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13th RWE, MARKET ACCESS,​ PRICING & REIMBURSEMENT World Congress 2026 Europe

Powering Market Access Through Real-World Evidence, Digital Innovation & Value-Based Strategies

Thursday 3rd - Friday 4th September 2026 - Hilton London Kensington, London, UK

INTRODUCTION

The 13th RWE, Market Access, Pricing & Reimbursement 2026 Europe takes place at a critical juncture for European healthcare, where the convergence of real world evidence (RWE), evolving HTA frameworks, pricing pressures, and digital transformation is redefining how value is assessed and access is granted. As the EU HTA Regulation moves into implementation, and healthcare systems face ongoing financial constraints, stakeholders must adapt to a rapidly changing environment that demands greater alignment, transparency, and innovation.

Across Europe, expectations around evidence generation are shifting. While randomised controlled trials (RCTs) remain essential, there is increasing reliance on RWE to complement clinical data and support decision-making across regulatory and HTA processes. The introduction of Joint Clinical Assessments (JCA) presents an opportunity to streamline evaluations across member states, but also raises important questions around methodological consistency, data quality, and national level interpretation. As a result, organisations must adopt integrated evidence strategies that align clinical development with real world insights to meet the needs of multiple stakeholders.

At the same time, pricing and reimbursement landscapes are becoming more complex and constrained. External reference pricing, policy reforms, and economic pressures are intensifying scrutiny on the value of new therapies. This is particularly evident for high-cost innovations, where payers are increasingly demanding clear and measurable outcomes. In response, the industry is advancing innovative pricing models, including outcomes-based agreements, indication based pricing, and risk- sharing approaches. However, scaling these models across diverse European markets requires robust data infrastructure and stronger collaboration between industry, payers, and regulators.

A key priority is the shift toward patient-centric value frameworks. Decision makers are placing greater emphasis on outcomes that matter most to patients, such as quality of life and long-term impact. This is especially important in areas like advanced therapies and rare diseases, where traditional evidence pathways are often limited and uncertainty remains high. Incorporating patient- reported outcomes and leveraging longitudinal RWE are becoming essential for demonstrating meaningful and sustainable value.

In parallel, digital transformation is accelerating the evolution of market access. Advances in artificial intelligence, data analytics, and digital health technologies are enabling more dynamic, data-driven decision-making. From wearable devices to integrated health data platforms, new sources of real-world data are expanding the evidence base. However, this progress also introduces challenges around data interoperability, governance, privacy, and ethical use, particularly within the context of GDPR and cross-border data sharing.

This congress brings together senior leaders and experts from across the healthcare ecosystem to explore these critical issues. Through focused sessions, panel discussions, and real world case studies, participants will gain practical insights into aligning evidence with HTA requirements, navigating pricing and reimbursement complexities, embedding patient-centricity, and leveraging digital innovation to improve access outcomes.

Ultimately, the 13th RWE, Market Access, Pricing & Reimbursement 2026 Europe provides a platform for collaboration, knowledge exchange, and forward thinking strategy. As Europe moves toward a more harmonised and data-driven future, the ability to translate evidence into value and value into patient access will be more important than ever.

We look forward to welcoming you to the MAPR 2026 congress!

Sincerely yours,

Facilitate Live Team

Gain the latest insights on:

  • Evaluate the role of real-world evidence (RWE) in European HTA and regulatory decision-making
  • Differentiate between RCT and RWE methodologies and assess their application in market access strategies
  • Interpret the implications of the EU HTA Regulation and Joint Clinical Assessments for evidence generation and submissions
  • Analyze variations in pricing, reimbursement, and market access pathways across key European markets
  • Develop integrated market access strategies that align clinical, HEOR, and commercial functions
  • Assess the impact of pricing pressures, policy changes, and budget constraints on access and reimbursement decisions
  • Compare innovative pricing and reimbursement models, including outcomes-based and value-based agreements
  • Evaluate the integration of patient- centric outcomes, including PROs, into HTA and reimbursement frameworks
  • Examine market access challenges and reimbursement approaches for advanced therapies and rare diseases
  • Assess the role of real-world data in demonstrating long-term outcomes and value post-launch
  • Evaluate the use of digital technologies, AI, and advanced analytics in pricing and market access decision-making
  • Formulate forward-looking strategies to adapt to evolving European policies, data ecosystems, and collaborative healthcare models

Who will you meet? 

