RWE4Decisions Learning Network
RWE4Decisions – Mission
RWE4Decisions is a multi-stakeholder initiative commissioned by the Belgian National Institute of Health and Disability Insurance (INAMI-RIZIV) and comprising policy makers, HTA bodies, payers, regulatory agencies, clinicians, patient groups, researchers, registry-holders, data analysts, industry and academic experts.
It brings together experts from all stakeholder groups to engage in dialogues that consider how fit-for-purpose RWE can be generated over the life cycle of highly innovative medicines through:
• horizon scanning systems that identify medicines which are most likely to need RWE
• identifying what RWE is needed to inform HTA/Payer decisions
• clarifying how RWE is generated by HTDs and will be assessed by HTA and used by Payers/decision-makers
• aligning planning and execution of effective Post Launch Evidence Generation (PLEG) studies.
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