Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
Hospital Pharmacy, Zuyderland Medical Center, Heerlen, the Netherlands.
Am J Health Syst Pharm. 2022 Nov 7;79(22):2001-2011. doi: 10.1093/ajhp/zxac235.
With the growing availability of biosimilars on the global market, clinicians and pharmacists have multiple off-patent biological products to choose from. Besides the competitiveness of the product's price, other criteria should be considered when selecting a best-value biological. This article aims to provide a model to facilitate transparent best-value biological selection in the off-patent biological medicines segment.
The presented model was developed on the basis of established multicriteria decision analysis tools for rational and transparent medicine selection, ie, the System of Objectified Judgement Analysis and InforMatrix. Criteria for the model were informed by earlier research, a literature search, and evaluation by the authors. The developed model includes up-to-date guidance on criteria that can be considered in selection and provides background on the allocation of weights that may aid hospital pharmacists and clinicians with decision-making in practice. Three main categories of criteria besides price were identified and included in the model: (1) product-driven criteria, (2) service-driven criteria, and (3) patient-driven criteria. Product-driven criteria include technical product features and licensed therapeutic indications. Service-driven criteria consist of supply conditions, value-added services, and environment and sustainability criteria. Patient-driven criteria contain product administration elements such as ease of use and service elements such as patient support programs. Relative weighting of the criteria is largely context dependent and should in a given setting be determined at the beginning of the process.
The practical model described here may support hospital pharmacists and clinicians with transparent and evidence-based best-value biological selection in clinical practice.
随着生物类似药在全球市场上的供应不断增加,临床医生和药剂师有多种专利过期的生物产品可供选择。除了产品价格的竞争力外,选择最佳价值生物制剂时还应考虑其他标准。本文旨在提供一个模型,以促进专利过期生物药物领域中透明的最佳价值生物制剂选择。
所提出的模型是基于合理透明的药物选择的多标准决策分析工具(即客观判断分析系统和 InforMatrix)开发的。该模型的标准来自早期研究、文献检索和作者评估。该模型包括了在选择中可以考虑的最新标准指南,并提供了分配权重的背景信息,这可能有助于医院药剂师和临床医生在实践中做出决策。除了价格外,还确定并纳入了三个主要类别的标准:(1)产品驱动标准,(2)服务驱动标准和(3)患者驱动标准。产品驱动标准包括技术产品特性和许可治疗适应症。服务驱动标准包括供应条件、增值服务以及环境和可持续性标准。患者驱动标准包含产品管理要素,如易用性和服务要素,如患者支持计划。标准的相对权重在很大程度上取决于背景,在给定的情况下,应在该过程开始时确定。
这里描述的实用模型可以支持医院药剂师和临床医生在临床实践中进行透明且基于证据的最佳价值生物制剂选择。