WP4 engages patients and regulators in developing HARMONY PLUS research projects and implementing the results of the research projects. In addition, WP4 supports the decision-making process for market access and reimbursement of novel drugs for Hematologic Malignancies. This is done by identifying regulatory and Health Technology Assessment consultation mechanisms useful for HARMONY visibility and recognition, and by developing a proof-of-principle project using one of these consultation mechanisms.
Objectives
- Developing a Stakeholders and Patient Organizations Forum that offers support to the WPs, in particular to WP2 for developing a Core Outcomes Set for each new indication of HARMONY PLUS;
- Streamlining the involvement of patient organizations in the research projects developed by WP2. Keeping them informed about the progress and results in collaboration with WP2;
- Developing guidance and decision tools to identify appropriate procedures and resources for regulators and payers in Europe with respect to the research projects of HARMONY PLUS;
- Proof of principle project: Identifying an appropriate topic in collaboration with WP2 and WP3, and delivering an early regulatory/Health Technology Assessment scientific advice procedure on the appropriateness of evidence to be used in regulatory and/or reimbursement submission.
Work Package Partners
LeukaNET, IECSCYL, Hospital La Fe, Charite, EHA, IJC, GPOH, EBMT, NICE, AEMPS, BfArM, Novartis, Celgene, Menarini, Pfizer.