Reason for request
First listing
Summary of opinion
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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