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中国药科大学国际医药商学院,南京 211198
Published:30 September 2024,
Received:29 May 2024,
Revised:18 August 2024,
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胡钊,管欣,刘永军.引入等值生命年获益优化成本-效用分析——以RAS突变型转移性结直肠癌为例 Δ[J].中国药房,2024,35(18):2258-2265.
HU Zhao,GUAN Xin,LIU Yongjun.Optimization of cost-utility analysis with equal value of life-year gained: a case study of RAS-mutant metastatic colorectal cancer[J].ZHONGGUO YAOFANG,2024,35(18):2258-2265.
胡钊,管欣,刘永军.引入等值生命年获益优化成本-效用分析——以RAS突变型转移性结直肠癌为例 Δ[J].中国药房,2024,35(18):2258-2265. DOI: 10.6039/j.issn.1001-0408.2024.18.12.
HU Zhao,GUAN Xin,LIU Yongjun.Optimization of cost-utility analysis with equal value of life-year gained: a case study of RAS-mutant metastatic colorectal cancer[J].ZHONGGUO YAOFANG,2024,35(18):2258-2265. DOI: 10.6039/j.issn.1001-0408.2024.18.12.
目的
2
为我国药物经济学评估方法的完善和卫生经济决策提供参考。
方法
2
从我国医疗卫生体系的角度出发,基于BECOME研究构建三状态分区生存模型,分别以质量调整生命年(QALY)和等值生命年获益(evLYG)为健康产出指标,运用成本-效用分析法评价贝伐珠单抗联合化疗方案对比化疗方案一线治疗
RAS
突变型转移性结直肠癌(mCRC)的经济性。循环周期为2周,研究时限为患者终身,贴现率为5%,意愿支付阈值为1~3倍我国2023年人均国内生产总值(89 358~268 074元)。采用单因素敏感性分析和概率敏感性分析评价结果的稳健性。
结果
2
以QALY为基础计算的贝伐珠单抗联合化疗方案相较于化疗方案的增量成本-效果比(ICER)为330 311.33元/QALY,大于意愿支付阈值(268 074元);以evLYG为基础计算的ICER值为254 085.64元/evLYG,低于意愿支付阈值(268 074元)。单因素敏感性分析结果显示,贝伐珠单抗成本对ICER值的影响最大。概率敏感性分析结果显示,以QALY为基础进行评估,贝伐珠单抗联合化疗方案更具经济性的概率约为3%;以evLYG为基础进行评估,该方案更加经济的概率上升至56%。
结论
2
采用按evLYG为健康产出指标计算的ICER值对
RAS
突变型mCRC患者医疗干预方案的经济性进行判断可能比按QALY计算的ICER值更为公平。建议针对特殊人群开展药物经济学评价时,可同时采用QALYs和 evLYGs作为健康产出指标进行评估,以实现医疗卫生资源的更优配置,提高决策的公平性。
OBJECTIVE
2
To provide a reference for the improvement of pharmacoeconomic evaluation and health economic decision-making in China.
METHODS
2
From the perspective of China’s healthcare system, a three-state partitioned survival model was constructed based on the BECOME study, the quality-adjusted life year (QALY) and equal value of life-year gained(evLYG) were used as the health gain measures respectively, and the cost-utility analysis was used to evaluate the cost-effectiveness of bevacizumab combined with chemotherapy regimen versus chemotherapy alone in the first-line treatment of
RAS
-mutant metastatic colorectal cancer (mCRC). The cycle length was 2 weeks, the time horizon was the pati
ents’ lifetime, the discount rate was 5%, and the willingness-to-pay threshold was 1 to 3 times China’s gross domestic product per capita in 2023 (89 358-268 074 yuan). One-way sensitivity analysis and probabilistic sensitivity analysis were used to assess the robustness of the results.
RESULTS
2
Compared to the chemotherapy alone, the incremental cost-effectiveness ratio (ICER) of the bevacizumab combined with chemotherapy regimen was calculated to be 330 311.33 yuan/QALY based on QALY, which exceeded the willingness-to-pay threshold (268 074 yuan). However, when the ICER was calculated based on evLYG, it was determined to be 254 085.64 yuan/evLYG, which fell below the willingness-to-pay threshold (268 074 yuan). The results of the one-way sensitivity analysis showed that the price of bevacizumab had the greatest impact on the ICER value. The results of the probabilistic sensitivity analysis showed that the probability of the bevacizumab combined with chemotherapy regimen being more cost-effective was approximately 3% when assessed by QALY; the probability of the regimen being more cost-effective rose to 56% when assessed by evLYG.
