“The future should not take us by surprise”: Preparation of an early warning system in Denmark

2004 ◽  
Vol 20 (3) ◽  
pp. 342-350 ◽  
Author(s):  
Karla Douw ◽  
Hindrik Vondeling ◽  
Jan Sørensen ◽  
Torben Jørgensen ◽  
Helga Sigmund
Keyword(s):  
Health Care ◽  
Health Technology Assessment ◽  
Health Care System ◽  
Technology Assessment ◽  
Early Warning ◽  
Early Warning System ◽  
Warning System ◽  
Health Technology ◽  
Danish Health ◽  
Danish Health Care System

Objectives:To explore and test methods for the operation of a national Early Warning System (EWS) in Denmark and to support decision making by the Danish Centre for Evaluation and Health Technology Assessment on this issue.Methods:On the basis of literature reviews, information from members of EuroScan, and supported by clinical experts and stakeholders, existing methods were adapted and new methods were developed as part of a feasibility study.Results:Approximately 200 technologies in 30 specialties were identified on the basis of information by EuroScan. A new instrument was developed to distinguish between important and unimportant technologies (filtering). Clinical experts in six specialties applied the instrument to sixty-two technologies in their respective fields, of which nine (15%) were judged potentially important for the Danish health care system. For priority setting, adapting a Dutch instrument to the Danish context was discussed. In principle, the instrument was acceptable, but several changes were proposed, for example, relating to the decentralized structure of the Danish health care system. For early assessment, the format and methods applied by SBU and Canadian Coordinating Office for Health Technology Assessment (CCOHTA) were compared and applied to pharmaceuticals (glitazones in treatment of type 2 diabetes mellitus) and a procedure (embolization of uterine fibromas). Given the main target group of the Danish EWS, local decision makers, the CCOHTA format was preferred.Conclusions:The findings of the study have laid the foundation for an EWS using appropriate methods adapted to local circumstances. On the basis of the findings, a decision was made to start an EWS.

Assessing the accuracy of forecasting: Applying standard diagnostic assessment tools to a health technology early warning system

2004 ◽  
Vol 20 (3) ◽  
pp. 381-384 ◽  
Author(s):  
Sue Simpson ◽  
Chris Hyde ◽  
Alison Cook ◽  
Claire Packer ◽  
Andrew Stevens
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Early Warning ◽  
Predictive Value ◽  
Gold Standard ◽  
Early Warning System ◽  
Warning System ◽  
Early Warning Systems ◽  
Health Technology ◽  
Warning Systems

Objectives:Early warning systems are an integral part of many health technology assessment programs. Despite this finding, to date, there have been no quantitative evaluations of the accuracy of predictions made by these systems. We report a study evaluating the accuracy of predictions made by the main United Kingdom early warning system.Methods:As prediction of impact is analogous to diagnosis, a method normally applied to determine the accuracy of diagnostic tests was used. The sensitivity, specificity, and predictive values of the National Horizon Scanning Centre's prediction methods were estimated with reference to an (imperfect) gold standard, that is, expert opinion of impact 3 to 5 years after prediction.Results:The sensitivity of predictions was 71 percent (95 percent confidence interval [CI], 0.36–0.92), and the specificity was 73 percent (95 percent CI, 0.64–0.8). The negative predictive value was 98 percent (95 percent CI, 0.92–0.99), and the positive predictive value was 14 percent (95 percent CI, 0.06–0.3).Conclusions:Forecasting is difficult, but the results suggest that this early warning system's predictions have an acceptable level of accuracy. However, there are caveats. The first is that early warning systems may themselves reduce the impact of a technology, as helping to control adoption and diffusion is their main purpose. The second is that the use of an imperfect gold standard may bias the results. As early warning systems are viewed as an increasingly important component of health technology assessment and decision making, their outcomes must be evaluated. The method used here should be investigated further and the accuracy of other early warning systems explored.

