Abstract

Background and Purpose: The availability of oncology biosimilars is deemed as a fundamental strategy to achieve sustainable health care. However, there is scarce systematic evidence on economic effectiveness of cancer biosimilars. We aimed to synthesize evidence from pharmacoeconomic evaluation of oncology biosimilars globally, provide essential data and methodological reference for involved stakeholders. Materials and Methods: This systematic review was conducted in PubMed, embase, the Cochrane library, CRD, ISPOR and NICE utill December 31, 2019. Information on basic characteristics, evaluation methodology and results were extracted. Quality of included studies was assessed using the Consolidated Health Economic Evaluation Reporting Standards Checklist. Results: For 17 studies identified (13 from Europe and four from United States), the overall quality was generally acceptable. A total of seven biological molecules involved with filgrastim, EPOETIN α, and trastuzumab leading the three. The mostly common evaluation perspective was payer, but the time horizon varied greatly. There were ten studies which adopted cost minimization analysis to evaluate efficiency while seven studies adopted budget impact analysis to address affordability, with cost ratio and cost saving being its corresponding primary endpoint. Although the comparability of included studies was limited and specific results were largely affected by uptake and price discount rates of the oncology biosimilar, the comprehensive results consistently favored its promotion. Conclusion: Globally, the economic evaluation of cancer biosimilars is in its initial phase. However, limited evidence from developed countries consistently supported both cost-effectiveness of efficiency and affordability of oncology biosimilars, while they were largely affected by uptake and price discount rate.

Highlights

  • With the expiration of patent and exclusivities of originator biologics worldwide, biosimilars have achieved remarkable expansion over the last decade (Schellekens et al, 2016; Huang et al, 2020)

  • A total of 17 studies were included in this study, and the detailed information is displayed in Figure 1 (Aapro et al, 2012a; Aapro et al, 2012b; Nikolaidi et al, 2013; Abraham et al, 2014; Ianotto et al, 2014; Mehta and Hay, 2014; Sun et al, 2015; Valentina et al, 2016; Bongiovanni et al, 2017; Cesarec and Likic, 2017; Gulácsi et al, 2017; McBride et al, 2017; Rognoni et al, 2018; Giuliani and Bonetti, 2019; Lee et al, 2019; Trautman et al, 2019; McBride et al, 2020)

  • In addition to six studies assessing anticancer MAB biosimilars, the other 11 studies were targeting on cancer supportive biosimilars, with seven on granulocyte colony-stimulating factor (G-CSF) and four on erythropoiesis-stimulating agents (ESA), respectively

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Summary

Introduction

With the expiration of patent and exclusivities of originator biologics worldwide, biosimilars have achieved remarkable expansion over the last decade (Schellekens et al, 2016; Huang et al, 2020). Moderate- or low-quality GRADE evidence suggested that both the anti-cancer and supportive care biosimilars could provide similar efficacy and safety profiles compared with corresponding reference biologics (Yang et al, 2019b; Yang et al, 2019a). Under the unprecedented growth of medical budget due to rapid progress of oncology biologics, the availability of oncology biosimilars is deemed as a fundamental strategy to achieve the aspiration of delivering sustainable and universal healthcare (Lyman et al, 2018). It’s of great importance to grasp an overview of available evidence on pharmacoeconomic evaluation of oncology biosimilars globally. The availability of oncology biosimilars is deemed as a fundamental strategy to achieve sustainable health care. We aimed to synthesize evidence from pharmacoeconomic evaluation of oncology biosimilars globally, provide essential data and methodological reference for involved stakeholders

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