Objectives

1. Establish a WP5 External Advisory Panel (EAP) comprised of key stakeholders who are world-leaders on regulatory-HTA-payer systems, supplemented by internationally leading clinical experts in the use of diagnostics to fight AMR, able to provide the consortium with the necessary insights to ensure that VALUE-Dx activities and outputs are meaningful for regulators, HTA bodies, payers and clinical practitioners.
2. Develop new health-economic models to determine the long-term clinical, public health and economic impact of diagnostics in terms of AMR prevention with the support of HTAs reflecting the integral value of diagnostics.
3. To support clinical trial development from the economic perspective and perform an economic analysis on the WP4 clinical trial results.
4. Review and analyse the current policy environment in Europe and identify good practices for assessments of innovative diagnostics.
5. To develop innovative frameworks to optimise assessment of the clinical and economic value of diagnostics and facilitate sustainable funding systems over the entire lifetime of the diagnostic.
6. Develop and apply a proposal for a mechanism to ensure transferability of findings into other countries’ settings.
7. Develop proposals for fit-for-purpose policies, to accelerate market entry of and accessibility to cost-effective diagnostics with the potential to be applied to cost effectively reduce AMR.
8. Explore and define the organisational, structural, ethical and social factors influencing widespread adoption of CA-ARTI-Dx by community care organisations across European countries and develop recommendations to facilitate implementation of diagnostics in routine clinical practice.