ISPOR Europe 2025

The EU Health Technology Assessment (HTA) regulation, introduced in January 2025, represents a pivotal step in unifying health technology evaluations across Europe. Aimed at streamlining processes, reducing redundancies, and accelerating patient access to innovative therapies, its first year revealed both progress and challenges for manufacturers adapting to the new framework. At ISPOR Europe 2025, the Cencora team engaged key stakeholders to uncover critical insights into the evolving EU HTA landscape. Their combined expertise provide valuable lessons on the progress, obstacles, and opportunities ahead for stakeholders navigating the EU HTA system. This article distills key learnings from these discussions to offer practical guidance for manufacturers and stakeholders preparing for success under the regulation

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.

The global healthcare landscape is rapidly evolving, with Europe’s pharmaceutical industry facing pressures from U.S. policy changes and China’s growing pharmaceutical ecosystem. At ISPOR Europe 2025, our expert Casper Paardekooper, Head of Pricing, Policy and Stakeholder Engagement, had the honor of moderating the symposium, “Navigating Global Policy Shifts: Implications for Europe’s Pharmaceutical Pricing, Market Access, and HTA Landscape,” featuring a panel of esteemed experts. Together, we examined the impact of global policy changes on Europe’s healthcare systems, opportunities for adaptation, and the importance of collaboration to drive innovation.

After a year of sweeping regulatory changes and shifting payer expectations, 2026 is poised to redefine market access for pharmaceutical manufacturers. Success will demand proactive strategies, organizational agility, and the smart application of emerging technologies to close data gaps and enhance communication. Download the report to learn more.

This edition features the conclusion of our three-part series on France’s Early Access Program (EAP), highlighting the potential of the National Health Database (SNDS) to streamline data collection and offering industry insights on enhancing the program. We also delve into the growing role of multilevel network meta-regression in health technology assessment (HTA), showcasing its ability to address challenges in comparing treatments with limited trial data. Lastly, we summarize findings from a study on leveraging Nordic real-world data to inform PICOs for Joint Clinical Assessments (JCAs), emphasizing the importance of proactive evidence generation and the unique value of Nordic health registries.