■虽然单个生物仿制药的价值是显而易见的,除了生物仿制药和发起人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。利益相关者可以考虑制造商的生物仿制药组合的价值,特别是在谈判基于投资组合的合同或其他返利计划时。然而,对其他类型的价值知之甚少,除了经济利益,决策者认为,与没有生物类似药的制造商相比,有生物类似药的制造商。这篇综合文献综述的目的是描述一个由主题组成的概念框架,这些主题可能有助于定义生物仿制药组合的价值。
■使用ExcerptaMedica数据库(Embase)和在线医学文献分析和检索系统(MEDLINE)进行了综合文献综述。搜索引擎的灰色文献检索,未在Embase或MEDLINE中索引的期刊,医疗保健支付者,卫生技术评估机构,价值框架,和非制药工业类似物也进行了。合格的研究报告了生物类似药组合在利益相关者决策中的价值。除了文学,从临床经验和观察中获得了见解。
■没有确定调查生物仿制药组合价值的研究;然而,确定了几个主题,这些主题可能有助于定义生物仿制药组合的价值:制造;采购,库存,和存储;管理;教育;和交易成本。确定了几种非制药行业类似物:产品线长度和单个供应商与多个供应商的采购。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,我们建立了生物类似药组合价值的概念框架。
■据我们所知,这是第一项系统评估和建立生物仿制药组合价值框架的研究。可以测试此处描述的概念框架,以量化与生物仿制药组合相关的临床和经济价值。
虽然单一生物仿制药的价值是显而易见的,除了生物仿制药和鼻祖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。我们确定了七个主题,可能有助于定义生物仿制药组合的价值:制造;采购,库存,和存储;管理;教育;交易成本;科学可信度;和研究。这些主题可以整合到一个概念框架中,该概念框架可以构成一个基础,以帮助量化生物仿制药组合对利益相关者的临床和经济效益。
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
Though the
value of single biosimilars is evident, little is known about the
value of a biosimilar portfolio beyond the cost savings incurred between biosimilars and originators.We identified seven themes that may help to define the value of a biosimilar portfolio: Manufacturing; procurement, inventory, and storage; administration; education; transaction costs; science credibility; and research.These themes may be integrated into a conceptual framework that may form a basis to help quantify the clinical and economic benefit of a biosimilar portfolio to stakeholders.