scholarly journals Influence of Government Price Regulation on the Price, Volume and Spending of Antibiotics in China: A Controlled Interrupted Time Series Study

Author(s):  
Haishaerjiang Wushouer ◽  
Zhenhuan Luo ◽  
Xiaodong Guan ◽  
Luwen Shi

Background: Chinese government established maximum retail prices for antibiotics listed in China’s National Reimbursement List in February 2013. This study aimed to analyze the impact of pharmaceutical price regulation on the price, volume and spending of antibiotics in China. Methods: An interrupted time series design with comparison series was used to examine impacts of the policy changes on average daily cost, monthly hospital purchase volume and spending of the 11 price-regulated antibiotics and 40 priceunregulated antibiotics in 699 hospitals. One intervention point was applied to assess the impact of policy. Results: After government price regulation, compared to price-unregulated antibiotics, the average daily cost of the price-regulated group declined rapidly (β=-5.68, P<.001). The average hospital monthly purchase spending of priceregulated antibiotics also decreased rapidly (β=-0.49, P<.010) and a positive trend change (β=0.04, P<.001) in average hospital spending of price-unregulated antibiotics was found. Conclusion: Government regulation can reduce the prices and spending of price-regulated antibiotics. To control increasing expenditure, besides price caps regulation, factors determining drug utilization also need to be considered in policy designing.

2019 ◽  
Vol 82 (06) ◽  
pp. 559-567
Author(s):  
Christina Niedermeier ◽  
Andrea Barrera ◽  
Eva Esteban ◽  
Ivana Ivandic ◽  
Carla Sabariego

Abstract Background In Germany a new reimbursement system for psychiatric clinics was proposed in 2009 based on the § 17d KHG Psych-Entgeltsystem. The system can be voluntary implemented by clinics since 2013 but therapists are frequently afraid it might affect treatment negatively. Objectives To evaluate whether the new system has a negative impact on treatment success by analysing routinely collected data in a Bavarian clinic. Material and methods Aggregated data of 1760 patients treated in the years 2007–2016 was analysed with segmented regression analysis of interrupted time series to assess the effects of the system on treatment success, operationalized with three outcome variables. A negative change in level after a lag period was hypothesized. The robustness of results was tested by sensitivity analyses. Results The percentage of patients with treatment success tends to increase after the new system but no significant change in level was observed. The sensitivity analyses corroborate results for 2 outcomes but when the intervention point was shifted, the positive change in level for the third outcome became significant. Conclusions Our initial hypothesis is not supported. However, the sensitivity analyses disclosed uncertainties and our study has limitations, such as a short observation time post intervention. Results are not generalizable as data of a single clinic was analysed. Nevertheless, we show the importance of collecting and analysing routine data to assess the impact of policy changes on patient outcomes.


BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e031658 ◽  
Author(s):  
Xiaodong Guan ◽  
Haishaerjiang Wushouer ◽  
Mingchun Yang ◽  
Sheng Han ◽  
Luwen Shi ◽  
...  

BackgroundIn October 2012, the Chinese government established maximum retail prices for specific products, including 30 antineoplastic medications. Three years later, in June 2015, the government abolished price regulation for most medications, including all antineoplastic medications. This study examined the impacts of regulation and subsequent deregulation of prices of antineoplastic medications in China.MethodsUsing hospital procurement data and an interrupted time series with comparison series design, we examined the impacts of the policy changes on relative purchase prices (Laspeyres price index) and volumes of and spending on 52 antineoplastic medications in 699 hospitals. We identified three policy periods: prior to the initial price regulation (October 2011 to September 2012); during price regulation (October 2012 to June 2015); and after price deregulation (July 2015 to June 2016).ResultsDuring government price regulation, compared with price-unregulated cancer medications (n=22, mostly newer targeted products), the relative price of price-regulated medications (n=30, mostly chemotherapeutic products) decreased significantly (β=−0.081, p<0.001). After the government price deregulation, no significant price change occurred. Neither government price regulation nor deregulation had a significant impact on average volumes of or average spending on all antineoplastic medications immediately after the policy changes or in the longer term (p>0.05).ConclusionCompared with unregulated antineoplastics, the prices of regulated antineoplastic medications decreased after setting price caps and did not increase after deregulation. To control the rapid growth of oncology medication expenditures, more effective measures than price regulation through price caps for traditional chemotherapy are needed.


