Barbier Liese, Simoens Steven, Declerck Paul, Vulto Arnold G, Huys Isabelle
Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
Hospital Pharmacy, Erasmus University Medical Center, Rotterdam, Netherlands.
Front Pharmacol. 2022 Jul 12;13:821616. doi: 10.3389/fphar.2022.821616. eCollection 2022.
By improving the affordability and accessibility of biologicals, biosimilar competition provides important benefits to healthcare systems and patients. In Belgium, biosimilar uptake and competition is limited compared to other European markets. Whereas other countries have initiated structured biosimilar introduction or switching plans, no such framework or guiding principles are yet available in Belgium. This study aims to develop recommendations that can inform policy action in Belgium on biosimilar use, especially in the context of switch decision-making, and this by drawing from the perspectives of healthcare professionals involved in procuring, prescribing, switching and dispensing biologicals including biosimilars. This study made use of the consensus-building Nominal Group Technique, consisting of a three-step process 1) individual grading, 2) three structured Focus Group Discussions, 3) final individual grading involving an expert group of Belgian healthcare professionals (physician specialists and hospital pharmacists). Participants ( = 13) voiced challenges with the use of biosimilars and switching in practice, and a lack of incentives to use them. Six concrete areas for policy development to support stakeholders with biosimilar use and switch decision-making were identified: 1) address stakeholder hesitations regarding (multiple) switching, 2) provide meaningful incentives, 3) guide healthcare professionals with product decision-making, 4), align practical product modalities when possible, 5) involve healthcare professionals in policy making, and 6) provide practical switch support and patient information material, particularly in the ambulatory care setting. For each area, specific consensus-based recommendations were developed. Furthermore, a set of switch management and patient communication principles was derived, including amongst others, generating buy-in from involved stakeholders prior to switching and communicating with a one-voice message. Without cohesive actions to reduce hurdles and without tangible benefits or steering mechanisms, changes in biosimilar use are unlikely in Belgium. To overcome this and stimulate market competitiveness, this study advances a set of concrete policy recommendations. At large, policy makers should develop an integrated policy framework, with a pro-active, best-value biological implementation roadmap that provides guidance and compelling measures to incentivize healthcare professionals to use biosimilars. Particular consideration should go to the ambulatory care setting, since drivers for biosimilar use are quasi absent in this context.
通过提高生物制品的可承受性和可及性，生物类似药竞争为医疗保健系统和患者带来了重要益处。在比利时，与其他欧洲市场相比，生物类似药的采用和竞争有限。其他国家已启动了结构化的生物类似药引入或转换计划，但比利时尚未有此类框架或指导原则。本研究旨在提出建议，为比利时生物类似药使用方面的政策行动提供参考，特别是在转换决策的背景下，通过借鉴参与生物制品（包括生物类似药）采购、开处方、转换和配药的医疗保健专业人员的观点来实现。本研究采用了达成共识的名义小组技术，该技术包括三个步骤：1）个人评分；2）三场结构化焦点小组讨论；3）最终个人评分，涉及比利时医疗保健专业人员（内科专科医生和医院药剂师）专家组。13名参与者表达了在实际使用生物类似药和进行转换时遇到的挑战，以及缺乏使用生物类似药的激励措施。确定了六个具体的政策制定领域，以支持利益相关者进行生物类似药使用和转换决策：1）解决利益相关者对（多次）转换的犹豫；2）提供有意义的激励措施；3）指导医疗保健专业人员进行产品决策；4）尽可能统一实际产品模式；5）让医疗保健专业人员参与政策制定；6）提供实际的转换支持和患者信息材料，特别是在门诊护理环境中。针对每个领域，制定了基于共识的具体建议。此外，还得出了一套转换管理和患者沟通原则，其中包括在转换前获得相关利益者的认可并以一致的信息进行沟通等。如果没有采取凝聚性行动来减少障碍，没有切实的利益或指导机制，比利时生物类似药的使用变化不太可能发生。为克服这一问题并刺激市场竞争力，本研究提出了一套具体的政策建议。总体而言，政策制定者应制定一个综合政策框架，制定一个积极主动、具有最佳价值的生物制品实施路线图，提供指导和有力措施，激励医疗保健专业人员使用生物类似药。应特别考虑门诊护理环境，因为在这种情况下几乎没有使用生物类似药的驱动因素。
