Co-Creating Real-World Evidence for Decision-Making
RWE4Decisions is an HTA/Payer-led initiative that fosters open, multi-stakeholder dialogue on how to generate fit-for-purpose real-world evidence (RWE) throughout the lifecycle of highly innovative medicines to better inform HTA/Payer decisions and support the needs of healthcare systems.
MISSION STATEMENT
PRINCIPLES OF ENGAGEMENT
MISSION STATEMENT
We work to:
Support systems to identify medicines most likely to require RWE early in development, and plan accordingly
Clarify how RWE should be generated by Health Technology Developers (HTDs), assessed by HTA bodies, and applied by payers and decision-makers
Strengthen the design and implementation of Post-Launch Evidence Generation (PLEG) and promote alignment of approaches across jurisdictions where possible
PRINCIPLES OF ENGAGEMENT
MISSION STATEMENT
PRINCIPLES OF ENGAGEMENT
Our work is underpinned by Transparency and Collaboration
We are committed to sharing learnings, enabling multi-stakeholder dialogues, and proposing solutions that help build trust. RWE4Decisions provides a neutral forum for stakeholders to align on how RWE can support HTA and payer decision-making for highly innovative medicines.
Our guiding principles include:
Openness and transparency in how evidence gaps are identified and addressed
Early and iterative engagement between stakeholders throughout the product lifecycle
Alignment across jurisdictions to reduce duplication of effort and support more consistent decision-making
Methodological robustness and reproducibility in the design and analysis of RWE
Patient and clinician involvement to ensure that outcomes measured reflect real-world needs and priorities
Model for multi-stakeholder collaboration to support decision-making
A platform for shared learning and coordinated action
RWE4Decisions provides a structured, inclusive forum where stakeholders contribute their expertise and perspectives to shape the generation and use of RWE. Our collaborative model brings together:Our genesis
From the INAMI papers, to Trust4RD and RWE4Decisions
The genesis of RWE4Decisions is deeply rooted in a series of strategic roundtables commissioned in 2016 by the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV), which in 2019 formalised into Trust4RD – short for Tool for Reducing Uncertainties in the evidence generation for Specialised Treatments for Rare Diseases.
2010’s
Under the thought leadership of Jo De Cock, former CEO of the Belgian payer INAMI-RIZIV, a series of multi-stakeholder roundtables laid the groundwork for a more structured approach to RWE in HTA/Payer decision-making. The ‘INAMI papers’ discussed ‘The use of RWD throughout an innovative medicine’s lifecycle’ (2016) and ‘Outcomes based pricing and reimbursement of innovative medicines’ (2017).
2019
Trust4RD built on these papers, with the goal to develop a pragmatic and structured approach for reducing uncertainties in evidence used to evaluate rare disease therapies. This resulted in a framework for collaborative, iterative planning of RWE generation, introducing the concept of a “principled compromise” between timely access and robust evidence.
2020
As Trust4RD gained recognition – including during the 2019 Finnish EU Presidency – it became clear that the methods and principles developed had wider applicability beyond rare diseases. This led to the establishment of RWE4Decisions in 2020, which retained the core principles of Trust4RD but expanded its focus to encompass all highly innovative medicines, especially those approved via expedited pathways or with immature data at launch.