The impact of “4 + 7” volume-based drug procurement on the volume, expenditures, and daily costs of antihypertensive drugs in Shenzhen, China: an interrupted time series analysis

Abstract

Background 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. Method 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). Results 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. Conclusions 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.

Impact of ‘4+7’ volume-based drug procurement on the use of policy-related original and generic drugs: a natural experimental study in China

“…These results support our earlier finding in policy-related antihypertensive drugs. 11 We supposed there is possibility that the price of drugs without the bound of volume–price contract increased after policy implementation, which might be related to the unreasonable prescription behaviour, such as overprescribing of medicines. 29 41 In the future, it is recommended to strengthen the policy monitoring regarding the prices and prescription of policy-related drugs in all healthcare settings, as well as to improve medical insurance payment standards and advance the reform of medical insurance payment mode.…”

“…10 Volume-price linkage was achieved under this procurement mechanism. 11 In the NCDP policy, only generic drugs that had previously passed the Generic Consistency Evaluation (GCE) and original branded drugs were eligible to be listed for procurement. 9 Historically, in China, generic drugs were needed only for demonstrating comparable quality with the other marketed generic drugs, and the interchangeability between generic and brand-name drugs was unknown.…”

“…In the policy, unique measures, such as 'ensuring drug quality', 'achieving volume-price linkage' and 'encouraging generic substitution and rational use', were applied to achieve price cuts and improve medicine affordability with higher quality. [9][10][11] Twenty-five drugs in the '4+7' procurement list were successfully purchased with an average price reduction of 52%, of which 22 were generic drugs that passed the GCE and 3 were original drugs. 17 Worldwide, tendering for off-patent medicines and promoting generic substitution are effective ways to enhance market competition, which contribute to drug cost-containment.…”

“…Volume-based drug procurement, also known as ‘group purchasing’, by integrating the procurement needs of all pilot cities, enhanced the negotiation power of hospitals and payers to maximise the price reduction of drugs 10. Volume–price linkage was achieved under this procurement mechanism 11…”

“…Under the GCE’s criterion of ‘essential similarity’ in this policy, however, generic drugs became equivalent to their corresponding original drugs, thus original drugs as well as generic drugs certified by GCE are considered to be of higher quality when compared with generic drugs that did not pass the GCE. In the policy, unique measures, such as ‘ensuring drug quality’, ‘achieving volume–price linkage’ and ‘encouraging generic substitution and rational use’, were applied to achieve price cuts and improve medicine affordability with higher quality 9–11. Twenty-five drugs in the ‘4+7’ procurement list were successfully purchased with an average price reduction of 52%, of which 22 were generic drugs that passed the GCE and 3 were original drugs 17…”