ISSUE: EU JCA aims at establishing a framework that promotes research, innovation, and more equitable access to products with large unmet medical needs. Process and timelines for submission and review have been recently finalized. While the 27 member states are still finalizing national processes and regulations, the fundamental question remains: is the designed process going to expedite patients’ access in EU?

New medicines generally launch first and faster in US, with a substantive delay between regulatory approval and access varying from 133 to 899 days in Europe. The objective of the panel is to compare the perspectives and approaches of both large and small health technology developers and oncology versus gene therapy (Gergana Zlateva and Francis Pang) in regard to EU JCA since heterogeneity may be expected. Fabrizio Gianfrate will provide the local payer perspective not just on local implementation, but also the trade-off between accelerating access and meeting the needs of all member states.

OVERVIEW: provided by Cristina Masseria. Processes and timelines were designed to guarantee high quality and a voice for all member states, providing an opportunity for raising the EU perspective, maximizing synergies, and eliminating inequity across the EU. However, the maximum number of Population, Intervention, Comparison and Outcomes (PICOs) has not been set and will vary by therapeutic areas. The potential requirements of Indirect Treatment Comparison to meet all the PICO requirements may be substantial in terms of additional RCT statistical analyses and data gathering. The opportunity for the pharmaceutical company to engage with the EU is limited, with a very tight submission timeline. Companies are incentivized to initiate local reimbursement at the same time in all member states following EU JCA complete assessment, removing the possibility for accelerated submission. Moreover, there is risk of losing innovation funding for certain therapeutic areas with implications on pipeline selection.