School of Health Sciences, Wuhan University, 115# Donghu Road, 430071, Wuhan, China.
Global Health Institute, Wuhan University, 115# Donghu Road, 430071, Wuhan, China.
BMC Health Serv Res. 2021 Nov 26;21(1):1275. doi: 10.1186/s12913-021-07143-3.
In 2019, Chinese government launched a nationwide volume-based drug procurement aiming at reducing drug prices and saving drug costs through economies of scale, which aroused widespread attention. The first round of the policy pilot was implemented in 4 municipalities and 7 sub-provincial cities, referred to as "4 + 7" policy. In the "4 + 7" policy, 7 antihypertensive drugs were included. This study was conducted to evaluate the impact of "4 + 7" policy on the use of policy-related antihypertensive drugs.
This study applied single-group Interrupted Time Series (ITS) design. We used drug purchasing data from the Centralized Drug Procurement Survey in Shenzhen 2019, covering 24 months from January 2018 to December 2019. Antihypertensive drugs related to "4 + 7" policy were selected as study samples, including 7 drugs in the "4 + 7" List and 17 alternative drugs. Alternative drugs refer to antihypertensive drugs that have an alternative relationship with "4 + 7" List drugs in clinical use and have not yet been covered by the policy. "4 + 7" List drugs were then divided into bid-winning and bid-non-winning products according to the bidding results. 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).
After "4 + 7" policy intervention, the procurement volume of bid-winning antihypertensive drugs significantly increased (3.12 million DDD, 95 % CI = 2.14 to 4.10, p < 0.001), while the volume of non-winning drugs decreased (-2.33 million DDD, 95 % CI= -2.83 to -1.82, p < 0.01). The use proportion of bid-winning antihypertensive drugs increased from 12.31 to 87.74 % after policy intervention. The overall costs of the seven "4 + 7" List antihypertensive drugs significantly declined (-5.96 million CNY, 95 % CI= -7.87 to -4.04, p < 0.001) after policy intervention, with an absolute reduction of 36.37 million CNY compared with the pre-"4 + 7" period. The DDDc of bid-winning antihypertensive drugs significantly decreased (-1.30 CNY, 95 % CI= -1.43 to -1.18, p < 0.001), while the DDDc of non-winning (0.28 CNY, 95 % CI = 0.11 to 0.46, p < 0.01) and alternative (0.14 CNY, 95 % CI = 0.03 to 0.25, p < 0.05) antihypertensive drugs increased markedly.
The implementation of "4 + 7" policy promoted the drug use hypertensive patients gradually concentrated on the quality-guaranteed bid-winning drugs, which might be conducive to improve the overall quality level of drug use of Chinese hypertensive patients. Besides, a preliminary positive policy effect of price cut and cost-saving was observed in the antihypertensive drug category. In the future, price monitoring and drug use management regarding policy-related drugs should also be strengthened.
2019 年,中国政府启动了全国范围内的以量换价药品集中采购政策,旨在通过规模经济降低药品价格和节省药品费用,引起了广泛关注。该政策的首轮试点在 4 个直辖市和 7 个副省级城市实施,简称“4+7”政策。“4+7”政策包含 7 种降压药。本研究旨在评估“4+7”政策对相关降压药使用的影响。
本研究采用单组中断时间序列(ITS)设计。我们使用了来自 2019 年深圳市集中药品采购调查的数据,涵盖了 2018 年 1 月至 2019 年 12 月的 24 个月。选择与“4+7”政策相关的降压药作为研究样本,包括“4+7”清单中的 7 种药物和 17 种替代药物。替代药物是指在临床使用中与“4+7”清单药物具有替代关系且尚未被政策覆盖的降压药。然后,根据招标结果,将“4+7”清单药物分为中标和未中标产品。采购量、支出和日费用被选为结局变量,分别用限定日剂量(DDD)、人民币(CNY)和限定日药费(DDDc)表示。
“4+7”政策干预后,中标降压药的采购量显著增加(312 万 DDD,95%置信区间[CI]:214 至 410,p<0.001),而非中标药物的采购量减少(-233 万 DDD,95%CI:-283 至-182,p<0.01)。政策干预后,中标降压药的使用比例从 12.31%增加到 87.74%。“4+7”清单中的 7 种降压药的总费用显著下降(-5960 万元人民币,95%CI:-7870 至-4040,p<0.001),与“4+7”前相比,绝对减少了 3637 万元人民币。中标降压药的 DDDc显著下降(-1.30 元人民币,95%CI:-1.43 至-1.18,p<0.001),而非中标(0.28 元人民币,95%CI:0.11 至 0.46,p<0.01)和替代(0.14 元人民币,95%CI:0.03 至 0.25,p<0.05)降压药的 DDDc明显增加。
“4+7”政策的实施促使高血压患者的用药逐渐集中在质量有保证的中标药物上,这可能有利于提高中国高血压患者整体用药质量水平。此外,在降压药类别中观察到了初步的降价和节省成本的积极政策效果。未来,还应加强对政策相关药物的价格监测和用药管理。