China's National Reimbursement Drug List (NRDL) covers medicines that are included in national health insurance schemes. NRDL updates take into account evidence and recommendations of experts from the fields of medicine, health economics, pharmacy and health policy. A negotiation mechanism between the government and manufacturers was introduced in 2017 to include a more detailed evaluation and negotiation for high cost drugs. However, the values that are considered in NRDL decision making are not well-understood. This study aims to investigate the influence of available evidence and other factors on coverage decisions.

Outcomes of the 2017 and 2018 NRDL negotiations were analyzed. Logistic regression was used to investigate factors associated with listing decisions. Ordinary least squares and Tobit regression were used to investigate factors associated with negotiated price discounts. Independent variables were published cost-effectiveness analysis (CEA), incremental cost-effectiveness ratio (ICER), disease area, burden of disease (disability-adjusted life years), company ownership (domestic or foreign) and regulatory approval year.

Twenty-eight out of sixty-two negotiated drugs had one or more published CEA studies in the English or Chinese language, although neither the presence of a study nor the central ICER estimates were predictive of price discount or listing. A longer time since regulatory approval was a significant predictor of listing (p < 0.05). Disease area (oncology) and ownership (foreign) were significant predictors of a higher price discount (p < 0.01).

The NRDL plays a key role in providing access to healthcare for the 95 percent of China's population that is covered by public insurance. We found several factors that were associated with reimbursement decisions. Many of the medicines in the NRDL negotiation have CEA evidence, although the role of CEA in reimbursement decision making in China remains inconclusive.