OBJECTIVE:To explore losses and gains (L&G) and L&G ratio induced by Essential Medicine System in a county. METHODS:By choosing a county in western China as sample area,field investigation was used to collect outpatient and inpatient visits,outpatient and inpatient income,drug income,total length of stay and medical insurance reimbursement criteria in primary medical institutions (township health centers,village health rooms) of the county during 2009-2015. By setting the year 2009 as the baseline year,the drug cost reimbursed by medical insurance was simulated and calculated when Essential Medicine System were not implemented;L&G and L&G ratio of medical insurance were calculated by comparing with actual drug cost reimbursed by medical insurance. RESULTS:The year 2012,in which the sample county fully implemented the Essential Medicine System was the turning year. Medical insurance funds lost in primary medical institutions of the county during 2010-2011(lost 437000,915000 yuan,respectively),but gained during 2012 to 2015(gained 199000,494000,858000,1290000 yuan, respectively);the L&G ratio increased from -0.67％ to 1.21％. For reimbursed outpatient drug cost and inpatient cost,L&G of medical insurance were different. For reimbursed drug cost of village health room and township health center,L&G of medical insurance were also different. CONCLUSIONS:The implementation of Essential Medicine System benefits to medical insurance within the county and Medical insurance funds can be saved.

OBJECTIVE: To conduct the economic evaluation of recombinant human type Ⅱ tumor necrosis factor receptorantibody fusion protein (trade name: Etanercept) in the treatment of rheumatoid arthritis.METHODS: By literature retrieval, foreign literatures about Etanercept "head to head" research or Chinese literatures about the comparison of recombinant human type Ⅱ tumor necrosis factor receptor-antibody fusion protein with infliximab and adalimumab were collected. The costs were localized, indicators of effectiveness were converted into quality-adjusted life year (QALY), then cost-utility analysis (CUA) and incremental cost-utility ratio (ICUR) were conducted. RESULTS: Three qualified literatures were acquired. The translational research of the first report of WU B and so forth (2012 year) showed that CUA of Etanercept, infliximab and adalimumab were 48. 2, 36. 6 and 104. 6 thousand yuan/QALY, and ICUR were 119. 8, 116. 4 and 313. 4 thousand yuan/QALY, respectively. The translational research of the second report of Santos-Moreno P and so forth (2015 year) showed that CUA of Etanercept, infliximab and adalimumab were 93. 1, 118. 2 and 249. 2 thousand yuan/QALY, and ICUR were 117. 5, 151. 3 and 327. 9 thousand yuan/QALY, respectively. The translational research of the third report of Santos-Moreno P and so forth (2016 year) showed that CUA of Etanercept, infliximab and adalimumab were 107. 0, 131. 6 and 273. 8 thousand yuan/QALY, and ICUR were 139. 6, 172. 5 and 369. 8 thousand yuan/QALY, respectively. ICUR of Etanercept were all smaller than 3 times of GDP 148. 1 thousand yuan in 2015. CONCLUSIONS: From the results of the study of these 3 literatures, compared with infliximab and adalimumab, Etanercept shows economy for rheumatoid arthritis.

Objective:To analyze the impact of Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ:IgG Fc Fusion Protein (rhTNFR:Fc) on medical insurance budget.Methods:Rheumatic drugs were select from the IMS data 2015.The drug quantity unit was converted to defined daily dose(DDD).The quantity of rhTNFR:FC in IMS data 2015 was taken as the baseline.The expenditure growth and its impact on rheumatic drugs and all drugs were calculated under 90％ and 80％ reimbursement rate as the different incremental proportion of the quantity of rhTNFR:Fc.National health insurance expenditure data was derived from statistical data of government departments.Results:According to 90％ reimbursement rate,medical insurance expenditure increased by 5.22～10.43 billion yuan.rheumatic drugs and all medical insurance drugs expenditure increased by 63.44～126.87％ and 0.04～0.08％ respectively while the consumption of rhTNFR:Fc increased 0-100％ in 2015.The increment of medical insurance expenditure reduced accordingly under the reimbursement ratio of 80％.Conclusion:The budget impact of rhTNFR:Fc was great on medical insurance expenditure of rheumatic drugs,which was very limited on the medical insurance expenditure of all drugs.

