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Reason for request
Key points
Favourable opinion for reimbursement only in the prevention of recurrence of episodes of breakthrough overt hepatic encephalopathy (with at least two previous episodes of hepatic encephalopathy) and following elimination of triggering factors.
Unfavourable opinion for reimbursement in other situations.
What therapeutic improvement?
TIXTAR or TARGAXAN medicinal products containing rifaximin provide a therapeutic improvement in the management of this condition.
Role in the care pathway?
Management is based on the identification and correction of triggering factors (infection, gastrointestinal bleeding, excessive protein intake, kidney failure, dehydration, electrolyte disturbances, sedative medicinal products, gastrointestinal disorders such as constipation). For overt HE, the preventive treatment of encephalopathy is based primarily on the use of lactulose (DUPHALAC) or lactitol (IMPORTAL), orally or as an enema, aimed at reducing blood ammonia levels, or the implementation of a low-protein diet. When encephalopathy is severe (coma), hospitalisation in an intensive care unit and assisted ventilation may be necessary. Finally, liver transplantation may be necessary in the event of refractory and/or recurrent chronic hepatic encephalopathy but it can only be performed in a minority of patients.
Role of TIXTAR (rifaximin) or TARGAXAN (rifaximin)
Based on the available clinical data, rifaximin, primarily used in combination with lactulose, can be offered for the prevention of recurrence of episodes of breakthrough hepatic encephalopathy, in adult patients with at least two previous episodes of hepatic encephalopathy, only following elimination of triggering factors.
In other situations, to date, rifaximin has no role in the care pathway.
Special recommendations
The Committee recommends that prescription be limited to internal medicine specialists and hepato-gastroenterology specialists.
Clinical Benefit
| Substantial |
The Committee deems that the clinical benefit of TIXTAR (rifaximin) remains substantial only in the prevention of recurrence of episodes of breakthrough overt hepatic encephalopathy (with at least two previous episodes of hepatic encephalopathy) and following elimination of triggering factors. |
| Insufficient |
The Committee deems that the clinical benefit remains insufficient to justify public funding cover in all other clinical situations. |
Clinical Added Value
| minor |
Considering:
the Committee considers that TIXTAR (rifaximin) provides a minor clinical added value (CAV IV) in the prevention of recurrence of episodes of breakthrough overt hepatic encephalopathy (i.e. with at least two previous episodes of hepatic encephalopathy and following elimination of triggering factors).
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