The implementation of the EU Health Technology Assessment Regulation (EU) 2021/2282 has reshaped the European market access landscape. With Joint Clinical Assessments (JCAs) now active for oncology treatments and Advanced Therapy Medicinal Products (ATMPs), Health Technology Developers face growing complexity in clinical evidence generation, dossier preparation, and evidence submission defense.

The first EU JCA reports are beginning to reveal important methodological and operational lessons and highlighting what teams need to consider as they prepare for JCA and subsequent national market access.

In this webinar, Cytel experts will share practical insights from early JCA experience, including how to manage multi-comparator clinical heterogeneity and execute robust Indirect Treatment Comparisons (ITCs) under tight timelines. They will explore how cross-functional teams — Global Value & Access, Regulatory, Biostatistics, and Medical Affairs — can align early to manage rapid response windows during the factual accuracy review and build strong JCA defense strategies. The webinar will also examine how EU-level JCA clinical findings can be translated into successful national market access strategies across individual Member States.

Key Topics 

• Identifying common methodological pitfalls in evidence reviews, comparative effectiveness, subgroup analyses, and unmanaged uncertainty highlighted in JCA reports
• Mastering operational readiness required to handle parallel EMA regulatory reviews and HTA IT platform submission milestones under condensed timelines
• Preparing robust defense protocols for draft report review, including factual accuracy checks and mitigating negative assessor interpretations
• Bridging EU JCA clinical conclusions into country-specific value dossiers and pricing/reimbursement discussions

Speakers

• Grammati Sarri – Vice President, Innovative Statistics
• Bastian Gaus – Associate Research Principal, Evidence, Value, and Access
• Ingrid Claverie-Chau – Associate Research Principal, Evidence, Value, and Access
• Charlotta Karner – Research Principal, Evidence, Value, and Access