Network with members of the boards, VP’s, Directors, Heads/Chiefs and Senior Managers of leading biopharmaceutical and biotech companies, government, CRO and solution providers involved in:

  • Real-World Evidence
  • Real-World Data
  • Clinical Research and Development
  • Data Science, Technologies and Analytics
  • Clinical Research
  • Epidemiology
  • Health Economics and Outcomes Research
  • Market Access
  • Reimbursement
  • Patient Outcomes
  • Drug Pricing
  • Health Economics and Outcomes Research
  • Payer Relations/ Evidence
  • Regulatory Affairs, Policy
  • Public/ Government Affairs
  • Payers, HTA Officials and Physicians
  • Business Development
  • Marketing
  • Commercial Executives
  • Product Launch
  • Commercialization
  • Value Strategy
  • Product Strategy
  • Forecaster
  • Finance Officer
    Wearable Sensors
    Electronic & Medical Records
  • Lab & Biomarkers
  • Medical and Pharmacy data
  • Technology Science and Development
  • Social Media
  • Academia
  • Pharma and Biotech

13th RWE, MARKET ACCESS, PRICING & REIMBURSEMENT World Congress 2026 Europe

Powering Market Access Through Real-World Evidence, Digital Innovation & Value-Based Strategies

Day 1 - Thursday 3rd September 2026 - Hilton 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
  • Current limitations of RWD: Real-world data is often fragmented across systems, inconsistent in quality, and difficult to access or harmonize across countries and institutions.
  • Promise of EHDS: The European Health Data Space could improve access, interoperability, and secondary use of health data, creating a stronger foundation for research, innovation, and evidence generation.
  • EHDS shortcomings: However, success will depend on practical implementation, governance clarity and data standardization.
  • Why partnerships matter: No single stakeholder can solve the RWD challenge alone; collaboration between industry, regulators, academia, healthcare providers, and technology partners is essential.
  • What are the ingredients of success: Can Industry create sustainable partnerships that can lead to better RWD for faster evidence generation, better patient outcomes, and shorter development times in Europe? What are the appropriate models?

Meni Styliadou, VP Health Data Partnerships, Data Science Institute, Takeda

  • Introduction to Cancer Patients Europe
  • When RCTs are not possible, what kind of evidence can be acceptable at regulatory and HTA level?
  • Where we stand today with patients’ involvement in the EU HTA (JCA & JSC)
  • What worked well and what needs to be improved
  • How we are preparing for the 2028 report on the EU HTA implementation

Antonella Cardone, CEO, Cancer Patients Europe

  • Identifying and mitigating selection bias
  • Ensuring data completeness and consistency
  • Transparency in methodologies and reporting
  • Building trust with regulators and payers

Senior Representative, Astrazeneca 

  • Opportunities from EU data-sharing initiatives
  • Accessing cross-border datasets
  • Data interoperability challenges
  • Governance and compliance considerations
  • Why RWE matters in rare disease decision-making?
  • What makes RWE credible, usable, and relevant for regulators, HTA bodies, and the NHS?
  • How can NICE dynamic advice improve your RWE submission?
  • Key lessons from working across policy, evidence generation, and stakeholder engagement.

Sheela Upadhyaya, Board Trustee, Medics for Rare Disease, Founder, Rarely Ordinary

Pricing & Market Access Strategies in a Constrained European Landscape

  • Rare disease is not a niche, but one of the largest structurally underserved populations in medicine.
  • Many rare disease programs do not fail because the science is wrong; they fail because the funding architecture collapses before the science can mature.
  • Traditional grant funding and venture capital are often poorly matched to rare disease timelines, small populations, regulatory uncertainty, and access complexity.
  • New funding architectures are needed, including venture philanthropy, public-private partnerships, blended finance, advanced market commitments, patient-driven funding networks, and outcome- linked financing.
  • Real-world-evidsence, regulatory alignment, transparent impact metrics, and AI-enabled portfolio management can help de-risk programs earlier and attract more durable capital.
  • The ultimate goal is a triple win: faster therapies for patients, more investable assets for partners, and a more sustainable rare disease innovation ecosystem.