Pharmaceutical industry's perspective on health technology assessment

2004 ◽  
Vol 20 (1) ◽  
pp. 97-101 ◽  
Author(s):  
Mickael Lothgren ◽  
Mark Ratcliffe
Keyword(s):  
Health Care ◽  
The Netherlands ◽  
Health Technology Assessment ◽  
Health Care System ◽  
Technology Assessment ◽  
Health Technology ◽  
Cost Driver ◽  
Successful Implementation ◽  
Implementation Barriers ◽  
Overall Efficiency

This article presents the pharmaceutical industry's perspective on health technology assessment (HTA) with specific comments on the HTA systems in England and Wales, France, The Netherlands, and Sweden. The comments are focused on the following main themes: (i) The contributions of the HTA system to overall efficiency in the health-care system, (ii) HTA as a cost-driver for industry, patients, government, and society, and (iii) The various implementation barriers that currently exist for a successful implementation of HTA results.

scholarly journals Health technology assessment processes for nanotechnologies: the ethical domain

2011 ◽  
Vol 1 (1) ◽  
pp. 1 ◽  
Author(s):  
Antonio G. Spagnolo ◽  
Pietro Refolo ◽  
Dario Sacchini ◽  
Viviana Daloiso
Keyword(s):  
Health Care ◽  
Health Technology Assessment ◽  
Health Care System ◽  
Technology Assessment ◽  
Health Technology ◽  
Legal Issues ◽  
The Other ◽  
Ethical Assessment ◽  
Care System

The ethical assessment of the use of technologies is generally considered a component of the health technology assessment (HTA) processes. HTA is a multidisciplinary process that summarizes information about medical, economic, organizational, ethical, psychological, social and legal issues related to the implementation of a certain health technology in health care system and its main purpose is to inform policymaking. Unlike the other technologies nanotechnologies pose different risks and, therefore, new bioethical implications should be assessed. So, the ethical assessment of nanotechnologies within the HTA processes could be more problematic. The article intends to debate this complexity.

Scanning the Horizon for Emerging Health Technologies: Conclusions from a European Workshop

1998 ◽  
Vol 14 (4) ◽  
pp. 695-704 ◽  
Author(s):  
Per Carlsson ◽  
Torben Jorgensen
Keyword(s):  
Health Care ◽  
Early Warning ◽  
Health Professionals ◽  
Early Warning System ◽  
Warning System ◽  
Health Technology ◽  
Policy Makers ◽  
Early Evaluation ◽  
Health Technologies ◽  
Limited Experience

AbstractTo share the existing, albeit limited, experience among nations and to explore the feasibility of international collaboration on the identification and early evaluation of health care technologies, an workshop was arranged in September 1997. Twenty-seven policy makers and researchers from twelve countries attended the meeting and concluded that: the policy environment in most European countries is characterized by insufficient data on safety, effectiveness, and cost-effectiveness of health care innovations; that an early warning system is perceived as an essential mechanism for facilitating communication among policy makers, technology experts, and health professionals; and that collaboration on early warning activities might be even more useful than traditional collaboration in health technology assessment.

scholarly journals Health Technology Assessment Challenges for Orphan Medicinal Products in Low- and Middle-Income Countries in Europe

2021 ◽  
Vol 70 (1) ◽  
Author(s):  
Anna Mateva ◽  
Konstantin Tachkov ◽  
Antoniya Yanakieva ◽  
Petya Milushewa
Keyword(s):  
Health Care ◽  
Health Technology Assessment ◽  
Health Care System ◽  
Technology Assessment ◽  
Health Technology ◽  
Medicinal Products ◽  
Middle Income ◽  
Middle Income Countries ◽  
Orphan Medicinal Products ◽  
Low And Middle Income

