OBJECTIVES Since 2016, China has established the national price negotiation process for the inclusion of premium-cost drugs in the National Reimbursement Drug List (NRDL). Although pharmacoeconomic evidence was highlighted in the official announcement, there is no guideline on the detailed methodology. All the small-molecule protein kinase inhibitors (PKIs) included in the current NRDL went through the negotiation process. Here we aim to assess the availability of relevant pharmacoeconomic evidence.

METHODS : A targeted review of pharmacoeconomic evaluations of the 20 small-molecule PKIs listed in NRDL was conducted in CNKI, Wanfang and Yaozhi databases. Studies of interest included cost-effectiveness analyses (CEAs), cost-utility analysis (CUAs) and budget impact analyses (BIAs) published in Chinese journals.

RESULTS : Of the 139 identified studies, 92 were excluded due to irrelevant methodologies and 47 studies were included. The earliest included study was published in 2005 and 47% of the studies were published after the first price-negotiation in 2016.

Among the 20 listed small-molecule PKIs, seven (35%) did not have any published economic evidence and only four (20%) had more than five published evidence to date. Three studies conducted BIAs along with CEA, while 17%, 32% and 45% studies conducted standalone BIAs, CUAs and CEAs, respectively. The number of BIAs increased 4.5 times over the past three years. On the other hand, there was no obvious change in the number of CUAs and CEAs studies published before and after the negotiation process in 2016.

CONCLUSIONS The pharmacoeconomic evidence was optional during the past price negotiation process. Nevertheless, pharmacoeconomic researches of PKIs have been increasing in China over the last three years. Future studies are needed to demonstrate the impact of adopting economic evidence in the NRDL decision-making process in China.