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Equilibrium between resources and expenditure of health sector of Social Security Fund: a case study of Iran 社会保障基金卫生部门资源与支出之间的平衡:伊朗案例研究
IF 0.5 Q4 HEALTH CARE SCIENCES & SERVICES Pub Date : 2017-10-20 DOI: 10.7175/FE.V18I1.1273
A. A. Dashtian, Mohsen Mardali
In Iran, Social Security is the most important institution of social insurance fund, currently insuring more than a half of country population, and it has a significant role in fulfilling short-term and long-term commitments. Therefore investigation of the balance of resources and expenditure of health sector of the fund can be a scientific process of the funding the future and can pave the way to provide necessary revisions in this sector. Analyzing equilibrium between resources and expenditure of health sector of Social Security Fund in the past years, the present study offers recommendations for improving it in terms of parametric and structural dimensions. The methodology includes documentary library methods and statistical part is descriptive using Excel. Findings indicated that, regarding the present lack of balance of resources and expenditure of health sector, keeping on with the present conditions can lead to many crises. As a result, to escape from the present conditions of the funds where lack of balance of resources and expenditure exists, carrying out parametric and management-structural revisions seems necessary.
在伊朗,社会保障是最重要的社会保险基金制度,目前为全国一半以上的人口提供保险,在履行短期和长期承诺方面发挥着重要作用。因此,对基金卫生部门资源和支出平衡情况的调查可以成为今后供资的一个科学过程,并可以为该部门提供必要的修订铺平道路。本文通过对历年社会保障基金卫生部门资源与支出平衡的分析,从参数和结构两个维度提出了改善社会保障基金卫生部门资源与支出平衡的建议。研究方法包括文献图书馆法,统计部分采用Excel进行描述。调查结果表明,就目前卫生部门的资源和支出缺乏平衡而言,继续保持目前的状况可能导致许多危机。因此,为了摆脱目前缺乏资源和支出平衡的资金状况,似乎有必要进行参数和管理结构的修订。
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引用次数: 0
Evaluation of the cost saving potential of introducing Benepali® and Flixabi® on the European and Italian markets 评估Benepali®和Flixabi®在欧洲和意大利市场的成本节约潜力
IF 0.5 Q4 HEALTH CARE SCIENCES & SERVICES Pub Date : 2017-10-10 DOI: 10.7175/FE.V18I1.1330
C. Negrini, E. Psachoulia
INTRODUCTION: Biosimilar products play an important role in improving the access to biological medicines for an increased number of patients and enhancing the financial sustainability of the health systems. AIM: To assess the cost saving potential associated with the introduction of two biosimilars (Benepali ® and Flixabi ® ) vs. their respective reference biological products on the European and Italian markets. METHODS: A budget impact model was developed to estimate the cost saving of the hypothetical introduction of Benepali ® and Flixabi ® vs. Enbrel ® and Remicade ® , respectively, in three European countries. The analysis was conducted from the payer perspective, over a 3-year period. In addition, the same model was used to assess the impact of Benepali ® vs. Enbrel ® in three Italian regions over a 2-year period. The model compares the costs associated with the current treatment patterns, used to manage patients with all the conditions which Benepali ® and Flixabi ® are authorized for, with that of a hypothetical treatment pattern in which biosimilar products have been introduced. Only direct costs associated with the drug acquisition were considered. The model was constructed using published country- or region-specific data, where available. Annual drug acquisition costs were calculated using the dosing information from SPCs and country-/region-specific price lists. RESULTS: The introduction of Benepali ® and Flixabi ® in the biologic therapeutic setting of three European countries resulted in substantial cost savings across the entire scenario, with different penetration over a 3-year period. Similarly, over a 2-year horizon, the introduction of Benepali ® in the biologic therapeutic setting of three Italian regions resulted in significant cost savings. In all cases, the greater savings were observed in the scenario where the biosimilars’ penetration was higher. CONCLUSIONS: The introduction of Benepali ® and Flixabi ® has a substantial cost saving potential for the Italian and European health systems, and the budget impact is sensitive to the uptake rates of the biosimilars market.
