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Methods: The Interrupted Time Series Analysis method was adopted, and the changes in average medical expenses per patient, average medical insurance payment cost per patient and actual reimbursement ratio were investigated by using the data of single-drug payments in Xuzhou from October to October Results: Following the implementation of the policy, there was a significant decrease in the average medical expenses per patient of national drug negotiation in Xuzhou, with a reduction of Additionally, the average medical insurance payment cost per patient decreased by Furthermore, the average medical expenses per patient of urban and rural medical insurance participants decreased by However, the mean total medical expenditures for individuals enrolled in employee medical insurance decreased by On the other hand, there was no discernible change in the actual reimbursement ratio. Conclusion: After the adoption of the NDPN policy, a noticeable decline has been observed in the average medical expenses per patient and the mean cost of the average medical insurance payment per patient, although to a limited extent. Notably, the reduction in employee medical insurance surpasses that of urban and rural medical insurance. Within the context of China, medical expenses have emerged as a significant concern, as their escalation has exerted a mounting impact on the overall burden borne by the nation and the per capita economic load. The growth rate of medical expenditure is faster than that of gross domestic product, and the reimbursement of high-priced drugs is limited. China is not alone in facing the financial burden of rising drug costs 2 , 3. The increasing attention paid by many countries to the impact of drug prices on the economic stress of individuals has led to the development of various strategies aimed at reducing drug prices. These approaches encompass internal reference pricing, external reference pricing 4 and special pricing agreements 5. Internal Reference Pricing IRP is the practice of setting or negotiating reimbursement of drug prices by reference to domestic prices for identical, similar or therapeutically equivalent drugs. In New Zealand, for example, manufacturers can charge higher prices, but government reimbursement is limited based on the reference price 4. External Reference Pricing ERP , is a price control mechanism whereby the government takes into account the prices of medicines in other countries in order to inform or set prices in its own country. For example, in Japan, drug prices are compared with the average price of drugs in four reference countries and prices are dynamically adjusted 6. Special Pricing Agreements SPAs are innovative agreements between governments and manufacturers for payers and pharmaceutical companies to align on value, speed to market and risk. In response to increasing expenditure on medicines, the Chinese government introduced a National Drug Price Negotiation NDPN policy in , whereby the state centrally organizes negotiations to determine drug prices. The main objective of the policy is to promote the centralization of drugs in public hospitals and reduce drug costs 8. In the context of this policy, insured persons have access to reimbursement for negotiated medicines, which improves cost-effectiveness, and thereby reduces the burden 9 , Since the implementation of the National Drug Policy, drug prices have been reduced by an average of Prior to the reform of the national-negotiated drug policy, most drugs were listed in hospitals before entering the health insurance scheme, giving the drugs enough time to go through the process of market promotion, accumulation of experience in clinical use and recognition by clinical experts for widespread use. In other regions, Sichuan Province in , a total of kinds of drugs to implement single-line payment management, lower than Xuzhou City, kinds. The basic medical insurance system for urban and rural residents mainly caters to the healthcare needs of rural residents, urban residents, students and children. In contrast, the basic medical insurance for urban workers is specifically designed to meet the healthcare needs of urban workers 12 , In terms of system design, the two types of health insurance show fundamental differences due to different resource endowments, with the actual reimbursement rate and affordability of urban and rural residents lower than those of urban workers The findings of this study should offer empirical insights and pertinent recommendations to enhance national policies, advance hospital reform and alleviate the financial burden on patients. The analysis covers the period spanning from October to October Therefore, the policy time point of September has been set for this study. The aforementioned data are sourced from the medical insurance data information system of the Xuzhou Municipal Medical Insurance Bureau, a government-managed entity that restricts public access to safeguard patient confidentiality. This database encompasses comprehensive medical and insurance information pertaining to all inhabitants within the specified region. ITSA is a highly regarded research design that enables the explicit identification of the intervention time point, making it the preferred analytical approach for evaluating the longitudinal impact of interventions 15 , This study aimed to examine the involvement of insured patients in the implementation of the NDPN policy as an intervention strategy in Xuzhou City, Jiangsu Province, in September The dependent variables encompassed the year, claim quantity, dosage, drug cost ratio and health insurance reimbursement amount. ITSA was employed for data analysis. To assess the changes in levels and trends of these indicators before and after the policy implementation, segmented linear multiple regression equations were established, as follows 17 :. Yt represents the monthly outcome variable observed from October to October Time is a continuous variable, denoting the duration in months over the course of the study. Segmented linear regression methods were employed to fit equations for multiple linear regression models, with the presence of autocorrelation frequently observed in time series data. The Durbin—Watson test was used to evaluate autocorrelation, where a value of approximately 2 signifies the absence of autocorrelation. In cases where the variables exhibited autocorrelation, the generalized least squares approach specifically the Prais—Winsten method was employed to rectify first-order