Dataset Information

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.

SUBMITTER: Yang Y

PROVIDER: S-EPMC8265121 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundIn September 2019, the "4 + 7" centralized procurement pilot program was expanded nationwide aiming at reducing drug prices by means of volume-based procurement and using accredited generic drugs for branded drug substitutes. Given the current uncertain effect of the policy outside pilot areas, this study was conducted to evaluate the impact of the National Volume-based Procurement policy on the use of policy-related drugs after expansion.MethodA single-group interrupted time series was applied using drug purchase data, covering 25 months from December 2018 to December 2020. Drugs related to the centralized procurement policy were selected as samples, including 25 first-batch policy-related drugs and 56 alternative drugs. Centralized procured drugs can be divided into bid-winning and non-winning products, where non-winning products were sorted into generic and branded drugs, and alternative products were classified according to different degrees of substitution. Purchase volume, expenditures, and daily costs were measured.ResultsAfter the implementation of the policy, a significant increase was associated with the volume of bid-winning drugs (p < 0.001) and the volume of generic and branded drugs decreased immediately. The DDDc of drugs under the same generic name significantly reduced (an instantaneous drop of bid-winning drugs by approximately 25%, 7.62 CNY for generics and 3.07 CNY for branded drugs), saving 48.2 million CNY of drug expenditures. The policy has a significant effect on the drug for the treatment of cardiovascular diseases and exerted little influence on the drug for the treatment of nervous diseases, and the substitution of generics for antitumor-branded drugs was not obvious. In addition, the procurement volume of alternative drugs appeared to be a "carry-over".ConclusionsThese findings indicated that the policy demonstrated positive effects in terms of price reductions and cost savings and accelerated the substitution of generics against branded drugs. The "patent cliff" for branded drugs has gradually emerged. Besides, a short-term "spillover effect" of the volume of alternative drugs was observed, requiring special attention and vigilance.

Project description:BackgroundIn 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.MethodThis 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).ResultsAfter "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.ConclusionsThe 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.

Project description:Objectives: The study aimed to estimate the effects of National Volume-based Drug Procurement (NVBP) policy on drug utilization and medical expenditures of hypertension patients in public medical institutions in mainland China. Methods: This study used patient-level data based on electronic health records retrieved from the hospital information system of Nanjing Hospital of Chinese Medicine. Data on patients with hypertension who received care at this institution between 2016 and 2021 was used for analysis. Segmented linear regression models incorporating Interrupted Time Series (ITS) analysis were adopted to examine the effects of NVBP policy on drug utilization and health expenditures of eligible patients. Drug utilization volume and health expenditures were the primary outcomes used to assess the policy effects, and were measured using the prescription proportion of each drug class and the overall per-encounter treatment costs. Results: After the implementation of NVBP policy, the volume of non-winning drugs decreased from 54.42% to 36.25% for outpatient care and from 35.62% to 15.65% for inpatient care. The ITS analysis showed that the volume of bid-winning drugs in outpatient and inpatient settings increased by 9.55% (p < 0.001) and 6.31% (p < 0.001), respectively. The volume changes in non-volume based purchased (non-VBP) drugs differed between outpatients and inpatients. The proportion of non-VBP drugs immediately increased by 5.34% (p = 0.002) overall, and showed an upward trend in the outpatient setting specially (p < 0.001) during the post-intervention period. However, no significant differences were observed in the proportion of non-VBP drugs in inpatient setting (p > 0.05) in term of level change (p > 0.05) or trend change (p > 0.05). The average per-visit expenditures of outpatients across all drug groups exhibited an upward trend (p < 0.05) post policy intervention. In addition, a similar increase in the overall costs for chemical drugs were observed in inpatient settings (coefficient = 2,599.54, p = 0.036), with no statistically significant differences in the regression slope and level (p = 0.814). Conclusion: The usage proportion of bid-winning drugs increased significantly post policy intervention, indicating greater use of bid-winning drugs and the corresponding substitution of non-winning hypertensive drugs. Drug expenditures for outpatients and health expenditures per visit for inpatients also exhibited an upward trend, suggesting the importance of enhanced drug use management in Traditional Chinese Medicine hospital settings.

