浏览全部资源
扫码关注微信
1.安徽中医药大学药学院,合肥;230012
2.中国科学技术大学附属第一医院(安徽省立医院)药剂科,合肥 230001
硕士研究生。研究方向:药物经济学。E-mail:2293480254@qq.com
主任药师,硕士生导师。研究方向:药物经济学、药事管理。E-mail:1649441800@qq.com
纸质出版日期:2023-04-30,
收稿日期:2022-10-22,
修回日期:2023-03-14,
扫 描 看 全 文
洪望龙,郑淼淼,马国强等.瑞戈非尼治疗经索拉非尼治疗失败后的肝细胞癌的经济性Δ[J].中国药房,2023,34(08):968-973.
HONG Wanglong,ZHENG Miaomiao,MA Guoqiang,et al.Cost-effectiveness of regorafenib for hepatocellular carcinoma after failure of sorafenib[J].ZHONGGUO YAOFANG,2023,34(08):968-973.
洪望龙,郑淼淼,马国强等.瑞戈非尼治疗经索拉非尼治疗失败后的肝细胞癌的经济性Δ[J].中国药房,2023,34(08):968-973. DOI: 10.6039/j.issn.1001-0408.2023.08.14.
HONG Wanglong,ZHENG Miaomiao,MA Guoqiang,et al.Cost-effectiveness of regorafenib for hepatocellular carcinoma after failure of sorafenib[J].ZHONGGUO YAOFANG,2023,34(08):968-973. DOI: 10.6039/j.issn.1001-0408.2023.08.14.
目的
2
从我国卫生体系角度出发,评估瑞戈非尼治疗经索拉非尼治疗失败后的肝细胞癌的经济性。
方法
2
基于一项Ⅲ期临床试验(RESORCE研究),分别构建分区生存模型(PSM)和Markov模型,循环周期设为4周,研究时限为患者终身,年贴现率为5%,药品成本数据来自药智网,其他成本数据来源于安徽省医保局数据和相关文献,效用数据来源于文献。以增量成本-效果比(ICER)为评价指标,意愿支付值为3倍的我国2022年人均国内生产总值(GDP),采用单因素敏感性分析和概率敏感性分析验证基础分析结果的稳健性。
结果
2
瑞戈非尼组对比安慰剂组在PSM和Markov模型中的增量成本分别为112 116.95元、96 617.19元;增量效果分别为0.31、0.32 QALYs;ICER分别为360 751.01、301 114.45元/QALY,ICER均大于意愿支付值,瑞戈非尼不具有经济性。单因素敏感性分析结果显示,无进展生存期状态和疾病进展状态的效用值以及瑞戈非尼单价对结果的影响较大,但在各参数浮动范围内,ICER始终大于意愿支付值;在3倍的我国2022年人均GDP的意愿支付值下,瑞戈非尼具有经济性的概率为0.8%(PSM)、11.4%(Markov模型)。
结论
2
在3倍的我国人均GDP下,瑞戈非尼对比安慰剂治疗经索拉非尼治疗失败后的肝细胞癌不具有经济性。
OBJECTIVE
2
To evaluate the cost-effectiveness of regorafenib in the treatment of hepatocellular carcinoma after failure of sorafenib from the perspective of Chinese health system.
METHODS
2
Based on a phase Ⅲ trial(RESORCE), the partition survival model (PSM) and Markov model were constructed. The cycle was set as four weeks, the duration of the study lasted for lifetime, the annual discount rate was 5%. Drug cost data was obtained from yaozhi.com, other cost data were obtained from Anhui Provincial Medical Insurance Bureau and related literature, and utility values were obtained from literature. The incremental cost-effectiveness ratio (ICER) was used as the evaluation index, and the value of willingness to pay (WTP) was three times of China’s gross domestic product (GDP) per capita in 2022; one-way sensitivity analysis and probabilistic sensitivity analysis were used to verify the robustness of the basic analysis results.
