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Official websites use. Share sensitive information only on official, secure websites. 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. To evaluate the implementation effect of hepatitis C medical insurance reimbursement policy in China from the view of medical institutions. The electronic medical record of a top tertiary hospital in Chengdu from January to December were extracted, and the interrupted time series model was used to analyze the changes in diagnosis and treatment behavior and disease burden of hepatitis C patients after the implementation of HCV insurance reimbursement policy. Hepatitis C medical insurance reimbursement policy can promote hepatitis C patients to actively seek medical treatment, promote the widespread use of DAA scheme, reduce the burden of patients, and improve the treatment efficiency of hepatitis C. Keywords: hepatitis C, policy analysis, medical insurance, interrupted time series analysis, real data analysis. The anti-HCV positivity rate in the general population in China is 0. Chronic hepatitis C is a long-term progressive disease, and most patients are diagnosed in terminal stage of the disease, and often has already developed into cirrhosis and liver cancer 4 , causing serious harm to the patient's life and health. Chronic hepatitis C also causes heavy financial burdens on patients, their families and the society. According to the results of a survey on the cost of patients with chronic HCV infection in China 5 and the statistics of the China Liver Transplant Registration, the average comprehensive treatment costs of compensated cirrhosis and de-compensated cirrhosis were 18, yuan and 30, yuan per year, respectively, and the treatment costs in the first and subsequent years of liver transplantation were , yuan and 92, yuan per year 1. Once HCV progresses, it places a heavy financial burden on the patient's family. Guidelines on chronic hepatitis C within China and abroad recommend that all patients with chronic hepatitis C HCV-RNA positive , regardless of cirrhosis, chronic kidney disease, or extrahepatic manifestations, should receive antiviral therapy to obtain cure, thus to prevent progressions to advanced liver diseases such as cirrhosis and liver cancer, to improve long-term survival rates, to improve quality of life of patients, and to prevent HCV transmission 6 — 8. Direct antiviral drugs DAAs are a class of small molecule compounds that can directly act on an important part of HCV replication and effectively inhibit the activity of the virus 9. In April , the first DAA drug, Daclatasvir and Asunaprevir, was approved in China for the treatment of adult genotype 1b chronic hepatitis C non-cirrhosis or compensatory cirrhosis. DAA treatment have significantly improved the therapeutic effect of hepatitis C, but the availability and affordability of DAA drugs have been limited due to higher drug prices Prior to , no DAA drugs have been included in the national medical insurance directory, but some regions have started to explore the medical insurance payment policy of DAA drugs according to the operation of their own medical insurance funds and the status of hepatitis C prevention and treatment. The exploration included payment by capitation, payment by classification, payment by disease category, inclusion in the provincial medical insurance directory, etc. Whether China's innovative medical insurance policies can effectively promote the prevention and treatment of hepatitis C to achieve elimination of hepatitis C and change in the medical burden of hepatitis C patients remain to be evaluated. Based on the real-world data of the database of a top tertiary hospital in Chengdu, this study proposes to analyze the changes in the diagnosis and treatment behavior and disease burden of hepatitis C patients before and after the implementation of the HCV medical insurance reimbursement policy from the aspects of diagnosis and treatment and medical costs, so as to provide support evidence for the prevention and treatment of hepatitis C and the formulation and improvement of medical insurance payment policies. The data of this study was derived from the electronic medical record of West China Hospital, a top tertiary hospital located in Chengdu and one of the largest hospitals in China. It is a designated medical institution for hepatitis C treatment, and receives the most HCV patients in southwest China. Empirical analysis was conducted using diagnosis and treatment data of DAA drugs for Hepatitis C patients registered in special disease outpatient reimbursement policy and general outpatient clinic from November to December , and therapeutic effectiveness data of hepatitis C patients from to The study was reviewed and approved by the Ethical Committee of West China Hospital in Sichuan University reference: and all subjects signed informed consent forms. Diagnosis and treatment indicators included outpatient visits and outpatient treatments. The registration number and the medical item details occurring at the same time were defined as one visit, and the medical item details that have drug use records were recorded as one treatment. Statistical analysis of the number of monthly visits and treatments from November to December were done based on the occurrence of medical details. The medical cost indicators mainly included the total cost of single outpatient visit, the out-of-pocket cost of single outpatient visit, the cost of of drugs for single outpatient visit, the total cost of all outpatient visits, the out-of-pocket cost of all outpatient visits, and the total cost of drug for all outpatient visits. Since the medical expenses of patients in the City of Chengdu are settled once every 3 months, the cost of single outpatient visit, the out-of-pocket cost of single