PRIMOVIST (acide gadoxetique)
Reason for request
Favourable opinion for reimbursement in the detection of focal liver lesions and the provision of information on the character of lesions in T1-weighted magnetic resonance imaging (MRI), when delayed phase imaging is required and not available with unenhanced magnetic resonance imaging.
What therapeutic improvement?
No clinical added value compared to MULTIHANCE (gadobenic acid).
Role in the care pathway?
Contrast agents are used to improve the display of parenchymal or vascular structures, giving better magnetic resonance image quality. Explorations using these products are conducted according to the “Guide du bon usage des examens d’imagerie médicale” (Guide to medical imaging examination best practices), which defines the role of the various examinations according to the disease.
The 2016 European Society of Gastrointestinal and Abdominal Radiology (ESGAR) guidelines in MRI of the liver are as follows:
- Liver-specific contrast agents are recommended in MRI of the liver.
In France, the liver-specific contrast agents with an MA are PRIMOVIST (gadoxetic acid) and MULTIHANCE (gadobenic acid). These two contrast agents provide identical vascular and interstitial enhancement images to other extracellular gadolinium contrast agents, but have the additional property of being taken up by hepatocytes before being partially excreted in the bile. This enables positive enhancement of biliary structures.
- The hepatobiliary phase (or late phase), characteristic of liver-specific contrast agents, improves detection and characterisation of hepatocellular lesions.
- Liver-specific contrast agents can improve the detection of liver cancers.
In 2019, the French National Gastroenterology Society (SNFGE) published guidelines on hepatocellular carcinoma (HCC/primary liver cancer). According to the SNFGE, the two reference investigations for the diagnosis of HCC are CT scan and MRI. MRI appears to be slightly better than CT in terms of sensitivity for the detection and characterisation of nodules.
The EASL (European Association for the Study of the Liver) issued similar guidelines in 2018. The EASL highlights that all studies tend to show that liver-specific contrast agents have a better sensitivity than extracellular contrast agents in the detection of HCC.
Role of the medicinal product in the care pathway
PRIMOVIST (gadoxetic acid) is used in the first-line diagnostic investigation of the liver when MRI diagnosis and delayed phase contrast enhancement are necessary, in the same way as MULTIHANCE (gadobenic acid).
Insofar as all GBCAs can cause gadolinium retention, healthcare professionals are advised to use these contrast agents only when the essential diagnostic information cannot be obtained by imaging without contrast enhancement. In addition, the lowest possible dose should be used.
It should be noted that the PRIMOVIST concentration (0.25 mol/L) is half that of MULTIHANCE (0.5 mol/L), enabling lower exposure to GBCA.
Insofar as all gadolinium-based contrast agents (GBCAs) can cause gadolinium retention, and as indicated in the SPC, healthcare professionals are advised to use these contrast agents only when the essential diagnostic information cannot be obtained by imaging without contrast enhancement. In addition, the lowest possible dose should be used.
The Committee deems that the clinical benefit of PRIMOVIST (gadoxetic acid) is substantial in the MA indication.
Clinical Added Value
|no clinical added value
the Transparency Committee considers that PRIMOVIST (gadoxetic acid) provides no clinical added value (CAV V) compared to MULTIHANCE (gadobenic acid).