Health Technology Assessment (HTA) bodies worldwide recognize the importance of demonstrating the impact of new drugs on patient-relevant outcomes (PRO). However, to date PRO data has had a limited impact on HTA decision-making. The webinar will discuss the path forward to increase the value of PRO data to inform HTA decision-making. PRO data is increasingly included in HTA submissions, but is rarely a decision driver. The extent to which PROs are being assessed, and the influence the data has on HTA recommendations, varies between HTA bodies as their data requirements and assessment methods differ.
This webinar will feature four expert panelists, who will lead you through essential aspects of “proving it with PROs”.
What you will learn
- Anke van Engen, MSc, IQVIA, Amsterdam, The Netherlands, will first describe the impact of PRO data in HTAs in different therapeutic areas and different countries. IQWiG has clear guidelines on the assessment of PRO data and Germany is one the exceptions where the impact of PRO data on HTA decision-making is more transparent.
- Yvonne-Beatrice Boehler, MD, MBA, TH Koeln, University of Applied Sciences, Leverkusen Germany, will present IQWiG’s methodology for assessing symptoms and functional scales; highlight common issues seen with the submitted PRO data and set out what manufacturers need to do in order to be successful.
- Stefan Holmstrom, Astellas, Leiden, The Netherlands, will offer the industry perspective, discussing an example highlighting some of the key challenges in convincing HTA bodies of patient-relevant improvements and illustrating that better guidance from HTA bodies is required. The industry also must present evidence in a more user-friendly format.
- Finn Boerlum Kristensen, MD, PhD, University of Southern Denmark, Odense, Denmark, will present the value assessment of the patient and social aspects in the Core Model developed by EUnetHTA and argue that there can be more consensus and emphasis on PROs by including them more prominently in the HTA Core Model.