Center for Bioethics and Social Sciences in Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.
Health Services Research and Development Center of Clinical Management Research, VHA Ann Arbor, Ann Arbor, MI, USA.
BMC Health Serv Res. 2024 Oct 9;24(1):1209. doi: 10.1186/s12913-024-11570-3.
Biosimilars are highly similar, but not identical, versions of originator biologic medications. Switching patients to biosimilars presents an opportunity to mitigate rising drug costs and expand patient access to important biologic therapies. However, decreased patient acceptance and adherence to biosimilar medications have been reported, which can lead to loss of treatment response, adverse reactions, and inefficient resource utilization. Understanding patient perceptions of biosimilars and biosimilar switching is needed to inform patient-centered care strategies that promote efficient resource utilization.
We used democratic deliberation methods to solicit the informed and considered opinions of patients regarding biosimilar switching. Patients with inflammatory bowel disease (IBD; n = 29) from the Veterans Health Administration (VHA) participated in 5-hour deliberation sessions over two days. Following educational presentations with experts, participants engaged in facilitated small group discussions. Transcripts and facilitators' notes were used to identify key themes. Participants completed surveys pre- and post-deliberation to collect sociodemographic and clinical features as well as to assess IBD treatment knowledge and attitudes toward care and approaches to biosimilar switching.
Five major themes emerged from the small group discussions in the context of biosimilar switching: 1) concerns about adverse consequences and unclear risk-benefit balance; (2) importance of communication and transparency; (3) desire for shared decision making and patient involvement in treatment decisions; (4) balancing cost-saving with competing priorities; and (5) advocating for individualized care and prioritization based on risk levels. These views led participants to favor approaches that prioritize switching the sickest patients last (i.e., those with poorly controlled disease) and that offer patients control and choices around biosimilar switching. Participants also expressed preferences for combining elements of different approaches to maximize fairness.
Approaches to biosimilar switching should consider patients' desires for transparency and effective communication about biosimilar switching and engagement in their medical decision-making as part of patient-centered care. Incorporating patient preferences around biosimilar switching is critical when navigating the quality and affordability of care in resource constrained settings, both within the VHA and in other healthcare systems.
生物类似药与原创生物药物高度相似，但并非完全相同。将患者转用生物类似药为降低药物成本和扩大患者获得重要生物治疗的机会提供了契机。然而，据报道，患者对生物类似药的接受度和依从性有所下降，这可能导致治疗反应丧失、不良反应和资源利用效率低下。了解患者对生物类似药和生物类似药转换的看法，对于制定以患者为中心的护理策略以促进资源利用效率至关重要。
我们使用民主审议方法征求患者对生物类似药转换的意见。退伍军人健康管理局（VA）的炎症性肠病（IBD）患者（n=29）参加了为期两天的 5 小时审议会议。在专家进行教育介绍后，参与者进行了小组讨论。使用转录本和协调员的笔记来确定主要主题。参与者在审议前后完成了调查，以收集社会人口统计学和临床特征，以及评估 IBD 治疗知识以及对护理的态度和对生物类似药转换的方法。
在生物类似药转换的背景下，从小组讨论中出现了五个主要主题：1）对不良后果和不清楚的风险效益平衡的担忧；2）沟通和透明度的重要性；3）共同决策和患者参与治疗决策的愿望；4）平衡节省成本与竞争优先事项；5）倡导基于风险水平的个体化护理和优先级。这些观点使参与者倾向于优先考虑最后转换病情最严重的患者（即疾病控制不佳的患者），并为患者提供对生物类似药转换的控制和选择。参与者还表示，他们希望结合不同方法的元素，以最大限度地实现公平。
生物类似药转换方法应考虑患者对生物类似药转换的透明度和有效沟通以及参与其医疗决策的愿望，作为以患者为中心的护理的一部分。在资源有限的环境中，无论是在 VA 内还是在其他医疗保健系统中，在考虑护理的质量和可负担性时，纳入患者对生物类似药转换的偏好至关重要。
