A quasi-experimental study of the volume-based procurement (VBP) effect on antiviral medications of hepatitis B virus in China.

Background: The Pilot Plan of National Centralized Volume-Based Procurement (NCVBP) was adopted to cope with the rapid increase in drug expenditures. This research aimed to quantitatively evaluate the impact of the NCVBP on antiviral medications for the hepatitis B virus. Methods: Data on nucleoside analogs (NAs) medications of hepatitis B virus monthly procurement records in the pilot cities from January 2018 to December 2019 were extracted from the China Drug Supply Information Platform (CDSIP). The impacts of the NCVBP on purchased volumes, expenditures, and pre-defined daily dose costs were evaluated by interrupted time-series (ITS) analysis using Stata 16.0. We constructed two segments with one interruptive point (March 2019). Results: Compared to the same period between pre-and post-intervention, the purchased volume of NAs medications were increased by 92.85%, and selected medications were increased by 119.09%. Analysis of changes in the level of NAs medication followed a decrease in purchased expenditure (coefficient: 5364.88, p < 0.001), meanwhile, the purchased volume was increased with statistical significance (coefficient:605.49, p < 0.001). The Defined Daily Dose cost (DDDc) of NAs medication followed a decrease (coefficient: 8.90, p < 0.001). The NCVBP reform was followed by an increase of 618.41 ten thousand Defined Daily Dose (DDD) (p < 0.001) in purchased volume and a reduction of 5273.84 ten thousand Chinese Yuan (CNY) (p < 0.001) in the purchased expenditure of selected medications in the level. The DDDc of selected medications decreased in the level (coefficient: 9.87, p < 0.001), while the DDDc of alternative medications increased in the slope (coefficient:0.07, p = 0.030). The purchased volume and expenditure of bid-winning products increased by 964.08 ten thousand DDD and 637.36 ten thousand CNY in the level (p < 0.001). An increase of 633.46 ten thousand DDD (p < 0.001) in purchased volume and a reduction of 4285.32 ten thousand CNY (p < 0.001) in the purchased expenditure of generic drugs in the level was observed. Conclusion: The NCVBP reduced the DDDc of NAs medication, improved the utilization of the selected medications, and promoted the usage of generic products.

Trends and Comparisons of Blood Pressure and Fasting Plasma Glucose in Patients with Hypertension, Diabetes, and Comorbidity: 4-Year Follow-Up Data.

Background: Patients with both diabetes and hypertension could face more health risks than those with either condition alone, and less attention has been paid to their management outcomes, so this study may be the first to specifically address this problem. We aimed to examine the management outcomes of blood pressure (BP) in hypertensive patients with/without diabetes and fasting plasma glucose (FPG) in diabetic patients with/without hypertension. Methods: Follow-up data were obtained from the National Basic Public Health Service Project in Sanming (2017-2021). A total of 25,795 adults with hypertension only, 4111 adults with diabetes only, and 5729 comorbid adults (namely, hypertensive patients with diabetes) were included. Generalized estimating equations were applied. Results: Systolic blood pressure (SBP) and diastolic blood pressure (DBP) in patients with hypertension only both dropped significantly (Coef. = -0.00088, P < 0.001; Coef. = -0.00081, P < 0.001). DBP in comorbid patients decreased considerably (Coef. = -0.00033, P < 0.001). Pulse pressure in comorbid patients grew rapidly (Coef. = 0.00044, P < 0.001). BP control rate in patients with hypertension only increased significantly (OR = 1.00039, P < 0.001). FPG control rates in diabetic patients with/without hypertension grew markedly (OR = 1.00013, P < 0.001; OR = 1.00020, P < 0.001). Comorbid patients had lower baseline SBP and DBP but higher latest SBP than patients with hypertension only (Coef. = -1.18872, P < 0.001; Coef. = -1.16049, P < 0.001; Coef. = 1.0634, P < 0.001). Comorbid patients had lower baseline BP and FPG control rates than those with either condition alone, and differences were greater at the latest follow-up (OR = 0.28086, P < 0.001; OR = 0.91012, P = 0.049; OR = 0.04020, P < 0.001; OR = 0.69465, P < 0.001). Conclusion: BP and FPG management outcomes have achieved progress. Comorbid patients have poorer performance than patients with either disease alone in BP levels especially the SBP level and control rates of SBP, DBP, and FPG. Future studies should be conducted using national data and include more confounding factors.

Fiscal autonomy of subnational governments and equity in healthcare resource allocation: Evidence from China.

