Since the beginning of 2025, member states of the European Economic Area (EEA) have been working together on joint clinical assessments (JCA) of new medicines. Recently, the first 9 JCAs were announced, assessing 2 ATMPs with Orphan drug status and 7 oncologics. Germany, France, and Ireland are currently among the most active HTA authorities.
Figure 1: Different price guidelines apply for the AMNOG price negotiations if ≥ 5 % of the study population are German Products with initial market entry after January 1st, 2025 are now benefiting from less strict pricing guidelines if the studies used for AMNOG benefit assessment included ≥ 5 % German patients.
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