Favourable opinion for reimbursement “for diagnostic use only, in adults and children aged 2 years and older for contrast-enhanced magnetic resonance imaging (MRI) to improve detection and visualisation of pathologies with disruption of the blood-brain-barrier (BBB) and/or abnormal vascularity of:
the brain, spine, and associated tissues of the central nervous system (CNS);
the liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system.
ELUCIREM should be used only when diagnostic information is essential and not available with unenhanced MRI”.
Clinical Benefit
Substantial
The Committee deems that the clinical benefit of ELUCIREM (gadopiclenol) 0.5 mmol/mL solution for injection is substantial in the MA indications.
Clinical Added Value
no clinical added value
Considering:
evidence of a non-inferiority of MRI with injection of ELUCIREM (gadopiclenol) at a dose of 05 mmol/kg compared to injection of gadobutrol at a dose of 0.1 mmol/kg, on 3 coprimary endpoints for visualisation of lesions in the CNS and body, in the PICTURE and PROMISE studies conducted in adults,
the pharmacokinetic profile in children similar to that observed in adults,
but:
the absence of comparison in the paediatric study and robust efficacy and safety data,
the limited safety data in terms of follow-up duration, limiting monitoring of the occurrence of adverse events (AE) such as retention of gadolinium in the brain or nephrogenic systemic fibrosis (NSF), an AE associated with the administration of a gadolinium-based contrast agent, the symptoms of which can develop several weeks to several months after its administration,
the Committee deems that ELUCIREM (gadopiclenol) 0.5 mmol/mL solution for injection provides no clinical added value (CAV V) compared with gadobutrol.
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