Home> Work Package 6: Payers/Providers/HTAs, EMA Alignment and Optimization
WP6 will group stakeholders into clusters and will be working to identify and address any evidence gaps which might delay decision-making by regulatory agencies, HTA bodies, and payers. Such activities will identify those factors which prevent patient access to innovative treatments for HM. The group’s work, building upon previously gained experience and other EU-funded projects and international initiatives, will lead to consensus-based decisions and facilitate interaction and consultation between all the relevant stakeholders.
HARMONY is currently conducting a Delphi Survey to Develop a Core Outcome Set (COS) for Acute Myeloid Leukemia. A COS constitutes the minimum set of outcomes that should be collected and reported in future clinical trials. Download the Delphi AML Study Protocol document to read more and to have an overview of the full outcome list in the annex.
AEMPS, Amgen, Bayer, BFArM, Celgene, EHA, HULAFE, IBSAL, Janssen, Leukanet, MediUni Wien, Menarini, NICE, Novartis, Synapse, University of York.
WP6 aims to identify and address evidence gaps which can delay decision-making by regulatory agencies, HTA bodies, and payers, thus compromising timely patient access to innovative treatments for HMs. For this, a Policy Health Stakeholder Feedback Forum (PHSFF) has been established. PHSFF will act as a key platform for interaction and consultation between stakeholder groups. Collecting input and discussing viewpoints from patient organizations, hematologists/clinicians, regulators and HTB bodies will be crucial to shaping the work of HARMONY.
In 2018, the Stakeholder Forum will continue to bring its support to WP2 for the development of overarching or common outcomes and specific outcomes to the individual HMs. It is the aspiration of WP2 and WP6 to see the development of a Core Outcomes Set for HMs. To be successful we need to obtain the viewpoints from patients’ organizations, hematologists/clinicians, regulators and HTA bodies.It will also provide input into WP7 (communication and dissemination) and WP8 (ethics and legal).
The other Stakeholder Forum objectives are to:
The Access Evidence Value Framework aims at developing an HM-specific clinical and economic evidence framework. In 2018, steps to consider are:
The Clinical Value Framework aims at developing an instrument able to quantify the added therapeutic value of new technologies for the treatment of HMs.