Abstract:
:Everybody acknowledges the merits of the European Medicines Evaluation Agency and the progress the European system has permitted in evaluating and approving medicinal products. Nevertheless, the system established in 1995 is ripe for updating and improvement in the light of experience. Some limitations of the procedures suggested by the european Community regulations seem to hamper achievement of the real aims. The scientific community needs to identify the problems and propose and debate solutions with the politicians concerned, so that the european regulatory authority can fulfil its commitment to the defense of public health. The European Commission has made its proposal for improving the system. Here are our first comments.
journal_name
Expert Rev Pharmacoecon Outcomes Resjournal_title
Expert review of pharmacoeconomics & outcomes researchauthors
Garattini S,Bertele' Vdoi
10.1586/14737167.2.1.51subject
Has Abstractpub_date
2002-02-01 00:00:00pages
51-6issue
1eissn
1473-7167issn
1744-8379journal_volume
2pub_type
杂志文章abstract::Objectives were to evaluate correlates, and economic outcomes of proton pump inhibitor (PPI) use by route in the intensive care unit from an institutional-payer perspective. A 13-month retrospective study of electronic medical records was conducted of 534 adult (≥19 year-old) intensive care unit patients receiving a P...
journal_title:Expert review of pharmacoeconomics & outcomes research
pub_type: 杂志文章
doi:10.1586/14737167.2014.940902
更新日期:2014-10-01 00:00:00
abstract::Health technology assessment (HTA) has become an integral part of decision-making on the coverage of new health technologies in most health systems in the developed world. In recent years, pressure to involve patients and members of the public in HTA has grown. In this article, we summarize findings from peer-reviewed...
journal_title:Expert review of pharmacoeconomics & outcomes research
pub_type: 杂志文章,评审
doi:10.1586/erp.10.82
更新日期:2011-02-01 00:00:00
abstract:BACKGROUND:Rotavirus diarrhea is a major health problem among young children worldwide with potential negative impacts on health-related quality of life (HRQoL). This study assessed the impact of rotavirus diarrhea on HRQoL of children and their caregivers. METHODS:We performed a cross-sectional study among 460 hospit...
journal_title:Expert review of pharmacoeconomics & outcomes research
pub_type: 杂志文章,多中心研究
doi:10.1080/14737167.2018.1386561
更新日期:2018-04-01 00:00:00
abstract:OBJECTIVE:To assess the cost-effectiveness of single pill fixed dose triple combination therapy vs. free triple combination therapy for the prevention of cardiovascular events among patients with hypertension. METHODS:A Markov model with a five year cycle was constructed. Two decision models incorporating strict and m...
journal_title:Expert review of pharmacoeconomics & outcomes research
pub_type: 杂志文章
doi:10.1080/14737167.2020.1800457
更新日期:2020-08-01 00:00:00
abstract::Prostate cancer is the most common non-skin cancer in American men, and prostate-specific antigen (PSA) testing is its common screening procedure. In May 2012, the US Preventive Services Task Force recommended against PSA-based screening. These recommendations contradict the current recommendations of other organizati...
journal_title:Expert review of pharmacoeconomics & outcomes research
pub_type: 杂志文章,评审
doi:10.1586/erp.13.26
更新日期:2013-06-01 00:00:00
abstract::In health and disability arenas, it is increasingly being recognized that removing or modifying environmental factors can have a greater influence over outcomes than many individually focused interventions. In 2001, the World Health Organization endorsed a major revision of its framework for assessing and classifying ...
journal_title:Expert review of pharmacoeconomics & outcomes research
pub_type: 杂志文章
doi:10.1586/14737167.3.2.125
更新日期:2003-04-01 00:00:00
abstract::Descemet's stripping endothelial keratoplasty (DSEK) is a relatively new technique that is rapidly replacing full-thickness procedures for those patients needing corneal transplantation for endothelial dysfunction. Benefits of DSEK include a faster recovery, reduced astigmatism, fewer postoperative complications and r...
journal_title:Expert review of pharmacoeconomics & outcomes research
pub_type: 杂志文章
doi:10.1586/14737167.7.2.137
更新日期:2007-04-01 00:00:00
abstract::The incidence of melanoma has been climbing steadily since the early 1970s. Although melanoma can be successfully cured by surgical excision in its early stages, it is the most common fatal form of skin cancer. The most critical factors in determining the prognosis for patients with melanoma are primary tumor thicknes...
journal_title:Expert review of pharmacoeconomics & outcomes research
pub_type: 杂志文章
doi:10.1586/14737167.4.6.667
更新日期:2004-12-01 00:00:00
abstract:INTRODUCTION:For optimum results from pharmacological management of overactive bladder, adherence to prescribed medication is required. Overactive bladder treatment has been compromised by low adherence and persistence to medications, losing many people who might benefit from treatment and exposing them to unnecessary ...