导言:生物类似药产品在改善越来越多的患者获得生物药物和增强卫生系统的财务可持续性方面发挥着重要作用。目的:评估两种生物仿制药(Benepali®和Flixabi®)在欧洲和意大利市场上与各自的参考生物制品相比的成本节约潜力。方法:在三个欧洲国家建立了预算影响模型,以估计分别引入Benepali®和Flixabi®与Enbrel®和Remicade®的成本节约。该分析是从付款人的角度进行的,为期3年。此外,同样的模型被用于评估Benepali®与Enbrel®在意大利三个地区2年期间的影响。该模型比较了与当前治疗模式相关的成本,用于管理Benepali®和Flixabi®授权治疗的所有病症患者,以及引入生物仿制药的假设治疗模式。只考虑了与药品收购相关的直接成本。该模型是使用已公布的国家或地区特定数据(如有)构建的。年度药品采购成本是根据国家/区域特定价目表和spc的剂量信息计算的。结果:在三个欧洲国家的生物治疗环境中引入Benepali®和Flixabi®,在整个方案中节省了大量成本,在3年的时间内具有不同的渗透率。同样,在2年的时间里,在意大利三个地区的生物治疗环境中引入Benepali®,显著节省了成本。在所有情况下,在生物仿制药渗透率较高的情况下观察到更大的节省。结论:Benepali®和Flixabi®的引入为意大利和欧洲的卫生系统节省了大量的成本潜力,并且预算影响对生物仿制药市场的吸收率很敏感。
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引用次数: 2
Recently approved recombinant factor VIII (rFVIII) for the replacement treatment in patients with hemophilia A in Italy 意大利最近批准重组因子VIII (rFVIII)用于血友病A患者的替代治疗
IF 0.5 Q4 HEALTH CARE SCIENCES & SERVICES Pub Date : 2017-10-06 DOI: 10.7175/fe.v18i1.1321
D. Roggeri, E. Zanon, A. Roggeri
HemopHilia a Inherited or acquired genetic mutation resulting in dysfunction or deficiency of factor VIII (FVIII) or acquired inhibitor that binds FVIII are causes of Hemophilia A, a rare bleeding disorder. Among patients with genetic Hemophilia A, up to one third of cases are the results of new mutations (not present in the mother’s X chromosome) [1]. Dysfunction or deficiency of FVIII leads to an insufficient generation of thrombin by the FIXa and FVIIIa complex by means of the intrinsic pathway of the coagulation cascade. This mechanism, in combination with the effect of the tissue-factor pathway inhibitor, generates, depending on the level of FVIII activity, a relevant trend towards easy bruising or inadequate clotting of traumatic or even mild injury or, particularly in subjects with severe hemophilia, with spontaneous hemorrhage [1]. Hemophilia A is classified as mild, moderate, or severe depending on the amount of the clotting FVIII in blood. In severe hemophilia A, the FVIII levels are practically undetectable (<1%) causing chronic debilitating joint disease results from repeated hemarthrosis, synovial membrane inflammation, hypertrophy and, in some cases, destructive arthritis. In order to prevent functional disability, early replacement of coagulation factors through infusion is necessary. In most developed countries, the standard of care is the prophylactic therapy starting in young patients [1]. LetteR to the edItoR
血友病a:遗传或获得性基因突变导致因子VIII (FVIII)或获得性结合因子VIII的抑制剂功能障碍或缺乏是导致血友病a的原因,这是一种罕见的出血性疾病。在遗传性A型血友病患者中,高达三分之一的病例是由于新的突变(不存在于母亲的X染色体中)[1]。FVIII功能障碍或缺乏导致FIXa和FVIII复合物通过凝血级联固有途径产生凝血酶不足。这一机制与组织因子通路抑制剂的作用相结合,根据FVIII活性水平的不同,产生了创伤性甚至轻度损伤容易瘀伤或凝血不足的相关趋势,特别是在严重血友病患者中,自发出血[1]。A型血友病根据血液中凝血FVIII的含量分为轻度、中度或重度。在严重的A型血友病中,FVIII水平几乎无法检测到(<1%),导致慢性衰弱性关节疾病,由反复的关节出血、滑膜炎症、肥厚和某些情况下的破坏性关节炎引起。为了防止功能障碍,早期通过输注替代凝血因子是必要的。在大多数发达国家,护理标准是从年轻患者开始的预防性治疗[1]。给编辑的信
