JCA and National HTA Submissions in Orphan Diseases

Identifying Interdependencies, Navigating Evidence Limitations and Aligning Data Requirements

Launching an orphan medicine in Europe has just become much more complex. Manufacturers must address stringent EU JCA requirements in addition to national HTA submissions.  Evidence generation requirements have been transformed and need to take into account these new requirements—specifically interdependencies. In this webinar, RTI-HS experts will demystify key methodologies and highlight practical approaches to meet evolving JCA requirements while maintaining concordance with national HTA expectations.

Through real-world examples, we will explore how to anticipate comparator and PICO variability across EU markets, optimize systematic literature reviews (SLRs), and select appropriate analytical methods for complex evidence landscapes. Attendees will gain insight into how automation and AI can support efficient, compliant submission development. And we will present key learnings from the first JCA report.