WP6 will provide the mechanism and platform for engagement of ROADMAP’s different work packages with experts from the regulatory, HTA and payer environment through the Expert Advisory Group (EXAG). The EXAG will enable ROADMAP to develop outputs that are not merely of high scientific quality but might have meaningful applicability in the regulatory, HTA, and payer contexts.

Overall objective: Develop guiding principles and recommendations for the development and incorporation of RWE into clinical and market access development plans for AD (WP6)

Read more about the work of our Regulatory and HTA Engagement team here.

Objectives

• Provide the mechanism for providing technical and process recommendations on the potential use of RWE for AD from the regulatory, HTA, and payer perspectives.
• Provide a platform for liaising with regulatory, HTA, and payer experts on the type and quality of RWE that might be appropriate in the context of new interventions for AD.
• Identify a possible RWE-specific regulatory/HTA pathway for AD with input from all healthcare system stakeholders.
• Identify current challenges in marketing authorisation, pricing and reimbursement of interventions in AD and identify how ROADMAP activities might address these.