Impact of National Centralized Drug Procurement Policy on Antiviral Utilization and Expenditure for Hepatitis B in China

BACKGROUND AND AIMS: The National Centralized Drug Procurement (NCDP) policy was launched in mainland China in April 2019, with entecavir (ETV) and tenofovir disoproxil fumarate (TDF) being included in the procurement list. We conducted the current study to investigate the impact of the NCDP policy on the utilization and expenditures of antiviral therapy for chronic hepatitis B (CHB) in China. METHODS: Procurement records, including monthly purchase volume, expenditure, and price of nucleos(t)ide analogs (NAs), were derived from the National Healthcare Security Administration from April 2018 to March 2021. The changes in volumes and expenditures of the first-line NAs and bid-winning products were calculated. The effects of price, volume, and structure related to drug expenditure were calculated by the Addis and Magrini (AM) Index System Analysis. RESULTS: The purchase volume of NAs significantly increased from 134.3 to 318.3 million DDDs, whereas the expenditure sharply decreased from 1,623.41 to 490.43 million renminbi (RMB) or 241.94 to 73.09 million US dollars (USD). The proportions of first-line NAs rose from 72.51% (ETV: 69.00%, TDF: 3.51%) to 94.97% (ETV: 77.42%, TDF: 17.55%). AM analysis showed that the NCDP policy decreased the expenditure of all NAs (S=0.91) but increased that of the first-line NAs in the bid-winning list (S=1.13). Assuming the population size of CHB patients remains stable and a compliance rate of ≥75%, the proportion of CHB patients receiving first-line antiviral therapy would increase from 6.36–8.48% to 11.56–15.41%. CONCLUSIONS: The implementation of the NCDP policy significantly increased the utilization of first-line NAs for CHB patients at a lower expenditure. The findings provided evidence for optimizing antiviral therapy strategy and allocating medical resources in China.