RWE4Decisions Learning Network
RWE4Decisions – Mission
RWE4Decisions is a multi-stakeholder Learning Network that supports open dialogues to determine how fit-for-purpose RWE can be generated over the life cycle of highly innovative medicines to inform HTA/Payer decisions:
– Systems to identify medicines most likely to need RWE and planning early for that
– Clarifying how RWE should be generated by Health Technology Developers and will be assessed by HTA and used by Payers/decision-makers
– Improving the execution of effective Post Launch Evidence Generation (PLEG) studies, and aligning them across jurisdictions where possible
Key Principles
All stakeholders worked together to agree what real-world data (RWD) can be collected for highly innovative technologies based on the principles of collaboration and transparency:
Collaboration
- RWE generation is a shared responsibility and should be pre-specified and planned with all stakeholders and other decision-makers, such as regulators.
- Iterative multi-stakeholder dialogues should be encouraged during the lifecycle of a highly innovative medicine to discuss plans for evidence generation and the potential for RWE to resolve important decision-relevant uncertainties and plan for RWD collection.
- Each stakeholder needs to take responsibility for aspects they can influence and work collaboratively with other stakeholders to achieve the common goal of developing RWE that can inform Payer/HTA decisions and improve patient care.
Transparency
Plans for RWD collection and generation of RWE should be shared publicly (in line with confidentiality agreements) to ensure that data sources can be designed, coordinated and combined by:
- Clarifying what questions RWD may be able to address in regulatory and Payer/HTA decisions.
- Publishing case studies showing how RWE has been assessed in HTA.
- Sharing information about PLEG studies being planned across different jurisdictions to enable data aggregation.
Model for Multi-Stakeholder Collaboration to Support Decision-Making
The multi-stakeholder collaboration involves policy-makers, HTA bodies, payers, regulatory agencies, patient groups, academic experts/researcher, clinicians and industry.
RWE4Decisions calls for a collaborative EU Learning Network premised on the Open Innovation 2.0. approach where all stakeholders work together to enable cross-fertilization of ideas to develop innovation beyond the scope of what one organization or initiative can do alone.
- HTA Bodies and Payer Networks
- Public Health Authorities
- Patients and Clinicians
- Academics, Registries, Analytics Experts
- Industry
