浏览全部资源
扫码关注微信
1.北京大学药学院,北京 100191
2.北京大学医药管理国际研究中心,北京 100191
3.中国药科大学国际医药商学院,南京 211198
硕士。研究方向:药物经济学。E-mail:sh9975206@163.com
研究员,硕士生导师,博士。研究方向:卫生政策、药物经济学、大数据分析。E-mail:hansheng@bjmu.edu.cn
纸质出版日期:2023-07-15,
收稿日期:2022-12-20,
修回日期:2023-06-18,
扫 描 看 全 文
苏杭,王琳,韩晟.舒格利单抗巩固治疗Ⅲ期非小细胞肺癌的药物经济学评价 Δ[J].中国药房,2023,34(13):1606-1610.
SU Hang,WANG Lin,HAN Sheng.Pharmacoeconomic evaluation of sugemalimab consolidation therapy for stage Ⅲ non-small cell lung cancer[J].ZHONGGUO YAOFANG,2023,34(13):1606-1610.
苏杭,王琳,韩晟.舒格利单抗巩固治疗Ⅲ期非小细胞肺癌的药物经济学评价 Δ[J].中国药房,2023,34(13):1606-1610. DOI: 10.6039/j.issn.1001-0408.2023.13.12.
SU Hang,WANG Lin,HAN Sheng.Pharmacoeconomic evaluation of sugemalimab consolidation therapy for stage Ⅲ non-small cell lung cancer[J].ZHONGGUO YAOFANG,2023,34(13):1606-1610. DOI: 10.6039/j.issn.1001-0408.2023.13.12.
目的
2
从我国卫生体系角度出发,评价舒格利单抗巩固治疗同步或序贯放化疗后疾病未进展的Ⅲ期非小细胞肺癌(NSCLC)患者的经济性。
方法
2
基于GEMSTONE-301研究,建立三状态的分区生存模型模拟疾病发展进程,模型周期定义为3周,时间范围为终生;主要模型输出指标为总成本、质量调整生命年(QALY)和增量成本-效果比(ICER);采用5%的贴现率对成本和健康产出进行贴现。以1~3倍我国2022年人均国内生产总值(GDP)作为意愿支付阈值,采用成本-效用分析法进行分析,并采用情境分析和敏感性分析来验证模型的稳健性。
结果
2
与安慰剂相比,舒格利单抗巩固治疗方案的ICER为59 872.57元/QALY,小于以1倍我国2022年人均GDP(85 698元)作为的意愿支付阈值;情境分析结果进一步确定了模型的稳健性。单因素敏感性分析结果表明,药品(帕博利珠单抗、舒格利单抗、多西他赛)成本、疾病进展状态效用值等对ICER的影响较大。概率敏感性分析结果显示,在以1倍我国2022年人均GDP作为意愿支付阈值的前提下,舒格利单抗巩固治疗方案具有经济性的概率为67.2%;在以20 000元[小于3倍我国2022年人均GDP(257 094元)]作为意愿支付阈值时,舒格利单抗巩固治疗方案具有经济性的概率超过98%。
结论
2
舒格利单抗巩固治疗同步或序贯放化疗后疾病未进展的Ⅲ期NSCLC具有经济性。
OBJECTIVE
2
To evaluate the cost-effectiveness of sugemalimab in patients with stage Ⅲ non-small cell lung cancer (NSCLC) whose disease had not progressed after concurrent or sequential chemoradiotherapy from the perspective of the Chinese healthcare system.
METHODS
2
Based on the GEMSTONE-301 clinical trial,a three-health state partitioned survival model (PartSA) was developed to simulate the progression of disease,with model cycle of 3 weeks and a lifetime time range; the main output indicators of the model were total cost,quality-adjusted life year (QALY),and incremental cost-effectiveness ratio (ICER); the cost and health output were discounted using 5% discount rate. Using 1-3 times China’s per capita gross domestic product (GDP) in 2022 as the willingness-to-pay (WTP) threshold,the cost-utility analysis method was used for analysis,and sensitivity analysis and scenario analysis were conducted to assess model robustness.
RESULTS
2
Compared with placebo,ICER for sugemalimab consolidation therapy was 59 872.57 yuan/QALY,which was less than one time China’s per capita GDP in 2022 (85 698 yuan) as the WTP threshold. The scenario analysis results further confirmed the robustness of the model. The results of single factor sensitivity analysis indicated that the cost of drugs (pembrolizumab,sugemalimab,docetaxel) and the utility value of disease progression status had a significant impact on ICER; the results of the probabilistic sensitivity analysis showed that sugemalimab had 67.2% probability of being cost-effective at one time China’s GDP per capita in 2022 as the WTP threshold; when 20 000 yuan (less than 3 times GDP per capita in China of 257 094 yuan) was used as the WTP threshold,the probability of sugemalimab consolidation therapy being cost-effective was greater than 98%.
CONCLUSIONS
2
The consolidation therapy with sugemalimab is cost-effective for stage Ⅲ NSCLC whose disease had not progressed after concurrent or sequential chemoradiotherapy.
舒格利单抗Ⅲ期非小细胞肺癌成本-效用分析分区生存模型药物经济学
stage Ⅲ non-small cell lung cancercost-utility analysispartitioned survival modelpharmacoeconomics
AUPÉRIN A,LE PÉCHOUX C,ROLLAND E,et al. Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer[J]. J Clin Oncol,2010,28(13):2181-2190.
