First Benefit Assessment for a diagnostic agent in Germany

IQWiG, for a first time , has evaluated a diagnostic agent (Gadopiclenol) within the AMNOG framework and the conclusion is: no evidence of an additional benefit.
Usually, diagnostic technologies in Germany go through a separate assessment process from the AMNOG benefit assessment for pharmaceutical products, but since contrast agents fall within the definition of a medicine (in European law), they are classified as medicinal products and if they meet AMNOG criteria, they will go through benefit assessment. Nevertheless, another contrast agent has been launched before but has not been eligible for a benefit assessment for instance due to low sales expectations.

You can read more about the assessment here: Gadopiclenol als MRT-Kontrastmittel: Erste Nutzenbewertung eines Diagnostikums

Examples of benefit assessments for pharmaceuticals used for diagnostic purpose only:

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