目的 从中国全社会角度出发,评价抗血管内皮生长因子(vascular endothelial growth factor,VEGF)类药物(雷珠单抗、阿柏西普)与激光光凝用于治疗糖尿病性黄斑水肿的成本-效果。方法 构建 Markov模型,通过随机对照试验、已发表文献和医院调研获得3种干预措施治疗糖尿病性黄斑水肿的临床疗效、健康效用及成本数据,对各干预措施下患者终身的疾病转归、质量调整生命年(QALYs)及成本进行长期模拟。计算增量成本-效果比(ICER),并进行单因素和概率敏感性分析。结果 与激光光凝相比,雷珠单抗的ICER值为61 174元·QALY-1,阿柏西普的ICER值为138 232元·QALY-1,均小于我国3倍人均GDP(59 660元,2017年),抗VEGF类药物具有经济性。比较雷珠单抗与阿柏西普,雷珠单抗QALY更高成本更低,占绝对优势。单因素和概率敏感性分析证明了结果的稳健性。结论 雷珠单抗、阿柏西普与激光光凝相比,在治疗糖尿病性黄斑水肿方面均具有成本-效果;其中雷珠单抗效果更好成本更低,在治疗糖尿病性黄斑水肿方面占绝对优势。
Abstract
OBJECTIVE To evaluate the cost-effectiveness of ranibizumab and aflibercept compared with laser photocoagulation for the treatment of diabetic macular edema (DME) from Chinese societal perspective. METHODS A Markov model was constructed to simulate the long-term outcomes and costs of treating DME. Transition probabilities were calculated from the raw data of randomized controlled trial and published network Meta-analysis. Health state utilities were estimated through literature, and costs were estimated from experts consultation of 6 hospitals in China and published literature. The primary outcomes of the model were costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER). Uncertainty was addressed via univariate and probabilistic sensitivity analyses. RESULTS The ICER comparing ranibizumab with laser photocoagulation was ￥61 174·QALY-1, comparing aflibercept with laser photocoagulation was ￥138 232·QALY-1. Based on the generally accepted ICER threshold of 3 times per-capita GDP (￥59 660, 2017 China), ranibizumab and aflibercept were found to be cost-effective compared with laser photocoagulation. Comparing ranibizumab with aflibercept, ranibizumab was the dominant therapy, with an incremental gain of 0.03 QALYs and cost savings of ￥22 053. Univariate and probabilistic sensitivity analysis demonstrated the robustness of the results. CONCLUSION Compared with laser photocoagulation, ranibizumab and aflibercept are the cost-effective treatment for DME; compared with aflibercept, ranibizumab is the dominant treatment for DME.
关键词
糖尿病黄斑水肿 /
雷珠单抗 /
阿柏西普 /
激光光凝 /
药物经济学
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Key words
diabetic macular edema /
ranibizumab /
aflibercept /
laser photocoagulation /
cost-effectiveness
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中图分类号：
R956
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参考文献
[1] Chinese Diabetes Society. Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2017 edition)[J]. Chin J Pract Intern Med (中国实用内科杂志), 2018, 38(4):292-344.
[2] YANG W, LU J, WENG J, et al. Prevalence of diabetes among men and women in China[J]. N Engl J Med, 2010, 362(12):1090-1101.
[3] GUNDOGAN F C, YOLCU U, AKAY F, et al. Diabetic macular edema[J]. Pak J Med Sci, 2016, 32(2):505-510.
[4] HONG T P, YANG J. Transformational medical research on diabetes prevention and treatment in China:opportunities and challenges[J]. Chin J Diabet Mell(中华糖尿病杂志), 2017, 9(12):729-731.
[5] STEPHEN G S, INGRID U S, MICHAEL W S, et al. Update on corticosteroids for diabetic macular edema[J]. Clin Ophthalmol, 2016,(10):1723-1730.
[6] ERCALIK N Y, IMAMOQLU S, KUMRAL E T, et al. Influence of the epiretinal membrane on ranibizumab therapy outcomes in patients with diabetic macular edema[J]. Arq Bras Oftalmol, 2016, 79(6):373-375.
[7] MITCHELL P, BANDELLO F, SCHMIDT-ERFURTH U, et al. The RESTORE study:ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema[J]. Ophthalmology, 2011, 118(4):615-625.
[8] SCHMIDT-ERFURTH U, LANG G E, HOLZ F G, et al. Three-year outcomes of individualized ranibizumab treatment in patients with diabetic macular edema:the RESTORE extension study[J]. Ophthalmology, 2014, 121(5):1045-1053.
[9] KOROBELNIK J F, DO D V, SCHMIDT-ERFURTH U, et al. Intravitreal aflibercept for diabetic macular edema[J]. Ophthalmology, 2014,121(11):2247-2254.
[10] HEIER J S, KOROBELNIK J F, BROWN D M, et al. Intravitreal aflibercept for diabetic macular edema:148-week results from the VISTA and VIVID studies[J]. Ophthalmology, 2016, 123(11):2376-2385.
[11] PAUL M, LIEVEN A. Cost-effectiveness of ranibizumab in treatment of diabetic macular oedema(DME) causing visual impairment:evidence from the RESTORE trial[J]. Br J Ophthalmol, 2012, 96(5):688-693.
[12] STEPHANE A RGNIER, MALCOLM W, HAIG J, et al. Cost-effectiveness of ranibizumab versus aflibercept in the treatment of visual impairment due to diabetic macular edema:a UK healthcare perspective[J]. Clinicoecon Outcomes Res, 2015,6(7):235-247.
[13] LIU G E. Guidelines and Guidelines for the Evaluation of Pharmacoeconomics in China:2015 Edition (中国药物经济学评价指南及导读:2015年版) [M]. Beijing:Science Press, 2015.
[14] REGNIER S, MALCOLM W, ALLEN F, et al. Efficacy of anti-VEGF and laser photocoagulation in the treatment of visual impairment due to diabetic macular edema:a systematic review and network Meta-analysis[J]. PLoS One, 2014, 9(7):e102309.
[15] BRAGG F, HOLMES M V, IONA A, et al. Association between diabetes and cause-specific mortality in rural and urban areas of China[J]. JAMA, 2017, 317(3):280-289.
[16] HIRAI F E, KNUDTSON M D, KLEIN B E, et al. Clinically significant macular edema and survival in type 1 and type 2 diabetes[J]. Am J Ophthalmol, 2008, 145(4):700-706.
[17] WHO. Global Health Observatory data repository, Life tables by country, China[EB/OL]. [2018-04-20] http://apps.who.int/gho/data/view.main.60340?lang=en.
[18] XIAO D G, FANG H L, LI J W, et al. Burden of low vision and blindness in Chinese elder population:data from field survey[J]. Value Health, 2016, 19(7):565-566.
[19] CZOSKI-MURRAY C, CARLTON J, BRAZIER J, et al. Valuing condition-specific health states using simulation contact lenses[J]. Value Health, 2009, 12(5):793-799.
[20] BALSHAW R F, GONDER J, FERREIRA A, et al. Evaluation of health utility in patients with retinal vein occlusion[J]. Value Health, 2012, 15(7):572.
[21] BRIGGS A, CLAXTON K, SCULPHER M. Decision Modelling for Health Economic Evaluation[M]. Oxford:Oxford University Press, 2006.
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