journal_title:Expert review of pharmacoeconomics & outcomes research
pub_type: 杂志文章,评审
doi:10.1080/14737167.2016.1203258
更新日期:2016-08-01 00:00:00
abstract:INTRODUCTION:During the past few years, medical-economic evaluation of lung cancers (LCs) has become unavoidable. Total management costs have been rising constantly, with values almost doubling every 10 years. The financial impact will be even greater with the new molecules now marketed. The methodology for these studi...
journal_title:Expert review of pharmacoeconomics & outcomes research
pub_type: 杂志文章,评审
doi:10.1080/14737167.2018.1485099
更新日期:2018-10-01 00:00:00
abstract:BACKGROUND:Biosimilars can directly reduce the cost of treating patients for whom a reference biologic is indicated by offering a highly similar, lower priced alternative. We examine factors related to biosimilar regulatory approval, uptake, pricing, and financing and the potential impact on drug expenditures in the U....
journal_title:Expert review of pharmacoeconomics & outcomes research
pub_type: 杂志文章
doi:10.1080/14737167.2018.1476142
更新日期:2018-08-01 00:00:00
abstract:BACKGROUND:Four hurdles associated with economic evaluations in welfare interventions were identified and discussed in a previous published literature review. These hurdles include (i) 'Ignoring the impact of condition-specific outcomes', (ii) 'Ignoring the impact of QoL externalities', (iii) 'Calculation of costs from...
journal_title:Expert review of pharmacoeconomics & outcomes research
pub_type: 杂志文章
doi:10.1080/14737167.2017.1282316
更新日期:2017-08-01 00:00:00
abstract::Despite the intense debates over state or private sector dominance in healthcare finance and provision, there are no clear winners. Failed models exist on either end of the ideological spectrum and no country in the world has one that is purely public or purely private. Neither does a perfect public-private mix exist;...
journal_title:Expert review of pharmacoeconomics & outcomes research
pub_type: 杂志文章
doi:10.1586/14737167.6.6.647
更新日期:2006-12-01 00:00:00
abstract::The 10th consecutive World Health Economics conference was organized jointly by International Health Economics Association and European Conference on Health Economics Association and took place at The Trinity College, Dublin, Ireland in July 2014. It has attracted broad participation from the global professional commu...
journal_title:Expert review of pharmacoeconomics & outcomes research
pub_type:
doi:10.1586/14737167.2014.967220
更新日期:2014-12-01 00:00:00
abstract::Electronic medical records (EMRs) have become a common source of data for outcomes research. This review discusses trends in EMR data use for outcomes research as well as strengths and limitations, and likely future developments to help optimize value and use of EMR data for outcomes research. EMR-based studies report...
journal_title:Expert review of pharmacoeconomics & outcomes research
pub_type: 杂志文章,评审
doi:10.1586/erp.13.7
更新日期:2013-04-01 00:00:00
abstract:INTRODUCTION:Breast cancer, the second most common cancer in women, exerts a multidimensional grave effect on affected women. Among the several subtypes of breast cancer, the overexpression of the human epidermal growth factor receptor-2 gene is associated with poorer survival and higher relapse rates. Trastuzumab, a m...
journal_title:Expert review of pharmacoeconomics & outcomes research
pub_type: 杂志文章
doi:10.1080/14737167.2019.1536549
更新日期:2019-04-01 00:00:00
abstract::Research on the quality of life (QL) of children/adolescents with psychological disorders has flourished over the last few decades. Given the developmental challenges of QL measurements in pediatric populations, the aim of this study was to ascertain the extent to which a developmental approach to QL assessment has be...
journal_title:Expert review of pharmacoeconomics & outcomes research
pub_type: 杂志文章,评审
doi:10.1586/14737167.2015.972377
更新日期:2015-02-01 00:00:00
abstract::Rheumatoid arthritis is a chronic inflammatory musculoskeletal disease with a prevalence rate of 1-3% in Western countries. In addition to limited physical function, rheumatoid arthritis patients also suffer from psychologic comorbidities. Depression in rheumatoid arthritis patients has been linked to disease outcomes...
journal_title:Expert review of pharmacoeconomics & outcomes research
pub_type: 杂志文章
doi:10.1586/14737167.5.5.645
更新日期:2005-10-01 00:00:00
abstract::Osteoarthritis is the single most important cause of disability and limitation of activity of elderly people in the UK. Although joint replacement is now commonplace for hips and increasingly so for knees, pharmacological management continues to be important. In this context, it is necessary to identify valid and acce...
journal_title:Expert review of pharmacoeconomics & outcomes research
pub_type: 杂志文章
doi:10.1586/14737167.2.4.337
更新日期:2002-08-01 00:00:00
abstract::Respiratory syncytial virus is the most common cause of bronchiolitis, a lower respiratory tract infection occurring in infancy. It is responsible for several rehospitalizations, substantial morbidity and occasional deaths in the UK every year. Palivizumab is a recombinant monoclonal antibody that has been shown to re...