2021 ◽  
Author(s):  
Ying Yang ◽  
Ruiwen Tong ◽  
Shicheng Yin ◽  
Lining Mao ◽  
Luxinyi Xu ◽  
...  

Abstract Background: On January 2019, Chinese government implemented the first round of the National Centralized Drug Procurement (NCDP) pilot of 25 drugs in 4 municipalities and 7 sub-provincial cities in mainland China, 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 antihypertensive drugs in the “4+7” List and 17 antihypertensive drugs that have an alternative relationship with the “4+7” List drugs in clinical use. 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), respectively. Segmented linear regression analysis was employed to examine the change of outcome variables before and after the policy intervention. Results: As of December 31, 2019, the completion rate of the agreed purchase volume of the 7 bid-winning antihypertensive drugs reached 173.42% in Shenzhen. After “4+7” policy, the DDDc of bid-winning antihypertensive drugs significantly decreased by 63.79% (-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 volume of bid-winning antihypertensive drugs significantly increased by 1311.76% (3.12 million DDD, 95% CI= 2.14 to 4.10, p<0.001). The overall costs of the seven “4+7” List antihypertensive drugs significantly declined by 101.34% (-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. Conclusion: An overall satisfying implementation effect was observed in Shenzhen. A preliminary positive policy effect of price cut and cost-saving was observed in the antihypertensive drug category. However, the DDDc of non-winning and alternative drugs increased after policy intervention, suggesting that the price monitoring and drug use management regarding NCDP policy-related drugs should be strengthened. Keywords: National Centralized Drug Procurement (NCDP); "4+7"; volume-based procurement; antihypertensive drugs; China


BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e024200
Author(s):  
Sakthivel Selvaraj ◽  
Habib Hasan Farooqui ◽  
Aashna Mehta

ObjectiveThe objective of this study was to examine the impact of medicines price regulation (Drug Price Control Order, 2013) on the market share of atorvastatin in the Indian retail market for statins.SettingAll Indian states, January 2012 to December 2015.DesignQuasi-experimental—interrupted time series analysis.DataPharmaceutical sales audit data set from IMS Health (now IQVIA) for the 48-month period from January 2012 to December 2015.Outcome measureShare of atorvastatin (in percentage) in the Indian market for statins in terms of sales volumes.ResultsWe observed that the price regulation notification (Drug Price Control Orders, 2013) was associated with 0.12% (p<0.001; 95% CI 0.06 to 0.18) increase in the trend of the average monthly market share of atorvastatin (5 mg and 10 mg). After 31 months of price ceilings notification, the average market share of atorvastatin was 3.41% higher than would have been expected had the price ceilings not been notified. In sensitivity analysis, with a control, our findings remain robust, we observed a 0.16% (p<0.001; 95% CI 0.08 to 0.24) rise in the trend of average monthly market share of atorvastatin (5 mg and 10 mg) as compared with the change in the control.ConclusionsPrice control as a public intervention did improve the relative sales of atorvastatin in the statin market in India.


2021 ◽  
Vol 8 (1) ◽  
Author(s):  
Yuri V. Sebastião ◽  
Gregory A. Metzger ◽  
Deena J. Chisolm ◽  
Henry Xiang ◽  
Jennifer N. Cooper

