Abstract
BACKGROUND: Government reimbursement negotiation (GRN) is an important policy tool to increase the accessibility of drugs. In China, the impact of GRN implementation on programmed death-1 (PD-1) drugs price, procurement volume, and expenditure is unknown. METHODS: This study used a multiple-treatment period interrupted time series design covering the period from the first-time recorded in Chinese Medical Economic Information database to 2022 to examine changes in hospital procurement price, volume and expenditure of PD-1 drugs after the implementation of GRN in China. Data were obtained from 698 public hospitals of 30 provinces in China. RESULTS: A total of four PD-1 drugs have been selected in the National Reimbursement Drug List via GRN between March 2019 and 2022. After the implementation of the first-time GRN, the prices of all PD-1 drugs decreased significantly, with Camrelizumab experiencing the largest reduction in price and the largest increase in volume and expenditure. The Camrelizumab's price decreased by 1151.75 Chinese Yuan (CNY) (β(2) = -1151.75; 95% confidence interval (CI) = -1254.534, 1048.96), volume increased by 159.549 thousand defined daily doses (β(2) = 159.549; 95% CI = 119.12, 199.979) and expenditure increased by 11.172 million CNY (β(2) = 11.172; 95% CI = 1.653, 20.692). Following the implementation of the second-time of GRN, Sintilimab showed the largest decrease in price, with price decreased by 164.099 CNY (β(4) = -164.099; 95% CI = -171.867, 156.331), Tislelizumab had the largest increase in volume and expenditure, with the volume increased by 102.185 thousand defined daily doses (β(4) = 102.185; 95% CI = 47.862, 156.509) and expenditure increased by 4.119 million CNY (β(4) = 4.119; 95% CI = -3.808, 12.047). CONCLUSIONS: The GRN policy improved the accessibility and affordability of PD-1 drugs. Health insurance policy-makers need to consider the legitimate interests of PD-1 drug manufacturers while ensuring the sustainability of the basic health insurance fund.