| IntroductionIn the past decade,with the rapid development of national economy and society,China's population structure and disease spectrum have also changed accordingly.Chronic non infectious diseases such as malignant cancers have become the main disease burden threatening the health of Chinese residents.A series of novel anti-cancer medicines,such as small molecule targeted drugs and monoclonal antibody drugs,have been widely used in the clinical treatment of cancer because of their more prominent effects than conventional treatment.But at the same time,because of the high price of such innovative drugs,it is difficult for ordinary families of patients in countries with imperfect public medical security system to bear,which brings heavy economic burden to families and society of patients.In order to promote the accessibility of a series of innovative drugs,including novel anti-tumor drugs,the World Health Organization(who)conducted a comprehensive assessment of all anti-tumor drugs in 2015,and included three novel targeted drugs in the WHO basic drug demonstration catalogue,and called on all countries to review the security policies for novel anti-tumor drugs.Based on the above domestic and foreign background,in order to meet the strong demand of using novel anti-tumor drugs in a timely and affordable manner for patients with malignant tumors in China,the state has intensively published in the past five years to encourage independent research and development of drugs,accelerate approval and listing,negotiate medical insurance prices,focus on procurement,reduce tariffs on novel cancer drugs,and finally include such drugs in the national basic medical insurance newspaper A series of policies,such as marketing scope,are aimed at promoting the accessibility of drugs,reducing the economic burden of cancer patients in China,and starting to establish a regulatory system to guarantee the use of innovative drugs,such as novel cancer drugs.From 2016 to 2018,three national health insurance drug negotiations reduced the price of a variety of novel anti-tumor drugs by 50%.However,due to its high price,there is still greater pressure on some patients.To what extent does the novel anti-tumor drug medical insurance policy benefit the patients?After the implementation of the policy,the changes of patients' personal economic burden,the policy factors that determine the benefits of patients,as well as the impact of medical insurance policy on drug utilization,economic burden and security fairness,all of these issues need to be studied.AimsThe study aims to evaluate the accessibility of novel anti-cancer drugs and the corresponding medical insurance system,and to explore the impact of the implementation of medical insurance policy on the utilization of novel anti-tumor drugs,the affordability of patients and medical insurance,and the fairness of the insurance policy.Based on the analysis results of real world data,this paper provides empirical evidence and policy recommendations for further improving the accessibility of novel cancer drugs for cancer patients,improving and promoting the implementation of more equitable novel anti-tumor drug insurance policy,improving the efficiency of medical insurance funds,and promoting the establishment of a long-term regulatory mechanism to reduce the economic burden of anti-tumor drug patients in China.Methods1.This study will systematically review the policy practice of novel anti-tumor drugs accessibility and safeguard policy system in China.Based on the retrospective literature study and qualitative semi-structured interview,this study will analyze the multiple accessibility of innovative drugs,including novel anti-tumor drugs,and make a qualitative evaluation of the policy practice,implementation effect and implementation progress in China.2.Based on the quantitative and qualitative analysis,the change trend of drug utilization before and after the novel anti-tumor drugs were included in the reimbursement scope of medical insurance for serious diseases in Zhejiang Province from January 2013 to December 2016,the economic burden of patients' drugs,and the possible impact of the novel anti-tumor drugs on the medical insurance fund after the implementation of medical insurance policy were evaluated.This paper analyzes the trend of drug utilization of five novel anti-tumor drugs included in the medical insurance before and after the implementation of the new policy of medical insurance in Zhejiang Province in 2015 by using the method of interval time series analysis;evaluates the drug economic burden of the standard course of treatment of patients by reviewing the policies and Literatures,combining with the telephone interview with the relevant institutions,and combining with the evaluation method of the drug economic burden of patients in who-hai The cost of medical insurance fund is estimated and sensitivity analysis is made based on drug utilization data.3.Taking HER-2+breast cancer as an example,based on the electronic medical record database and other information databases of Fujian Provincial Hospital,a retrospective collection of HER-2+breast cancer patients was conducted from January 2015 to June 2019.Through cross-sectional study and interval time series analysis,the benefit of patients treated with trastuzumab before and after its inclusion into the medical insurance policy in 2017 was analyzed.4.Taking HER-24+breast cancer as an example,based on the electronic medical record database and expense settlement database of Fujian Provincial Hospital,the patients with HER-2+breast cancer who went to see a doctor from January 2015 to June 2018 and completed the targeted/conventional chemotherapy treatment after operation,as well as the expenses and self payment ratio in the complete course of treatment from January 2015 to June 2019 were collected retrospectively.Through multiple linear regression,this paper studies the influence fac tors of treatment cost and out of pocket proportion before and after the implementation of the policy;by creating a patient sample based on the tendency value matching,this paper analyzes the influence effect of medical insurance policy on treatment cost and out of pocket proportion of patients,and based on the different matching fmction,uses bootstrap self-help sampling for sensitivity analysis.Results1.Analysis on the