The project aims to develop a new universal framework for evaluating the therapeutic/clinical value of innovative medical technologies compared to available alternatives.
Based on clinicians’ experiences (HARMONY KOLs ), patients, regulators, HTA (EUnetHTA Joint Action 2) and other key stakeholders represented in PHSFF, project leaders and partners will develop a tool to quantify the therapeutic added value of new technologies in the treatment of HMs. This could prove to be a helpful tool to facilitate early regulatory approval, as conditional marketing approval requires establishing a significant therapeutic benefit over alternative treatments). In addition, it will help achieve substantial benefits demonstration for orphan drugs, recommendations for HTA (in particular, harmonization of assessment criteria for added therapeutic value), development of treatment guidelines and their adoption by clinicians and patients. The EMA will contribute to the project upon request through existing regulatory pathways.
Title of the paper the HARMONY Alliance Taskforce in the Elsevier ScienceDirect Journal is: "Value in Health: Building a Healthcare Alliance for Resourceful Medicine Offensive Against Neoplasms in HematologY Added Value Framework for Hematologic Malignancies: A Comparative Analysis of Existing Tools".