CONCLUSIONS
2
When evaluating the cost-effectiveness of interventions for
RAS
-mutant mCRC, ICER values based on evLYG may provide a fairer measure compared to ICER values calculated by QALY. It is recommended that when pharmacoeconomic evaluations are conducted for special populations, both QALY and evLYG can be used as health outcome indexes for evaluation to achieve a better allocation of healthcare resources and improve the fairness of decision-making.
等值生命年获益质量调整生命年RAS突变型转移性结直肠癌药物经济学
quality-adjusted life yearRAS-mutant metastatic colorectal cancerpharmacoeconomics
SANDERS G D,NEUMANN P J,BASU A,et al. Recommendations for conduct,methodological practices,and reporting of cost-effectiveness analyses:second panel on cost-effectiveness in health and medicine[J]. JAMA,2016,316(10):1093-1103.
COOKSON R,MIRELMAN A J,GRIFFIN S,et al. Using cost-effectiveness analysis to address health equity concerns[J]. Value Health,2017,20(2):206-212.
CAMPBELL J D,WHITTINGTON M D,PEARSON S D. An alternative measure of health for value assessment:the equal value life-year[J]. Pharmacoeconomics,2023,41(10):1175-1182.
TANG W T,REN L,LIU T S,et al. Bevacizumab plus mFOLFOX6 versus mFOLFOX6 alone as first-line treatment for RAS mutant unresectable colorectal liver-limited metastases:the BECOME randomized controlled trial[J]. J Clin Oncol,2020,38(27):3175-3184.
刘月姣. 《中国居民营养与慢性病状况报告(2020年)》发布[J]. 中国食物与营养,2020,26(12):2.
LIU Y J. The Report on Nutrition and Chronic Diseases of China Residents(2020) was released[J]. Food Nutr China,2020,26(12):2.
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,2020:27-28.
LIU G E. China guidelines for pharmacoeconomics evaluation 2020[M]. Beijing:China Market Press,2020:27-28.
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.
SHI F H,SHANG Y,RUI M J,et al. Application of survHE package of R for health economic evaluation[J]. Chin Health Econ,2020,39(9):9-14.
FÄRKKILÄ N,SINTONEN H,SAARTO T,et al. Health-related quality of life in colorectal cancer[J]. Colorectal Dis,2013,15(5):e215-e222.
SHU Y M,DING Y F,HE X C,et al. Cost-effectiveness of osimertinib versus standard EGFR-TKI as first-line treatment for EGFR-mutated advanced non-small-cell lung cancer in China[J]. Front Pharmacol,2022,13:920479.
XIANG G Y,GU L N,CHEN X,et al. Economic evalu-ation of first-line camrelizumab for advanced non-small-cell lung cancer in China[J]. Front Public Health,2021,9:743558.
SWINBURN P,LLOYD A,NATHAN P,et al. Elicitation of health state utilities in metastatic renal cell carcinoma[J]. Curr Med Res Opin,2010,26(5):1091-1096.
ZHU Y W,LIU K,YANG Q P,et al. First-line immuno-chemotherapy for extensive-stage small-cell lung cancer:a network meta-analysis and cost-effectiveness analysis[J]. Front Public Health,2023,11:1028202.
HALL F,DE FREITAS H M,KERR C,et al. Estimating utilities/disutilities for high-risk metastatic hormone-sensitive prostate cancer(mHSPC)and treatment-related adverse events[J]. Qual Life Res,2019,28(5):1191-1199.
HIROSE C,FUJII H,IIHARA H,et al. Real-world data of the association between quality of life using the EuroQol 5 dimension 5 level utility value and adverse events for outpatient cancer chemotherapy[J]. Support Care Cancer,2020,28(12):5943-5952.
LLOYD A J,DEWILDE S,NOBLE S,et al. What impact does venous thromboembolism and bleeding have on cancer patients’ quality of life?[J]. Value Health,2018,21(4):449-455.