serial correlation errors All p -values obtained from the Dickey—Fuller tests conducted in this study were found to be below the threshold of 0. Concurrently, the mean total medical expenses incurred by insured individuals exhibited a decline from Similarly, the average medical insurance payment cost per patient also experienced a reduction from Similarly, the average medical expenses per patient in medical insurance for urban and rural residents decreased from The average medical insurance payment cost per patient experienced a decrease from Furthermore, the average medical insurance payment cost per patient for employees participating in medical insurance decreased from Prior to the implementation of the policy alteration, the average medical expenses per patient of drugs negotiated by the state in Xuzhou exhibited a notable decline, with a monthly reduction of Despite a subsequent increase of The alteration in the average reimbursement rate of drugs negotiated by the state did not exhibit a significant change before and after the policy implementation, with only a 7. Further information can be found in Table 1. Figure 1. Changes in the cost of negotiated drugs for insured people in Xuzhou, — A—C Nodes: monthly average expense; Lines: fitted value. Subsequent to the policy change, this reduction decreased to The implementation of the policy resulted in an immediate increase of However, the change in the average annual rate of return for these participants before and after the policy implementation is not statistically significant, as shown in Table 2 Figure 2. Figure 2. Prior to the implementation of the policy alteration, there was a notable reduction of However, immediately following the policy change, there was a significant increase of Similarly, the average medical insurance payment cost per patient for employees participating in medical insurance experienced a decrease of Subsequently, there was a decrease of For further details, please refer to Table 3. The average annual rate of return for employees enrolled in medical insurance experienced a sudden increase of However, there was no statistically significant difference observed before and after the policy implementation, as shown in Figure 3. Figure 3. This section presents a comprehensive overview of the alterations observed in the mean aggregate medical expenditures, average medical insurance payment cost per patient and mean annual reimbursement rate among insured individuals residing in Xuzhou City subsequent to the enactment of the national drug negotiation policy. The research studies presented here provide evidence of the notable efficacy of this policy in mitigating medical expenditures and facilitating expense coordination, thereby yielding a discernible direct intervention impact. Since the inception of the policy, a consistent decrease in both the mean aggregate medical expenses and the average medical insurance payment cost per patient has been observed, commencing in the initial month. Furthermore, the enduring effectiveness of the policy intervention is supported by the consistent decline observed within the initial year of implementation. This discovery provides substantial evidence for the positive influence of national drug policy negotiations in mitigating the financial strain on patients and bestowing significant advantages upon a substantial population. The reduction amounted to This indicates a consistent downwards trend in the average medical expenses per patient for both groups, with a comparable magnitude of reduction. Consequently, the resulting reduction in medical expenses is comparable. The disparity in the reduction in overall payment is evident, potentially attributed to variations in the actual reimbursement rate across different medical insurance categories. One intriguing observation pertains to the abrupt surge in average medical expenses per patient and monthly expenses at the onset of the year. This phenomenon can be attributed to the settlement of critical illness insurance in Xuzhou, where patients who incur higher fees receive supplementary compensation. Consequently, medical expenses toward the end of the year surpass those at the commencement of the subsequent year, thereby elucidating the immediate rise in expenses following the intervention Other countries like Germany and Switzerland have also adopted a negotiated approach to reduce drug prices and ease the burden on patients. For example, Germany 20 and Switzerland 21 have resolved the problem of high prices of anti-cancer drugs through drug price negotiations. Although the United States has not conducted any drug price negotiation, its drug prices are on an upward trend. After the implementation of price negotiation in Germany, the price of drugs in the United States is higher than that in Germany, and the price gap between the two countries has widened Previous studies have underscored the impact of drug policy reform on the affordability and accessibility of pharmaceuticals and its potential to alleviate economic burdens for insurance plan beneficiaries, aligning with our own findings Following the implementation of the national drug negotiation policy in Xuzhou, patients have experienced a reduction in economic pressures, although with variations across different medical insurance categories. This discrepancy may stem from the distinct resource allocations in the design of basic medical insurance systems for urban workers and urban and rural residents. Urban and rural residents exhibit lower levels of and economic strength than urban workers. However, the singular focus on minimizing medical costs may inadvertently result in patients incurring higher expenses for examinations, materials and nursing care. The findings of a number of scholars suggest that the alteration of drug policies can potentially influence the practices of healthcare providers in China, consequently leading to elevated costs for medications, medical supplies and out-of-pocket expenditures subsequent to the implementation of drug reforms 10 , It is recommended that medical insurance benefits be established in a reasonable manner to mitigate disparities in treatment among patients with varying insurance types. Simultaneously, it is essential to foster the growth of local supplementary medical insurance, investigate system design to enhance the cost-effectiveness of medical insurance funds, enhance the establishment of a multi-tiered medical insurance system and augment security efficiency. The objective of this study is to thoroughly assess the