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Title: The Role of RWE for Devices and Diagnostic Market Access in Europe
Tuesday, July 9, 2024
10:00AM EDT | 2:00PM UTC | 4:00PM CEST
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Description
Evidence aligned to the needs of economic decision makers is a key success factor for delivering patient access to medical devices and diagnostics (MD&D) in Europe. Designing research with market access in mind will accelerate progress towards addressing public health evidence needs while also improving market uptake. Due to the increasing importance of real-world evidence (RWE) in bridging data gaps and helping to alleviate uncertainty, it is of special interest for manufacturers, consultants, and other key stakeholders to investigate and discuss the current and future role of RWE to support market access objectives for MD&Ds in Europe. According to current MD&D market revenue estimates, Germany, the United Kingdom, and France constitute key European markets with a combined MD&D revenue of nearly 50%. Hence, speakers taking the viewpoint of stakeholders in these three markets will present and discuss the current and future role of RWE for market access and reimbursement purposes. Additionally, an industry representative will provide examples of successful integration of RWE into the evidence generation strategy for reimbursement and market access. To inform and guide this discussion, the speakers will present country-specific key decision pathways for MD&D reimbursement to compare and contrast evidence requirements and explore whether RWE can fulfill those needs. These elements will be accompanied by examples which will consider the impact of country related HTA hurdles, RWE definitions and the validation of RWE to make it acceptable for decision-making bodies. The debate will then focus on the strengths and limitations of real-world data in the context of reimbursement decision making; this will include the acceptance of RWE from other regions (eg., the US) in Europe, issues around the use/access of RWE in compliance with GDPR rules and the perspectives on RWE quality to ensure fit for purpose.
Learning Objectives
- Understand country-specific key decision pathways for MD&D reimbursement and learn which of these requirements can be satisfied by real-world evidence
- Learn specific examples on how RWE was used to satisfy country-specific HTA hurdles
- Understand the strengths and limitations of real-world data in the context of utility in reimbursement decision making
Moderator:
Bjoern Schwander, PhD, Founder & General Manager, AHEAD GmbH, Bietigheim-Bissingen, Germany
Speakers:
Axel Muhlbacher, PhD, Professor, Hochschule Neubrandenburg, Neubrandenburg, Germany
Stephen Duffield, PhD, MD, Associate Director for Real-World Evidence Methods, National Institute for Health & Care Excellence (NICE), Liverpool, England, UK
Sandrine Bourguignon, Founder & CEO, RWEality, Paris, France
James Lavin, MS, Senior Manager, HEOR Europe, Intuitive, Aubonne, Switzerland
Brought to you by: ISPOR Medical Devices and Diagnostics Special Interest Group
Please note: On the day of the scheduled webinar, the first 1000 registered participants will be accepted into the webinar. For those who are unable to attend, or would like to review the webinar at a later date, the full-length webinar recording will be made available at the ISPOR Educational Webinar Series webpage approximately 2 days after the scheduled Webinar.
Reservations are on a first-come, first-served basis.
