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. Patty 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.
Video interview

Access now to prepare for the future of EU HTA

Video interview
Watch 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

Video interview

Corporate partner insights interview by ISPOR – Part 1

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.

Corporate partner insights interview by ISPOR – Part 2

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.
EU HTA

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.

Related resources

Article

Insights for innovation: AMCP Nexus 2025 educational videos
Learn more

Article

HTA Quarterly Winter 2025 Summary
Learn more

Article

Multilevel network meta-regression: A step forward in HTA evidence synthesis?
Learn more

Cencora.com is providing automated translations to assist in reading the website in languages other than English. For these translations, reasonable efforts have been made to provide an accurate translation, however, no automated translation is perfect nor is it intended to replace human translators. These translations are provided as a service to users of Cencora.com and are provided "as is." No warranty of any kind, either expressed or implied, is made as to the accuracy, reliability, or correctness of any of these translations made from English into any other language. Some content (such as images, videos, Flash, etc.) may not be accurately translated due to the limitations of the translation software.

Any discrepancies or differences created in translating this content from English into another language are not binding and have no legal effect for compliance, enforcement, or any other purpose. If any errors are identified, please contact us. If any questions arise related to the accuracy of the information contained in these translations, please refer to the English version of the page.