Objective:To analyze losses and gains (L&G) of basic medical institutions induced by the Essen-tial Medicines Policy.Methods: Choosing some poverty-stricken county in western China as sample area to conduct field research,using 2009 as baseline year,to calculate L&G and L&G ratio of basic medical institutions caused by adjustments of drug policy,medical services prices, and government subsidies from 2009—2015. Results: Medical facilities have gained after the implementation of the Essential Medicines Policy as a whole. Gains were on an upward trend from 2009—2015,and L&G ratio increased from -2.15% in 2009 to 47.70% in 2015. For medical facilities at different levels, their gains attributed to different causes. Gains for medical facilities at village and town levels mainly attributed to government subsidies;gains for medical facilities at county level mainly attributed to adjustment of medical services prices. Conclusions:Implementation of the Essential Medicines Policy has helped adjust composi-tion of losses and gains of medical facilities. Moving forward,functions and development of medical facilities should be strengthened with a focus on adjusting medical services prices for medical facilities at town level.

目的:探索仿制药/原研药的比价(PR)与仿制药的生产厂家数量(QM)的关系.方法:采用上海医院购药信息系统(HPDIS)的数据,筛选出仿制药及其对应的原研药,计算两者有效成份最小计量单位的PR,同时,统计每个仿制药的QM,并对PR与QM进行相关和回归分析.结果:PR的均值为0.54±0.26,中位数为0.57;QM的均值为3.07±2.46,中位数为2.00;两者的相关系数为-0.36,线性回归方程为PR=-0.04QM +0.66.结论:本研究结果可以为有关管理部门合理控制PR和QM提供参考.

目的:通过对仿制药与原研药的比价的实证研究,探讨其管理策略.方法:采用2014年上海医院购药信息系统的数据,获取276对仿制药及其对应原研药的配对样本,把配对样本的价格转换成可比价格进行比较.结果:仿制药与原研药的全部比价在0.01～ 1.41之间,均值为0.54±0.26,均值的95％置信区间为0.51～ 0.57,第一四分位数为0.34,中位数为0.57,第三四分位数为0.73.结论:对仿制药与原研药价格管理策略的建议是把比价的第一和第三四分位数之间的区间作为过渡性合理区间,将来结合仿制药质量一致性评价结果,引导仿制药与原研药的比价向更加合理的区间移动,最终基本实现由市场决定仿制药与原研药的比价,同时,要出台鼓励使用仿制药的配套措施.

目的:研究国内湿性老年性黄斑变性的疾病负担.方法:采用多中心、回顾加现况调查设计.北京、成都、广州和上海作为样本城市,各个城市分别选取若干家样本医院.按照入选和剔除标准筛选病例,分为光动力疗法、光凝、手术、联合和支持5个组,对直接成本、间接成本和疾病负担进行研究.统计软件用SPSS17.0.结果:获得合格病例417例,男性占51.32％,女性占48.68％.每眼年的疾病负担为32 882元.每眼全病程的疾病负担为230 172元.在疾病负担中直接医疗成本所占的比例并不高(26.35％),而间接成本所占的比例较高(68.58％).结论:湿性老年性黄斑变性的疾病负担已经比较高,应当引起利益相关者的重视.新的诊疗方法尽管会增加直接医疗成本,但有可能会降低疾病负担,这为新技术的应用展示了空间.推行诊疗规范既有利于对患者的规范治疗又有利于对直接医疗成本的管理.对年轻患者的优先防治有利于社会总疾病负担的降低.

Objective:To conduct a budget impact analysis(BIA) of using alverine citrate/simeticone(ACS) for treatment of irritablebowel syndrome(IBS), provide references for its reimbursement policy.Methods:Literature study was adopted. Based on the originalpaper of Ondemand Treatment with Alverine Citrate/Simeticone Compared with Standard Treatments for Irritable Bowel Syndrome: Results of a Randomised Pragmatic Study Reported by Ducrotte, the costs of ondemand treatment with ACS and standard treatments forIBS were localized. The BIA was conducted at direct cost and total cost levels respectively according to the prevalence and consultation rate in China.Results:Taking the budget of all patients included in standard treatments as the baseline, the saving budget gradually grew with the proportion of patients adopting ondemand treatment with ACS raised. The budget that could be saved also gradually increased with 37.736 billion yuan(45.90%) for the maximum direct cost and 42.787 billion yuan(41.14%) for the maximum totalcost diameter.Conclusion:ACS ondemand treatment could save budget greatly compared with standard treatments, which was worthto be brought into reimbursement scope.

Through reviewing the literatures on the pharmacoeconomics evaluation of inflixmab in the treatment of ankylosing spondylitis,this study shows thatankylosing spondylitiswith the treatment of inflixmab could reduce its disease burden and improve the quality of life,which is provided with better economics significance.

This study focused on the pharmacoeconomicsevaluation of infliximab in the treatment of Crohn's Disease through literature review.Compared to traditional medicines,infliximab is more cost-effectiveness in childern.Combined therapy of infliximab and azathioprine is also more cost-effectiveness than infliximab monotherapy.

