BACKGROUND:Health technology assessment (HTA) should provide an assessment of a technology's effects on health and of the related social, economic, organisational and ethical issues. HTA reports on biosimilars can specifically assess their immunogenicity, their extrapolation to one or more conditions, and the risks of interchangeability and substitution. We aimed to complete a scoping review within the context of HTA organisations to synthesise HTA reports on biosimilars and to map the extension, scope and methodological practices. MAIN BODY:A scoping review methodology was applied. The sources for biosimilars HTA reports were database searches and grey literature from HTA organisation websites up to June 2019. HTA reports of biosimilars were classified as full HTA, mini-HTA or rapid reviews. Data were extracted and recorded on a calibrated predefined data form. We identified 70 HTA reports of biosimilars of 16 biologic products (65.71% in 2015-2018) produced by 13 HTA organisations from 10 countries; 2 full HTAs, 4 mini-HTAs and 64 rapid reviews met the inclusion criteria. Almost all the rapid reviews gave no information regarding any evidence synthesis method and approximately half of the rapid reviews did not appraise the risk of bias of primary studies or the overall quality of evidence. All full-HTAs and mini-HTAs addressed organisational, ethical, social and legal considerations, while these factors were assessed in less than half of the rapid reviews. The immunogenicity and extrapolation of one or more conditions were often considered. The majority of full-HTAs and mini-HTAs contained an assessment of switching and a discussion of an educational approach about biosimilars. No HTA report rejected the adoption/reimbursement of the biosimilar assessed. CONCLUSION:HTA of biosimilars are emerging in the context of HTA organisations and those that exist often duplicate reports of the same biosimilar. Most HTA reports of biosimilars do not conduct a systematic literature review or consider economic issues. No report has rejected the adoption/reimbursement of biosimilars. There is a need to standardise the minimum criteria for the development of HTA on biosimilars to ensure a better understanding and better decision-making.

译文

背景:卫生技术评估(HTA)应该提供对技术对健康的影响以及相关的社会,经济,组织和道德问题的评估。关于生物仿制药的HTA报告可以专门评估其免疫原性,将其推导至一种或多种条件以及可互换和替代的风险。我们的目标是在HTA组织范围内完成范围界定审查,以合成有关生物仿制药的HTA报告,并绘制其扩展名,范围和方法实践。
主体:采用了范围界定审查方法。截至2019年6月,生物仿制药HTA报告的来源是来自HTA组织网站的数据库搜索和灰色文献。生物仿制药的HTA报告被分类为完整HTA,小型HTA或快速评论。提取数据并将其记录在已校准的预定义数据表格中。我们确定了70个来自10个国家的13个HTA组织生产的16种生物制品的生物仿制药的HTA报告(2015-2018年为65.71%); 2个完整的HTA,4个小型HTA和64个快速审核符合纳入标准。几乎所有的快速评论都没有提供有关任何证据合成方法的信息,并且大约一半的快速评论都没有评估偏倚于基础研究或整体证据质量的风险。所有完整的HTA和小型HTA都针对组织,道德,社会和法律方面的考虑,而在不到一半的快速评估中对这些因素进行了评估。通常考虑一种或多种条件的免疫原性和外推法。完整的HTAs和迷你HTA大多包含转换评估和有关生物仿制药的教育方法的讨论。没有HTA报告拒绝接受所评估的生物仿制药的报销。
结论:生物仿制药的HTA是在HTA组织的背景下出现的,并且存在的生物仿制药经常重复相同生物仿制药的报道。关于生物仿制药的大多数HTA报告都没有进行系统的文献综述或考虑经济问题。没有报告拒绝采用/偿还生物仿制药。有必要标准化开发生物仿制药HTA的最低标准,以确保更好的理解和更好的决策。

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