The impacts of Chinese drug volume-based procurement policy on the use of policy-related antibiotic drugs in Shenzhen, 2018–2019: an interrupted time-series analysis

Abstract

Background In 2019, Chinese government implemented volume-based procurement of 25 drugs in 4 municipalities and 7 sub-provincial cities, i.e. “4 + 7” policy. Competitive bidding was conducted by the government based on the annual agreed procurement volume submitted by each public medical institution in pilot cities. Pilot cities were required to implement bid winning results in March 2019 and the use volume of bid winning products was examined to ensure the completion of agreed procurement volume. In the policy, an oral antibiotic (cefuroxime) was included. Given the current condition of the irrational use of antibiotics in China, this study aims to evaluate the impact of “4 + 7” policy on the use of policy-related antibiotics. Methods This study used drug purchase data from the Centralized Drug Procurement Survey in Shenzhen 2019, covering 24 months from January 2018 to December 2019. Oral antibiotic drugs related to “4 + 7” policy were selected as study samples, including cefuroxime and 12 antibiotic drugs that have an alternative relationship with cefuroxime in clinical use. Purchase volume and expenditures were selected as outcome variables, and were measured using Defined Daily Doses (DDDs) and Chinese yuan, respectively. Segmented linear regression analysis with interrupted time series was adopted to examine the effect of “4 + 7” policy. Results After the implementation of “4 + 7” policy, the overall volume of cefuroxime and its alternative drugs increased from 9.47 million DDDs to 13.42 million DDDs, with an increase of 41.8 %. The results of segmented linear regression showed that the volume of cefuroxime significantly increased 161.16 thousand DDDs after “4 + 7” policy (95 % CI: 59.43 to 262.90, p-value = 0.004). The volume of alternative drugs significantly increased 273.65 thousand DDDs (95 % CI: 90.17 to 457.12, p-value = 0.006). The overall “4 + 7” policy-related antibiotics significantly increased 436.31 thousand DDDs (95 % CI: 190.81 to 681.81, p-value = 0.001) after “4 + 7” policy. Conclusions This study provides evidence that the implementation of “4 + 7” volume-based procurement policy was associated with significant increases in the volume of policy-related antibiotic drugs. The increase in antibiotic use after the policy needs special attention and vigilance.

Influence of Chinese National Centralized Drug Procurement on the price of policy-related drugs: an interrupted time series analysis

“…The purpose of this study is to examine the impact of "4 + 7" policy on prices of policy-related drugs. Thus, we included samples with the following criteria: (a) the drug scope was "4 + 7" policy-related drugs [14,17], including 25 drugs involved in the "4 + 7" procurement list (called "4 + 7" List drugs) and their alternative drugs (supplementary Table 1). The alternative drug refers to drug substances that have an alternative relationship with "4 + 7" List drugs in clinical use, which was determined according to the Monitoring Plan Work of National Centralized Drug Procurement and Use issued by the NHSA of the PRC [22].…”

“…In the policy, original branded drugs, as well as generic drugs that have passed the consistency evaluation of quality and efficacy are assigned as the criteria for participating national volume-based procurement [13]. One of the highlights of "4 + 7" policy lies in "trade-for-price" [14]. Under "4 + 7" policy, each public medical institution in pilot cities was required to submit the agreed procurement volume of each drug in the procurement list (called "4 + 7" List drug) to the National Health Security Administration (NHSA).…”

Implementation and Impact of National Centralized Drug Procurement Policy in China: Evidence from the National Drug Procurement Database

“…Following the implementation of "4 + 7" policy, there exists a negative impact on the increase in the use of non-centralized purchased drugs, which, to a degree, diminishes the welfare of the policy to the general public [37]. Yang et al [42] reported a signi cant increase in overall consumption of policy-related antibiotic drugs after the implementation of "4 + 7" policy, suggesting that the risk of overuse of antibiotic drugs may increased after policy intervention. Therefore, in order to avoid such negative impacts, it is recommended to further expand the drug scope of NCDP policy and include more drugs that commonly used.…”

Will the Volume-Based Procurement Policy Promote Pharmaceutical Firms’ R&D Investment in China? An Event Study Approach

“…Since the end of 2018, China has piloted the volume-based procurement policy in 11 key cities, known as the "4 + 7" procurement policy [19,20]. After the announcement of this policy, drug prices have witnessed significant reduction [18,21]. Afterwards, the policy was continuously promoted.…”

“…China's new volume-based procurement policy is not only to reduce the drug cost but also to try to slash margins of the drugs by centralized procurement of the generic drugs, and thus to promote the development of innovative drugs. However, the studies after the release of the centralized procurement policy mainly focus on the impact of the policy on drug prices and patient medication [14,16,18,21,[26][27][28][29]. Furthermore, few theoretical and empirical studies have systematically investigated the relationship between the centralized procurement policy and the innovation of the pharmaceutical industry [7].…”