Reporting Quality in Health Economic Evaluation Studies of Immune Checkpoint Inhibitors: A Systematic Review

Abstract

Abstract Objectives This study assessed the reporting quality of health economic evaluation (HEE) studies of immune checkpoint inhibitors (ICIs). Methods We conducted a systematic literature search of four databases (PubMed, EMBASE, Cochrane CENTRAL, and the International HTA Database) for studies published between January 1, 2014 and December 31, 2022. Three pairs of reviewers independently screened and reviewed the full text and extracted the data. We included all ICIs approved up to December 31, 2022, in the United States (US), European Union, China, and Japan. Reporting quality was assessed using the Consolidated Health Economic Evaluation Reporting Standards published in 2013 (CHEERS 2013). Subgroup analyses were also performed based on the risk of sponsorship bias or citation of CHEERS 2013. Results A total of 5,368 records were identified, 252 of which were included after full-text review. The study design, setting, and ICIs most frequently observed were cost-effectiveness and cost-utility analyses (63.5%), the US (46.0%), and pembrolizumab (38.1%), respectively. Of the 24 items of CHEERS 2013, fully reported items were limited, particularly in the Methods section. Setting and location were not reported in 94.4% of the records. Similar trends were observed in subgroup analysis. Conclusion HEE studies on ICIs between 2014 and 2022 had limited reporting across the 24 items of CHEERS 2013, regardless of sponsorship bias risk or citations. The items on setting and location in the Methods section were particularly underreported, emphasizing the need for transparent reporting in HEE studies of ICIs. Highlights The reporting quality of health economic evaluation (HEE) studies was evaluated using the Consolidated Health Economic Evaluation Reporting Standards published in 2013 (CHEERS 2013). However, the reporting quality of HEEs of immune checkpoint inhibitors (ICIs), which is an emerging health policy issue for the economic burden of cancer, remains unknown. Despite the passage of a decade since the publication of CHEERS 2013, HEE studies on ICIs have generally not fully adhered to the CHEERS 2013 guidelines in the Methods section. This is particularly evident in the setting and location items, even after stratification by the presence or absence of risk of sponsorship bias or whether CHEERS 2013 statement was cited. This study highlights the insufficient reporting of CHEERS items among current HEE studies of ICIs, especially in the Methods section, to researchers who conduct HEE studies of ICIs, and informs policymakers and stakeholders who refer to HEE studies of ICIs about underreporting.