IS THE GOAL OF UNIVERSAL COMPARATIVE EFFECTIVENESS EVIDENCE ACROSS JURISDICTIONS ACHIEVABLE?

Author(s)

Hans-Georg Eichler, MD, MSc, European Medicines Agency, London, UK; Sarah Garner, PhD, National Institute for Health and Care Excellence (NICE), London, UK; Pall Jonsson, PhD, National Institute for Health and Care Excellence (NICE), Manchester, UK; Rob Thwaites, MA, MCom, Takeda, London, UK

ISSUE: A key aspiration that is shared between regulators, health technology assessment (HTA) agencies and the pharmaceutical industry is to have evidence that will allow patients earlier access to new effective medicines across all jurisdictions. This requires a global development strategy that produces evidence of effectiveness to meet the differing needs of regulatory and HTA agencies. The panel will debate the minimum requirements for this to be achievable, making reference to current and recent collaborative initiatives. Pall Jonsson will moderate and introduce key themes and issues. Rob Thwaites will represent the industry perspective and describe how the Innovative Medicine Initiative's GetReal project is exploring the acceptability of real-world evidence (RWE) in effectiveness research. Hans-Georg Eichler will discuss the regulatory perspective and whether RWE has a role in regulation. Sarah Garner will provide a HTA perspective and discuss whether collaborative solutions can be developed. OVERVIEW: Evidence on comparative effectiveness is a necessary condition for effective and cost-effective health care. In order for the development of such evidence to be viable in different jurisdictions, a number of minimum requirements have to be met, including: agreement on outcomes; infrastructure to capture patient-level outcomes; methodologies to analyse the data; and agreement that the data are acceptable and what role they will play in decision-making. Views on relevance and acceptability of different types of real-world data, evidence and methods vary across stakeholders and jurisdictions. The panel will reflect on their different perspectives and debate with the audience whether a convergence of real-world data methods and polices can be achieved across jurisdictions.

Conference/Value in Health Info

2016-10, ISPOR Europe 2016, Vienna, Austria

Code

IP8

Topic

Clinical Outcomes, Organizational Practices

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