Cook John W, McGrath Megan K, Dixon Margie D, Switchenko Jeffrey M, Harvey R Donald, Pentz Rebecca D
Winship Cancer Institute, School of Medicine, Emory University, Atlanta, GA, USA.
Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, USA.
Ther Adv Med Oncol. 2019 Jan 6;11:1758835918818335. doi: 10.1177/1758835918818335. eCollection 2019.
With increasing numbers of oncology biosimilars in the approval pipeline, it is important to investigate oncology clinicians' understanding of biosimilars and what information they need prior to adoption.
Between January and May 2018, 77 oncology clinicians (52 physicians, 16 pharmacists, and 9 advanced practice providers) completed a survey covering three domains: clinician understanding, prescription preferences, and patient involvement. An in-depth interview was designed based on themes identified in the first 50 surveys: cost, safety and efficacy, patient preference, and disease stage. Participants were chosen to participate in the interview based on outlying responses to survey questions.
When asked to define a biosimilar, 74% (57/77) of respondents could not give a satisfactory definition, and 40.3% (31/77) considered a biosimilar the same as a generic drug. The most important factor in biosimilar prescription was safety and efficacy (4.51 out of 5) followed closely by cost differences (4.34 out of 5). A 40% increase (53.2-94.8%) in clinicians' prescribing likelihood was seen after a biosimilar is designated as interchangeable. Participants in this study were split regarding the importance of shared decision-making with patients [50.7% (39/77) important or extremely important, 39.0% (30/77) somewhat or not at all important]. Clinicians were also split concerning the role that pharmacists should play in the decision to prescribe or substitute biosimilars.
Understanding of biosimilars is low, and educational needs are high. The information that clinicians deem important to assess, such as safety, efficacy and cost, will need to be provided before they are comfortable prescribing biosimilars.
随着越来越多的肿瘤生物类似药进入审批流程,调查肿瘤临床医生对生物类似药的理解以及他们在采用之前需要哪些信息变得很重要。
在2018年1月至5月期间,77名肿瘤临床医生(52名医生、16名药剂师和9名高级执业人员)完成了一项涵盖三个领域的调查:临床医生的理解、处方偏好和患者参与度。基于在前50份调查问卷中确定的主题设计了一次深入访谈:成本、安全性和有效性、患者偏好以及疾病阶段。根据对调查问卷问题的异常回答选择参与者参加访谈。
当被要求定义生物类似药时,74%(57/77)的受访者无法给出令人满意的定义,40.3%(31/77)的受访者认为生物类似药与仿制药相同。生物类似药处方中最重要的因素是安全性和有效性(5分制中得4.51分),紧随其后的是成本差异(5分制中得4.34分)。在一种生物类似药被指定为可互换后,临床医生的处方可能性增加了40%(从53.2%增至94.8%)。本研究中的参与者在与患者共同决策的重要性方面存在分歧[50.7%(39/77)认为重要或极其重要,39.0%(30/77)认为有点重要或根本不重要]。临床医生在药剂师在生物类似药处方或替代决策中应扮演的角色方面也存在分歧。
对生物类似药的理解较低,教育需求较高。在临床医生放心开具生物类似药之前,需要提供他们认为评估时重要的信息,如安全性、有效性和成本。