Clinical Epidemiology Unit, Greater Paris University Hospitals (AP-HP) , Paris, France.
Judge Business School, University of Cambridge , Cambridge, UK.
Expert Rev Pharmacoecon Outcomes Res. 2020 Aug;20(4):405-409. doi: 10.1080/14737167.2019.1635458. Epub 2019 Jun 26.
Our primary objective was to compare the grading of the value of cancer drugs ('Amélioration du Service Médical Rendu' [ASMR] level) by the French health technology assessment authority ('Haute Autorité de santé' [HAS]) with that by the American Society of Clinical Oncology Value Framework (ASCO-VF) and the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). Our secondary objective was to study the drivers of the French grading system.
We included new drugs for solid tumors assessed by the HAS between 2010 and 2016 and compared their ASMR level to scores calculated by the 2016-updated ASCO-VF and 2015 ESMO-MCBS.
We investigated 27 new cancer drugs assessed by the French HAS between 2010 and 2016. Among the 17 drugs eligible for comparison, the correlation between ASMR levels and ASCO and ESMO scores was weak (r = 0.34 and r = 0.27, respectively). The agreement between the HAS and ESMO regarding the level of meaningful additional benefit was moderate (kappa = 0.43). We found no significant association between 12 potential variables and ASMR level of additional benefit of drugs.
Our findings show inconsistencies in cancer drug appraisals among the three appraisers.
我们的主要目的是比较法国卫生技术评估机构（HAS）和美国临床肿瘤学会价值框架（ASCO-VF）与欧洲肿瘤内科学会临床获益量表（ESMO-MCBS）对癌症药物价值的评级（“医疗服务改善”[ASMR]级别）。我们的次要目的是研究法国分级系统的驱动因素。
我们纳入了 2010 年至 2016 年 HAS 评估的新的实体瘤药物，并将其 ASMR 水平与 2016 年更新的 ASCO-VF 和 2015 年 ESMO-MCBS 计算的评分进行比较。
我们调查了 2010 年至 2016 年法国 HAS 评估的 27 种新的癌症药物。在 17 种符合比较条件的药物中，ASMR 水平与 ASCO 和 ESMO 评分之间的相关性较弱（r = 0.34 和 r = 0.27）。HAS 和 ESMO 对有意义的附加获益水平的一致性为中度（kappa = 0.43）。我们未发现 12 个潜在变量与药物附加获益的 ASMR 水平之间存在显著关联。
我们的研究结果表明，三个评估机构对癌症药物评估存在不一致性。
