Armoiry Xavier, Spath Hans-Martin, Clarke Aileen, Connock Martin, Sutcliffe Paul, Dussart Claude
Pharmacy Department, University of Lyon, School of Pharmacy (ISPB)/UMR CNRS 5510 MATEIS/Lyon University Hospitals, "Edouard Herriot" Hospital, Lyon, France.
Warwick Medical School, University of Warwick, Coventry, UK.
J Mark Access Health Policy. 2019 Jul 30;7(1):1648971. doi: 10.1080/20016689.2019.1648971. eCollection 2019.
: The appraisal of medicines is often a complex and iterative process. We compared the health technology assessment (HTA) process in England and France taking as a case study the example of ixazomib for multiple myeloma. : We undertook an analysis of eight relevant published documents identifed from the websites of the French and English HTA bodies (HAS and NICE, respectively). We analyse patients' availability of ixazomib resulting in the different stages of the appraisal process. : We identified differences in the assessment, one of these being the use of an appraisal scope in England allowing the differentiation of populations and comparators according to previously approved treatments. Ixazomib became available earlier in France as part of an early access programme, but the availability was soon discontinued for newly eligible patients following an HAS determination that Ixazomib yielded no additional benefit. This opinion resulted in long pricing discussions. In England, despite the absence of an early access programme and following a process that included cost-effectiveness evaluation combined with pricing discussions, the medicine was fairly rapidly recommended for use. : Differences in the HTA process may result in appreciable differences in time from marketing authorisation to health service adoption of newly licensed drugs.
药品评估通常是一个复杂且反复的过程。我们以用于治疗多发性骨髓瘤的伊沙佐米为例,比较了英国和法国的卫生技术评估(HTA)过程。我们对分别从法国和英国的HTA机构(分别为HAS和NICE)网站上识别出的八份相关已发表文件进行了分析。我们分析了伊沙佐米在评估过程不同阶段的可及性情况。我们发现了评估过程中的差异,其中之一是英国使用评估范围,允许根据先前批准的治疗方法区分人群和对照药物。伊沙佐米作为早期准入计划的一部分,在法国更早可及,但在HAS判定伊沙佐米未产生额外益处后,新符合条件的患者很快就无法再使用该药。这一观点引发了漫长的定价讨论。在英国,尽管没有早期准入计划,且经过了包括成本效益评估和定价讨论在内的过程,但该药还是很快被推荐使用。HTA过程的差异可能导致从新药上市许可到被卫生服务采用的时间出现明显差异。