Webinar with Prof. Dr Lieven Annemans, health economist and past president of ISPOR
FREE EDUCATIONAL WEBINAR
9 February 2027, 13:00 - 13:45 PM CET (*)
Within the framework of the Health Technology Assessment Regulation (EU HTAR), several Joint Clinical Assessments (JCAs) have by now been completed.
The outcomes thus far can be labelled as:
“The good, the bad and the ugly”
The good news: the first cases proved that the tight timelines that were foreseen in the regulation seem to work in practice.
The bad news is that the first JCAs point to several challenges. First, the PICO approach (populations, interventions, comparators, and outcomes) whereby companies have to address numerous separate PICO requests coming from different Member States, turns out to be an almost impossible task. Second, the EU assessors seem to have an inherent bias against single-arm trials and the use of real-world evidence, hence penalising innovative therapies (especially ultra-orphan therapies) for which traditional RCTs are often impossible.
And then the ugly truth: whereas patients are formally consulted, their feedback has largely been ignored in final reports.
The lecture will illustrate these challenges with examples and suggest ways forward.
What you will learn:
What the first Joint Clinical Assessments (JCAs) under the EU HTA Regulation tell us about how the process works in practice
Why addressing numerous separate PICO requests from different member states is such a challenge for companies
How EU assessors look at single-arm trials and real-world evidence, and what this means for innovative and ultra-orphan therapies
To what extent patient feedback is reflected in the final JCA reports
Which ways forward can help you prepare for your own JCA
About the expert:
Prof. Dr Lieven Annemans, expert trainer of the courses Health Economics for Non-Health-Economists, Basics of Health Economics, and Critical New HTA Developments in Europe: Challenges & Solutions, is one of Europe’s most respected voices in health economics and HTA.
He has experience in health economic evaluations across more than 20 countries and numerous therapeutic areas, and is a long-standing expert advisor in national and EU-level HTA initiatives, with deep insight into methodology, implementation and policy.
He is an academic professor, past president of ISPOR, author of “Health Economics for Non-Economists”, and has published more than 350 peer-reviewed papers. A CELforPharma faculty member since 2009, he is consistently praised for his engaging, pragmatic and entertaining teaching style.
(*) Can’t attend live? Register anyway and you will receive the recording afterwards.