Project description:Objective: National centralized drug procurement organized by the Chinese government currently represents the largest group purchasing organization worldwide, to establish a reasonable price formation mechanism. This study aimed to evaluate the effects of centralized procurement policy on drug price and price ratio in China. Method: Monthly drug procurement data of public medical institutions were extracted from the national procurement database, including 11 pilot cities and 36 months from January 2018 to December 2020. Centralized procured INNs (International Nonproprietary Names) (n = 25) and their alternative INNs (n = 96) were selected as study samples. Centralized procured INNs were divided into bid-winning and non-winning products according to the bidding results. Drug price, price distribution, and price ratio were measured. Multi-intervention interrupted time series analysis was performed to estimate the policy impacts in two centralized procurement periods. Results: The price of centralized procured INNs showed an immediate drop of 44.57% (β = -0.59, p < 0.001) at the policy implementation, among which bid-winning drugs decreased by 61.71% (β = -0.96, p < 0.001). No significant change in the price level or trends was found for non-winning products and alternative drugs in the first-year procurement period (all p-values > 0.05). During the second-year procurement period, alternative drugs in four therapeutic categories detected significant increases in the price level (all p-values < 0.05). The overall coefficient of variation of price distribution exhibited upward trends after policy implementation. Among the most centralized procured INNs, the price ratio between certificated generics (generics that have passed the consistency evaluation) and original drugs declined significantly after policy intervention (p < 0.05), whereas the price ratio between uncertificated and certificated generics increased significantly (p < 0.05). Conclusion: Chinese government-organized group purchasing resulted in prominent price reduction of bid-winning drugs. The policy observed a short-term "spillover" effect of synergistic price reduction, while the effect wore off after 1-year procurement period. The extremely dispersed price distribution, as well as unreasonable price ratios, requires further effective price regulation means.

Project description:Centralizing procurement for prescription drugs has the potential to reduce drug spending by creating economies of scale and by improving purchasing power. In March 2019, the Chinese government launched a volume-based purchasing (VBP) pilot program using a competitive bidding process to purchase accredited generic drugs for which branded drug substitutes were available. We performed an interrupted time-series design to estimate the change in monthly drug purchase quantity and spending comparing 14 months before and 7 months after the VBP pilot. We obtained monthly prescription drug purchase data for all purchases from public medical institutions in the three large pilot cities (Beijing, Shanghai and Xi’an) and two non-pilot cities (Changsha and Zhengzhou) between January 2018 to September 2019. We used negative binomial regression and log-linked Gamma Generalized Linear Model for purchase quantity and spending respectively. We evaluated heterogeneity of impact by pilot city, drug type (selected or non-selected drugs), and therapeutic class (cardiovascular disease, mental disorder and cancer) separately. The implementation of the pilot reform was associated with a 132% (95%-CI: 104–165%, p < 0.001) increase in the purchase quantity of selected drugs in pilot cities compared to an 17% decrease (95%-CI: 9–25%, p < 0.001) in control cities. In contrast, the purchase quantity of branded and other drugs in pilot cities decreased by 38% (95%-CI: 27–46%, p < 0.001) and 77% (95%-CI: 71–81%, p < 0.001), respectively; while in control cities, these remained at similar levels. Overall, in pilot cities, there was a 35% (95%-CI: 28–41%, p < 0.001) decrease in the purchase spending for all drugs in the first post-policy month, from 8.1 billion CNY estimated in the absence of VBP down to 5.3 billion CNY; in control cities, the change was negligible. The largest reduction in spending occurred for drugs for the treatment of cardiovascular diseases. The evidence suggests a positive impact of the VBP pilot in reducing overall drug spending and increasing the use of accredited generics in three pilot cities. This overall trend is not observed in two non-pilot cities. Assessments of long-term impact of the VBP policy on additional key outcomes including drug prescriptions, drug utilization, patients’ health outcomes and payments on drugs are needed.

