Abstract：
This study aims to provide an overview of the gaps and challenges in the value assessment of biosimilars and to identify potential approaches to address them.
A multidisciplinary, international team of biosimilar experts identified gaps and challenges. A systematic review was conducted of the peer-reviewed literature in PubMed, EMBASE, Web of Science Core Collection, EBSCOhost Business Source Complete; and of the gray literature. Preliminary results were presented at ISPOR conferences and this article benefited from 2 review rounds among ISPOR Biosimilar Special Interest Group members.
Given that a biosimilar is highly similar to its reference biologic, health technology assessment agencies should accept the comparability exercise approved by regulatory authorities and, thus, conduct a price comparison when biosimilar reimbursement is requested for the same indication as the reference biologic. If the reference biologic is not reimbursed or is not the standard of care, a full economic evaluation of the biosimilar versus a relevant comparator needs to be conducted. To date, little consideration has been given to specific challenges, such as how biosimilar value assessment can account for the nocebo effect, potential differences between biologic-naive and biologic-experienced patients, the availability of intravenous and subcutaneous administration forms or different administration devices for the same active compound, value-added services, and the contribution of biosimilars for generating health gain at the population level.
There is a need to gather further insights in the methodology of value assessment for biosimilars, and health technology assessment agencies need to develop more elaborate guidance on biosimilar value assessment in specific circumstances.
A multidisciplinary, international team of biosimilar experts identified gaps and challenges. A systematic review was conducted of the peer-reviewed literature in PubMed, EMBASE, Web of Science Core Collection, EBSCOhost Business Source Complete; and of the gray literature. Preliminary results were presented at ISPOR conferences and this article benefited from 2 review rounds among ISPOR Biosimilar Special Interest Group members.
Given that a biosimilar is highly similar to its reference biologic, health technology assessment agencies should accept the comparability exercise approved by regulatory authorities and, thus, conduct a price comparison when biosimilar reimbursement is requested for the same indication as the reference biologic. If the reference biologic is not reimbursed or is not the standard of care, a full economic evaluation of the biosimilar versus a relevant comparator needs to be conducted. To date, little consideration has been given to specific challenges, such as how biosimilar value assessment can account for the nocebo effect, potential differences between biologic-naive and biologic-experienced patients, the availability of intravenous and subcutaneous administration forms or different administration devices for the same active compound, value-added services, and the contribution of biosimilars for generating health gain at the population level.
There is a need to gather further insights in the methodology of value assessment for biosimilars, and health technology assessment agencies need to develop more elaborate guidance on biosimilar value assessment in specific circumstances.
摘要：
目的：本研究旨在概述生物仿制药价值评估中的差距和挑战，并确定解决这些问题的潜在方法。
方法：多学科，国际生物仿制药专家小组确定了差距和挑战。对PubMed的同行评审文献进行了系统回顾，EMBASE,WebofScience核心合集,EBSCOhost业务来源完整；以及灰色文献。初步结果在ISPOR会议上发表，本文受益于ISPOR生物类似药特别利益集团成员的2轮审查。
结果：鉴于生物仿制药与其参考生物学高度相似，卫生技术评估机构应接受监管机构批准的可比性工作，因此，当要求与参考生物制剂相同的适应症报销时，进行价格比较。如果参考生物制剂没有报销或不是护理标准，需要对生物仿制药与相关比较物进行全面的经济评估。迄今为止,很少考虑具体挑战，例如生物类似品价值评估如何解释nocebo效应，幼稚生物和有生物经验的患者之间的潜在差异，相同活性化合物的静脉内和皮下给药形式或不同给药装置的可用性，增值服务，以及生物仿制药在人口水平上产生健康收益的贡献。
结论：有必要收集生物仿制药价值评估方法的进一步见解，卫生技术评估机构需要在特定情况下对生物仿制药价值评估制定更详细的指导意见。
方法：多学科，国际生物仿制药专家小组确定了差距和挑战。对PubMed的同行评审文献进行了系统回顾，EMBASE,WebofScience核心合集,EBSCOhost业务来源完整；以及灰色文献。初步结果在ISPOR会议上发表，本文受益于ISPOR生物类似药特别利益集团成员的2轮审查。
结果：鉴于生物仿制药与其参考生物学高度相似，卫生技术评估机构应接受监管机构批准的可比性工作，因此，当要求与参考生物制剂相同的适应症报销时，进行价格比较。如果参考生物制剂没有报销或不是护理标准，需要对生物仿制药与相关比较物进行全面的经济评估。迄今为止,很少考虑具体挑战，例如生物类似品价值评估如何解释nocebo效应，幼稚生物和有生物经验的患者之间的潜在差异，相同活性化合物的静脉内和皮下给药形式或不同给药装置的可用性，增值服务，以及生物仿制药在人口水平上产生健康收益的贡献。
结论：有必要收集生物仿制药价值评估方法的进一步见解，卫生技术评估机构需要在特定情况下对生物仿制药价值评估制定更详细的指导意见。
