Article
Harmonizing Health Technology Assessment: PICO consolidation under the EU HTA Regulation
Corporate partner insights interview by ISPOR
The EU HTA regulation (EU HTAR) is reshaping global market access, bringing both opportunities and challenges for manufacturers. In this exclusive Corporate partner insights interview by ISPOR, Ruairi O'Donnell, Vice President of Market Access and Healthcare Consulting Europe at Cencora, joins Dr. Patti Peeples to explore how the industry can adapt to this new reality. Ruairi shares actionable strategies to navigate the complexities of EU HTA and PICO consolidation. From harmonizing clinical evidence across Europe to addressing unrealistic comparators and leveraging real-world evidence (RWE), this discussion provides a roadmap for success.
The EU HTA regulation (EU HTAR) is reshaping global market access, bringing both opportunities and challenges for manufacturers. In this exclusive Corporate partner insights interview by ISPOR, Ruairi O'Donnell, Vice President of Market Access and Healthcare Consulting Europe at Cencora, joins Dr. Patti Peeples to explore how the industry can adapt to this new reality. Ruairi shares actionable strategies to navigate the complexities of EU HTA and PICO consolidation. From harmonizing clinical evidence across Europe to addressing unrealistic comparators and leveraging real-world evidence (RWE), this discussion provides a roadmap for success.
Meet Ruairi O’Donnell, EU HTA Lead at Cencora
A 20-year veteran of the global market access and HEOR consulting services sector, Ruairi has held numerous leadership positions in leading global consulting organizations, with a strong background in value strategy, evidence development, and market access pathways. Prior to taking on his role as EU HTA lead for Cencora, he was Senior Director of Evidence Generation and Value Communications.
Watch the interview below to prepare for the future of EU HTA
Access the interview to uncover key lessons from early oncology and ATMP submissions, and gain forward-looking insights to navigate one of the most significant disruptions in market access today. Key topics include:
- The reality of harmonization under EU HTA and its impact on evidence planning
- Challenges with PICO consolidation and strategies to address unrealistic comparators
- Lessons learned from early submissions
- The role of RWE in meeting EU HTA expectations
- Strategic advice for manufacturers to protect access and adapt to regulatory demands
Available in English only
Corporate partner insights interview by ISPOR – Part 1
Available in English only
In this segment, Ruairi delves into the complexities of harmonizing clinical evidence across Europe while balancing national HTA sovereignty, highlighting the operational and strategic challenges manufacturers face. He shares insights into how companies can approach evidence planning, address unrealistic comparator demands, and navigate the risks of misaligned expectations. The conversation also introduces the growing role of RWE in meeting EU HTA requirements. Ruairi also provides a critical perspective on the potential pitfalls of misusing RWE and emphasizes the importance of strategic evaluation.
Available in English only
Available in English only
Corporate partner insights interview by ISPOR – Part 2
Available in English only
In this segment, Ruairi explores strategies for EU HTA success, covering challenges for small innovators, and Health Economics and Outcomes Research (HEOR)’s proactive evolution. Ruairi emphasizes timing, planning, agility, and collaboration as critical factors, urging manufacturers to address evidence gaps, leverage partnerships, and adopt artificial intelligence (AI) and advanced methodologies. He highlights collaboration, skill-building, and decisive action as key to thriving under EU HTA while navigating uncertainties.
Available in English only
EU Health Technology Assessment (HTA) consulting
As the European Union takes bold strides towards harmonizing and enhancing its healthcare landscape, the implementation of the Joint Clinical Assessment (JCA) stands as a pivotal moment. At Cencora, we help companies at all stages of the EU HTA journey, from early evidence to post-JCA implementation at the national level.
Connect with our team
Our team of leading value experts is dedicated to transforming evidence, policy insights, and market intelligence into effective global market access strategies. Let us help you navigate today’s complex healthcare landscape with confidence. Reach out to discover how we can support your goals.
