The impact of National Centralised Drug Procurement policy on the use of policy‐related original and generic drugs in China

Abstract

Aims To evaluate the effects of the first round of National Centralised Drug Procurement pilot (so‐called ‘4+7’ policy) on the use of policy‐related original and generic drugs. Methods This study used drug purchasing order data from the Centralised Drug Procurement Survey in Shenzhen 2019, covering 24 months from January 2018 to December 2019. ‘4+7’ policy‐related drugs were selected as study samples, including 25 drugs in the ‘4+7’ procurement list and 69 alternative drugs that have an alternative relationship with ‘4+7’ List drugs in clinical use. ‘4+7’ List drugs were then divided into bid‐winning and bid‐non‐winning products according to the bidding results. Included drugs were sorted into original and generic drugs. Purchase volume, expenditures, and daily costs were selected as outcome variables, and were measured using Defined Daily Doses (DDDs), Chinese Yuan (CNY), and Defined Daily Drug cost (DDDc). A single‐group Interrupted Time Series analysis was adopted to quantify policy effect. Results After policy intervention, the overall policy‐related original drugs significantly decreased by 0.39 CNY (95% CI: −0.62 to −0.17, p < 0.01) in DDDc, 5949.36 thousand DDDs (95% CI: −8276.67 to −3622.05, p < 0.001) in volume, and 31,575.08 thousand CNY (95% CI: −41,812.68 to −21,337.49, p < 0.001) in expenditures. The volume proportion of generic drugs increased from 78.6% to 91.0%, and the expenditure proportion of increased from 30.9% to 49.8%. Conclusion ‘4+7’ policy promoted the substitution use of domestic generics against original branded drugs and played positive effects on drug price cut and medication burden reduction. The proportion of original branded drugs and generics that passed generic consistency evaluation significantly increased after policy intervention, indicating the improvement of the overall quality level of drug use in China.

The change of drug utilization in China’s public healthcare institutions under the “4 + 7” centralized drug procurement policy: Evidence from a natural experiment in China

“…As a consequence, bid-winning drugs became more dominant in use among the centralized procurement drugs, increasing from 14 to 74%. Also, these results are in line with the body of literature ( Chen et al, 2020 ; Yang et al, 2021a ; Chen et al, 2021 ; Wen et al, 2021 ; Yang et al, 2022a ; Wang et al, 2022 ). In particular, such changes were found to be more prominent in PHCs, compared to those in secondary and tertiary hospitals, which indicated that the bid-winning drugs among the centralized procurement drugs may be more reflective to the drug demands at PHC level.…”

“…The procurement data extracted from the CDSIP database include drug name, the name of medical institution, procurement date, dosage form, specification, packaging, manufacturer, unit price, procurement unit (by box, bottle, or branch), procurement quantity, procurement expenditures, etc. In the present study, we selected “4 + 7”-related drugs as study samples ( Wang N. et al, 2021 ; Yang et al, 2022a ; Wang et al, 2022 ), which were defined as drug INNs in the “4 + 7” procurement List (“4 + 7” List drugs) as well as their alternative drugs that have not yet been covered by the “4 + 7” procurement policy. Next, the identification of alternative drugs followed the definition of the NHSA in the Monitoring Plan for Centralized Drug Procurement and Use Pilot Work ( NHSA, 2019b ), which refers to the clinically substitutable drugs of the same kind with “4 + 7” List drugs.…”

“…In addition to the primary volume indicator for drug use, four drug use structure indicators were included for measuring drug utilization by referring to government assessment documents ( General Office of the State Council, 2019b ; NHSA, 2019b ) and relevant literature ( Xie et al, 2021 ; Yang et al, 2022a ; Luo et al, 2022 ; Wang et al, 2022 ), including the use proportion of bid-winning drugs, the proportion of generics, the proportion of bid-winning and originators, and the proportion of “4 + 7” List drugs. Also, an indicator—the “procurement completion rate”—was included as the process parameter according to the NHC documents ( NHC, 2019a ; NHC, 2019b ).…”

“…Previous studies revealed fruitful evidence on drug utilization change after the implementation of “4 + 7” centralized drug procurement: for instance, the prominently increased use of bid-winning drugs after policy intervention ( Yang et al, 2021a ; Yang et al, 2021b ; Chen et al, 2021 ; Wen et al, 2021 ; Wang et al, 2022 ). Besides, Wang et al (2022) , Yang et al (2022a) , and Xie et al (2021) revealed the increase in substitution rate of generic drugs based on the descriptive comparison before and after “4 + 7” policy. Wang Y. et al (2021) reported a reduction in the irrational utilization rate of antiplatelet drugs from 10.54 to 1.60% in one hospital.…”

Knowledge, Attitudes and Practice of Healthcare Providers, Healthcare Regulatory Practitioners and Patients Toward Biosimilars in China: Insights From a Nationwide Survey

“…The majority of HCPs and healthcare regulatory practitioners supported biosimilars utilization if they were covered by the Chinese centralized drug procurement program ( Wang et al, 2021 ). It is shown that this aforementioned policy promoted the use of generics and had positive effects on drug price cut and medication burden reduction ( Yang et al, 2022 ). Similarly, uptake of biosimilars and control of medical costs might also gain benefit if biosimilars could be selected in centralized procurement program.…”