招标和生物仿制药:增值服务扮演什么角色?

Q2 Medicine
Journal of market access & health policy Pub Date : 2019-12-22 eCollection Date: 2020-01-01 DOI:10.1080/20016689.2019.1705120
Steven Simoens, Raymond Cheung
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引用次数: 16

摘要

背景:整个欧洲生物药物(包括生物仿制药)的获取在很大程度上由卫生当局进行招标。在招标中过度依赖治疗费用有可能阻碍竞争,破坏生物仿制药的长期可持续性。目的:为了评估在生物仿制药招标中考虑“增值服务”(VAS)的程度和影响,我们对已发表的文献进行了叙述性回顾。结果:基于调查的出版物的调查结果表明,生物仿制药的招标做法被广泛使用,成本是成功的主要决定因素,而其他适用标准的细节很少。英夫利昔单抗(原药和生物仿制药)的招标规范包括价格以外的标准(治疗和技术利益),而同一产品的单独招标包括治疗药物监测、抗体测量和钙保护蛋白形式的VAS。结论:缺乏关于将VAS纳入生物仿制药招标的公开证据。制定和实施标准化的招标标准和评估方法可以避免制造商面临细分市场,鼓励竞争和生物仿制药的长期可持续性,并实现这些治疗方法可以带来的医疗保健系统和患者利益。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Tendering and biosimilars: what role for value-added services?

Tendering and biosimilars: what role for value-added services?

Tendering and biosimilars: what role for value-added services?

Background: Access to biologic medicines (including biosimilars) across Europe is largely governed by a process of tendering conducted by health authorities. Over-reliance on treatment costs in awarding tenders has the potential to hinder competition and undermine the long-term sustainability of biosimilars. Objective: To assess the extent and impact of consideration of 'value-added services' (VAS) in tendering for biosimilars, we conducted a narrative review of published literature. Results: Findings from survey-based publications indicated that tendering practices for biosimilars are widely used, with cost being the main determinant of success and little detail being available on other criteria where these apply. Criteria (of therapeutic and technical interest) beyond price were included in one tendering specification for infliximab (originator and biosimilars), while a separate tender for the same product included VAS in the form of therapeutic drug monitoring, measurement of antibodies and calprotectin. Conclusions: Published evidence concerning inclusion of VAS in tendering for biosimilars is lacking. Development and implementation of standardized criteria and methods of assessment for tenders may avoid manufacturers facing segmented markets, encourage competition and the longer-term sustainability of biosimilars, and realize the healthcare system and patient benefits these treatments can bring.

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来源期刊
CiteScore
4.90
自引率
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