Objective:To understand the current knowledge-attitude-practice situation of pharmacoeconomics in different stakeholders. Methods:A survey was conducted to professionals working in the government, pharmaceutical companies,hospitals and research intitutions in the field of pharmacoeconomics by using KAP questionnaire. Results and Conclusion:The respondents were senior workers in pharmacoeconomics field. The way to access knowledge regarding pharmacoeconomics was mainly from work training. The main research direction was to consider the needs of the decision-making,the research results were mostly published articles,and it was difficult to transform the research findings into policy. Therefore,it is recommended to improve the quality of pharmacoeconomics research,strengthen pharmacoeconomics knowledge training in policy makers,and promote the development of pharmacoeconomics in China.

Objective: To compare utility values measured by different instruments. Methods: Different instruments were used to measure utility values in 350 patients who were diagnosed as age-related macular degeneration at the same time. The median of utility values measured by different instruments was regarded as relative standard utility value to process comparison, analysis of variance, correlation analysis and curve estimation. Results: Most differences and correlations among utility values measured by different instruments were significant, as well as equations estimated from relative standard utility value and utility values measured by different instruments, but the degree of fitting was not high. Conclusion: The utility values of the same subject measured by different instruments are quite different. The results of the study could provide correction reference to the utility value measured by single instrument in the absence of absolute standard.

Objective: In order to understand the general situation of off-patent originals and generics in the domestic market, evidences for quality consistency evaluation for generics and related policies were provided. Methods: Through data reduction and analysis of Shanghai Purchasing Drug Information System (HPDIS), quantity, dosage form distribution and price ratios of generics and their off-patent originals were researched. Results: There are 300 generic names of off-patent originals in the domestic market. Half dosage forms of generics are tablets and capsules, 33% are injections, and the rest own a smaller proportion. The overall price ratio of generics and their off-patent originals in the same year and the same dosage form is about 60%, but there are also some great disparities and price inversions between generics and their off-patent originals. Conclusion: Quality consistency evaluation for generics will have a strong impact on quality, industry, pricing and expenditure of pharmaceuticals, parties concerned should predict and prepare for it.

Objective To evaluate the cost-effectiveness of Ticagrelor compared with Clopidogrel for patients presenting with ACS in China based on the model simulation.Methods In this study,the overall study design,inclusion standard,the number of cases,clinical centers and countries involved,dosing regimens,the primary efficacy and safety indicators are all based on global PLATO study.Based on data from the PLATO study and PLATO health economics evaluation model,which is a two-part construct with a one-year decision tree,and a Markov model for long-term extrapolation,all cost data are based on the pricing table(2010) of medical services or drugs in Shanghai,and then carrying on a cost-effectiveness analysis.Results Based on the long-term Markov model,the cost per QALY gain with ticagrelor was RMB14094,which is far less than one GDP per capita in Shanghai in 2010.Conclusion From the perspective of health service providers,Ticagrelor is cost-effectivess in treating ACS patients in Shanghai using GDP per capital as the QALY-threshold.

Objective: To evaluate the antipsychotic drugs in National Essential Medicine List of 2012 edition using pharmacoeconomics method so as to provide the scientific evidence for the selection of essential medicines for severe mental illness. Methods:Based on the defined daily dose (DDD) and the daily dose cost (DDC) of different antipsychotic drugs and using the sales data of psychiatric drugs during 2009-2011 from 120 sampled hospitals in Shanghai, the market share of different antipsychotic agents was analyzed. A systematic review was conducted of 24 international and domestic literatures to collect evidence-based cost-effectiveness evaluation results. Results:The second generation antipsychotics are of low rate of side effects and have a predominance market share with a yearly increasing trend. By the comparison of relative cost-effectiveness analysis, the results ranked as clozapine, risperidone, olanzapine and guetiapine. Conclusion:It is necessary to enrol the second generation antipsychotics in National Essential Medicine List of 2012 edition. For the selection of essential medicines, consideration should not only be given to the clinical efficacy and their cost, but also the costs for the long-term treatment and adverse reactions. In the future, more studies should be done on modeling method, value-cost comparison and budget impact analysis.

OBJECTIVE:To evaluate the effect of the implementation of national essential drug system on rational use of drugs in community health service centers from Shanghai area.METHODS:50 prescriptions had been randomly sampled every month from 6 sampling institutions during last six months of 2010 and 2011.A total of 3 600 prescriptions were collected.6 indicators had been calculated and compared,such as drug cost per prescription,drug types per prescription,amount of drugs per prescription,percentage of antibiotics,percentage of hormone and percentage of injection.RESULTS:The value of 6 indicators decreased after the implementation of national essential drug system;amount of drugs per prescription in urban sampling institutions,drug cost per prescription,amount of drug per prescription,percentage of antibiotics and percentage of injection in rural sampling institutions were all decreased;there were statistical significances(P0.05),compared with before the implementation of the system.CONCLUSION:National essential drug system plays a role in rational use of drugs in community health service centers;the implementation of national essential drug system mainly promote rational drug use of rural community health service centers,because drug use of urban centers is already reasonable before that.