outpatient visit, and the cost of drugs for single outpatient visit per person from November to December were calculated based on the onset of the treatment. The cost of treatment for hepatitis C patients was calculated based on a course of at least 48 weeks for the traditional treatment interferon peg and ribavirin and a week course for the DAA treatment. Since patient data was only obtained from one designated hospital, which might include data of patients with incomplete treatment, it was not possible to accurately obtain the cost of each patient's course of treatment. Therefore, for patients using the traditional protocol, the cost of all single visits in 3 months multiplying by 4 was used to calculated the cost of the entire course of treatment, and for patients using the DAA protocol, the cost of all single visits in 3 months approximates to the cost of the entire course of DAA treatment. Based on the availability of data, the number of monthly usage of DAA drugs from November to December and the use of each DAA program were analyzed. Therapeutic effect indicators included SVR rate, time to obtain SVR, annal outpatient visits, and annual per capita outpatient interval. The main measure of a patient's therapeutic effectiveness was SVR, i. Patients who had at least one positive HCV-RNA test from to were screened in this study, proportion of patients using DAA drugs and patients using traditional protocols who tested negative for RNA 3—6 months after completing a course of treatment were calculated, and the average time needed for positive RNA results to turn negative for patients in each treatment were calculated. In this study, descriptive statistical analysis methods were applied to the drug use indicators and treatment effect indicators to analyze the changes in the types of drugs used and the number of users, and the therapeutic effects of patients in different treatments over time. Measurement data of outcome indicators at multiple time points before and after each policy implementation were collected to compare the instantaneous horizontal changes and trend changes in outcome indicators before and after policy implementation to assess the impact of interventions. For hepatitis C patients, an outpatient reimbursement policy and a one-line payment policy for state-negotiated drugs were successfully adopted in Chengdu. The outpatient reimbursement policy was implemented in November in Chengdu as a pilot policy, so the pre-intervention observation period of the special disease outpatient reimbursement policy was set from November to October , and the observation period after the intervention was set from November to December Medical expenses other than drug costs are paid on a per-item basis and reimbursed in accordance with the special disease outpatient payment policy. The diagnosis and treatment fee is settled by the medical insurance handling agency and the designated medical institution, and the drug fee is settled by the medical insurance handling agency and the drug supply coverage entity. At the end of , three DAA drugs entered the medical insurance directory through the national medical insurance price reduction negotiation, including Albavir Gravivir, Lydipaivir Sophosbuvir, and Sophobuvir vipatamivir. The single-line payment policy covered three DAA drugs was implemented thereby in Chengdu. In this reimbursement policy, there is no differentiation between outpatient and hospitalization, minimum deductible is not set, and it is directly paid by the basic medical insurance in a certain proportion. Compared with other negotiated drugs that are included in the scope of Class B management, DAA drugs for hepatitis C are given better reimbursement policy. The single-line payment policy was implemented in January , so the observation period after the intervention of the single-line payment policy is set from January to December The possible changes in the projection outcome indicators after the implementation of the two policies are shown in Table 1. The effects of policy interventions may take some time to become observant, there may be a lag in the actual analysis process. To avoid mis-estimating the effects of policies, outcome values during the transition period were statistically excluded in this study 13 , The statistical model of intermittent time series constructed in this study 15 is as follows:. In this study, ordinary Least Squares regression models OLS was used to perform data analysis, and the Durbin-Watson test and lagrange Multiplier LM test were used to test the sequence correlation of the model 16 , and the White test was used to perform a heteroscedasticity test for the modeling process Heteroskedasticity and Autocorrelation Consistent Standard Error HAC were used to correct for autocorrelation and heteroscedasticity of model data. EViews 8 software was applied for interrupted time series analysis. A total of 2, hepatitis C cases were collected before and after the implementation of the policy, including special outpatient cases using DAA drugs, and ordinary outpatient cases using DAA drugs. According to the statistical results, November to February was a policy transition period, in order to avoid mis-estimating the effect, the data during the transition period were not included in the statistical analysis. The results of the interrupted time series analysis of the number of patient visits and treatments of hepatitis C patients are shown in Figures 1 , 2 ; Table 2. The results of the intermittent time series analysis of the single settlement medical expense of hepatitis C patients are shown in Figures 3 , 4 ; Table 3. The cost of a single settlement for the above 3 months does not represent the actual medical cost burden of the patients using different treatment options, so the change in the cost of a course of treatment for patients