Abstract
OBJECTIVE: National Reimbursement Drug Price Negotiation (NRDPN) refers to a government-led process of negotiating with pharmaceutical companies to reach reasonable prices for exclusive drugs covered by national reimbursement. Since 2016, the Chinese government has regularly implemented eight rounds of NRDPN. This systematic review aimed to determine the effects of NRDPN on drug price, availability, affordability, utilization, cost, and health outcomes in China in the years 2016-2023. METHODS: We searched the electronic databases PubMed (which includes MEDLINE), Web of Science, China National Knowledge Infrastructure (CNKI), Wanfang, and VIP for all associated studies published in English or Chinese between January 2016 and December 2023. One of the following outcomes had to be reported: drug price, availability, affordability, utilization, cost, or health outcomes. The study design had to be a randomized or non-randomized trial, an interrupted time series (ITS) analysis, a repeated measures study, or a controlled before-after (CBA) study. Two reviewers independently extracted data and assessed the studies according to Cochrane Effective Practice, Organization of Care (EPOC) guidelines. RESULTS: From a total of 2628 studies, we identified 20 studies that met the inclusion criteria (16 interrupted time-series studies and 4 controlled before-after studies). Most of the studies (66%, n = 12) have some limitations (unclear risk of bias). The published studies indicated the implementation of the NRDPN policy decreased drug prices, ranging from 24 to 72%, which increased the affordability of success-negotiated drugs (refer to those medications that have undergone a successful price negotiation process between pharmaceutical companies and healthcare authorities) and decreased out-of-pocket expenditures. The availability rate increased form 27% to 47%. It has been suggested that the NRDPN was conducive to narrowing disparities in availability and affordability across regions, hospital levels, and types of health insurance. In addition, it was associated with the increased drug expenditure by 61% due to the increased use of successful-negotiated drugs. However, there is insufficient evidence to explore the health outcome changes after the NRDPN policy. CONCLUSION: Evidence to date generally suggests the NRDPN policy is an effective way to decrease drug prices, improve access to innovative medicines, and improve fairness. It provides useful experience and lessons in improving access to innovative medicines for other low-and middle-income countries.