THE GET-REAL NAVIGATOR- SUPPORTING HTA AND PAYER EVALUATION OF NEW MEDICINES
Author(s)
Stegenga H1, Chambers M2, Jonsson P3, Thwaites R4, Garner S1
1National Institute for Health and Care Excellence, London, UK, 2MCHCE, London, UK, 3National Institute for Health and Care Excellence (NICE), Manchester, UK, 4Takeda, London, UK
Objectives: Payers and health technology assessment (HTA) agencies are tasked with assessing the effectiveness of new medicines relative to usual practice. There is a role for real-world evidence (RWE) to support traditional trial data in this respect but stakeholders have different views of the acceptability of using RWE. The European IMI GetReal project (www.imi-getreal.eu) was tasked with seeking clarity on the topic and communicating this to stakeholders. Results: We describe a web-based tool, the “RWE Navigator” (rwe-navigator.eu). The tool is an educational resource, a source of guidance, and a directory of resources related to RWE in medicines development. The tool includes a two-step process to explore potential effectiveness issues and potential options using RWE to address these issues. Other components include overviews of authoritative links to data sources, and on the governance, synthesis, quality assessment, and bias adjustment such data. The RWE navigator also contains summaries of case studies examined in GetReal and overviews of current policies and perspectives, and related initiatives. Conclusions:The RWE Navigator is a valuable shared platform for stakeholders to address the inclusion of alternative study designs and analyses in medicines development using RWE but further work is needed. This work has supported engagement and dialogue between industry and decision-makers, and has driven forward the scientific and policy agenda.
Conference/Value in Health Info
2017-05, ISPOR 2017, Boston, MA, USA
Value in Health, Vol. 20, No. 5 (May 2017)
Code
PRM194
Topic
Methodological & Statistical Research
Topic Subcategory
Confounding, Selection Bias Correction, Causal Inference
Disease
Multiple Diseases