long-term effects of this policy. However, this study is subject to certain limitations. First, the observation of national drug negotiation costs prior to was hindered by the limited availability of data within the specified time frame. Second, the significant variation in the implementation methods of national drug policy negotiation across provinces precludes the identification of a suitable control group to investigate factors other than policy implementation that contribute to changes in drug usage. Third, the scope of this study is confined to Xuzhou City, Jiangsu Province, thereby limiting the generalizability of the findings to regions with similar economic characteristics. However, notably, these indicators exhibit strong consistency, suggesting the presence of internal mixed factors. Furthermore, it is crucial to recognize that a reduction in medical expenses does not automatically translate to an enhancement of fairness. Therefore, in future reforms, greater attention should be directed toward achieving equalization of financing and welfare to thoroughly investigate the implementation effect of the national drug negotiation policy. Xuzhou City, through the implementation of the NDPN policy, so that some drugs zero price difference into the pharmacy, not only opened up the sales channels of prescription drugs, so that patients to buy drugs more convenient, but also to reduce the burden on patients. Furthermore, this study ensures the equitable functioning of the medical insurance fund and potentially fosters the sustainable development of said fund. We thank the Xuzhou Medical Insurance Fund Management Center for their support on this research, as well as all the participants involved in this research for their time and contributions. The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher. Main drivers of health expenditure growth in China: a decomposition analysis. Examining the density in out-of-pocket spending share in the estimation of catastrophic health expenditures. Eur J Health Econ. Financial risk protection from out-of-pocket health spending in low- and middle-income countries: a scoping review of the literature. Health Res Policy Syst. Crossref Full Text Google Scholar. Government pharmaceutical pricing strategies in the Asia-Pacific region: an overview. J Market Access Health Policy. Innovative pharmaceutical pricing agreements in five European markets: a survey of stakeholder attitudes and experience. Health Policy Amsterdam, Netherlands. Overview of external reference pricing Systems in Europe. Faunce, TA. Reference pricing for pharmaceuticals: is the Australia-United States free trade agreement affecting Australia's pharmaceutical benefits scheme? Med J Aust. Progress on drug pricing negotiations in China. Biosci Trends. Barcellos, SH, and Jacobson, M. The effects of Medicare on medical expenditure risk and financial strain. Am Econ J Econ Policy. Trends in accessibility of negotiated targeted anti-Cancer medicines in Nanjing, China: an interrupted time series analysis. Front Public Health. Association between provincial income levels and drug prices in China over the period Soc Sci Med. The urban resident basic medical insurance: a landmark reform towards universal coverage in China. Health Econ. Effects of urban and rural resident basic medical insurance on healthcare utilization inequality in China. Int J Public Health. How health insurance design affects access to care and costs, by income in eleven countries. Health Affairs Project Hope. Interrupted time series regression for the evaluation of public health interventions: a tutorial. Int J Epidemiol. Segmented regression analysis of interrupted time series studies in medication use research. J Clin Pharm Ther. Methodological framework for model selection in interrupted time series studies. J Clin Epidemiol. Testing for spatial autocorrelation among regression residuals. Geogr Anal. A global comparison of the cost of patented cancer drugs in relation to global differences in wealth. The impact of Price regulation on the availability of new drugs in Germany. Accessibility of Cancer drugs in Switzerland: time from approval to pricing decision between and Lancet Oncol. Longitudinal trends in use and costs of targeted therapies for common can cers in Taiwan: a retrospective observational study. BMJ Open 6:e Impacts of National Drug Price Negotiation on expenditure, volume, and availability of targeted anti-Cancer drugs in China: an interrupted time series analysis. Promoting access to innovative anticancer medicines: a review of drug Price and National Reimbursement Negotiation in China. Li, L, and Yu, Q. Does the separating of hospital revenue from drug sales reduce the burden on patients? Evidence from China. Int J Equity Health. Keywords: drug cost, national drug price negotiation, health policy, interrupted time series analysis, patient burden. Public Health. The use, distribution or reproduction in other forums is permitted, provided the original author s and the copyright owner s are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher. Top bar navigation. About us About us. Sections Sections. About journal About journal. Article types Author guidelines Editor guidelines Publishing fees Submission checklist Contact editorial office. Public Health , 05 June The influence of the national drug price negotiation policy reform on the medical expenses of patients in Xuzhou City: an interrupted time series analysis. Introduction Within the context of China, medical expenses have emerged as a significant concern, as their escalation has exerted a mounting impact on the overall burden borne by the nation and the per capita economic load. Data sources The aforementioned data are sourced from the medical insurance data information system of the Xuzhou Municipal Medical Insurance Bureau, a government-managed entity that restricts public access to safeguard patient confidentiality. Table 1. ITSA results of the policy effect on average medical expenses per patient. Table 2. ITSA results of the average medical insurance payment cost per patient. Table 3. ITSA results for the effect of policies on actual reimbursement ratios. Keywords: drug cost, national drug price negotiation, health policy, interrupted time series analysis, patient burden Citation: Qin Z, He M, Shen H, Liu S, Xu S and Chen L The influence of the national drug price negotiation policy reform on the medical expenses of patients in Xuzhou City: an interrupted time series analysis.

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