Home> Work Package 6: Payers/Providers/HTAs, EMA Alignment and Optimization

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.

Objectives

Providing support and advice to other WPs to ensure that all relevant perspectives (from HTA bodies, patients, regulators, policy-makers, etc.) are reflected;
Engaging all stakeholders to collect input and ensure the long-term implementation of the project's outcomes;
Creating an evidence framework to enhance decision-making processes, thereby facilitating centralized regulatory approval and national/regional HTA;
Developing a clinical value framework to assess how effective new clinical interventions are and to assess their relative therapeutic value;
Inviting input in terms of multiple viewpoints and requirements on the part of stakeholders;
Fostering consensus among the stakeholders, thus facilitating the development of and access to innovative solutions and therapies for HMs;
Integrating stakeholder participation and evidence;
Providing guidance on methodologies for evidence generation and analysis of real-life evidence.

Work Package Partners

AEMPS, Amgen, Bayer, BFArM, Celgene, EHA, HULAFE, IBSAL, Janssen, Leukanet, MediUni Wien, Menarini, NICE, Novartis, Synapse, University of York.

Work Package Leadership

Public-private partnership for Big Data in Hematology

HARMONY and HARMONY PLUS are funded through the Innovative Medicines Initiative (IMI), Europe's largest public-private initiative aiming to speed up the development of better and safer medicines for patients. Funding is received from the IMI 2 Joint Undertaking and is listed under grant agreement for HARMONY No. 116026 and grant agreement for HARMONY PLUS No. 945406. This Joint Undertaking receives support from the European Union’s Horizon 2020 Research and Innovation Programme and the European Federation of Pharmaceutical Industries and Associations (EFPIA).