LIKOZAM (clobazam) - Epilepsy

Opinions on drugs - Posted on Dec 15 2025

Reason for request

Inclusion on list

Summary of opinion

Favourable opinion for reimbursement only in:

the short-term symptomatic treatment (2-4 weeks) of anxiety that is severe, disabling or subjecting the individual to unacceptable distress, including anxiety states associated with mood disorders in adults;
the treatment of partial or generalised epilepsy, in combination with another antiepileptic treatment in adults or children aged 2 years and older, following the failure of two consecutive monotherapies.

Unfavourable opinion for reimbursement in the short-term symptomatic treatment of excitation and agitation in patients with schizophrenic or other psychotic illnesses.

Clinical Benefit

Substantial

The clinical benefit of LIKOZAM (clobazam) is substantial:

in the short-term symptomatic treatment of anxiety that is severe, disabling or subjecting the individual to unacceptable distress, including anxiety states associated with mood disorders in adults,
in combination with another antiepileptic treatment in adults or children aged 2 years and older, following the failure of two consecutive monotherapies.

Insufficient

The clinical benefit of LIKOZAM (clobazam) is insufficient to justify public funding in the short-term symptomatic treatment (2-4 weeks) of excitation and agitation in adults with schizophrenic or other psychotic illnesses.

Clinical Added Value

no clinical added value

Considering the absence of an efficacy comparison between clobazam in tablet form and clobazam in oral suspension form, LIKOZAM provides no clinical added value (CAV V) compared to URBANYL clobazam tablets in the short-term symptomatic treatment of anxiety that is severe, disabling or subjecting the individual to unacceptable distress, including anxiety states associated with mood disorders in adults.

The Transparency Committee recognises the value of an oral suspension form of clobazam, particularly in patients for whom the tablet form is not suitable, as well as in children aged 6 years or younger.

However, considering:

the absence of an efficacy comparison between clobazam in tablet form and clobazam in oral suspension form in adults and children aged 6 years or older,
the absence of efficacy data for clobazam in oral suspension form in children aged 2 years to 6 years,

LIKOZAM, in combination with another antiepileptic treatment, provides no clinical added value (CAV V) in the care pathway for the treatment of partial or generalised epilepsy in adults or children aged 2 years and older, following the failure of two consecutive monotherapies.

Not applicable