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引用次数: 1
Cost-effectiveness analysis of empagliflozin in the treatment of patients with type 2 diabetes and established cardiovascular disease in Italy, based on the results of the EMPA-REG OUTCOME study 基于EMPA-REG OUTCOME研究结果,对意大利恩格列净治疗2型糖尿病和既定心血管疾病患者的成本-效果进行分析
IF 0.5 Q4 HEALTH CARE SCIENCES & SERVICES Pub Date : 2017-10-05 DOI: 10.7175/FE.V18I1.1332
S. Iannazzo, E. Mannucci, O. Reifsnider, A. Maggioni
INTRODUCTION: The EMPA-REG OUTCOME trial demonstrated the efficacy of empagliflozin in the treatment of type 2 diabetes (T2D) with a previous history of cardiovascular (CV) disease. The drug is currently reimbursed for T2D Italian patients, but the reduction of CV mortality and morbidity shown in the trial opens a new treatment perspective in those patients with associated high CV risk. OBJECTIVE: Cost-effectiveness analysis of empagliflozin for the treatment of T2D patients with a previous history of CV disease, from the Italian National Health Service (NHS) perspective. METHODS: The analysis was performed with an individual simulation model, which can predict the time to CV events or death through a set of time-dependent regressions estimated on the patient-level data of the EMPA-REG OUTCOME trial. This design allows the direct simulation of long-term outcomes and costs without the need for surrogate endpoints. The model was adapted to the Italian setting, considering local epidemiological data, baseline quality of life (QoL) utility, background mortality and unit costs from current prices and tariffs. The cost perspective was that of the Italian NHS and the horizon of the simulation was lifetime. Costs and benefits were discounted at a 3.5% rate. RESULTS: Base case results were estimated on a cohort of 5,000 patients, which ensured the convergence of the simulation. Patients treated with empagliflozin in add-on to the standard of care (SoC) lived on the average 13.8 undiscounted years as compared to 11.8 years of patients on SoC alone. The gain in discounted quality-adjusted life years (QALYs) was 1.0, due to improved survival and QoL linked to the reduced incidence of CV events and CV mortality. The incremental cost-effectiveness ratio (ICER) was 4,811 €/QALY, well below the commonly applied threshold of 30,000-50,000 €/QALY. CONCLUSION: Empagliflozin in add-on to the SoC is a highly cost-effective strategy for the treatment of T2D patients with known CV disease in the Italian setting.
