International journal of technology assessment in health care
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Int J Technol Assess Health Care · Jul 2013
Collaboration in health technology assessment (EUnetHTA joint action, 2010-2012): four case studies.
The aim of this study was to present the first four collaborative health technology assessment (HTA) processes on health technologies of different types and life cycles targeted toward diverse HTA users and facilitators, as well as the barriers of these collaborations. ⋯ Timely and efficient, different collaborative HTA processes on relative efficacy/effectiveness and safety on different types and life cycles of health technologies, targeted toward diverse HTA users in Europe are possible. There are still barriers to overcome.
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Int J Technol Assess Health Care · Jul 2012
Pre-market clinical evaluations of innovative high-risk medical devices in Europe.
High-quality clinical evidence is most often lacking when novel high-risk devices enter the European market. At the same time, a randomized controlled trial (RCT) is often initiated as a requirement for obtaining market access in the US. Should coverage in Europe be postponed until RCT data are available? We studied the premarket clinical evaluation of innovative high-risk medical devices in Europe compared with the US, and with medicines, where appropriate. ⋯ For innovative high-risk devices, new EU legislation should require the premarket demonstration of clinical efficacy and safety, using an RCT if possible, and a transparent clinical review, preferably centralized.
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Int J Technol Assess Health Care · Apr 2012
Comparative StudyUpdate of the Dutch Manual for Costing in Economic Evaluations.
In 2000, the first "Dutch Manual for Costing: METHODS and Reference Prices for Economic Evaluations in Healthcare" was published, followed by an updated version in 2004. The purpose of the Manual is to facilitate the implementation and assessment of costing studies in economic evaluations. New developments necessitated the publication of a thoroughly updated version of the Manual in 2010. The present study aims to describe the main changes of the 2010 Manual compared with earlier editions of the Manual. ⋯ The Action Plan is quite similar to many health economic guidelines in healthcare. However, the recommendations on particular aspects may differ between national guidelines in some respects. Although the Manual may serve as an example to countries intending to develop a manual of this kind, it should always be kept in mind that preferred methods predominantly depend on a country's specific context.
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Int J Technol Assess Health Care · Jan 2012
Incidence-based cost-of-illness model for metastatic breast cancer in the United States.
This study aims to estimate the annual U.S. societal costs associated with treatment of metastatic breast cancer (MBC) patients using an incidence-based cost-of-illness (COI) framework. ⋯ The societal burden of MBC in the United States is substantial. Earlier detection and effective treatment could lead to a significant decrease in costs while improving overall disease prognosis.