RWE4Decisions Learning Network

RWE4Decisions Mission and Vision

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 stakeholders together to agree what real-world data could be collected for highly innovative technologies – when, by whom and how – in order to generate real-world evidence that informs decisions by healthcare systems (HTA bodies / Payers), clinicians and patients.

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.
  • Iterative dialogues should involve all stakeholders throughout the lifecycle of a technology to discuss plans for evidence generation and the potential for RWE to resolve important decision uncertainties.
  • 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 to ensure that data sources can be focused, coordinated and combined by:

  • Clarifying what questions RWD may be able to address in regulatory and Payer/HTA decisions.
  • Publishing methods for critical assessment of RWE.
  • Sharing information about RWD studies underway across different jurisdictions to enable data amalgamation.
  • Use of clear processes for managing conflicts of interest among stakeholders.

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