journal_title:Expert review of pharmacoeconomics & outcomes research
pub_type: 杂志文章
doi:10.1586/14737167.7.5.445
更新日期:2007-10-01 00:00:00
abstract::Alzheimer's disease is a neurodegenerative disorder characterized by cognitive and behavioral deficits. Donepezil and memantine are two medications used to treat the symptoms of cognitive decline in Alzheimer's disease. A modeled cost-effectiveness analysis found that treatment with donepezil to be less costly and mor...
journal_title:Expert review of pharmacoeconomics & outcomes research
pub_type: 评论,杂志文章
doi:10.1586/erp.12.21
更新日期:2012-06-01 00:00:00
abstract::Interest is rising in measuring subjective health outcomes, such as treatment outcomes that are not directly quantifiable (functional disability, symptoms, complaints, side effects and health-related quality of life). Health economists in particular have applied probabilistic choice models in the area of health evalua...
journal_title:Expert review of pharmacoeconomics & outcomes research
pub_type: 杂志文章,评审
doi:10.1586/erp.12.85
更新日期:2013-02-01 00:00:00
abstract::Healthcare reform in any nation is an evolving process. Brought about by demographic, technological, social, cultural, economic and political factors, all healthcare systems are continually confronting issues related to cost, access and quality. This paper examines other countries' approaches to healthcare in the ongo...
journal_title:Expert review of pharmacoeconomics & outcomes research
pub_type: 杂志文章
doi:10.1586/14737167.2.3.279
更新日期:2002-06-01 00:00:00
abstract::This review addresses hidden costs associated with the Bayer VERSANT assay, Roche AMPLICOR MONITOR test and COBAS AMPLICOR MONITOR test and how these influence the final per reportable cost to a testing laboratory in resource-rich and -poor countries. An in-depth evaluation and recommendation of the most cost-effectiv...
journal_title:Expert review of pharmacoeconomics & outcomes research
pub_type: 杂志文章
doi:10.1586/14737167.3.4.383
更新日期:2003-08-01 00:00:00
abstract::The goal of asthma management during pregnancy is to keep the mother symptom free and to prevent complications in the fetus. Asthma is a common chronic condition in pregnancy that, if inadequately treated, has the potential to cause adverse effects for both mother and fetus. Aggressive treatment during pregnancy can d...
journal_title:Expert review of pharmacoeconomics & outcomes research
pub_type: 杂志文章
doi:10.1586/14737167.6.1.67
更新日期:2006-02-01 00:00:00
abstract::Quality of life has become an important end point in clinical trials and academic studies. The questionnaires developed by the European Organisation for Research and Treatment of Cancer Quality of Life Group are widely used to measure quality of life in cancer patients. The expanding geographical coverage of current s...
journal_title:Expert review of pharmacoeconomics & outcomes research
pub_type: 杂志文章,评审
doi:10.1586/erp.11.27
更新日期:2011-06-01 00:00:00
abstract:BACKGROUND:The cost of interferon-free combination therapies remains high to provide widespread access to treatment, regardless of fibrosis stage. AIM:To estimate the cost-effectiveness of simeprevir/daclatasvir (SMV/DCV) therapy in treatment-naïve chronic hepatitis C genotype-1b patients with moderate fibrosis. METH...
journal_title:Expert review of pharmacoeconomics & outcomes research
pub_type: 杂志文章
doi:10.1586/14737167.2015.1081061
更新日期:2016-01-01 00:00:00
abstract::Smoking cessation is the only strategy that has shown a lasting reduction in the decline of lung function in patients with chronic obstructive pulmonary disease. This study aims to evaluate the cost-effectiveness of smoking cessation interventions in patients with chronic obstructive pulmonary disease, to assess the q...
journal_title:Expert review of pharmacoeconomics & outcomes research
pub_type: 杂志文章,评审
doi:10.1586/14737167.2015.1001976
更新日期:2015-04-01 00:00:00
abstract::Influenza, the seventh leading cause of death in the USA, accounts for 35,000 deaths and over 200,000 hospitalizations annually in that country alone. Recent advances in influenza vaccines, diagnosis and treatment have created numerous options for practicing clinicians, as well as economic opportunities for the makers...
journal_title:Expert review of pharmacoeconomics & outcomes research
pub_type: 杂志文章
doi:10.1586/14737167.5.2.141
更新日期:2005-04-01 00:00:00
abstract::The Resonance metallic stent is a new wire-based ureteral stent that was initially developed for patients with malignant ureteral obstruction. Potential advantages over traditional stents include resistance to encrustation and to external compression, allowing for increased dwell times and the maintenance of upper tra...
journal_title:Expert review of pharmacoeconomics & outcomes research
pub_type: 杂志文章
doi:10.1586/erp.09.74
更新日期:2010-02-01 00:00:00