PARK J I,BAEK H,JUNG H H. CKD and health-related quality of life:the Korea national health and nutrition exa-mination survey[J]. Am J Kidney Dis,2016,67(6):851-860.
RIESCO-MARTÍNEZ M C,BERRY S R,KO Y J,et al. Cost-effectiveness analysis of different sequences of the use of epidermal growth factor receptor inhibitors for wild-type KRAS unresectable metastatic colorectal cancer[J]. J Oncol Pract,2016,12(6):e710-e723.
LAKDAWALLA D N,DOCTOR J N. A principled approach to non-discrimination in cost-effectiveness[J/OL]. Eur J Health Econ,2024(2024-02-07)[2024-04-05].https://pubmed.ncbi.nlm.nih.gov/38411845/https://pubmed.ncbi.nlm.nih.gov/38411845/. DOI:10.1007/s10198-023-01659-7http://dx.doi.org/10.1007/s10198-023-01659-7.
PAULDEN M,SAMPSON C,O’MAHONY J F,et al. Logical inconsistencies in the health years in total and equal value of life-years gained[J]. Value Health,2024,27(3):356-366.
WANG D Y,XIE S T,WU J,et al. The trend in quality of life of Chinese population:analysis based on population health surveys from 2008 to 2020[J]. BMC Public Health,2023,23(1):167.
WHITEHEAD S J,ALI S. Health outcomes in economic evaluation:the QALY and utilities[J]. Br Med Bull,2010,96:5-21.
WHITEHURST D G T,ENGEL L. Disability discrimination and misdirected criticism of the quality-adjusted life year framework[J]. J Med Ethics,2018,44(11):793-795.
BASU A,CARLSON J,VEENSTRA D. Health years in total:a new health objective function for cost-effectiveness analysis[J]. Value Health,2020,23(1):96-103.
PEARSON S D. Why the coming debate over the QALY and disability will be different[J]. J Law Med Ethics,2019,47(2):304-307.
SCHNEIDER P. The QALY is ableist:on the unethical implications of health states worse than dead[J]. Qual Life Res,2022,31(5):1545-1552.
AMADO R G,WOLF M,PEETERS M,et al. Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer[J]. J Clin Oncol,2008,26(10):1626-1634.
BENJAMIN L E. Commentary on “KRAS mutation status is predictive of response to cetuximab therapy in colo-rectal cancer”[J]. Cancer Res,2016,76(15):4309-4310.
国家卫生健康委员会. 中国结直肠癌诊疗规范:2023版[J]. 中华消化外科杂志,2023,22(6):667-698.
National Health Commission. Chinese protocol of diagnosis and treatment of colorectal cancer:2023 edition[J]. Chin J Dig Surg,2023,22(6):667-698.
KABBINAVAR F F,SCHULZ J,MCCLEOD M,et al. Addition of bevacizumab to bolus fluorouracil and leucovorin in first-line metastatic colorectal cancer:results of a randomized phase Ⅱ trial[J]. J Clin Oncol,2005,23(16):3697-3705.
HURWITZ H,FEHRENBACHER L,NOVOTNY W,et al. Bevacizumab plus irinotecan,fluorouracil,and leucovorin for metastatic colorectal cancer[J]. N Engl J Med,2004,350(23):2335-2342.
RAMJEE L,VURGUN N,NGAI C,et al. Cost-effectiveness analysis of Nefecon versus best supportive care for people with immunoglobulin A nephropathy(IgAN)in the United States[J]. Clinicoecon Outcomes Res,2023,15:213-226.
WHITTINGTON M D,CAMPBELL J D,RIND D,et al. Cost-effectiveness and value-based pricing of aducanumab for patients with early Alzheimer disease[J]. Neurology,2022,98(9):e968-e977.
BENJAMIN D J,PADULA W V,HSU R C. Cost effectiveness of immunotherapy combination therapies for endometrial cancer[J]. Gynecol Oncol Rep,2024,52:101351.
KLIMCHAK A C,SEDITA L E,RODINO-KLAPAC L R,et al. Assessing the value of delandistrogene moxepar-vovec(SRP-9001) gene therapy in patients with Duchenne muscular dystrophy in the United States[J]. J Mark Access Health Policy,2023,11(1):2216518.
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