Insights from ISPOR 2024: The evolving landscape of PICO assessments in the EU
5 questions with Kim Joline Schmidt
What inspired this research?
The scoping process is a fundamental part of the JCA, defining the PICO (population, intervention, comparator, outcome) requirements to be addressed by Health Technology Developers (HTDs) in the HTD submission dossier.
This research was inspired by internal engagements in the EU-HTA task forces and the industry's need to better understand the scoping process within the framework of the JCA. We also sought to identify associated risks and opportunities of PICO simulations.
Was there a hypothesis that was confirmed through the research?
Was there anything in the research that was surprising, that you didn't expect, that you found out?
An interesting yet expected finding was the varying time frames for innovative product launches across the assessed countries. In some countries, the most recently authorized medicinal products were not yet available, which likely contributed to the high number of comparators and thus consolidated PICOs in our analysis.
Additionally, we discovered that the high number of PICOs was primarily driven by 5 countries—Germany, Ireland, Italy, Portugal, and Spain—which required comparisons against all relevant comparators. According to the EUnetHTA 21 scoping guideline, each requested comparator leads to a single PICO in the consolidation process.
What are the next steps from this research?
A crucial methodological guideline by the Health Technology Assessment Coordination Group (HTACG) is still pending, and it remains to be seen if there will be any significant changes to the EUnetHTA 21 guideline that underpinned our analysis.
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