Strategic Insights From 5 Years of the EU HTAR: Unleashing the Ambition for Orphan Products and Vaccines

Unlock practical, actionable insights from the live educational symposium we delivered at ISPOR Europe 2025 in Glasgow. Our team of market access and health economic experts distilled 5 years of hands-on engagement with the EU health technology assessment regulation (EU HTAR) into clear steps as HTDs prepare for the next waves of EU HTA: orphan drugs (2028) and vaccines (2030).

Watch the recording and gain:

• Insights from 5 years experience navigating EU HTAR: With endpoint, comparator, and real-world data frameworks you can apply to orphan and vaccine programs
• Smart PICO: Building precise population, intervention, comparator, outcomes (PICO) definitions that reflect real EU practice and are feasible to assess
• Early readiness that delivers: Practical steps to starting conversations early with stakeholders, PICO scoping and integrated evidence planning
• Evidence built for Europe—and beyond: Designs that satisfy the EU joint clinical assessment (JCA) while staying globally relevant
• Evidence timing and feasibility: Bridging the gap between regulatory timelines and JCA expectations; planning long term outcomes without delaying access