Igarashi A, Tanaka S, De Moor R, Li N, Hirozane M, Wu DB, Hong LW, Yu DY, Hashim M, Hutton B, Tantakoun K, Olsen C, Fashami FM, Samjoo IA, and Cameron C
Introduction: Indirect treatment comparisons (ITCs) evaluate novel treatments compared to appropriate comparators when direct evidence is unavailable or infeasible. The objective of this study was to highlight the prevalence of different ITC methods in oncology drug submissions and to provide insights into how ITCs have been used in recent regulatory approval, reimbursement recommendations, or pricing decisions across various regions and diverse assessment frameworks., Methods: A targeted literature review was conducted to identify assessment documents for oncology drug submissions that included ITCs. This included hand searches of the websites of four regulatory bodies and four health technology assessment (HTA) agencies with varying assessment frameworks across North America, Europe, and Asia-Pacific., Results: A total of 185 documents were included for synthesis. Documents were retrieved from all four HTA agencies and the European Medicines Agency (EMA), the only regulatory body with eligible records. Within these, 188 unique submissions included a total of 306 supporting ITCs of various methods. Authorities more frequently favored anchored or population-adjusted ITC techniques for their effectiveness in data adjustment and bias mitigation. Furthermore, ITCs in orphan drug submissions more frequently led to positive decisions compared to non-orphan submissions., Conclusions: This review highlights the crucial role and widespread use of ITCs in global healthcare decision-making, particularly when direct evidence is lacking, and in the discernment of market-specific clinical benefits. This work contributes to bolstering the credibility and recognition of ITCs across regulatory and HTA agencies of diverse regions and assessment frameworks., Competing Interests: Declarations Conflict of Interest Ataru Igarashi received consulting fees from PhRMA Japan, JPMA, EFPIA Japan, Janssen, Eli Lilly Japan K.K., Shionogi & Co. Ltd., Takeda Pharmaceuticals, Novo Nordisk Japan, Eisai Japan, Medtronic Japan, Chugai Pharmaceuticals, Edwards LifeScience, GSK Japan. Ataru Igarashi received collaborative research funds from Moderna Japan Inc, Taiho Yakuhin, Otsuka Pharmaceuticals, Intuitive Surgical Inc. Shiro Tanaka has received lecture fee from MSD K.K. and Datack. He has received consultation fee and outsourcing fee from Daiichi Sankyo Company, Limited, Janssen Pharmaceutical K.K., and Public Health Research Foundation. He has received a research grant from Novo Nordisk. De Moor Raf, Li Nan, and Hirozane Mariko are employees of Janssen Pharmaceutical K.K. Wu David Bin-Chia, Hong Li Wen, and Yu Dae Young are employees of Janssen Pharmaceutical Companies of Johnson and Johnson Asia Pacific Regional Office Singapore. Mahmoud Hashim is an employee of Janssen Vaccines & Prevention B.V. in the Netherlands. De Moor Raf, Li Nan, and Hirozane Mariko have stock or stock options of Johnson & Johnson. Brian Hutton has previously received honoraria from EVERSANA™ and Evidinno Outcomes Inc. for the provision of methodologic advice related to systematic reviews, meta-analyses, and indirect comparisons. Krista Tantakoun, Christopher Olsen, Fatemeh Mirzayeh Fashami, Imtiaz Samjoo, and Chris Cameron are employees of EVERSANA™, which was a paid consultant to Janssen Pharmaceutical K.K. in connection with the development of this manuscript; Chris Cameron is also a shareholder of EVERSANA™. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Ethical Approval This article is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors., (© 2024. The Author(s).)