RESULTS
2
The incremental cost of regorafenib group versus placebo group in PSM and Markov model was 112 116.95 yuan and 96 617.19 yuan, respectively. The incremental effectiveness was 0.31 QALYs and 0.32 QALYs, respectively. The ICERs were 360 751.01 yuan/QALY and 301 114.45 yuan/QALY, which were both greater than the value of WTP; regorafenib was not cost-effective. Results of one-way sensitivity analysis showed that the utility of progression-free survival and progressive disease, the unit cost of regorafenib had the greatest influence on the results, but ICER was always greater than the WTP within the floating range of each parameter. Under the WTP of 3 times China’s per capita GDP in 2022, the probabilities of regorafenib with cost-effectiveness were 0.8% (PSM) and 11.4% (Markov).
CONCLUSIONS
2
Under the WTP of 3 times the per capita GDP of China, regorafenib is not cost-effective in the treatment of hepatocellular carcinoma after failure of sorafenib treatment, compared with placebo.
瑞戈非尼肝细胞癌分区生存模型Markov模型药物经济学
hepatocellular carcinomapartition survival modelMarkov modelpharmacoeconomics
SUNG H,FERLAY J,SIEGEL R L,et al. Global cancer statistics 2020:GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries[J]. CA Cancer J Clin,2021,71(3):209-249.
安澜,曾红梅,冉显会,等. 肝细胞癌和肝内胆管细胞癌流行病学研究进展[J]. 中国肿瘤,2020,29(11):879-884.
BRUIX J,SHERMAN M,American association for the study of liver diseases. Management of hepatocellular carcinoma:an update[J]. Hepatology,2011,53(3):1020-1022.
PARIKH N D,MARSHALL V D,SINGAL A G,et al. Survival and cost-effectiveness of sorafenib therapy in advanced hepatocellular carcinoma:an analysis of the SEER-Medicare database[J]. Hepatology,2017,65(1):122-133.
MARRERO J A,KUDO M,VENOOK A P,et al. Observational registry of sorafenib use in clinical practice across Child-Pugh subgroups:the GIDEON study[J]. J Hepatol,2016,65(6):1140-1147.
LLOVET J M,RICCI S,MAZZAFERRO V,et al. Sorafenib in advanced hepatocellular carcinoma[J]. N Engl J Med,2008,359(4):378-390
CHENG A L,KANG Y K,LIN D Y,et al. Sunitinib versus sorafenib in advanced hepatocellular cancer:results of a randomized phase Ⅲ trial[J]. J Clin Oncol,2013,31(32):4067-4075.
JOHNSON P J,QIN S K,PARK J W,et al. Brivanib versus sorafenib as first-line therapy in patients with unresec-table,advanced hepatocellular carcinoma:results from the randomized phase Ⅲ BRISK-FL study[J]. J Clin Oncol,2013,31(28):3517-3524.
CAINAP C,QIN S K,HUANG W T,et al. Linifanib versus sorafenib in patients with advanced hepatocellular carcinoma:results of a randomized phase Ⅲ trial[J]. J Clin Oncol,2015,33(2):172-179.
ABOU-ALFA G K,NIEDZWIESKI D,KNOX J J,et al. Phase Ⅲ randomized study of sorafenib plus doxorubicin versus sorafenib in patients with advanced hepatocellular carcinoma (HCC):CALGB 80802 (Alliance)[J]. J Clin Oncol,2016,34(15_suppl):4003.
LLOVET J M,DECAENS T,RAOUL J L,et al. Brivanib in patients with advanced hepatocellular carcinoma who were intolerant to sorafenib or for whom sorafenib failed:results from the randomized phase Ⅲ BRISK-PS study[J]. J Clin Oncol,2013,31(28):3509-3516.
ZHU A X,KUDO M,ASSENAT E,et al. Effect of everolimus on survival in advanced hepatocellular carcinoma after failure of sorafenib:the EVOLVE-1 randomized clinical trial[J]. JAMA,2014,312(1):57-67.
WILHELM S M,DUMAS J,ADNANE L,et al. Regorafenib (BAY 73-4506):a new oral multikinase inhibitor of angiogenic,stromal and oncogenic receptor tyrosine kinases with potent preclinical antitumor activity[J]. Int J Cancer,2011,129(1):245-255.
