Author: Prof. Matthias P. Schönermark, MD, PhD, Chief Strategy Officer
JCA readiness: How to prepare for success in the new EU HTA system
The introduction of the Joint Clinical Assessment (JCA) is designed to harmonise clinical evidence evaluation across all EU member states. By creating a single framework for assessing the relative clinical benefit of new therapies, the JCA aims to reduce duplication, streamline decision-making, and ultimately improve patient access to innovative medicines.
Complexity to Clarity – Navigating the JCA Landscape
While harmonisation offers clear benefits, it also introduces new complexities and operational challenges. Pharmaceutical companies must now navigate a dual system where a centralised clinical assessment runs parallel to a centralised market authorisation process and preludes national pricing and reimbursement processes. With tight timelines, extensive evidence requirements, and the need to align with multiple country demands, it is understandable why some may feel uncertain about the road ahead. However, complexity should not mean hesitation.
With early planning, clear strategic focus, and an understanding of how to prioritise efforts, the JCA framework is manageable and presents an opportunity to enhance the accessibility of innovations.
In this article published on PharmaPhorum, Prof. Matthias Schönermark, MD, PhD, and Chief Strategy Officer at Kintiga explores the key challenges of the JCA and offers actionable insight to tackle uncertainty with confidence.
