LUNCH WORKSHOP 7
Friday, 4 October 2019 | 12.00-13.30 | Kursaal C
With the increasing use of accelerated regulatory tools like the Food and Drug Administration’s breakthrough designation, there are mounting challenges for European health technology assessors (HTAs) to make an accurate assessment of the long-term value and performance of many new therapies. Data presented in evidence is often extrapolated from outcomes measures collected at six months follow-up or less, and what is good enough for regulatory approval often does not meet the requirements for reviewing comparative effectiveness and value in terms of health outcomes for HTAs. This session will introduce a novel, practical approach to harnessing electronic health records and real-world evidence (RWE) to help solve this problem. However, access to robust deidentified patient records in Europe is key.
This session will address the following questions
ANJA SCHIEL, Senior Adviser & Statistician, Unit for HTA and Reimbursement, Norwegian Medicines Agency (NoMA)
BETTINA RYLL, Founder, Melanoma Patient Network Europe
NIGEL HUGHES, Scientific Director, Quantitative Sciences, Janssen & Co-Lead, IMI EHDEN
DUANE SCHULTHESS, Managing Director, Vital Transformation