Day 1 - Thursday 3rd September 2026
13th RWE, MARKET ACCESS, PRICING & REIMBURSEMENT World Congress 2026 Europe
Powering Market Access Through Real-World Evidence, Digital Innovation & Value-Based Strategies
Thursday 3rd September 2026
Copthorne Tara Hotel London Kensington, London, UK
RWE Integration in European HTA & Evidence Strategy
- EU HTA Regulation and Joint Clinical Assessments (JCA)
- Acceptance of RWE across member states
- Methodological challenges and credibility
- Future outlook for hybrid evidence models
Moderator:
Panelist:
- Key requirements under Joint Clinical Assessments (JCA)
- Aligning clinical development with HTA expectations
- Evidence submission timelines and coordination challenges
- Strategic implications for pan-European launches
- Study designs that meet payer and HTA standards
- Selecting appropriate real-world data sources
- Ensuring reproducibility and methodological rigor
- Addressing cross-country evidence expectations
- Integrating RWE endpoints into trial design
- Hybrid trial models (RCT + RWE integration)
- Early planning for post-launch evidence generation
- Cross-functional alignment across clinical and access teams
- Identifying and mitigating selection bias
- Ensuring data completeness and consistency
- Transparency in methodologies and reporting
- Building trust with regulators and payers
- Opportunities from EU data-sharing initiatives
- Accessing cross-border datasets
- Data interoperability challenges
- Governance and compliance considerations
- Overview of product and market context
- Evidence strategy and RWE integration
- Key success factors in HTA acceptance
- Lessons learned for future submissions
Pricing & Market Access Strategies in a Constrained European Landscape
- Structure and mechanics of alternative pricing models
- Benefits and risks for payers and manufacturers
- Implementation challenges across Europe
- Real-world examples of adoption
- Review use of RWD to guide pipeline and portfolio strategy
- Considerations when using RWD to inform internal decisions
- The growing use of data tokenization and advanced analytical techniques based on artificial intelligence in RWE
- The importance of data quality and methodological transparency in RWE.
- How to use patient-level external controls in a comparative efficacy analysis
- Explore the evaluation and selection of index dates for RW subjects
- Discuss the impacts and potential biases of common index date selection methods
- Tips for considering which indexing method to use in studies that use external controls
- Macro-economic pressures on healthcare budgets
- Policy reforms affecting pricing decisions
- Increasing scrutiny on high-cost therapies
- Strategic pricing adaptations
- Structuring value narratives effectively
- Integrating clinical, economic, and patient outcomes
- Tailoring dossiers for different markets
- Common mistakes in value communication
- External reference pricing and cross-border impact
- National vs EU-level pricing tensions
- Balancing access, affordability, and innovation
- Increasing payer influence