The HTA Core Model®-10 Years of Developing an International Framework to Share Multidimensional Value Assessment.

BACKGROUND AND OBJECTIVES The HTA Core Model® as a science-based framework for assessing dimensions of value was developed as a part of the European network for Health Technology Assessment project in the period 2006 to 2008 to facilitate production and sharing of health technology assessment (HTA) information, such as evidence on efficacy and effectiveness and patient aspects, to inform decisions. METHODS It covers clinical value as well as organizational, economic, and patient aspects of technologies and has been field-tested in two consecutive joint actions in the period 2010 to 2016. A large number of HTA institutions were involved in the work. RESULTS The model has undergone revisions and improvement after iterations of piloting and can be used in a local, national, or international context to produce structured HTA information that can be taken forward by users into their own frameworks to fit their specific needs when informing decisions on technology. The model has a broad scope and offers a common ground to various stakeholders through offering a standard structure and a transparent set of proposed HTA questions. It consists of three main components: 1) the HTA ontology, 2) methodological guidance, and 3) a common reporting structure. It covers domains such as effectiveness, safety, and economics, and also includes domains covering organizational, patient, social, and legal aspects. There is a full model and a focused rapid relative effectiveness assessment model, and a third joint action is to continue till 2020. CONCLUSION The HTA Core Model is now available for everyone around the world as a framework for assessing value.

[1]  Sarah Kleijnen,et al.  Can a Joint Assessment Provide Relevant Information for National/Local Relative Effectiveness Assessments? An In-Depth Comparison of Pazopanib Assessments. , 2015, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[2]  Finn Børlum Kristensen,et al.  Involving stakeholders and developing a policy for stakeholder involvement in the European network for Health Technology Assessment, EUnetHTA , 2009, International Journal of Technology Assessment in Health Care.

[3]  Julia Mayer,et al.  [HTA goes Europe: European collaboration on joint assessment and methodological issues becomes reality]. , 2015, Zeitschrift fur Evidenz, Fortbildung und Qualitat im Gesundheitswesen.

[4]  Claudia Wild,et al.  COLLABORATION IN HEALTH TECHNOLOGY ASSESSMENT (EUnetHTA JOINT ACTION, 2010–2012): FOUR CASE STUDIES , 2013, International Journal of Technology Assessment in Health Care.

[5]  Gottfried Endel,et al.  DEVELOPING THE HTA CORE MODEL FOR THE ONLINE ENVIRONMENT , 2014, International Journal of Technology Assessment in Health Care.

[6]  Finn Børlum Kristensen,et al.  European network for Health Technology Assessment, EUnetHTA: Planning, development, and implementation of a sustainable European network for Health Technology Assessment , 2009, International Journal of Technology Assessment in Health Care.

[7]  Tom Jefferson,et al.  COLLABORATIVE MODELS FOR THE JOINT PRODUCTION OF CORE HEALTH TECHNOLOGY ASSESSMENTS: NEGATIVE AND POSITIVE ASPECTS FOR THE JOINT WORK OF DIFFERENT EUROPEAN AGENCIES , 2014, International Journal of Technology Assessment in Health Care.

[8]  Claudia Wild,et al.  Divergent evidence requirements for authorization and reimbursement of high-risk medical devices – The European situation , 2014 .

[9]  Andrew Cook,et al.  European network for Health Technology Assessment Joint Action (EUnetHTA JA): a process evaluation performed by questionnaires and documentary analysis. , 2014, Health technology assessment.

[10]  Wim G. Goettsch,et al.  STANDARDIZED REPORTING FOR RAPID RELATIVE EFFECTIVENESS ASSESSMENTS OF PHARMACEUTICALS , 2014, International Journal of Technology Assessment in Health Care.

[11]  E. Jonsson,et al.  A history of health technology assessment at the European level , 2009, International Journal of Technology Assessment in Health Care.

[12]  Claudia Wild,et al.  Contrasting clinical evidence for market authorisation of cardio-vascular devices in Europe and the USA: a systematic analysis of 10 devices based on Austrian pre-reimbursement assessments , 2014, BMC Cardiovascular Disorders.

[13]  Marina Cerbo,et al.  HTA report: new devices for the management of glycaemia in young diabetics , 2012 .

[14]  Kristian Lampe,et al.  Practical tools and methods for health technology assessment in Europe: Structures, methodologies, and tools developed by the European network for Health Technology Assessment, EUnetHTA , 2009, International Journal of Technology Assessment in Health Care.

[15]  M. Drummond,et al.  Improving medical device regulation: the United States and Europe in perspective. , 2014, The Milbank quarterly.

[16]  Finn Børlum Kristensen,et al.  The HTA Core Model: A novel method for producing and reporting health technology assessments , 2009, International Journal of Technology Assessment in Health Care.

[17]  Claudia Wild.  European Collaboration in HTA , 2001 .