Objectives: Promoting equity in healthcare resource allocation (EHRA) has become a critical political agenda of governments at all levels since the ambitious Universal Health Coverage was launched in China in 2009, while the role of an important institutional variable-fiscal autonomy of subnational governments-is often overlooked. The present study was designed to determine the effect of FASG on EHRA and its potential mechanism of action and heterogeneity characteristics to provide empirical support for the research field expansion and relative policies making of EHRA. Methods: From the start, we utilized the Theil index and the entropy method to calculate the EHRA index of 22 provinces (2011-2020) based on the medical resource data of 287 prefecture-level cities. Furthermore, we used the two-way fixed effects model (FE) to identify and analyze the impact of FASG on EHRA and then used three robustness test strategies and two-stage least squares (2SLS) regression to verify the reliability of the conclusions and deal with potential endogeneity problems, respectively. At last, we extend the baseline regression model and obtain the two-way FE threshold model for conducting heterogeneity analysis, which makes us verify whether the baseline model has nonlinear characteristics. Results: The static value and the trend of interannual changes in the EHRA values in different provinces are both very different. The regression results of the two-way FE model show that FASG has a significant positive impact on EHRA, and the corresponding estimated coefficient is - 0.0849 (P < 0.01). Moreover, this promotion effect can be reflected through two channels: enhancing the intensity of government health expenditure (IGHE) and optimizing the allocation of human resources for health (AHRH). At last, under the different economic and demographic constraints, the impact of FASG on EHRA has nonlinear characteristics, i.e., after crossing a specific threshold of per capita DGP (PGDP) and population density (PD), the promotion effect is reduced until it is not statistically significant, while after crossing a particular threshold of dependency ratio (DR), the promotion effect is further strengthened and still statistically significant. Conclusions: FASG plays an essential role in promoting EHRA, which shows that subnational governments need to attach great importance to the construction of fiscal capability in the allocation of health care resources, effectively improve the equity of medical and health fiscal expenditures, and promote the sustainable improvement of the level of EHRA.

The impacts of the "4+7" pilot policy on the volume, expenditures, and daily cost of Serotonin-Specific Reuptake Inhibitors (SSRIs) antidepressants: A quasi-experimental study.

Objectives: The purpose of this study was to quantitatively evaluate the impacts of the"4 + 7" pilot policy on purchase volume, purchase expenditures, and daily cost and to find the changes in the use of SSRIs. Methods: Data was collected covering 31 months, before, during, and after the "4 + 7" pilot policy was implemented in Shenzhen. Interrupted time-series (ITS) analysis was used to examine whether there had been a significant effect with the onset of the "4 + 7" pilot policy in March 2019. Findings: The daily cost of policy-related drugs had a substantial drop of 2.93 yuan under the "4 + 7" pilot policy. The result has shown a 76.70% increase in volume and a 3.39% decrease in the expenditure on policy-related drugs. This study found that the "4 + 7" pilot policy increased the proportion of purchasing winning drugs, with an increment of 85.60 percent. After the implementation of the "4 + 7" pilot policy, policy-related drugs decreased by 443.55thousand Chinese yuan. The study indicated that volume of winning products significantly increased as shown in the regression with a level coefficient (ß 2 ) of -224.17 (p < 0.001) and trend coefficient (ß 3 ) of 15.74 (p < 0.001). The result revealed that both volume and expenditures on branded products showed a significant decrease in the regression in the post-intervention period (level coefficient of volume: ß 2 = -57.65, p < 0.01, trend coefficient of volume: ß 3 = -3.44, p < 0.01; level coefficient of expenditure: ß 2 = -712.98, p < 0.01, trend coefficient of expenditure: ß 3 = -40.10, p < 0.01). Conclusion: The volume-based procurement has successfully led to price reductions and improved the affordability of medicines, especially for those with chronic diseases. The volume-based procurement has demonstrated initial success in reshaping the composition of the Chinese pharmaceutical market in favor of generics with high quality and low prices.

Association between blood pressure control status, visit-to-visit blood pressure variability, and cognitive function in elderly Chinese: A nationwide study.