EMPA-REG OUTCOME试验证实了恩格列净治疗有心血管疾病史的2型糖尿病(T2D)的疗效。该药物目前在意大利用于T2D患者的报销,但试验中显示的CV死亡率和发病率的降低为那些相关的高CV风险患者开辟了新的治疗视角。目的:从意大利国家卫生服务(NHS)的角度分析恩格列净治疗既往CV病史的T2D患者的成本-效果。方法:采用个体模拟模型进行分析,该模型可以通过EMPA-REG OUTCOME试验的患者水平数据估计的一组时间相关回归来预测发生心血管事件或死亡的时间。这种设计允许直接模拟长期结果和成本,而不需要替代终点。考虑到当地流行病学数据、基线生活质量(QoL)效用、背景死亡率以及当前价格和关税带来的单位成本,该模型适用于意大利的环境。成本的角度是意大利国民保健服务,模拟的范围是终身。成本和收益按3.5%折现。结果:基本病例结果是在5000名患者的队列中估计的,这确保了模拟的收敛性。在标准治疗(SoC)的基础上加用恩格列净治疗的患者平均生存时间为13.8年,而单独使用SoC治疗的患者平均生存时间为11.8年。贴现质量调整生命年(QALYs)的增加为1.0,这是由于与CV事件发生率和CV死亡率降低相关的生存率和QoL的改善。增量成本效益比(ICER)为4,811欧元/QALY,远低于通常应用的30,000-50,000欧元/QALY的门槛。结论:在意大利,恩帕列净加用SoC治疗已知CV疾病的T2D患者是一种高成本效益的策略。
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引用次数: 14
Varenicline treatment for smoking cessation in high risk patients: a budget impact analysis 伐尼克兰治疗高危患者戒烟:预算影响分析
IF 0.5 Q4 HEALTH CARE SCIENCES & SERVICES Pub Date : 2017-10-02 DOI: 10.7175/FE.V18I1.1331
F. Spandonaro, L. Mancusi, B. Polistena
INTRODUCTION: The promotion of smoking cessation is a worldwide Public Health priority. OBJECTIVE: To estimate the budget impact on the Italian National Health Service (NHS) of the access to reimbursement of varenicline for the treatment of high risk patients with bronchopulmonary, diabetic and cardiovascular diseases. METHODS: A closed-group Markov model was developed in order to compare the costs incurred by the NHS to promote smoking cessation with cessation-related savings, using an alternative scenario in which aids to cessation are not reimbursed by the NHS. The analysis was conducted over a 5-year time horizon, in the perspective of the Italian NHS. Efficacy was expressed in terms of smoke abstinence for at least one year, and data was derived from clinical trials; the savings associated with smoking cessation were derived from cost-of-illness studies. RESULTS: The results show how costs would concentrate in the first year: they are estimated at € 200.6 million, of which € 162.4 million for drug therapy and € 38.2 million for counseling. Average annual savings over the first five years are estimated at € 77.7 million, with a cumulative net impact at 5 years of € -188.0 million (cost-saving). The analysis appears to be robust: sensitivity analyses show that the covering of initial costs occurs in any case between the third and fourth year, and that the treatment remains cost-saving at 5 years. CONCLUSIONS: The financial impact on the Italian NHS of the reimbursement of varenicline for the treatment of high risk smoking population would be a sustainable healthcare policy, resulting in cost savings starting from the fourth year.
引言:促进戒烟是世界范围内的公共卫生重点。目的:评估伐尼克兰治疗支气管肺、糖尿病和心血管疾病高危患者对意大利国家卫生服务体系(NHS)获得报销的预算影响。方法:开发了一个闭组马尔可夫模型,以比较NHS为促进戒烟而产生的成本与戒烟相关的节省,使用NHS不报销戒烟辅助的替代方案。分析是在5年的时间范围内进行的,从意大利NHS的角度来看。疗效表现为戒烟至少一年,数据来源于临床试验;与戒烟相关的节省来自疾病成本研究。结果:结果显示了第一年的费用集中情况:估计为2.006亿欧元,其中药物治疗费用为1.624亿欧元,咨询费用为3820万欧元。前5年的平均年节省预计为7770万欧元,5年累计净影响为1.880亿欧元(节省成本)。分析似乎是可靠的:敏感性分析表明,在任何情况下,在第三年和第四年之间都可以覆盖初始成本,并且治疗在第5年仍然节省成本。结论:使用伐尼克兰治疗高危吸烟人群对意大利NHS的财务影响将是一项可持续的医疗保健政策,从第四年开始就可以节省成本。
