The aim of this workshop was to bring together companies, patient representatives and HTA, payer and regulatory agencies to discuss current perspectives and opportunities for Facilitated Regulatory Pathways (FRPs) and Facilitated Access and Reimbursement Pathways (FARPs) as part of the regulatory/HTA toolbox to enable earlier patient access, especially where these is high unmet medical need. For the purposes of this meeting, FRPs include regulatory pathways to enable the more rapid development, availability, review and/or approval of medicines and FARPs include the integration of HTA and payers into the accelerated access process.
Workshop objectives
- Determine if the current collaborative models being piloted or used are meeting different stakeholders’ needs and what solutions are being used to enable an integrated, holistic and sustainable approach
- Ascertain how companies, regulators and health technology assessors would like to use regulatory FRPs together with FARPs and what systems are required to use these in an integrated manner to successfully to meet the needs of patients and healthcare systems
- Recommend how best to evolve and ensure success of new medicines FRPs and FARPs for patients and the critical success factors to manage uncertainty, ensure proper use and to interpret continuity with evidence generated during early phases of study
