Day 1 - Tuesday 29th April 2025

12th Market Access, Pricing & Reimbursement Global Congress 2025 Europe

Comprehensive Strategies and Embracing Innovations to Overcome Barriers in Patient Access
Tuesday 29th - Wednesday 30th April 2025
Copthorne Tara Hotel London Kensington, London, UK

Matthias Heck, Senior Advisor Strategic Alliance Development, EUCOPE

MARKET ACCESS TRENDS & STRATEGIES

  • Navigating complex requirements to achieve and maintain market access in the EU and globally
  • Addressing varying market access and payer models to accelerate patient access to treatment
  • Integrating evidence development with market access strategy
  • Creating a robust clinical evidence for HTA assessment
  • Tackling the challenges on drug affordability

Moderator:

Alison Lawrence, Associate Principal, Decisive Consulting Ltd

Panelist:

Simon Lande, CEO & Co-founder, HealthLumen

  • Impact of the new EU Regulation on HTA, and the new requirements that companies need to address to access Member State markets.
  • Recommendations on how to ensure efficient and effective implementation of the JCA at the national level
  • Identify metrics that will enable iterative learning among stakeholders.
  • Future considerations for involvement in JCA and national implementation at the Member State level.

Adrian Griffin, VP, HTA & Access Policy, J&J Innovative Medicine

Points of Discussion to follow shortly

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

  • As interventional technologies gallop forward, payers react by evolving their methodologies for assessing effectiveness and willingness to reimburse. As we plan clinical development, we must strategise to ensure the best investment for patients, businesses, and the healthcare market. Accurate accounting for market access opportunities and challenges is critical across the pre-launch and post- launch timeline. This presentation will focus on how the pharmaceutical multidisciplinary team must work together to ensure the healthcare system can treat patients in a timely and effective way.

Alison Lawrence, Associate Principal, Decisive Consulting Ltd

  • In all HTA assessments, but specifically as part of the European JCA, companies are asked to provide comparative evidence for all relevant PICOs.
  • Whereas it is common sense that RCTs and literature-based indirect comparisons can generate that evidence, it is less clear what RWE can do in this respect
  • The presentation focuses on how such comparative RWE can be generated, and what needs to be taken
    into account regarding data access and methodology.

Thomas Wilke, PhD, Scientific Lead, GIPAM GmbH

  • The MHRA data strategy
  • Introducing the Real-World Evidence Scientific Dialogue Programme
  • The MHRA Real-World Data Guidance series

  Dr Rebecca Ghosh, Real-World Evidence Specialist, MHRA

  • 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.

Riad Dirani, VP of Global HEOR, Medical Operations and Excellence, Teva

  • 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

Marc De Benedetti, Global Biometrics & Data Sciences, Bristol Myers Squibb

  • Challenges and obstacles in bringing this highly complex therapies to market
  • Lessons learned and applications for new entrants
  • Strategies that can be taken to improve timely market access and access for patients
  • Innovative contracting for cell & gene therapies in the EU
  • Stakeholder collaboration on the road towards a solution

Matias Olsen, Senior Manager, Public Affairs and Policy, EUCOPE

  • Access to innovative medicines remains a key issue worldwide
  • Identifying the root cause of inequitable access
  • Limitations of the some of the initiatives to address this such as the EUnetHTA JCA and the changes in
    legislation in Europe
  • Developing solutions that are sustainable and scalable
  • How can pharmaceutical companies and health authorities work together to bridge the gap

Moderator:
Matthias Heck, Senior Advisor Strategic Alliance Development, EUCOPE

Panellist:

Nazanin Mehin, Head of Global Market Access and Pricing for Immunology, Sanofi
Zavy Gabriel, Head of International Market Access, AstraZeneca

Matthias Heck, Senior Advisor Strategic Alliance Development, EUCOPE

Day 2 Agenda
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