Clinical and Economic Value of a Biosimilar Portfolio to Stakeholders: An Integrative Literature Review

Grace Fox, Mark Bernauer, Jennifer Stephens, Bianca Jackson, Joshua Roth, A. Shelbaya
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Abstract

Purpose: While the value of individual biosimilars is evident, little is known about the value of a biosimilar portfolio beyond the cost savings between biosimilars and originators. Stakeholders may consider the value of a manufacturer’s biosimilar portfolio, especially when negotiating portfolio-based contracts or other rebate programs. However, little is known about what other types of value, in addition to financial benefits, decision-makers perceive regarding a manufacturer with a biosimilar portfolio compared to those without one. The objective of this integrative literature review was to describe a conceptual framework consisting of themes that may help define the value of a biosimilar portfolio. Methods: An integrative literature review was conducted using Excerpta Medica Database (Embase) and Medical Literature Analysis and Retrieval System Online (MEDLINE). Grey literature searches of search engines, journals not indexed in Embase or MEDLINE, healthcare payers, health technology assessment bodies, value frameworks, and non-pharmaceutical industry analogs were also conducted. Eligible studies reported on the value of a biosimilar portfolio in decision-making by stakeholders. Apart from the literature, insights were gained from clinical experience and observation. Results: No studies investigating biosimilar portfolio value were identified; however, several themes were identified that may help define the value of a biosimilar portfolio: Manufacturing; procurement, inventory, and storage; administration; education; and transaction costs. Several non-pharmaceutical industry analogs were identified: Product line length and single-supplier versus multiple-supplier procurement. Several themes were identified through other sources: Science credibility and research. Based on these themes, we developed a conceptual framework for biosimilar portfolio value. Conclusion: To our knowledge, this is the first study to systematically assess and create a framework for biosimilar portfolio value. The conceptual framework described here could be tested to quantify the clinical and economic value associated with a biosimilar portfolio.
生物仿制药组合对利益相关者的临床和经济价值:综合文献综述
目的:虽然单个生物仿制药的价值显而易见,但除了生物仿制药与原研药之间的成本节约之外,人们对生物仿制药组合的价值知之甚少。利益相关者可能会考虑制造商的生物仿制药组合的价值,尤其是在谈判基于组合的合同或其他回扣计划时。然而,除了经济利益外,决策者对拥有生物仿制药组合的生产商与没有生物仿制药组合的生产商相比还有哪些其他类型的价值却知之甚少。本综合文献综述的目的是描述一个概念框架,该框架由有助于定义生物类似药组合价值的主题组成。方法:使用Excerpta Medica数据库(Embase)和医学文献分析与检索系统在线版(MEDLINE)进行了综合文献综述。此外,还对搜索引擎、Embase 或 MEDLINE 未收录的期刊、医疗支付机构、卫生技术评估机构、价值框架以及非制药行业类似物进行了灰色文献检索。符合条件的研究报告了生物仿制药组合在利益相关者决策中的价值。除文献外,还从临床经验和观察中获得了一些见解。研究结果未发现对生物类似药组合价值进行调查的研究;但发现了几个有助于界定生物类似药组合价值的主题:制造;采购、库存和储存;管理;教育;以及交易成本。确定了几个非制药行业的类似物:产品线长度和单一供应商采购与多个供应商采购。通过其他来源确定了几个主题:科学可信度和研究。基于这些主题,我们制定了生物仿制药组合价值的概念框架。结论:据我们所知,这是第一项系统评估和创建生物类似药组合价值框架的研究。本文所述的概念框架可用于量化生物类似药组合的相关临床和经济价值。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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