Abstract
BACKGROUND: Hepatitis B virus (HBV) infection is a global public health issue, with approximately 1.5 million new infections and around 820,000 deaths annually around the globe. China carries the heaviest burden of HBV infection in the world, making it crucial to improve the accessibility of antiviral treatment for hepatitis B. In 2019, China implemented a National Volume-Based Procurement (NVBP) policy, which included two nucleoside/nucleotide analog drugs (NAs) -- Entecavir (ETV) and Tenofovir Disoproxil Fumarate (TDF) -- in the list for centralized procurement. The policy aimed to reduce drug prices and alleviate financial burden on patients. This study aimed to evaluate the impact of the NVBP policy on purchase volume and expenditures for antiviral drugs to treat HBV. METHODS: The study used interrupted time series analysis of national procurement data for six antiviral therapies from January 2019 to December 2020. It examined the changes in monthly drug procurement volume and expenditures at national level and in different levels of hospitals. RESULTS: After the policy implementation, the prices of ETV and TDF decreased in all provinces, with maximum price reductions of 98.50% and 98.61%, respectively. Both ETV and TDF showed significant increases in purchase volume (38.0 [P < 0.001] and 6.8 [P < 0.001] million DDDs, respectively) and significant reductions in expenditures (-143.7 [P < 0.001] and − 30.4 [P < 0.001] million CNY, respectively) immediately after policy implementation. The absolute change in purchase volume and expenditure was highest in tertiary hospitals, but the relative change in magnitude was greatest in primary hospitals. CONCLUSION: The NVBP policy was effective in reducing the cost of ETVs and TDFs and significantly increased the prescribing volume. More patients were likely to have access to NA drugs after the policy was implemented. This policy successfully reduced the financial burden on patients and facilitated their access to hepatitis B treatment.