Dear RWE4Decisions Learning Network,
The new year officially marks the beginning of European collaboration under the EU HTA Regulation, with new oncology medicines and ATMPs undergoing Joint Clinical Assessments. Given the often limited clinical evidence available for these innovative treatments, the use of Real-World Evidence (RWE) becomes increasingly relevant.
As in previous years, RWE4Decisions will continue to provide a platform for stakeholder dialogues to determine how fit-for-purpose RWE can be generated throughout the life cycle of highly innovative medicines to inform HTA/Payer decisions. But before we dive into our planned activities for 2025, let’s celebrate our 2024 achievements by reading the newsletter below!
Stakeholder Actions to generate better Real-World Evidence for Payers and HTA bodies
Throughout 2024, we collaborated to develop new recommendations for six stakeholder groups on generating better Real-World Evidence for HTA/Payers. These Stakeholder Actions were unveiled at the 2024 RWE4Decisions Symposium and further discussed at the 2024 ISPOR RWE Summit.
The RWE4Decisions Steering Group co-authored a paper outlining the key themes and learnings, which will be published in 2025.
A heartfelt thank you to the Learning Network for all your invaluable contributions to developing the Actions!
Post-Launch Evidence Generation (PLEG) Roundtables
In 2024, we set out to learn more about how countries operationalise PLEG, in support of Member States’ potential voluntary collaboration on PLEG under the EU HTA Regulation.
RWE4Decisions roundtables focused on:PLEG Anticipation and Planning in France, England and Spain. The insights have been included in a paper which was accepted for publication in the Clinical Pharmacology & Therapeutics Journal – stay tuned!
PLEG process developments in Italy, Germany and the French DESCAR-T Registry. A report is underway, outlining how national systems are rethinking their PLEG frameworks, in a resource-intensive process, which must account for patients’ need for innovation.
Can endpoints from digital technologies provide meaningful outcomes for HTA?
Our June 2024 webinar discussed how data from digital technologies can be used for a multitude of purposes, ranging from patient self-management to HTA and medicines regulation. If you missed it, we have you covered with a recording and written report, available on the RWE4Decisions website.
HTA/Payer Collaboration in the Nordics
The Role of Real-World Evidence
The October 2024 webinar focused on the new regional collaboration JNHB (the Joint Nordics HTA Bodies), their work in the context of the HTA Regulation, and how RWE is assessed at the national level. While there are no RWD/RWE guidelines in the Nordics, speakers highlighted the Canadian and English guidances as important international resources for assessing RWE. Discussions also underlined the importance of data transportability and early dialogue with developers.
RWE4Decisions Annual Symposium
Developing Real-World Evidence to Deliver Innovation in HTA
On 14 November, the RWE4Decisions Learning Network gathered in Brussels for a half-day Symposium looking at the Real-World Evidence opportunities of the EU HTA Regulation and EHDS. Representatives from EU Member States, the European Medicines Agency, HTA/Payers from across Europe, patient organisations and industry explored the role of RWE to drive innovation in HTA. Symposium materials are available on the RWE4Decisions website, and an extensive report will follow shortly.
HTAi 2024 Annual Meeting in Barcelona
RWE4Decisions held two panels at the 2024 HTAi Annual Meeting, moderated by François Meyer. We discussed:
Can We Agree When an RCT Is Not Possible and the Implications for Comparative Effectiveness?, with
- Anne-Pierre Pickaert (ELLyE)
- Antoine Vanier (HAS)
- James Ryan (AstraZeneca)
PLEG: Can We Anticipate When and What We Need?, with
- Judith Fernandez (HAS)
- Carlos Martín Saborido (Spanish Ministry of Health)
- Steve Williamson (NICE)
- Joshua Ray (Roche)
Looking ahead to 2025
On 20 February we will partner with the WHO Novel Medicines Platform to discuss their Draft Guide Principles for Managed Entry Agreements during a Roundtable with the RWE4Decisions Learning Network.
The RWE4Decisions Steering Group will be disseminating the revised Stakeholder Actions to Generate Better RWE for HTA/Payers and gathering examples of how organisations implement these Actions. Should you already have any implementation stories, we invite you to share them with the Secretariat.
We have many more activities planned, to be announced throughout the year. If you have collaboration ideas, don’t hesitate to get in touch!
Wishing you a happy and healthy 2025,
The RWE4Decisions Secretariat