P316: Evolving Trends in the Use of Clinical Outcome Assessments in FDA and EU Health Technology Agency Decisions
Poster Presenter
Catherine Coulouvrat
Head of Health Value Translation
Sanofi France
Objectives
Understand trends in COA inclusion in US FDA labels and European HTAs over the past 10 years; impact of current trends from sponsor, HTA, patient perspectives.
Method
The inclusion of nonmandatory COAs was analyzed in FDA labels and HTAs of German, French, and English bodies, from 2012 to 2022. Changes in COA use are reported overall, by COA type, concept, and therapeutic area.
Results
In FDA labels, the inclusion of nonmandatory COA increased from 18.6% to 28.4% from 2012-2016 to 2017-2022. The average number of unique COAs in FDA labels approximately doubled. Nonmandatory COA inclusions in HTAs increased from 45.2% to 64.9%. The average number of unique COAs per HTA also approximately doubled. Patient-reported outcomes were the most reported COAs in FDA labels and HTAs in both time periods. In FDA labels and HTAs, most therapeutic areas showed increases in nonmandatory COA inclusion. In FDA labels, COA instruments mostly measured signs and symptoms. In HTAs, they mostly measured health status and quality of life.
Conclusion
The findings show increasing trends in the use of nonmandatory COA in HTAs and, to a lesser extent, FDA labels, suggesting a greater awareness of COA benefits and a changing practice of inclusion toward more patient centricity.
