School of Epidemiology and Public Health, University of Ottawa, Room 101, 600 Peter Morand Crescent, Ottawa, ON, K1G 5Z3, Canada.
Robarts Clinical Trials, Robarts Research, University of Western Ontario, London, Canada.
Appl Health Econ Health Policy. 2018 Jun;16(3):279-288. doi: 10.1007/s40258-018-0371-0.
Biosimilars are becoming increasingly available internationally as patents expire on the originator biologic drugs they are intended to copy. Although substitution policies seen with generic drugs are being considered as a means to reduce expenditures on biologics, some biosimilars pose particular challenges in that the act of substitution may eventually lead to increased rates of therapeutic failure. As evidence requirements from regulators do not directly address this challenge, switch trials of biosimilars have emerged that may provide further answers. Using infliximab in inflammatory bowel disease as an example, we critically examine emerging evidence from two key switch trials (NOR-SWITCH and NCT020968610) and discuss the clinical and economic implications of these and what policy options may be most reasonable for payers. Options include reimbursing biosimilars for only newly diagnosed patients, using product-listing agreements to manage uncertainty, or using tiered co-payments or other incentives to promote biosimilar use.
生物类似药在国际上的可获得性越来越高，因为它们旨在复制的原创生物药物的专利已经到期。虽然正在考虑采用仿制药的替代政策来降低生物制剂的支出，但某些生物类似药带来了特殊的挑战，因为替代行为最终可能导致治疗失败的发生率增加。由于监管机构的证据要求并没有直接解决这一挑战，因此出现了生物类似药的转换试验，这些试验可能会提供更多的答案。我们以炎症性肠病中的英夫利昔单抗为例，批判性地审查了两项关键转换试验（NOR-SWITCH 和 NCT020968610）中的新出现证据，并讨论了这些证据的临床和经济意义，以及对于支付方来说哪些政策选择可能是最合理的。这些选择包括仅为新诊断的患者报销生物类似药，使用产品清单协议来管理不确定性，或使用分级共付额或其他激励措施来促进生物类似药的使用。
