New Study Identifies Notable Differences in How 6 European Health Agencies Assess Real-World Data

Report Includes Findings from TLV (Sweden), NICE (UK), IQWiG (Germany), HAS (France), AIFA (Italy), and ZIN (Netherlands)

Princeton, NJ—April 18, 2017—Value in Health, the official journal of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), announced today the publication of new research reviewing and comparing the policies of 6 European health technology assessment (HTA) agencies on incorporating real-world data into health technology assessments. The report of these findings, Policies for Use of Real-World Data in Health Technology Assessment: A Comparative Study of 6 HTA Agencies, was published in the April 2017 issue.

The authors collected information on real-world data policies for a number of countries’ HTA agencies, including TLV (Dental and Pharmaceutical Benefits Agency in Sweden), NICE (National Institute for Health and Care Excellence in the UK), IQWiG (Institute for Quality and Efficiency in Health Care in Germany), HAS (High Authority for Health in France), AIFA (Italian Medicines Agency in Italy), and ZIN (National Healthcare Institute in the Netherlands). The research specifically considered these agencies’ policies regarding whether real-world data was generally accepted or specifically requested for their assessment of health technologies. The study also examined the agencies’ policies for the appraisal of real-world data in 3 discrete contexts: initial reimbursement discussions, pharmacoeconomic analysis, and conditional reimbursement schemes. Policies for real-world data use in relative effectiveness assessments of drugs notably differed across the contexts both within and between HTA agencies.

“The potential uses of real-world data are numerous and varied,” said lead author Amr Makady, National Healthcare Institute (ZIN), the Netherlands. “However,” he added, “because the movement toward the use of such data in health technology assessment has only recently gained momentum, little is known about how HTA institutions currently incorporate real-world data in practice. Moreover, it remains unclear whether policies developed to do so are harmonized across different institutions. We are pleased to contribute to a further understanding of how agencies appraise real-world data and the effect of evidence hierarchies on agencies’ attitudes toward the use of real-world data in health technology assessments.”

The authors suggest that the policy variations discovered in the current review might discourage the use of real-world data for HTA. They propose that to facilitate the use of real-world data for HTA across Europe, more alignment of policies seems necessary. HTA agencies within Europe may collaborate to align policies on real-world data and provide guidance on practical aspects of real-world data collection and analysis. Recently published position papers and future project proposals by EUnetHTA may provide a starting point for discussions and a suitable platform for HTA agencies to achieve this.



Value in Health (ISSN 1098-3015) is an international, indexed journal that publishes original research and health policy articles that advance the field of health economics and outcomes research to help health care leaders make evidence-based decisions. The journal’s 2015 impact factor score is 3.824. Value in Health is ranked 3rd out of 74 journals in health policy and services (social sciences), 8th out of 87 journals in health care sciences and services, and 10th out of 344 journals in economics (social sciences). Value in Health publishes 10 issues a year and circulates to more than 10,000 readers around the world.
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The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) is a nonprofit, international, educational and scientific organization that promotes health economics and outcomes research excellence to improve decision making for health globally.
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