accessibility of novel anti-cancer medicines in China—from health system perspective1.1 in order to obtain new anti-tumor drugs,Chinese patients must go through the process of transformation from drug research results,application for new drug review and marketing license,enterprise pricing and price negotiation,incorporation into public medical security system,centralized procurement and terminal use of medical institutions,affordable drug use for patients,and drug monitoring.The inclusion of new tumor drugs in medical insurance and the accessibility of patients' drugs are closely related to the policies of the whole chain and all links of the above processes.1.2 the main obstacles to the access of Chinese patients to innovative drugs such as new tumor drugs are:obstacles to drug research and development and clinical trial approval;obstacles to the intellectual property rights of the original drugs;obstacles to the affordability and economic burden guarantee system of drugs;obstacles to centralized procurement and supply;obstacles to the administrative management of medical institutions.1.3 due to the high price of new tumor drugs,it still has a high cost after reducing 50%into the medical insurance in time.At the same time,due to the "starting payment,capping line","the proportion of first out of pocket" and the guarantee treatment based on the financing level in China's medical insurance system,the patients may still have financial burden difficulties.1.4 through multi department cooperation,the government has improved the price reduction of new cancer original research drug enterprises due to health administration,drug supply and centralized drug purchase.2.Analysis on the utilization and affordability of new anti-cancer medicines influenced by medical insurance policy2.1 before being included in the medical insurance,the hospital utilization of five study drugs decreased significantly(p<0.01).In the third month after the implementation of the medical insurance policy,the hospital utilization of the target drugs increased sharply,with an increase of 15.58-439.14 standard units(p<0.05),and then remained stable.2.2 After the target drugs were included in the medical insurance reimbursement for serious diseases in Zhejiang Province,the economic burden of urban and rural patients was further reduced to 2.1-0.6 times and 4.5-1.6 times of the per capita disposable income of urban and rural residents in 2016.2.3 in the first two years before the target drug was included in the implementation of the medical insurance policy,46%of the total financing of the catastrophic health insurance plan of Hangzhou City,Zhejiang Province in 2015 and 2016 will be used for the five new anti-tumor drugs studied.3.Analysis of the beneficiaries of the novel anti-cancer medicine insurance policy with HER-2+breast cancer3.1 the average proportion of the first treatment with target drugs increased from 37.4%before the implementation of the policy to 69.2%after the implementation of the policy.After the implementation of the policy,the number of patients in all subgroups treated with the target drug for the first time increased(p<0.01).3.2 the proportion of patients in urban areas was significantly higher than that in rural areas before the implementation of the policy(p=0.03).The distribution of disposable income in the area where the patients were treated for the first time with the target drugs was significantly different before the implementation of the policy(p=0.01)and after(p=0.04).The higher the income level in the area where the patients were treated for the first time,the higher the proportion of people who were treated for the first time with the target drugs.Before the implementation of the policy,there was a significant difference in the distribution of patients'medical insurance types(p=0.02).The proportion of patients who took the initial treatment with the target drugs was the highest,and the distribution difference after the implementation of the policy was no longer statistically significant(p=0.32).3.3 before the implementation of the policy,patients in rural areas were significantly less likely to choose the target drug for the first time than those in urban areas(OR=0.52,95%CI:0.29-0.74,p<0.01).The probability of target drug selection in high-income areas before the implementation of the policy(5.76 times,OR=5.76,95%CI:1.48-12.17,p=0.01)and after(1.98 times,OR=1.98,95%CI:1.42-17.27,p=0.02)was significantly higher than that in low-income areas.Before the implementation of the policy,the probability of choosing the first treatment of the target drugs for the patients participating in the medical insurance for urban and rural residents was significantly lower than that for the patients participating in the medical insurance for urban employees(OR=0.50,95%CI:0.35-0.79,p=0.03);after the implementation of the policy,the influence of the two types of insurance on the first treatment of the target drugs was not statistically significant(p=0.91).4.Analysis of the economic burden and policy effect of novel anti-cancer medicine insurance policy on the course of treatment of patients with HER-2+breast cancer4.1 the influencing factors of breast cancer treatment cost changed from the urban-rural distribution before the implementation of the policy,the level of disposable income in the region,tumor stage,medical insurance type and whether to choose new targeted drug treatment scheme to the age group,urban-rural distribution and tumor stage after the implementation of the policy(p<0.05).The difference between urban and rural areas was 74 655.78 yuan(95%CI:21420.74-147 503.34,p=0.03)and 20 076.23 yuan(95%CI:5102.54-37 452.44,p=0.04)higher than that between urban and rural areas;the difference between middle-income and low-income areas was 30 912.24 yuan(95%CI:6056.68,84 540.35,p=0.03)no longer statistically significant(p>0.05).4.2 there were significant differences in the factors affecting the proportion of out of pocket patients from the distribution of urban and rural areas before the implementation of the policy,the level of disposable income in the region,the type of medical insurance,whether to see a doctor in another place,and whether to choose the targeted drug treatment scheme(p<0.05).Compared with the rural areas,the proportion of out of pocket patients in the urban areas decreased from 