{"title":"Varenicline treatment for smoking cessation in high risk patients: a budget impact analysis","authors":"F. Spandonaro, L. Mancusi, B. Polistena","doi":"10.7175/FE.V18I1.1331","DOIUrl":"https://doi.org/10.7175/FE.V18I1.1331","url":null,"abstract":"INTRODUCTION: The promotion of smoking cessation is a worldwide Public Health priority. OBJECTIVE: To estimate the budget impact on the Italian National Health Service (NHS) of the access to reimbursement of varenicline for the treatment of high risk patients with bronchopulmonary, diabetic and cardiovascular diseases. METHODS: A closed-group Markov model was developed in order to compare the costs incurred by the NHS to promote smoking cessation with cessation-related savings, using an alternative scenario in which aids to cessation are not reimbursed by the NHS. The analysis was conducted over a 5-year time horizon, in the perspective of the Italian NHS. Efficacy was expressed in terms of smoke abstinence for at least one year, and data was derived from clinical trials; the savings associated with smoking cessation were derived from cost-of-illness studies. RESULTS: The results show how costs would concentrate in the first year: they are estimated at € 200.6 million, of which € 162.4 million for drug therapy and € 38.2 million for counseling. Average annual savings over the first five years are estimated at € 77.7 million, with a cumulative net impact at 5 years of € -188.0 million (cost-saving). The analysis appears to be robust: sensitivity analyses show that the covering of initial costs occurs in any case between the third and fourth year, and that the treatment remains cost-saving at 5 years. CONCLUSIONS: The financial impact on the Italian NHS of the reimbursement of varenicline for the treatment of high risk smoking population would be a sustainable healthcare policy, resulting in cost savings starting from the fourth year.","PeriodicalId":41585,"journal":{"name":"Farmeconomia-Health Economics and Therapeutic Pathways","volume":"36 1","pages":""},"PeriodicalIF":0.5,"publicationDate":"2017-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90696273","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
[Reply to Letter to the Editor in reference to " Clinical and economic evaluation of the introduction of the combinazion trametinib + dabrafenib in the management of advanced melanoma in the Italian market”] 【回复关于“在意大利市场引入曲美替尼+达非尼联合治疗晚期黑色素瘤的临床和经济评价”的致编辑的信】
IF 0.5 Q4 HEALTH CARE SCIENCES & SERVICES Pub Date : 2017-09-21 DOI: 10.7175/FE.V18I1.1329
L. Pradelli, P. Ascierto
{"title":"[Reply to Letter to the Editor in reference to \" Clinical and economic evaluation of the introduction of the combinazion trametinib + dabrafenib in the management of advanced melanoma in the Italian market”]","authors":"L. Pradelli, P. Ascierto","doi":"10.7175/FE.V18I1.1329","DOIUrl":"https://doi.org/10.7175/FE.V18I1.1329","url":null,"abstract":"","PeriodicalId":41585,"journal":{"name":"Farmeconomia-Health Economics and Therapeutic Pathways","volume":"84 1","pages":""},"PeriodicalIF":0.5,"publicationDate":"2017-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83973124","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
[In reference to "Clinical and economic evaluation of the introduction of the combinazion trametinib + dabrafenib in the management of advanced melanoma in the Italian market”] 【参考《在意大利市场引入曲美替尼+达非尼联合治疗晚期黑色素瘤的临床和经济评价》】
IF 0.5 Q4 HEALTH CARE SCIENCES & SERVICES Pub Date : 2017-09-12 DOI: 10.7175/FE.V18I1.1315
M. Ferrario, G. Giuliani