OBJECTIVE:To analyze the changes of the situation of essential drugs supply in community health centers after the implementation of national essential drug system(NEDS) in Shanghai.METHODS:The changes of the quantity and types of essential medicines supplied were compared before and after the implementation of NEDS;the diversity of drugs species supplied by different community health centers was also compared.RESULTS CONCLUSION:After the implementation of NEDS,355 types of essential drugs are provided evenly by the sample institutions,increased by 30 types than before at the same period.The quantity of essential drugs supplied is affected by the total fixed budget of medical insurance in Shanghai and the cancellation of drugs markup rate.After the implementation of NEDS,nitroglycerin and other 20 kinds of western drugs,Baoji pills and other 28 kinds of Chinese patent medicines are additionally provided by the sample institutions;15 kinds of western drugs and 4 kinds of chinese medicines disappear among essential drugs.There are some differences in the types of essential drugs among sample institutions.140 kinds of drugs are provided in every sample institution.166 kinds of drugs are provided in none of sample institution,in which 13 types haven't acquired public bidding and 12 types not tender by pharmaceutical enterprises.

OBJECTIVE:To analyze the changes of drugs economic burden of patients after the implementation of national essential drug system in Shanghai.METHODS:Using Excel 2007 for data input and analysis,the changes of the retail prices of drugs,the total costs of drugs,the drugs expense of outpatient and emergency department each time and the average drugs expense of discharged patients each time were analyzed as well as the changes of drug economic burden of specific diseases both in urban and rural areas.RESULTS:The weighted retail prices of drugs had decreased by 11.83%;the total costs of drugs had decreased by 6.25% in community health care center,the average drugs expense of outpatient and emergency department each time had decreased by 5.87%,the average drugs expense of discharged patients each time had decreased by 3.42%;the average expense of patients with hypertension each time had decreased from 100.60 yuan to 88.32 yuan in urban areas,67.30 yuan to 53.99 yuan in rural areas;the average expense of patients with acute upper respiratory infection each time had decreased from 73.10 yuan to 69.24 yuan in urban areas,70.47 yuan to 42.86 yuan in rural areas.Results of survey showed 38.64% and 34.21% of the patients thought their medical expense had a reduction in urban areas in rural areas.CONCLUSION:After implementation of national essential drug system,drug cost decrease to some extent,while patients have no obvious feeling and great gap of economic burden exist between urban area and rural area;the physicians' behavior should be standard,for there is a tendency to over-prescribing drugs and over-expensive drugs in community health care center.

OBJECTIVE:To analyze the effects of the implementation of national essential drug system(NEDS) on grass-roots terminal market of pharmaceutical industrial enterprises in Shanghai.METHODS:The number and the market concentration ratio(CR) of pharmaceutical industrial enterprises in the primary terminal market were compared before and after the implementation of NEDS;the number and the market concentration ratio(CR) of pharmaceutical industrial enterprises in the grass-roots terminal market and non-primary terminal market were compared after the implementation of NEDS.RESULTS CONCLUSION:The implementation of NEDS induces cards-shuffling effect among pharmaceutical industrial enterprises in the grass-roots terminal market;NEDS has showed market crowding-out effect.NEDS promotes the primary terminal market CR of the pharmaceutical industrial enterprises.CR1,CR4 and CR8 have elevated by 6.18%,17.52% and 29.96% respectively in the second half of 2011;large-scale enterprises,large-scale foreign enterprises and non-Shanghai enterprises have the trend of occupying more market share in the primary terminal market.

Eoupean Union carried out social security work of rare diseases at the strategic level from all over Europe in 2008,and had gained some good work experiences related rare diseases,from which China can learn.By summing up the overview of the EU rare diseases and its orphan drugs list,organization structure and strategic plan,financing and payment systems,and services providing system,etc.we analyzed the advantages and disadvantages of the security system of EU's rare disease,and proposed the implementation recommendations to carrying out social protection of rare disease in China,which including unifying rare diseases definition,coding,and catalogue;constructing the organization system for health care;drawing up national and regional plans and policies;optimizing services for rare diseases;constructing sustainable financing system for rare diseases;focusing on the comprehensiveness and regional disparity,and provided a reference to improving prevention and control of rare disease,and strengthed the sustainability development of China's rare diseases security system.