OMNIPAQUE (iohexol) - Contrast medium for contrast-enhanced

The Committee deems that the clinical benefit of OMNIPAQUE 300 and 350 mg I/mL (iohexol) solution for injection is substantial only in patients: 

• with contraindications to MRI, in:
  • diagnostic dead end situations;
  • locoregional staging assessment;
  • tumour assessment before and after neoadjuvant chemotherapy;
• without contraindications to MRI, in locoregional staging assessment or before/after neoadjuvant chemotherapy, for the assessment of tumour size, in particular for its perfect match with mammography images; 

Considering:

• the data and conclusions of the report assessing the value of dual-energy contrast-enhanced spectral mammography in the diagnostic strategy for breast cancer produced by the HAS in 2021, and, in particular, the clinical situations in which the value of contrast-enhanced mam mography has been recognised; 
• the diagnostic performance of contrast-enhanced mammography with OMNIPAQUE based on 
  publications in the literature in the same clinical situations as those explored in the 2021 report;
•  the already well established safety profile of ULTRAVIST, with no new data calling into question 
  this safety profile;
• the medical need currently partially met by the existence of diagnostic alternatives

The Committee deems that OMNIPAQUE 300 and 350 mg I/mL (iohexol) solution for injection provides no clinical added value (CAV V) in the current care pathway, which includes the clinically relevant comparators.