Collaboration Between Regulators and HTA Organizations to Improve Health Care Decision Making

Lawrenceville, New Jersey, UNITED STATES

PRINCETON, N.J., June 25, 2014 (GLOBE NEWSWIRE) -- As announced today by the European network for Health Technology Assessment (EUnetHTA) and European Medicines Agency (EMA), Value in Health, the official journal for the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), was pleased to publish the following article, "Improving the Contribution of Regulatory Assessment Reports to Health Technology Assessments — A Collaboration between the European Medicines Agency and the European network for Health Technology Assessment," which details the results of a recent collaboration between the EMA and EUnetHTA. This is the first joint project of such collaboration between regulators and HTA bodies on a European level.

This collaboration, which began in February 2010 and was performed over two years, aimed at improving the contribution European Public Assessment Reports (EPARs) can make to the assessment of relative effectiveness by European health technology assessment (HTA) bodies. 

As a result of this project, the templates for preparing EPARs were revised to better address the needs of heath technology organizations, and in turn, each organization gained a better understanding of the information needed for assessment by their counterpart.

The authors from the EMA and EUnetHTA state, "With the improved presentation of data and information in the EPAR, it is envisaged that this regulatory document through harmonised efficacy data presentation will be more useful in the context of rapid relative effectiveness assessments by HTA bodies when they inform policy makers and health care decision makers in the future." 

As a scientific and educational organization, ISPOR is also contributing to the collaboration of health care decision makers - regulatory agencies, health care payers, clinicians, hospitals, clinics, health authorities, and patients through the creation of ISPOR HTA Roundtables in Europe and North America and ISPOR HTA networks in Latin America and Asia. These roundtables and networks provide a forum to discuss, debate, and share health technology issues as well as bridge the gap between HTA agencies, health care decision makers and outcomes researchers to optimize health care decisions using outcomes research. In addition, ISPOR offers a myriad of tools for decision makers, such as:


The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) ( is a nonprofit, international, educational, and scientific organization that strives to increase the efficiency, effectiveness, and fairness of health care resource use to improve health.


Value in Health (ISSN 1098-3015) publishes papers, concepts, and ideas that advance the field of pharmacoeconomics and outcomes research as well as policy papers to help health care leaders make evidence-based decisions. The journal is published bi-monthly and has over 8,000 subscribers (clinicians, decision makers, and researchers worldwide). 


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