before and after the implementation of the policy is further compared. The results of the intermittent time series analysis during the course of treatment in hepatitis C patients are shown in Figures 5 , 6 ; Table 4. The number of patients using DAA drugs increased significantly in March and April , respectively, and decreased after September The number of patients using DAA drugs each month varies over time as shown in Figure 7. From November to December , a total of 7 DAA regimens were actually used by hepatitis C patients, namely Sofosbuvir and velpatasvir Before the implementation of the single-line payment policy in January , the use of Sofosbuvir and velpatasvir, Dasabuvir combined with Ombitasvir and Elbasvir and Grazoprevir were more frequent; After January , all patients started to only use the three DAA drugs included in the national health insurance list. According to the results of the special disease outpatient diagnosis and examination of past visits from to , for patients treated with traditional treatment, the SVR rate was The statistical results show that the average number of outpatient visits for hepatitis C patients in — shows a downward trend, and the annual per capita outpatient time interval shows an upward trend. In , the number of outpatient visits per capita for hepatitis C patients decreased from 3. See Figures 9 , From the perspective of trend changes, the number of outpatient visits and treatments for hepatitis C has always shown a downward trend, which is inconsistent with the expected assumptions. On the one hand, this is because this study only included the data from one hospital, which may have a certain bias from the overall number of patients. On the other hand, it may be due to the gradual decrease in the number of hepatitis C patients in the context of existing treatment methods and safeguard policies, resulting in a decrease in the number of patients visited, reflecting the positive effect of existing policies on the elimination of hepatitis C. From the perspective of level change, after the implementation of the special disease outpatient reimbursement policy in Chengdu, the number of outpatient visits and treatment trips have increased instantaneously, and although the number of outpatient treatments still shows a downward trend, its reduction rate has slowed down significantly, indicating that the medical insurance reimbursement policy can significantly motivate hepatitis C patients to seek medical treatment, which is conducive to improving the diagnosis rate and treatment rate of hepatitis C infected people. After the implementation of the special disease outpatient reimbursement policy at the end of , the per capita single settlement cost has increased significantly, of which the drug cost accounts for the largest proportion, This is due to the fact that DAA drugs were involved in the medical insurance per the outpatient reimbursement policy in Chengdu without any price adjustment, which contributed to the significant increase in the outpatient expense. However, due to the implementation of the reimbursement policy, the average increase in OOP per patient is much smaller than the total cost of outpatient clinics. In addition, short term medical expense cannot represent actual medical burden as DAA treatment only lasts for 12 weeks where as traditional pegyneol interferon treatment lasts up to 48 weeks. By further analyzing the change in the treatment costs before and after the implementation of the policy, it was discovered that the total treatment cost and out-of-pocket treatment cost of hepatitis C patients have not changed significantly under outpatient special disease reimbursement policy, and the out-of-pocket costs during the course of treatment have basically remained below 20, yuan, which is slightly lower than the relevant results conducted by other research teams using data from the Chengdu Municipal Medical Insurance Bureau The result may due to the fact that the patients included in this study are participants of special disease outpatient reimbursement policy, whose reimbursement ratio for examinations and treatments costs other than drug costs are higher. Drug price is an important factor that impacts the medical expense of hepatitis patients. The price reduction of DAA drugs has significantly reduced the average drug cost and drug cost of total treatment of hepatitis C patients, which in turn significantly reduced the total out-of-pocket of a single visit and the total out-of-pocket cost of treatment for hepatitis C patients. The overall results showed that after the implementation of the two policies, the financial burden of hepatitis C patients has been significantly reduced. The number of users reveals that there is a lag of 2 to 3 months in the implementation of the special diseases outpatient reimbursement policy and the single-line payment policy, as such implementation efficiency of relevant medical insurance policies in need to be improved. Since April , the number of users of DAA treatment has shown an increasing trend, indicating that the national hepatitis C medical insurance policies have played a role in promoting the promotion and use of DAA treatment. The slight decrease in the number of DAA drug users after September was due to the overall decrease in the number of infections and the number of hospital visits by hepatitis C. In terms of treatment options, the WHO guidelines for the diagnosis and treatment of hepatitis C and the guidelines for the prevention and treatment of hepatitis C in China both preferentially recommend the use of pan-genotype for treatment 2 , 6 , which do not require genotyping before treatment, require less monitoring during treatment, and are more convenient to use and manage than genotype-specific regimens. Sofosbuvir and velpatasvir is the world's first