Project description:ObjectivesIn December 2018, China launched national volume-based procurement (NVBP) to negotiate drug prices with manufacturers. Gefitinib was one of the 25 pilot drugs, which is used for treatment of non-small cell lung cancer. Lung cancer is the most common type of cancer in China and targeted drugs like gefitinib have been proven to provide clinical benefits to patients. This study aims to explore the impact of NVBP policy on the usage and expenditure of anticancer drugs.MethodsGefitinib and alternative drugs (icotinib and erlotinib) were used as objects of study. Quarterly data from the China Hospital Pharmaceutical Audit database in 9454 hospitals in China were used for analysis. Descriptive analysis was conducted using purchase volume and expenditure as variables. Interrupted time-series (ITS) analysis was applied to further analyse the effect of NVBP policy on the medicines under study.ResultsDuring the 12-month period before (2018Q2-2019Q1) and after (2019Q2-2020Q1) the NVBP policy, the total purchase volume of medicines rose from 4.48 million defined daily dose (DDD) to 7.02 million DDD, with an increase of 56.66%. Purchase volume of gefitinib and alternative drugs increased 100.61% and 14.88%, respectively. After the implementation of NVBP policy, procurement volume of alternative drugs decreased by 72 051 DDD (p value=0.044) and trend change decreased by 56 738 DDD (p value<0.01). The overall expenditure reduction was 14.7%, with the expenditure of gefitinib reducing by 38.47% and alternative drugs increasing by 10.70%. ITS analysis indicated statistically significant differences in level and trend changes for expenditure of total drugs and gefitinib.ConclusionsThe evidence provided in this study indicated that the implementation of NVBP policy was related to the expenditure reduction of the first generation of anti-EGFR lung cancer drugs. The policy effectively controlled the increase in expenditures for corresponding drugs while ensuring the use of drugs.

Project description:IntroductionIn March 2016, the Centers for Disease Control and Prevention issued opioid prescribing guidelines for chronic noncancer pain. In response, in April 2016, the North Carolina Medical Board launched the Safe Opioid Prescribing Initiative, an investigative program intended to limit the overprescribing of opioids. This study focuses on the association of the Safe Opioid Prescribing Initiative with immediate and sustained changes in opioid prescribing among all patients who received opioid and opioid discontinuation and tapering among patients who received high-dose (>90 milligrams of morphine equivalents), long-term (>90 days) opioid therapy.MethodsControlled and single interrupted time series analysis of opioid prescribing outcomes before and after the implementation of Safe Opioid Prescribing Initiative was conducted using deidentified data from the North Carolina Controlled Substances Reporting System from January 2010 through March 2017. Analysis was conducted in 2019-2020.ResultsIn an average study month, 513,717 patients, including patients who received 47,842 high-dose, long-term opioid therapy, received 660,912 opioid prescriptions at 1.3 prescriptions per patient. There was a 0.52% absolute decline (95% CI= -0.87, -0.19) in patients receiving opioid prescriptions in the month after Safe Opioid Prescribing Initiative implementation. Abrupt discontinuation, rapid tapering, and gradual tapering of opioids among patients who received high-dose, long-term opioid therapy increased by 1% (95% CI= -0.22, 2.23), 2.2% (95% CI=0.91, 3.47), and 1.3% (95% CI=0.96, 1.57), respectively, in the month after Safe Opioid Prescribing Initiative implementation.ConclusionsAlthough Safe Opioid Prescribing Initiative implementation was associated with an immediate decline in overall opioid prescribing, it was also associated with an unintended immediate increase in discontinuations and rapid tapering among patients who received high-dose, long-term opioid therapy. Better policy communication and prescriber education regarding opioid tapering best practices may help mitigate unintended consequences of statewide policies.

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