18.7%(95%CI:0.081-0.288,p<0.01)to 10.6%(95%CI:0.037-0.192),p=0.01);the difference between urban and rural residents was no longer statistically significant(p>0.05)from 19.4%(95%CI 0.118-0.269,p<0.01)to 9.3%(95%CI 0.041-0.158,p=0.04).4.3 compared with the patients before the implementation of the policy,the average treatment cost of breast cancer patients after the implementation of the nearest matching construction policy was reduced by 140380.88 yuan(p<0.01);the effect of the policy based on self-help sampling estimation was that the treatment cost was reduced by 130550.21 yuan(95%CI:96752.47-197280.64,p<0.01).Compared with the patients before the implementation of the policy,the average course cost of breast cancer patients after the implementation of the policy constructed by kernel match was reduced by 148077.33 yuan(p<0.01);the effect of the policy based on self-help sampling was that the course cost was reduced by 139 289.23 yuan(95%CI:103 825.30-203 227.65,p<0.01).4.4 compared with the patients before the implementation of the policy,the patients after the implementation of the nearest matching construction policy had a 23%(p<0.01)reduction in the average OOP rate of breast cancer patients;the effect of the policy based on the self-help sampling estimation was a 24%(95%CI:0.20-0.27,p=0.01).Compared with the patients before the implementation of the policy,the patients after the implementation of the policy constructed by kernel match had a 22%reduction in the average proportion of patients' out of pocket(p<0.01);the effect of the policy based on self-help sampling was a 23%reduction in the proportion of patients' out of pocket(95%CI:0.17-0.28,P=0.02).Conclusions and Suggestions1.In order to gradually eliminate the accessibility barriers for patients to obtain novel cancer drugs,a series of reforms have been carried out in China,including drug listing approval,balancing intellectual property rights and patients' needs,as well as drug management in medical institutions and ultimately medical insurance.The integration of medical insurance and its related negotiations,procurement,and the implementation of medical insurance management policies in medical institutions have significantly improved the drug access of patients,but at the same time,it should be noted that the existing medical insurance policies are difficult to solve the drug access barriers of all patient groups.The scientific evaluation of the implementation effect of medical insurance policy will provide quantitative evidence for further improvement of medical insurance policy.2.Interrupted time series analysis of medicine utilization showed that after the implementation of the novel cancer drug insurance policy,drug demand was released and drug use level increased significantly.The analysis of patients' drug economic burden shows that patients' economic burden has been greatly reduced,which effectively improves the accessibility of such drugs,and the market demand of the original drugs and their generic drugs has been released to a certain extent.Compared with the income of rural patients,the economic burden of drug treatment is still heavy.With the development of domestic generic manufacturers,and the promotion of quality and efficacy evaluation of generic drugs,the economic burden of patients with new anti-tumor drugs will be further reduced.3.The accessibility of novel anti-cancer medicine is closely related to the medical insurance policies and actual security level enjoyed by patients.Generally speaking,the level of per capita financing guarantee of medical insurance in China is still relatively weak.The comprehensive evaluation of the implementation effect of medical insurance policy and the establishment of a reasonable cost sharing mechanism to optimize the level of medical security are conducive to improving the accessibility of innovative drugs for patients and promoting their timely application of drug treatment.At the same time,we need to pay attention to ensure the sustainability of medical insurance fund,so as to gradually improve the level of medical service security of the whole society.4.The medical insurance policy of novel anti breast cancer drugs generally benefits all patients with different social and economic backgrounds,and the utilization ratio of patients' target drugs is increasing after the implementation of the medical insurance policy.The policy benefits for patients in different places are still insufficient.We need to further strengthen the policy benefits to low-income areas and residents.The factors that affect patients' choice of target drug treatment are related to patients' medical insurance treatment.It is of great significance to strengthen the medical insurance treatment of patients from low-income areas and urban and rural residents to improve the universality and fairness of the new anti-tumor drug medical insurance policy.5.The novel anti breast cancer medicine insurance policy reduces the average treatment cost and the proportion of self payment of breast cancer patients to a certain extent,but the benefits and fairness of the policy to patients in the real world still need to be further improved.The new anti breast cancer drugs into the medical insurance policy for rural patients,urban and rural residents and remote medical patients are relatively weak,we need to improve their medical treatment to strengthen the protection of innovative anti-cancer drugs into the medical insurance.In the real world,the effect of this policy on the cost of treatment courses and the proportion of out of pocket expenses of patients is lower than the theoretical estimation based on the price change of target drugs and the proportion of medical insurance reimbursement.The results indicate that after the innovative anti-cancer drugs are included in the medical insurance,it is necessary to further adjust the medical insurance treatment,narrow the medical insurance treatment gap between different medical insurance co-ordination areas and different insured groups,improve the medical insurance reimbursement policy in different places,and give preferential policies to cancer patients with low payment ability but high treatment costs.By eliminating the difference of medical insurance treatment between people and regions,we can improve the policy's universality. |
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