Abstract

Objectives

Comprehensive evidence on nationwide impact of China’s National Reimbursement Drug List (NRDL) negotiation policy is lacking. This study is to assess the availability, affordability, and regional equity of negotiated drugs included in NRDL using nationally representative data.

Methods

This cross-sectional study utilized 3 drug databases: 2 nationwide databases in China (2018-2021 and 2019-2021) and 1 multinational database (2017-2022). We examined changes in 6 indicators for negotiated drugs added to the NRDL: proportion of procurement hospital and defined daily doses (DDDs) for availability; defined daily dose cost (DDDc), reimbursement proportion (RP), and drug price index (DPI) for affordability; and Gini coefficient for equity. Drugs were grouped depending on approval time, negotiation year, and status (new vs renewed listing) across the Anatomical Therapeutic Chemical (ATC) classification. We performed inter- and intragroup descriptive analyses to show trends over time and across categories. The DPI was compared with 10 countries.

Results

For availability, the proportion of procurement hospital increased by 0.89% to 53.44%, and DDDs grew substantially across all groups (compound annual growth rate [CAGR]:25.21%-26,700%). For affordability, DPI decreased from a mid-level among reference countries (10 other countries) in 2017 to the lowest in 2022. DDDc declined after negotiation (CAGR: −6.28% to −70.20%). Reimbursement proportion remained stable (62.40%-80.12%) from 2019 to 2021. Regional equity improved with most ATC classifications (60.66%) having a Gini coefficient below 0.4.

Conclusions

China’s NRDL negotiation policy has improved drug availability and affordability while ensuring geographic equity, although risks remain. This study offers insights for policy makers, particularly in low-accessibility countries, to refine drug pricing policies.