{"title":"[In reference to \"Clinical and economic evaluation of the introduction of the combinazion trametinib + dabrafenib in the management of advanced melanoma in the Italian market”]","authors":"M. Ferrario, G. Giuliani","doi":"10.7175/FE.V18I1.1315","DOIUrl":"https://doi.org/10.7175/FE.V18I1.1315","url":null,"abstract":"","PeriodicalId":41585,"journal":{"name":"Farmeconomia-Health Economics and Therapeutic Pathways","volume":"32 1","pages":""},"PeriodicalIF":0.5,"publicationDate":"2017-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81695227","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Budget Impact analysis of the first-line treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) adult patients 费城染色体阳性慢性髓性白血病(Ph+ CML)成人患者一线治疗的预算影响分析
IF 0.5 Q4 HEALTH CARE SCIENCES & SERVICES Pub Date : 2017-07-28 DOI: 10.7175/FE.V18I1.1318
F. Mennini, A. Marcellusi, R. Viti, G. Saglio
Background: Tyrosine kinase inhibitors (TKI) have dramatically improved survival in chronic myeloid leukemia in chronic phase (CML‐CP), with a high percentage of patients reaching a major molecular response (MMR). Recently, several clinical trials demonstrated that some patients with CML-CP who achieve a sustained MMR on tyrosine kinase inhibitor (TKI) therapy can safely discontinue their therapy and attempt treatment-free remission (TFR). Objective: The aim of the study was to evaluate the clinical and economic impact of TFR in naive patients with CML-CP who start treatment with nilotinib, imatinib or dasatinib as first-line therapy, from the perspective of the Italian National Health Service (NHS). Methods: An Excel-based budget impact model was developed, in order to estimate the costs of the patients in first-line pharmacological treatment with CML. A specific Markov model was built, to simulate seven years of treatment with different TKIs. A systematic literature review was carried out, to identify the epidemiological and economic data, which were subsequently used to inform the model. The model considers two scenarios: 1) a Standard of Care (SoC) scenario, with the current estimated distribution of patients over the various TKI treatment, versus 2) an innovative scenario, characterized by an increase in the use of nilotinib (+28%) and generic imatinib (+35%) and a decrease in the use of dasatinib (-17%). A one-way deterministic sensitivity analysis was performed, in order to consider the variability of the results as a function of the main parameters considered in the model. Results: The model estimated that 775 patients with CML-CP could be treated with a TKI as first-line drug. The innovative scenario could increase TFR patients by approximately 60% and reduce the costs by more than € 30 million over 7 years. The increase in the use of nilotinib and the generic imatinib would generate a significant expenditure reduction. Conclusions: This study demonstrates the economic effects of discontinuing TKIs in CML-CP patients. The increase in the use of nilotinib and the generic imatinib could generate an increase in the number of patients who achieve TFR, as well as an actual cost reduction.
背景:酪氨酸激酶抑制剂(TKI)显著提高慢性髓系白血病慢性期(CML - CP)患者的生存率,达到主要分子反应(MMR)的患者比例很高。最近,一些临床试验表明,一些CML-CP患者在酪氨酸激酶抑制剂(TKI)治疗下达到持续MMR后,可以安全地停止治疗并尝试无治疗缓解(TFR)。目的:本研究的目的是从意大利国家卫生服务(NHS)的角度,评估以尼罗替尼、伊马替尼或达沙替尼作为一线治疗的CML-CP初发患者TFR的临床和经济影响。方法:建立基于excel的预算影响模型,估算CML患者一线药物治疗的费用。建立了一个特定的马尔可夫模型,以模拟使用不同tki的七年治疗。进行了系统的文献综述,以确定流行病学和经济数据,随后将这些数据用于模型。该模型考虑了两种情况:1)标准护理(SoC)情况,即目前各种TKI治疗中患者的估计分布;2)创新情况,其特点是尼洛替尼(+28%)和非专利伊马替尼(+35%)的使用增加,达沙替尼的使用减少(-17%)。为了将结果的可变性作为模型中考虑的主要参数的函数,进行了单向确定性敏感性分析。结果:该模型估计775例CML-CP患者可将TKI作为一线药物治疗。该创新方案可使TFR患者增加约60%,并在7年内减少超过3000万欧元的成本。尼罗替尼和非专利伊马替尼使用的增加将大大减少支出。结论:本研究证明了CML-CP患者停用TKIs的经济效应。尼罗替尼和仿制药伊马替尼使用的增加可能会增加实现TFR的患者数量,并实际降低成本。
