Practical challenges and considerations in adopting biosimilars in oncology clinical practice within a large healthcare system.

IF 3.6 3区 医学 Q2 PHARMACOLOGY & PHARMACY
Mansoor A Khan, Laila Carolina Abu Esba, Consuela Cheriece Yousef, Mohammed Alharbi, Hind Modaimegh, Hend Metwali, Hana Abdulkarim, Majed Alshamrani, Mohamad Aseeri, Mubarak Almansour, Ahmad Alsaeed, Mousa Alahmari, Anjum Naeem Ansari, Meteb Alfoheidi, Ahmed Absi, Turki Alfayea, Eman Youssif, Ayman Alhejazi, Mansour Alodhaib
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Abstract

Introduction: Biosimilars have the potential to offer cost savings with comparable efficacy and safety to innovator products and, thus, increase access to treatment for more patients. However, there were significant challenges in the acceptance of oncology biosimilars in our organization in the beginning which we addressed by implementing practical strategies described in the paper.

Areas covered: While much of the published literature places an emphasis on the pharmacoeconomic impact of biosimilars, this paper is a novel addition to the literature because it provides practical experience and detailed processes for the formulary adoption and implementation of oncology biosimilars along with a focus on their pharmacoeconomic impact, education of oncology healthcare professionals, pharmacovigilance, and integration into the electronic health record. A narrative literature review was conducted to identify the existing evidence on biosimilar adoption and implementation in the oncology setting.

Expert opinion: Healthcare organizations must establish a consistent method for assessing and adopting oncology biosimilars to increase efficiency and coordination among the many team members responsible for their introduction into clinical practice. Conducting medication use evaluations and real-world evidence studies of biosimilars can help in building trust among healthcare professionals and patients in biosimilars.

实际的挑战和考虑采用生物仿制药在肿瘤临床实践中的大型医疗保健系统。
生物仿制药有潜力提供与创新产品相当的疗效和安全性的成本节约,从而增加更多患者获得治疗的机会。然而,在我们的组织中接受肿瘤生物仿制药在开始时存在重大挑战,我们通过实施论文中描述的实际策略来解决这些挑战。所涵盖的领域:虽然许多已发表的文献都强调生物仿制药的药物经济学影响,但本文是文献的一个新颖补充,因为它为肿瘤生物仿制药的处方采用和实施提供了实践经验和详细的过程,并重点介绍了它们的药物经济学影响、肿瘤医疗保健专业人员的教育、药物警戒和整合到电子健康记录中。我们进行了一项叙述性文献综述,以确定肿瘤环境中生物仿制药采用和实施的现有证据。专家意见:医疗保健组织必须建立一致的方法来评估和采用肿瘤生物仿制药,以提高将其引入临床实践的许多团队成员之间的效率和协调。进行药物使用评估和生物仿制药的真实世界证据研究有助于在医疗保健专业人员和患者之间建立对生物仿制药的信任。
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来源期刊
Expert Review of Clinical Pharmacology
Expert Review of Clinical Pharmacology PHARMACOLOGY & PHARMACY-
CiteScore
7.30
自引率
2.30%
发文量
127
期刊介绍: Advances in drug development technologies are yielding innovative new therapies, from potentially lifesaving medicines to lifestyle products. In recent years, however, the cost of developing new drugs has soared, and concerns over drug resistance and pharmacoeconomics have come to the fore. Adverse reactions experienced at the clinical trial level serve as a constant reminder of the importance of rigorous safety and toxicity testing. Furthermore the advent of pharmacogenomics and ‘individualized’ approaches to therapy will demand a fresh approach to drug evaluation and healthcare delivery. Clinical Pharmacology provides an essential role in integrating the expertise of all of the specialists and players who are active in meeting such challenges in modern biomedical practice.
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