As we head into the final stretch of summer, we’re excited to share key updates from our multi-stakeholder Learning Network. From advancing Stakeholder Actions to deepening our Post-Launch Evidence Generation (PLEG) dialogue, this issue highlights our collective efforts to strengthen the role of real-world evidence (RWE) in HTA and Payer decision-making.
Stakeholder Actions in IJTAHC
We’re proud to share that our paper, Actions for Stakeholders to Develop Better RWE for HTA Bodies and Payers Decision- Making has been published in the International Journal of Technology Assessment in Health Care (IJTAHC).
A heartfelt thank you to everyone who contributed over the past year – through focus group, roundtables, webinars, and more. Your insights were instrumental in shaping this work.
This publication marks an important milestone, but it is only the beginning. Our collective goal now shifts toward implementation. We will be tracking progress through real-world examples and invite you to share your stories on how these actions are being put into practice. Exciting developments lie ahead – stay connected and engaged!
Enlarged RWE4Decisions Steering Group
Earlier this year, we had the pleasure of welcoming two new members to our Steering Group:
Dr Francis Arickx, Head of Reimbursement of Medicines and Pharmaceutical Policy, at the Belgian National Institute for Health and Disability Insurance (RIZIV-INAMI). Dr Arickx brings a deep well of international collaboration experience, holding key roles in initiatives such as BeNeLuxA, the International Horizon Scanning Initiative and the European medicine price database (EURIPID). He succeeds Dr Diane Kleinermans in the Steering Group seat, who we warmly thank for her longstanding commitment and invaluable contributions.
Dr Seamus Kent, Assistant Professor at the Erasmus School of Health Policy & Management, who joins as the newest academic member of the RWE4Decisions Steering Group. Dr Kent brings a wealth of expertise in RWE and HTA shaped across leading organisations. Before academia, he played a key role at the UK’s National Institute for Health and Care Excellence where he led the development of the NICE real-world evidence framework. Dr Kent co-authored the paper Post-Launch Evidence Generation: Lessons from France, England and Spain discussing learnings from earlier RWE4Decisions roundtables.
COMING UP
Roundtable – RWE for HTA Decision-Making in Oncology
On 18 September, 14:30–17:00 CEST, our forthcoming multi-stakeholder roundtable will bring together experts to discuss the evolving role of real-world evidence in HTA Decision-Making in Oncology. Co-moderated by Shaun Rowark (NICE) and François Meyer (RWE4Decisions), the programme will feature a keynote presentation by Dr Beate Wieseler (IQWiG) on HTA Coordination Group guidance on evidence synthesis, including RWE. Case studies from Robert Szulkin (TLV) and Mattias Ekman (AstraZeneca) will provide multi-stakeholder insights, and breakout room discussions will explore ways to enhance the use of RWE in oncology decision-making.
Roundtables are by-invitation meetings; get in touch to ask for an invite.
Webinar – Transforming RWE with AI: From Data to Decisions
Artificial Intelligence (AI) is rapidly reshaping the use of RWE across the lifecycle of medicines. While HTA and Payer bodies are increasingly recognising the potential of AI to enhance evidence generation and the efficiency of their evaluations, pharmaceutical companies are leveraging AI to strengthen evidence generation for HTA submissions.
This public webinar will be co-moderated by Niklas Hedberg (TLV) and Karen Facey (RWE4Decisions). Keynotes will feature Stephen Duffield (NICE) on NICE’s position statement on AI in evidence generation, and Jing Wang-Silvanto (Astellas) on industry applications of AI in real-world evidence. They will be joined by Julián Isla (EMA/Microsoft) and Farah Husein (CDA-AMC) for a multi-stakeholder discussion with the audience on the potential and pitfalls associated with the use of AI for RWE generation in HTA.
Join the webinar on 15 October, from 15:00 to 16:30 CEST to explore these evolving dynamics and foster dialogue on aligning innovation with the needs of patients, clinicians, and decision-makers.
Save the date for the Annual RWE4Decisions Symposium!