Background: Cognitive function is a concern among the elderly, which is related to the quality of life, life expectancy, and economic burdens. The relationship between blood pressure (BP) control status, visit-to-visit BP variability, and cognitive function remains controversial. Methods: We aimed to explore the association between BP control status at baseline, visit-to-visit BP variability, and cognitive function. This study included 3,511 elderlies in the China Health and Retirement Longitudinal Study, covering four waves for 7-year follow-up (baseline 2011, 2013, 2015, and 2018). BP was measured in Wave 2011, 2013, and 2015. Cognitive function was measured by Mini-Mental State Exam in Wave 2018. Participants were divided into two groups: mid-old group for reflecting midlife BP and cognition (45-59 years at baseline but aged 60 or over in Wave 2018), and old-old group for reflecting late-life BP and cognition (aged 60 or over at baseline). We use univariate analysis and general linear model to analyze. Results: Late-life BP showed stronger associations with cognitive function than midlife BP. As to late-life BP control status, controlled hypertension group get higher cognitive score than uncontrolled hypertension group in language (adjusted ß = -0.34, 95%CI -0.68 to 0.00), and untreated hypertension group in orientation (adjusted ß = -0.41, 95%CI -0.72 to -0.11), language (adjusted ß = -0.35, 95%CI -0.67 to -0.04), and total (adjusted ß = -0.99, 95%CI -1.85 to -0.12). Regarding visit-to-visit BP variability, midlife visit-to-visit systolic blood pressure (SBP) variability was associated with language (adjusted ß = -3.70, 95% CI -5.83 to -1.57), while late-life visit-to-visit SBP variability was associated with orientation (adjusted ß = -2.99, 95% CI -4.84 to -1.14), recall (adjusted ß = -1.69, 95% CI -2.89 to -0.48), language (adjusted ß = -2.26, 95% CI -4.13 to -0.38), and total (adjusted ß = -9.50, 95% CI -14.71 to -4.28); Midlife diastolic blood pressure (DBP) variability and pulse pressure (PP) variability showed a significant relationship with language (adjusted ß = 3.25, 95% CI -1.31 to -5.19) and calculation (adjusted ß = -0.26, 95% CI -0.47 to -0.04), respectively. No significant correlation was found between midlife BP control status, late-life visit-to-visit DBP variability, late-life visit-to-visit PP variability, and cognitive score. There was no significant correlation between BP and memory. Conclusions: BP control status and visit-to-visit BP variability were significantly related to cognitive function among the Chinese elderly. Receiving effective late-life antihypertensive treatment and keeping SBP stable might contribute to prevent the development of cognitive impairment and dementia, especially for orientation and language function.

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

OBJECTIVE: To evaluate the impact of the first round of the National Centralized Drug Procurement pilot (so-called '4+7' policy) on the use of policy-related original and generic drugs. METHODS: A retrospective natural experimental design was adopted. Drug procurement data from the China Drug Supply Information Platform database were used, involving 9 '4+7' pilot cities in intervention group and 12 non-pilot provinces in control group. '4+7' policy-related drugs were selected as study samples, including 25 drugs in the '4+7' procurement list and their alternative drugs that have not yet been covered by the policy. '4+7' List drugs were divided into bid-winning and non-winning products according to the bidding results. Included drugs were sorted into original and generic products. Difference-in-difference method was employed to estimate the net effect of policy impact. RESULTS: After policy intervention, the DDDs (defined daily doses) of '4+7' List original drugs significantly reduced (ß=-39.10, p<0.001), while generic drugs increased (ß=40.43, p<0.01). 17.08% of the original drugs in DDDs were substituted by generic drugs. Prominent reduction was observed in the monthly expenditure of '4+7' List drugs (¥726.40 million) and overall policy-related drugs (¥654.47 million). The defined daily drug cost (DDDc) of bid-winning original and generic drugs, as well as non-winning original drugs, decreased by 44.44%, 79.00% and 15.10% (all p<0.01), while the DDDc of non-winning generic drugs increased by 64.81% (p<0.001). The use proportion of higher-quality drugs raised prominently from 39.66% to 91.93%. CONCLUSIONS: '4+7' policy is conducive to generic substitution, drug price reduction and pharmaceutical cost-containment in China. The overall quality level of drug use of the Chinese population increased after policy intervention, especially in primary healthcare settings. However, the increased DDDc of non-winning generic drugs and alternative drugs should draw the importance of further policy monitoring.

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.

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.

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

BACKGROUND: The Chinese government implemented the first round of National Centralized Drug Procurement (NCDP) pilot (so-called "4 + 7" policy) in mainland China in 2019. This study aims to examine the impact of "4 + 7" policy on the price of policy-related drugs. METHODS: This study used drug purchasing order data from the Centralized 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 57 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. Single-group Interruption Time Series (ITS) analysis was adopted to examine the change of Drug Price Index (DPI) for policy-related drugs. RESULTS: The ITS analysis showed that the DPI of winning (- 0.183 per month, p < 0.0001) and non-winning (- 0.034 per month, p = 0.046) products significantly decreased after the implementation of "4 + 7" policy. No significant difference was found for the immediate change of DPI for alternative drugs (p = 0.537), while a significant decrease in change trend was detected in the post-"4 + 7" policy period (- 0.003 per month, p = 0.014). The DPI of the overall policy-related drugs significantly decreased (- 0.261 per month, p < 0.0001) after "4 + 7" policy. CONCLUSIONS: These findings indicate that the price behavior of pharmaceutical enterprises changed under NCDP policy, while the price linkage effect is still limited. It is necessary to further expand the scope of centralized purchased drugs and strengthen the monitoring of related drugs regarding price change and consumption structure.