ABOU-ELKACEM L,ARNS S,BRIX G,et al. Regorafenib inhibits growth,angiogenesis,and metastasis in a highly aggressive,orthotopic colon cancer model[J]. Mol Cancer Ther,2013,12(7):1322-1331.
吕晓雯,王甦. 瑞戈非尼治疗肝细胞癌的机制及临床效果[J]. 临床肝胆病杂志,2020,36(5):1175-1180.
BRUIX J,QIN S,MERLE P,et al. Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE):a randomised,double-blind,placebo-controlled,phase 3 trial[J]. Lancet,2017,389(10064):56-66.
李美月. 肝动脉灌注化疗联合索拉非尼治疗晚期肝癌的成本-效用分析[D]. 福州:福建医科大学,2021.
RUI M J,LI H C. Cost-effectiveness of osimertinib vs docetaxel-bevacizumab in third-line treatment in EGFR T790M resistance mutation advanced non-small cell lung cancer in China[J]. Clin Ther,2020,42(11):2159-2170.e6.
刘国恩. 中国药物经济学评价指南2020[M]. 北京:中国市场出版社,2020:36-46.
石丰豪,商叶,芮明军,等. R语言survHE程序包在卫生经济学评价中的应用[J]. 中国卫生经济,2020,39(9):9-14.
GUYOT P,ADES A E,OUWENS M J,et al. Enhanced secondary analysis of survival data:reconstructing the data from published Kaplan-Meier survival curves[J]. BMC Med Res Methodol,2012,12:9.
周挺,马爱霞,付露阳. 药物经济学评价Markov模型中转移概率计算的探讨[J]. 中国卫生经济,2017,36(12):40-42.
徐赫,马爱霞. 基于分区生存模型的帕博利珠单抗单药与化疗一线治疗PD-L1肿瘤比例分数不同的非小细胞肺癌的成本-效果分析[J]. 中国医院药学杂志,2020,40(23):2468-2473.
国家卫生健康委医政医管局. 原发性肝癌诊疗指南:2022年版[J]. 中国实用外科杂志,2022,42(3):241-273.
WU B,ZHANG Q,SUN J. Cost-effectiveness of ni-volumab plus ipilimumab as first-line therapy in advanced renal-cell carcinoma[J]. J Immunother Cancer,2018,6(1):124.
WAN X M,ZHANG Y C,TAN C Q,et al. First-line nivolumab plus ipilimumab vs sunitinib for metastatic renal cell carcinoma:a cost-effectiveness analysis[J]. JAMA Oncol,2019,5(4):491-496.
DRANITSARIS G,YU B,KING J,et al. Nab-paclitaxel,docetaxel,or solvent-based paclitaxel in metastatic breast cancer:a cost-utility analysis from a Chinese health care perspective[J]. Clinicoecon Outcomes Res,2015,7:249-256.
朱建波,王江峰,吕良忠. 呋喹替尼与瑞戈非尼作为转移性结直肠癌三线治疗的成本-效用分析[J]. 药物流行病学杂志,2022,31(3):173-177.
贾才凤,张森,徐浩,等. 帕妥珠单抗联合曲妥珠单抗、多西他赛一线治疗HER2阳性转移性乳腺癌的成本-效用分析[J]. 中国药房,2022,33(4):481-486.
康朔. 卡瑞利珠单抗联合化疗一线治疗晚期非鳞状非小细胞肺癌的药物经济学评价[D]. 石家庄:河北医科大学,2021.
GUAN X,LI H C,XIONG X M,et al. Cost-effectiveness analysis of fruquintinib versus regorafenib as the third-line therapy for metastatic colorectal cancer in China[J]. J Med Econ,2021,24(1):339-344.
PARIKH N D,SINGAL A G,HUTTON D W. Cost effectiveness of regorafenib as second-line therapy for patients with advanced hepatocellular carcinoma[J]. Cancer,2017,123(19):3725-3731.
SHLOMAI A,LESHNO M,GOLDSTEIN D A. Regorafenib treatment for patients with hepatocellular carcinoma who progressed on sorafenib:a cost-effectiveness analysis[J]. PLoS One,2018,13(11):e0207132.
0
浏览量
5
下载量
0
CSCD
关联资源
相关文章
相关作者
相关机构