James Levine, President, Ipsen Foundation

  • 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

John Purdy, Global Access- Population Health Strategy Lead. Roche

  • 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

Moderator:
Funmi Oluwa, Head, Market Access & External Engagement, UK/Ireland, UCB

Panellist:

Pedro Borga, Director, Regional Market Access and Pricing, Amicus Therapeutics
Robert Fairless, Vice President, Law and Compliance International, Incyte

13th RWE, MARKET ACCESS,​ PRICING & REIMBURSEMENT World Congress 2026 Europe​

Powering Market Access Through Real-World Evidence, Digital Innovation & Value-Based Strategies

Day 2 - Friday 4th September 2026 - Hilton London Kensington, London, UK

Patient-Centric Value, Outcomes & Advanced Therapies

  • Patient-reported outcomes (PROs) in HTA
  • Equity and access disparities
  • Outcomes-based agreements
  • Value frameworks beyond clinical endpoints

Moderator:

Panelist:

Robert Fairless, Vice President, Law and Compliance International, Incyte

  • How can we ensure PROs are given due consideration in HTA assessments – timing, credibility and scope
  • How do we measure the value derived from integrating PROs into HTAs
  • What lessons regarding PROs for the patient community and pharma can be seen from the recent EMA assessment of Tiractricol in MCT8 deficiency and UK Managed access appraisal of Brineura in CLN2 Batten disease.

Nigel Nicholls, General Manager UK/Nordics & Baltics, Egetis Therapeutics

  • Structuring outcomes-based reimbursement contracts
  • Data collection and performance tracking
  • Operational and administrative challenges
  • Scalability across multiple markets
  • Expanding value beyond traditional endpoints to reflect real world patient and societal impact
  • Leveraging real world and digital evidence to address evolving payer evidence expectations
  • Integrating real world evidence across the product lifecycle

Marta Contente, Senior Director, Pipeline Head of Immunology, GHEVO, Teva

  • Annuity and staged payment models
  • Risk-sharing agreements
  • Linking payment to long-term outcomes
  • Financial sustainability considerations
  • The increasing importance of Real-World Evidence in healthcare
  • How RWE supports HTA, market access, reimbursement, and regulatory decisions
  • The role of evidence strategy in turning data into meaningful insights
  • Building data-driven and patient-centred approaches to healthcare decision-making

Dr Mohamed Elsayed, International Medical Evidence Delivery Associate Director, AstraZeneca

  • The Structural Mismatch: Why Innovative Therapies Inevitably Diverge from HTA Gold Standards
  • Fit-for-Purpose Evidence: Leveraging RWE to Address Uncertainty Where Traditional Data Falls Short
  • From Advocacy to Action: Embedding Flexibility into the HTA Reform Agenda

Marion Bouillon-Pichault, Director Global Policy & Access, Intercon & APAC, Bristol Myers Squibb

Digital Transformation, Data & the Future of Market Access

  • Leveraging predictive analytics for pricing and reimbursement decisions
  • Scenario modelling to optimise launch and access strategies
  • AI-driven insights to strengthen payer engagement and negotiations
  • Challenges, limitations, and governance of AI in decision-making
  • Expanding beyond traditional data: wearables, apps, and remote monitoring
  • Validating digital endpoints for regulatory and HTA acceptance
  • Integrating new data streams into evidence generation strategies
  • Opportunities and risks in using patient-generated health data

Meni Styliadou, VP Health Data Partnerships, Data Science Institute, Takeda

  • Overcoming fragmentation across national health data systems
  • Advancing interoperability standards and cross-border data sharing
  • Role of European data initiatives and collaborations
  • Public-private partnerships enabling scalable data ecosystems
  • Navigating GDPR and evolving European data regulations
  • Ethical considerations in secondary use of health data
  • Digital platforms for payer and stakeholder engagement
  • Ensuring transparency, trust, and security in data-driven access models
  • Transitioning from static evidence to real-time, data-driven decision-making in pricing and reimbursement
  • The growing role of AI and advanced analytics in shaping market access and payer negotiations
  • Overcoming data fragmentation and interoperability challenges across European healthcare systems
  • Balancing innovation with regulation, GDPR compliance, and ethical use of health data
  • Ensuring equitable, patient-centric access in an increasingly digital and data-driven ecosystem

Moderator:

John Purdy, Global Access- Population Health Strategy Lead. Roche

Panelists:

Pedro Borga, Director, Regional Market Access and Pricing, Amicus Therapeutics

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