Join us online on 20 November, from 14:00 to 17:00 CET, for the Annual RWE4Decisions Symposium — a timely conversation as the EU enters a critical phase of implementing major health data initiatives. Confirmed speakers include representatives from the Danish EU Presidency, European Commission, European Medicines Agency, national HTA/Payers, patient and industry representatives.
This year’s focus: how real-world data can meaningfully support decision-making in the context of the HTA Regulation, the European Health Data Space, the rise of Artificial Intelligence in evidence generation, and the future of HTA collaboration across Europe.
Breakout room discussions will explore regional developments across the globe, and the RWE4Decisions Steering Group will reflect on our priorities for 2026 and beyond.
Keep an eye out for more updates!
Updates from the Secretariat team
We bid a heartfelt farewell to Serena Rama whose dedication and energy have shaped RWE4Decisions Secretariat’s work over the past three years. Her contributions have been invaluable, and we wish her every success in the next chapter of her journey.
At the same time, we are delighted to welcome Ştefania Cebuc back to the team following her internship at the European Commission’s DG SANTE. Her return brings fresh insights and renewed momentum to our work.
In case you missed – Highlights from earlier this year
WHO Europe Novel Medicines Platform Draft Guide Principles for Managed Entry Agreements (20 February)
RWE4Decisions proudly co-hosted a roundtable with WHO Europe’s Novel Medicines Platform (NMP) on principles for Managed Entry Agreements (MEAs).
Feedback gathered from the RWE4Decisions Community will shape the final WHO NMP guidance — a tangible result of trusted, multi-stakeholder dialogue.
Cross-Border Use of RWE: Advancing Data Transportability in HTA/Payer Decisions (7 May)
Our latest roundtable focused on the use of real-world data from other jurisdictions in HTA and payer decisions. Experts discussed when transported RWD is appropriate, how it should be assessed, and key challenges around comparability, transparency, and local context. Breakout groups explored practical scenarios in rare diseases, oncology, and high-prevalence conditions.
A peer-reviewed paper capturing these insights is being developed — stay tuned!
From Policy to Practice: EHDS Implementation to Support Better Real-World Evidence for HTA/Payers (9 April)
Over 200 participants joined our public webinar to explore how the European Health Data Space (EHDS) can unlock robust real-world evidence for better, faster HTA and payer decisions. Distinguished speakers shared practical insights on EHDS implementation, spotlighting national and EU-level efforts to enable secure secondary data use — and the growing role of RWE in shaping patient-centred decisions.
SHAPING THE CONVERSATION
Call for Effective Stakeholder Engagement and Capacity Building during the Implementation of the EHDS
With the adoption of the EHDS Regulation, attention now turns to how it will be implemented. As part of a 39-member coalition, RWE4Decisions co-signed a joint statement outlining key priorities for success, with a strong focus on inclusive, transparent stakeholder engagement. We called for:
- A Stakeholder Forum to ensure diverse voices, including payers, are heard
- Capacity-building to support cross-border knowledge exchange
- Greater transparency in the EHDS Board, with meaningful integration of stakeholder input
We’re pleased that the European Commission has acknowledged our recommendations, reinforcing the importance of collaboration as EHDS moves from policy to practice.
RWE4Decisions at the ISPOR Nordic Chapter launch
Our Special Advisor, François Meyer, participated in the launch of the ISPOR Nordic Chapter, where he discussed RWE4Decisions’ mission and approach to advancing real-world evidence in decision-making across Europe. Best wishes to this new ISPOR chapter!
Lessons Across Europe on Post-Launch Evidence Generation
Earlier this year, RWE4Decisions was invited to contribute to a special edition of Clinical Pharmacology and Therapeutics. We are grateful to Seamus Kent for acting as lead author on a paper summarising our 2024 roundtable: Planning Post-Launch Evidence Generation (PLEG): Lessons from France, England and Spain, and to all co-authors for sharing their learnings.
The article discusses how PLEG systems are used in France, Spain, and England. It highlights both differences in approaches and the common challenges stakeholders face – particularly around anticipating PLEG needs early and streamlining data collection. Findings point to the importance of stronger scientific advice processes and greater international collaboration to identify data gaps upfront, ensuring more efficient and effective evidence collection that can speed up and improve reimbursement and pricing decisions.