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招标与生物类似药:增值服务扮演何种角色?

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

作者信息

Simoens Steven, Cheung Raymond

机构信息

Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.

Medical Affairs, Inflammation and Immunology, Innovative Medicines Business, Pfizer Inc, New York, NY, USA.

出版信息

J Mark Access Health Policy. 2019 Dec 22;8(1):1705120. doi: 10.1080/20016689.2019.1705120. eCollection 2020.

Abstract

: 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. : 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. : 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. : 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.

摘要

在欧洲,获取生物药品(包括生物类似药)在很大程度上受卫生当局进行的招标程序的管理。在授予招标时过度依赖治疗成本有可能阻碍竞争并破坏生物类似药的长期可持续性。

为了评估在生物类似药招标中考虑“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综述。

基于调查的出版物的结果表明,生物类似药的招标做法被广泛使用,成本是成功的主要决定因素,而在适用的其他标准方面几乎没有详细信息。除价格外的标准(具有治疗和技术相关性)被纳入英夫利昔单抗(原研药和生物类似药)的一份招标规范中,而针对同一产品的另一份招标则将治疗药物监测、抗体测量和钙卫蛋白形式的增值服务纳入其中。

缺乏关于在生物类似药招标中纳入增值服务的已发表证据。制定和实施标准化的招标评估标准和方法可以避免制造商面临分割的市场,鼓励竞争和生物类似药的长期可持续性,并实现这些治疗所能带来的医疗系统和患者益处。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e894/6968494/a235412115d0/ZJMA_A_1705120_F0001_OC.jpg

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