pan-genotype DAA drug that can be used to treat hepatitis C patients with all six genotypes 6. In November , Sofosbuvir and velpatasvir was the only pan-genotype program in the scope of reimbursable DAA drugs in Chengdu outpatient clinics, and among the DAA drugs included in the national medical insurance list in , the drug was the only non-gene type 1b reimbursable treatment drug. The results of the real-world patient medication study based on the database of a hospital in Sichuan Province also conform to the guidelines and recommendations and relevant medical insurance policies, and the proportion of patients using Sofosbuvir and velpatasvir has always remained high, which is consistent with the results of other studies related to drug use in China The price of genotype-specific regimens is lower than that of pan-genotype regimens 6 , as such it is still recommended clinically. After December , the patient's medication regimen is concentrated in Sofosbuvir and velpatasvir, Elbasvir and Grazoprevir, and Ledipasvir and Sofosbuvir, because after DAA drugs are included in the national medical insurance list, other drugs other than the three drugs in the medical insurance list are no longer reimbursed, so the use of drugs within the scope of protection is given priority to reduce the patient's out-of-pocket costs, and the choice of drug is consistent with the national medical insurance policy. With the continuous expansion of the variety of DAA drugs included in the scope of reimbursement in the future, clinicians should select appropriate treatment plans for precise treatment according to factors such as patient genotype, disease severity, treatment history, drug price and reimbursement rules, and further improve the therapeutic effect of patients. In this study, the SVR rate of patients using the traditional interferon treatment was only Among the patients who were cured, the average treatment time of patients using DAA drugs was 2. As the treatment time required by patients was significantly reduced, it positively improved patient medication compliance and treatment efficiency of hepatitis C patient. Therefore, the marketing and promotion of DAA drugs will have a clear positive effect on improving the therapeutic effect of hepatitis C and achieving the goal of eliminating hepatitis C. There were a certain limitations in this study. First of all, although Chengdu is the provincial capital with a population second only to Beijing, Shanghai and Chongqing, there are variations in China's hepatitis C medical insurance policies in different cities. It is necessary to carry out real world research involving more cities or at national levels to have a more comprehensive understanding of the implementation effect of hepatitis C medical insurance policies. In addition, considering the availability of data, the use of DAA drugs is only included in the data after the implementation of the special disease outpatient reimbursement policy in November , so it is still impossible to collect data on the number, proportion and cost of DAA drugs before the implementation of the policy. We need to further expand the sample size to evaluate the effect before and after the implementation of the special disease outpatient reimbursement policy. This study found that China's hepatitis C medical insurance policy, taking Chengdu as an example, has had a positive effect on the prevention and treatment of hepatitis C and the reduced the disease burden of patients. Firstly, Advanced experience needs to be summarized in a timely manner, the content and methods of hepatitis C medical insurance reimbursement policy needs continuous expansion and optimization, and the policy needs to be actively promoted it other co-ordination regions. Sorted the data and wrote the paper: LY and GL. Collected data and statistical analysis: GZ and FH. Managed and supervised the project: FH and HM. All authors contributed to the article and approved the submitted version. The authors gratefully acknowledge FH of West China Hospital of Sichuan University for providing technical support for data collection and HM for the guidance on the topic and valuable suggestions on the article writing. 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. This section collects any data citations, data availability statements, or supplementary materials included in this article. As a library, NLM provides access to scientific literature. Front Public Health. Find articles by Yiyao Liu. Find articles by Liangwen Gou. Find articles by Zhaoting Guo. Find articles by Zhiang Wu. Find articles by Qin He. Find articles by Haihuan Feng. Find articles by Ming Hu. Received Oct 17; Accepted Dec 20; Collection date First indicators Secondary indicators Possible outcome of classified outpatient payment policy Open in a new tab. Results of intermittent time series model of diagnostic and therapeutic indicators. Outcome of cost of single settlement in Intermittent time series model. Similar articles. Add to Collections. Create a new collection. Add to an existing collection. Choose a collection Unable to load your collection due to an error Please try again. Add Cancel. Encourages patients to actively seek medical advice. Encouraged patients to actively seek medical advice. Encourages patients to actively seek medical treatment. Encouraged patients to actively seek medical treatment. Reduce the burden of medical expenses on patients. Out-of-pocket expenses for outpatient settlement. Reduce the burden of out-of-pocket medical expenses. Reduce the burden of medical expenses on patients throughout the treatment process. Reduce the burden of out-of-pocket medical expenses throughout the patient's treatment. Reduce the burden of drug costs throughout the patient's treatment. Estimated value.

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