Impact of China Guidelines for Pharmacoeconomic Evaluations on study quality: a systematic review of economic evaluations in China

Objective Given the critical role of pharmacoeconomics in supporting decision-making and the urgent need to address the study quality of economic evaluations (EEs), this study aimed to analyse whether the China Guidelines for Pharmacoeconomic Evaluations (China PE Guidelines, 4 versions) improved the study quality of EEs and summarize existing methodological issues of EEs in China. Methods We searched 4 Chinese databases (China National Knowledge Infrastructure, Wanfang Database, VIP Database, and China Biology Medicine disc) and included original EEs since 2016 in China. The quality assessment included 6 dimensions and was conducted using the framework of China PE Guidelines 2020. Study quality was compared between studies referencing and not referencing the China PE Guidelines, studies published before and after the China PE Guidelines 2020, and traditional Chinese medicine (TCM) and non-TCM studies. Results A total of 3,046 studies were included. Most studies did not report the study perspective (76.8%). Individual-level data-based studies were the most common type (75.0%), with the characteristic of a short time horizon. There were 2,044 studies reporting time horizon, and 437 studies reported discounting rate among 722 studies with time horizon longer than 1 year. And 2,484 studies measured direct cost only. Clinical outcomes and patient-reported outcomes were the most commonly used primary outcomes (81.5%). Most of cost-effectiveness analysis was used (71.4%), and approximately half of the studies did not conduct incremental analysis or uncertainty analysis (52.6% and 55.6%, respectively). The quality of studies referencing any of the 4 China PE Guidelines (435 studies) was better in all six assessment dimensions, and the study quality improved after the release of China PE Guidelines 2020 (686 studies) in most included dimensions. Whether before or after the release of the China PE Guidelines 2020, the quality of TCM studies (459 studies) was better than that of non-TCM studies (2587 studies). Conclusions China PE Guidelines have improved the study quality of EEs in China. To better support decision-making, the quality of EE remains to be improved, especially in terms of the study perspective, time horizon, cost identification scope and discounting aspects.