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引用次数: 2
Utilization patterns of complementary and alternative medicine in Australia, Canada and the United States: popularity of dietary supplements, mind-body and manipulative therapies 澳大利亚、加拿大和美国补充和替代医学的使用模式:膳食补充剂、身心和操纵疗法的普及
IF 0.5 Q4 HEALTH CARE SCIENCES & SERVICES Pub Date : 2017-05-08 DOI: 10.7175/FE.V18I1.1304
Marina Luketina Sunjka, A. Pejčić, M. Jakovljevic
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引用次数: 4
Nintedanib for the treatment of idiopathic pulmonary fibrosis in Italy 尼达尼布在意大利用于治疗特发性肺纤维化
IF 0.5 Q4 HEALTH CARE SCIENCES & SERVICES Pub Date : 2017-04-14 DOI: 10.7175/FE.V18I1S.1300
A. Belisari, D. Bettoni, P. Cortesi, Lucia S D'Angiolella, L. Mantovani, Gerardo Miceli Sopo, M. Nonis
To date, there are few therapeutic answers for Idiopathic pulmonary fibrosis (IPF) and only two pharmacological treatments have a marketing authorization for this disease. Recently nintedanib (Ofev®) has been authorized as a new therapeutic option and its economic profile has been evaluated by international Health Technology Assessment (HTA) bodies. IPF has important implications for everyday life of patients and their carers, negatively influencing their quality of life and bringing heavy economic burden to the NHS and to the entire society. It is, therefore important to consider these aspects for the Italian environment and to perform a pharmacoeconomic evaluation to define the efficiency of nintedanib in IPF by means of a Cost-Utility Analysis (CUA). As IPF is a chronic and progressive disease, a lifetime Markov model has been therefore developed with health states describing the patient’s condition as a combination of lung function and exacerbation history. The cohort entered in the model at different Forced Vital Capacity (FVC%) predicted health states, without exacerbation. The Clinical data used to perform this CUA were derived from clinical trials and the relative efficacy of nintedanib versus the comparator (pirfenidone) was then obtained from a Network Meta-Analysis (NMA) combining data reported in each primary study (INPULSIS 1-2 and TOMORROW trials for nintedanib, and CAPACITY and ASCEND trials for pirfenidone, respectively). At base-case, treatment with nintedanib resulted in a slightly lower estimated total cost vs pirfenidone, better safety profile and lower risk of acute exacerbations with an advantage in Quality Adjusted Life years (QALYs) gained. These results were confirmed by the sensitivity analysis. Although nintedanib appears to be a valuable option for the NHS to treat IPF patients, future data evidence, as long-term or real-life data, will help to confirm these results. [In Italian]
迄今为止,特发性肺纤维化(IPF)的治疗方案很少,只有两种药物治疗方法获得了该疾病的上市许可。最近,nintedanib (Ofev®)已被批准作为一种新的治疗选择,其经济概况已由国际卫生技术评估(HTA)机构进行了评估。IPF对患者及其护理人员的日常生活具有重要影响,对患者的生活质量产生负面影响,给NHS和整个社会带来沉重的经济负担。因此,重要的是考虑意大利环境的这些方面,并通过成本效用分析(CUA)进行药物经济学评估,以确定尼达尼布在IPF中的效率。由于IPF是一种慢性进行性疾病,因此建立了一个终生马尔可夫模型,将患者的健康状态描述为肺功能和加重史的组合。以不同的强迫肺活量(FVC%)进入模型的队列预测健康状态,没有恶化。用于执行此CUA的临床数据来自临床试验,然后从网络荟萃分析(NMA)中获得尼达尼布与比较剂(吡非尼酮)的相对疗效,并结合每个主要研究(尼达尼布的INPULSIS 1-2和TOMORROW试验,以及吡非尼酮的CAPACITY和ASCEND试验)中报告的数据。在基本情况下,与吡非尼酮相比,尼达尼布治疗的估计总成本略低,安全性更好,急性发作风险更低,在质量调整生命年(QALYs)方面具有优势。敏感性分析证实了这些结果。虽然nintedanib似乎是NHS治疗IPF患者的一个有价值的选择,但未来的数据证据,如长期或现实数据,将有助于证实这些结果。(意大利)
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引用次数: 0
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