Policy Health Stakeholder Feedback Forum

Challenge

To develop the Health Policy Stakeholder Forum (PHSFF) – a new platform for multi-stakeholder dialogue among HARMONY partners, associate members and external experts at the EU and Member State level. PHSFF aims to identify and address evidence gaps that may delay decision-making by regulatory agencies, HTA bodies, and payers, thus compromising timely patient access to innovative treatments for HMs.

This platform will provide input and advice to the tasks of the Working Group to ensure that the framework for evidence and clinical value can be applied to agencies in EU member states. Within the PHSFF, the following issues will be discussed: behavioral, ethical, legal, social implications, gender and age dimensions.

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Project Partnership

• NICE, CELGENE, AEMPS, BfArM, UoY, EHA, HULAFE 

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Project Leadership

• Leukanet

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Impact

• Develop a new model for multi-stakeholder dialogue 
• Generate input from patient organizations, hematologists/clinicians, regulators, HTA bodies, payers, pharma industry;
• Prepare a report on the current situation of market access decision criteria and evidence requirements for HM treatments and define a potential roadmap needed to increase integration;
• Generate and collect relevant evidence from data to support decision-making concerning regulatory approval, HTA recommendation, reimbursement approval and patient access.

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Project Summary

Significant amounts of data have been recently generated and shared from increasingly diverse sources, for example, electronic medical records. By analyzing data on the HARMONY Big Data platform, new knowledge is gained, creating new opportunities for strengthening evidence in HMs treatment, supporting decision-making in relation to regulatory approval, HTA recommendation, reimbursement approval, and patient access. In order to initiate a dialogue regarding these challenges, The Policy Health Stakeholder Feedback Forum (PHSFF) will be established – a platform of consultation between all stakeholder groups.

The Health Policy Stakeholder Forum (PHSFF) includes HARMONY Partners/Associate Members and external experts at the EU and Member State level, including patients and clinicians, regulators, HTA bodies and payers, and stakeholders involved in evidence generation. The platform will provide input and advice to the tasks of the Working Group to ensure that the framework for evidence and clinical value can be generalized and applied to agencies in EU member states. 
The dialogue within the PHSFF will take into account the evidence frameworks for innovative technologies (task 6.2), the Clinical Value framework to quantify the therapeutic value of innovative technologies for HMs (task 6.3), and the discussions of novel methodologies and proof-of-principle study (task 6.4). 

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