[A26-13] Gadopiclenol (contrast-enhanced magnetic resonance imaging, 0 to < 2 years) – Benefit assessment according to §35a Social Code Book V

Last updated 01.06.2026

Project no.:
A26-13

Commission:
Commission awarded on 19.02.2026 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Topic:
Diagnostics

Indication:

Children from birth to < 2 years of age for contrast-enhanced MRI to improve detection and visualization of pathologies with disruption of the blood-brain-barrier and/or abnormal vascularity of:

  • the brain, spine and associated tissues of the CNS
  • the liver, kidney, pancreas, breast, lung, prostate and musculoskeletal system

It should be used only when diagnostic information is essential and not available with unenhanced MRI.

Result of dossier assessment:

Added benefit not proven

Note:

After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) conducts a commenting procedure. This may provide supplementary information and as a result lead to a modified benefit assessment. Further information and the decision on the early benefit assessment can be found on the relevant page of the G-BA website.

DOI:

https://doi.org/10.60584/A26-13

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