Abstract Background We aimed to estimate the impact of the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) coding transition on traumatic injury-related hospitalization trends among young adults across a geographically and demographically diverse group of U.S. states. Methods Interrupted time series analyses were conducted using statewide inpatient databases from 12 states and including traumatic injury-related hospitalizations in adults aged 19–44 years in 2011–2017. Segmented regression models were used to estimate the impact of the October 2015 coding transition on external cause of injury (ECOI) completeness (percentage of hospitalizations with a documented ECOI code) and on population-level rates of injury-related hospitalizations by nature, intent, mechanism, and severity of injury. Results The transition to ICD-10-CM was associated with a drop in ECOI completion in the transition month (− 3.7%; P < .0001), but there was no significant change in the positive trend in ECOI completion from the pre- to post-transition periods. There were significant increases post-transition in the measured rates of hospitalization for traumatic brain injury (TBI), unintentional injury, mild injury (injury severity score (ISS) < 9), and injuries caused by drowning, firearms, machinery, other pedestrian, suffocation, and unspecified mechanism. Conversely, there were significant decreases in October 2015 in the rates of hospitalization for assault, injuries of undetermined intent, injuries of moderate severity (ISS 9–15), and injuries caused by fire/burn, other pedal cyclist, other transportation, natural/environmental, and other specified mechanism. A significant increase in the percentage of hospitalizations classified as resulting from severe injury (ISS > 15) was observed when the general equivalence mapping maximum severity method for converting ICD-10-CM codes to ICD-9-CM codes was used. State-specific results for the outcomes of ECOI completion and TBI-related hospitalization rates are provided in an online supplement. Conclusions The U.S. transition from ICD-9-CM to ICD-10-CM coding led to a significant decrease in ECOI completion and several significant changes in measured rates of injury-related hospitalizations by injury intent, mechanism, nature, and severity. The results of this study can inform the design and analysis of future traumatic injury-related health services research studies that use both ICD-9-CM and ICD-10-CM coded data. Level of evidence II (Interrupted Time Series)


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ying Yang ◽  
Lei Chen ◽  
Xinfeng Ke ◽  
Zongfu Mao ◽  
Bo Zheng

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.


Author(s):  
Youseop Shin

Chapter Seven explains interrupted time series analysis. This chapter includes the impact analysis of the Three-Strikes-Out law with October 1994 (when Public Law 103-322 was enacted) as the intervention point.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ni Wang ◽  
Ying Yang ◽  
Luxinyi Xu ◽  
Zongfu Mao ◽  
Dan Cui

Abstract 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.


2020 ◽  
Vol 36 (10) ◽  
Author(s):  
Lucas Silva ◽  
Dalson Figueiredo Filho ◽  
Antônio Fernandes

In response to the COVID-19 pandemic, governments worldwide have implemented social distancing policies with different levels of both enforcement and compliance. We conducted an interrupted time series analysis to estimate the impact of lockdowns on reducing the number of cases and deaths due to COVID-19 in Brazil. Official daily data was collected for four city capitals before and after their respective policies interventions based on a 14 days observation window. We estimated a segmented linear regression to evaluate the effectiveness of lockdown measures on COVID-19 incidence and mortality. The initial number of new cases and new deaths had a positive trend prior to policy change. After lockdown, a statistically significant decrease in new confirmed cases was found in all state capitals. We also found evidence that lockdown measures were likely to reverse the trend of new daily deaths due to COVID-19. In São Luís, we observed a reduction of 37.85% while in Fortaleza the decrease was 33.4% on the average difference in daily deaths if the lockdown had not been implemented. Similarly, the intervention diminished mortality in Recife by 21.76% and Belém by 16.77%. Social distancing policies can be useful tools in flattening the epidemic curve.


Author(s):  
Ni Wang ◽  
Ying Yang ◽  
Luxinyi Xu ◽  
Zongfu Mao ◽  
Dan Cui

In 2019, Chinese government implemented the first round of National Centralized Drug Procurement (NCDP) pilot (so-called "4+7" policy) in mainland China, achieved a prominent price reduction of 52% on average for 25 bidding winning products. Under cross-price elasticity theory, the price behavior of pharmaceutical enterprises for policy-related drugs might change. This study used drug purchasing data from the Centralized Drug Procurement Survey in Shenzhen 2019, and applied single-group Interruption Time Series (ITS) design to examine the impact of "4+7" policy on the drug price index (DPI) of policy-related drugs. The ITS analysis showed that the DPI of winning (-0.183 per month, p&amp;lt;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&amp;lt;0.0001) after "4+7" policy. 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.


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