Germany's health technology assessment body has announced the specifics of its initial involvement in the new European process for assessing oncology medicines.
In a press release issued in September 2025, the German Institute for Quality and Efficiency in Health Care (IQWiG) has confirmed it has begun work on its first four joint clinical assessments (JCAs) under the new EU-HTA Regulation. This marks the formal start of the Institute’s practical role in the phased implementation of the European process, which began in January 2025 for oncology drugs and advanced therapies.
The announcement provides new details on these first assessments. IQWiG is acting as assessor or co-assessor for four unnamed oncology drugs, in partnership with the national HTA bodies of Portugal (Infarmed), Hungary (NCPHP), and Slovenia. A further project on the drug tovorafenib, for a rare paediatric glioma, began in March 2025 with Ireland's NCPE, with a final assessment expected in the second quarter of 2026. The other assessments are scheduled for completion in the third quarter of 2026.
Regina Skavron, Head of the Methodology and Coordination of European HTA Division at IQWiG, noted that the aim is to provide member states with a shared scientific assessment to inform national healthcare decisions. The process will be expanded to include orphan drugs in 2028 and all new medicines from 2030.
While a single clinical assessment dossier will now be prepared at a European level, national procedures for determining added benefit and negotiating prices will remain. The output of the JCA will form the clinical evidence base for subsequent national assessments, such as Germany's established AMNOG procedure.
Date: 18 September 2025
