The implementation of the EU Health Technology Assessment Regulation (HTAR) marked the beginning of a new era of harmonised clinical evaluation across Europe. Following the landmark first Joint Clinical Assessment (JCA) of tovorafenib for paediatric low-grade glioma, subsequent assessments of tarlatamab and lurbinectedin for extensive-stage small cell lung cancer (ES-SCLC) have provided valuable insights into how the JCA framework operates across different therapeutic areas and evidence landscapes.
While the objectives of the JCA framework are clear; reducing duplication, improving consistency in clinical assessments, and supporting more timely patient access to innovation, these early assessments highlight both the strengths and challenges associated with implementing a single European clinical assessment process.