The purpose of this research is to provide a short overview of the differences in access to and health technology assessment of OMPs in selected low- and middle-income countries in Europe and discuss these in terms of some challenges in the face of HTA comparing with high-income countries. This is a retrospective, desktop study of already published official inquiries of national or international institutions, scientific publications, and reports from national governing bodies who regulate and monitor HTA in low- and middleincome economies in Europe, with further regards to HTA of orphan medicinal products. Among all selected low- and middle-income countries in Europe - Bulgaria, Serbia, North Macedonia, Moldova, Ukraine, and Georgia, have available and up-to-date information regarding their health care legislation. During 2000-2019 EMA approves 164 orphan medicines and out of them from 23 to 133 were found in the selected countries. We found that Bulgaria has a special HTA body. Since 2015 in Ukraine the health care system is experienced dynamic reform. In particular, a legislative framework has been adopted that regulates pharmaceutical pricing and reimbursement policies, the introduction of health technology assessment (HTA), etc. Despite the fact that Serbia is not part of the European Union there is an HTA commission established by the Ministry of Health where members of the HTA committee have 5- year mandates. According to our research, Georgia and North Macedonia do not use HTA. Meanwhile, United Kingdom is well known to show a strong interest in evidence health care. system. On the other hand, ?he Statutory health insurance system (SHI reform), since 2000, established a federally funded HTA program with a database of relevant HTA results. Even though that the high-income countries have more developed HTA guidelines and stronger and more secure health systems, all the countries mentioned in this work are facing similar challenges. All the countries have limite

Developing Health Technology Assessment to address health care system needs

Health Policy ◽  
2010 ◽  
Vol 94 (3) ◽  
pp. 196-202 ◽  
Author(s):  
Marcial Velasco Garrido ◽  
Ansgar Gerhardus ◽  
John-Arne Røttingen ◽  
Reinhard Busse
Keyword(s):  
Health Care ◽  
Health Technology Assessment ◽  
Health Care System ◽  
Technology Assessment ◽  
Health Technology ◽  
Care System

scholarly journals Implementation of health technology assessment at the stage of market access for pharmaceuticals in Ukraine

2020 ◽  
pp. 45-58
Author(s):  
O. B. Piniazhko ◽  
L. I. Kovtun ◽  
O. M. Zaliska ◽  
O. M. Oleshchuk ◽  
M. V. Leleka ◽  
...  
Keyword(s):  
Health Care ◽  
Health Technology Assessment ◽  
Health Care System ◽  
Technology Assessment ◽  
Market Access ◽  
Health Technology ◽  
Essential Medicines ◽  
Ministry Of Health ◽  
Expert Center ◽  
Care System

Market access for pharmaceuticals is a set of strategies, activities and processes developed by pharmaceutical companies to provide affordable medicines at appropriate fair prices in a particular health care system. Access to the pharmaceutical market covers main areas of stages, including the health technology assessment (HTA). The aim of the work was to analyze the stages of market access for pharmaceuticals in particular the implementation of HTA based on regulatory review, tasks and activities of the HTA Department of the State Expert Center of the Ministry of Health and the Expert Committee for Selection and Use of Essential Medicines and directions of HTA use in the health care system in Ukraine. Materials: legislation governing the conduction of HTA in Ukraine, international publications on the subject of the study. Research methods: system and content analysis, data synthesis and generalization of information, extrapolation, retrospective analysis. We have generalized the legislation for the introduction of HTA in Ukraine, the stages of institutionalization of the direction, the HTA roadmap, current state of financing of medicines using several regulatory lists from the perspective of state payer, including: National list of essential medicines, nomenclature of central procurement, insulin reimbursement. The mechanisms of selection of new medicines and evaluation with the use of HTA methods for inclusion on the regulatory lists, is in particular only for the National list, by criteria are presented: morbidity, disease prevalence and mortality; evidence of comparative efficacy (effectiveness), safety and cost-effectiveness; demand; the results of the budget impact analysis; pharmacokinetic properties of drugs; WHO recommendations on the use of essential medicines. In order to inform decisions on the rational allocation and use of financial resources in the health care system in January 2019, the HTA Department in Ukraine was established at SE "State Expert Center of the Ministry of Health of Ukraine" to conduct HTA and examination of applications for inclusion of medicines on National list. It is substantiated that the institutionalization of the direction with the establishment of the HTA Department is an important step in ensuring the ecosystem of decision-making based on HTA in the Ukrainian health care system. The developed methodological support, in particular the first HTA guidelines, the model of multicriteria decision analysis, experience in assessment of applications for inclusion of medicines on the National list indicate the feasibility of further expanding the use of HTA for other regulatory lists, including the list of central procurement programs and development of single positive list of medicines for public funding in Ukraine.

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