Favourable opinion for maintenance of 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.
Clinical Benefit
Substantial
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
Clinical Added Value
minor
Considering:
data from the pivotal studies already assessed (RFHE3001 double-blind study and RFHE3002 open-label study) having demonstrated the efficacy of rifaximin in combination with lactulose (91% of patients receiving concomitant lactulose) versus placebo in terms of risk of HE breakthrough at 6 months, with maintenance of efficacy after 2 years, corresponding to the best level of evidence available to date concerning the efficacy of rifaximin,
data from a previously assessed meta-analysis suggesting an additional impact of rifaximin in combination with lactulose on morbidity and mortality but with several methodological reservations,
new data available suggesting an improvement in clinical manifestations with rifaximin in combination with lactulose but not enabling an additional impact on mortality to be confirmed, and also associated with numerous methodological reservations,
the substantial medical need given the high risk of recurrence in patients who already have a history of two prior episodes of hepatic encephalopathy,
and despite:
the lack of robust data available concerning the effect of rifaximin as monotherapy in the prevention of recurrence of episodes of breakthrough overt hepatic encephalopathy,
the lack of robust data available concerning the effect of rifaximin on the quality of life of adult patients, in combination with lactulose or as monotherapy,
the previous assessment of the Committee is not modified: 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).
Listen
