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Clinical Value Framework to quantify therapeutic value of innovative technologies for HMs

HARMONY, Multi-stakeholder


Currently available non-validated tools for quantifying the therapeutic value of innovative technologies for HMs, do not consider either evidence from single-arm studies or “real-life” evidence. And this is even though they are particularly relevant in the context of HM.

The project aims to develop a new universal framework for evaluating the therapeutic/clinical value of innovative medical technologies compared to available alternatives.

Project Partnership

Project Leadership


Project Summary

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.


Value frameworks that are currently used to evaluate the clinical value of novel therapies for Hematologic Malignancies make insufficient use of routine care data (also referred to as 'real-world data') and patient-reported outcomes. That is the conclusion of the HARMONY Alliance Taskforce in a paper that was published in the Elsevier ScienceDirect Journal: Value in Health

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". 

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