朱正飞,谭佩欣. GEMSTONE-301:同步/序贯放化疗后舒格利单抗巩固治疗可提高不可手术的Ⅲ期非小细胞肺癌患者的生存[J]. 循证医学,2022,22(1):4-7.
ANTONIA S J,VILLEGAS A,DANIEL D,et al. Durvalumab after chemoradiotherapy in stage Ⅲ non-small-cell lung cancer[J]. N Engl J Med,2017,377(20):1919-1929.
BI N,WANG Y,WANG L H. Sequential chemoradiotherapy followed by sugemalimab for locally advanced NSCLC[J]. Lancet Oncol,2022,23(4):e158.
ZHOU Q,CHEN M,JIANG O,et al. Sugemalimab versus placebo after concurrent or sequential chemoradiotherapy in patients with locally advanced,unresectable,stage Ⅲ non-small-cell lung cancer in China (GEMSTONE-301):interim results of a randomised,double-blind,multicentre,phase 3 trial[J]. Lancet Oncol,2022,23(2):209-219.
ROSELL R,GONZÁLEZ-CAO M. Ablating lung cancer,knowing the tumor better[J]. Lancet Reg Health Eur,2022,22:100494.
GONG J F,CAO J N,ZHANG Q Y,et al. Safety,antitumor activity and biomarkers of sugemalimab in Chinese patients with advanced solid tumors or lymphomas:results from the first-in-human phase 1 trial[J]. Cancer Immunol Immunother,2022,71(8):1897-1908.
DHILLON S,DUGGAN S. Sugemalimab:first approval[J]. Drugs,2022,82(5):593-599.
EISENHAUER E A,THERASSE P,BOGAERTS J,et al. New response evaluation criteria in solid tumours:revised RECIST guideline:version 1.1[J]. Eur J Cancer,2009,45(2):228-247.
中国国家统计局.中华人民共和国2021年国民经济和社会发展统计公报[EB/OL].(2022-02-28)[2022-07-18]. http://www.stats.gov.cn/xxgk/sjfb/zxfb2020/202202/t20-220228_1827971.htmlhttp://www.stats.gov.cn/xxgk/sjfb/zxfb2020/202202/t20-220228_1827971.html.
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,2020:1-8.
SALUJA R,CHENG S,DELOS SANTOS K A,et al. Estimating hazard ratios from published Kaplan-Meier survival curves:a methods validation study[J]. Res Synth Methods,2019,10(3):465-475.
BULLEMENT A,MENG Y,COOPER M,et al. A review and validation of overall survival extrapolation in health technology assessments of cancer immunotherapy by the National Institute for Health and Care Excellence:how did the initial best estimate compare to trial data subsequently made available?[J]. J Med Econ,2019,22(3):205-214.
药智数据.药品中标价[EB/OL].[2022-07-18]. https://db.yaozh.com/yaopinzhongbiaohttps://db.yaozh.com/yaopinzhongbiao.
姚林利,佘龙江,丁冬,等.Duravlumab在中国Ⅲ期非小细胞肺癌放化疗后巩固治疗中的成本效果分析[J].中国医学工程,2021,29(3):7-11.
GUAN H J,LIU G,XIE F,et al. Cost-effectiveness of osimertinib as a second-line treatment in patients with EGFR-mutated advanced non-small cell lung cancer in China[J]. Clin Ther,2019,41(11):2308-2320.e11.
WAN N,ZHANG T T,HUA S H,et al. Cost-effectiveness analysis of pembrolizumab plus chemotherapy with PD-L1 test for the first-line treatment of NSCLC[J]. Cancer Med,2020,9(5):1683-1693.
CHEN X,YANG Z G,XIANG G Y,et al. Durvalumab consolidation therapy in patients with stage Ⅲ non-small cell lung cancer after concurrent chemoradiation:a China-based cost-effectiveness analysis[J]. Expert Rev Pharmacoecon Outcomes Res,2022,22(4):647-654.
国家统计局.中国统计年鉴[EB/OL].[2022-11-02]. http://www.stats.gov.cn/tjsj/ndsj/http://www.stats.gov.cn/tjsj/ndsj/.
LU S,YE M,DING L M,et al. Cost-effectiveness of gefitinib,icotinib,and pemetrexed-based chemotherapy as first-line treatments for advanced non-small cell lung cancer in China[J]. Oncotarget,2017,8(6):9996-10006.
NAFEES B,LLOYD A J,DEWILDE S,et al. Health state utilities in non-small cell lung cancer:an international study[J]. Asia Pac J Clin Oncol,2017,13(5):e195-e203.
中国医师协会肿瘤医师分会,中国医疗保健国际交流促进会肿瘤内科分会. Ⅳ期原发性肺癌中国治疗指南:2021年版[J]. 中华肿瘤杂志,2021,43(1):39-59.
中国临床肿瘤学会指南工作委员会. 中国临床肿瘤学会(CSCO)非小细胞肺癌诊疗指南:2021[M]. 北京:人民卫生出版社,2021:88-96.
0
浏览量
4
下载量
0
CSCD
关联资源
相关文章
相关作者
相关机构