markov模型,模拟化疗引起的中性粒细胞减少症对上皮性卵巢癌患者短期和长期生存的影响,评估预防性使用PEG-rhG-CSF和rhG-CSF的成本效用。基础分析结果显示ICER值为-8393.90元/QALY,PEG-rhG-CSF具有绝对经济学优势,敏感性分析结果和情景分析结果均证明了基础分结果的稳健性。
本研究证实了PEG-rhG-CSF较rhG-CSF用于预防中国卵巢癌患者化疗引起的中性粒细胞减少症具有绝对经济学优势,与国外研究结果一致[9-10]。研究显示,虽然PEG-rhG-CSF价格远高于rhG-CSF,但其每周期仅需1次给药,发生FN、RDI<85%的风险更低,而短效rhG-CSF每周期需多次给药,患者承受更多治疗痛苦和更大治疗风险。此外,单因素敏感性分析和情景分析结果均提示PEG-rhG-CSF价格是影响ICER的主要影响因素之一,在新一轮集采价格调控时可参考本研究情景分析结果,对PEG-rhG-CSF价格适当下调,不仅节约医保基金,患者也更能获益。另外,PEG-rhG-CSF和rhG-CSF虽均在国家医保药品目录内,但限定了支付范围,PEG-rhG-CSF限前次化疗发生过重度中性粒细胞减少合并发热的患者,rhG-CSF限放化疗后的骨髓抑制。在当前集采政策下,PEG-rhG-CSF的药品可负担性已大幅度提高,或许在未来的集采政策价格进一步调控下,结合医保基金可负担性,可考虑将PEG-rhG-CSF预防性用药也纳入医保支付范围。
本研究也存在一定的局限性:①收集的数据来自于真实世界回顾性病例,混杂因素较多,虽然采用统计方法消除可能存在的偏倚,但可靠性可能不如RCTs;②模型中的部分转移概率、效用值来自于国外参考文献,与中国卵巢癌患者疾病特点可能存在一定差异;③卵巢癌患者存在长期复发的问题,由于复发状态的复杂性,本研究长期模型未考虑患者复发状态,有待在接下来的研究中进一步完善;④由于未找到卵巢癌患者全部化疗周期结束后2年及以上时间患者健康效用值,仅将患者全部化疗周期结束后1年健康效用值作为长期模型中卵巢癌化疗后的效用值。
总之,本研究结果表明,与rhG-CSF相比,PEG-rhG-CSF用于预防中国卵巢恶性肿瘤患者化疗引起的中性粒细胞减少症更具有经济学优势。
基金
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  • 河南省医学科技攻关(软科学)项目资助(RKX202102017)
文献
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参考文献 引证文献
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2024年第59卷第4期
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doi: 10.11669/cpj.2024.04.010
  • 接收时间：2023-06-30
  • 首发时间：2025-11-13
  • 出版时间：2024-02-22
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  • 收稿日期：2023-06-30
基金
河南省医学科技攻关(软科学)项目资助(RKX202102017)
作者信息
    1 郑州大学第一附属医院药学部, 郑州 450001
    2 信阳市中心医院药学部, 河南 信阳 464099
    3 河南科技大学第一附属医院药学部, 河南 洛阳 471003
    4 新乡市中心医院药学部, 河南 新乡 453099

通讯作者:

*杜书章,男,主任药师 研究方向:药物经济学与医院药学 Tel:(0371)66913134
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
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