In a recent publication in the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Report, researchers sought to provide an overview of the gaps and challenges in the value assessment of biosimilars and to find potential approaches to address them.
For this study, a multidisciplinary, international team of biosimilar experts identified gaps and challenges during a series of internal meetings involving eight members of the ISPOR Biosimilar Special Interest Group leadership team.
The authors wrote, “Shedding light on the methodology of economic evaluation for biosimilars may serve to inform future biosimilar value assessments and, ultimately, improve access to these therapies in different jurisdictions.”
The experts identified relevant scientific literature by systematically reviewing the peer-reviewed literature in PubMed, EMBASE, Web of Science Core Collection, EBSCOhost Business Source Complete, and the gray literature.
The search strategy discovered 12,473 unique records, of which 273 full-text records were integrated for data extraction, complemented with 15 records identified in the gray literature.
The authors noted that examples of predefined challenges in biosimilar value evaluations and the health economic approaches identified included the technique of economic evaluation, nocebo effect, value-added services, and health gains at the population level.
The results revealed that since available data show that a biosimilar is extremely comparable to its reference biologic, health technology assessment agencies should accept the comparability exercise approved by regulatory authorities and, therefore, perform a price comparison when biosimilar reimbursement is requested for the exact indication as the reference biologic.
The authors wrote, “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.”
They also noted, “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.”
Based on their findings, the authors concluded that obtaining additional insights in the methodology of value assessment for biosimilars is necessary, and health technology assessment agencies need to develop more intricate guidance on biosimilar value assessment in specific situations.
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