PBAC's latest decision on Stiripentol: Recommended with restriction (2020). Considered for Adjunctive therapy for severe myoclonic epilepsy in infancy (SMEI, also known as Dravet syndrome) with primary generalised clonic and tonic-clonic seizures in patients not adequately controlled by valproate and a benzodiazepine (usually clobazam).
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
1
first 2020
Submissions
1
2020 → 2020
Eligible population
Severe myoclonic epilepsy in infancy (SMEI, Dravet syndrome) with primary generalised tonic-clonic and clonic seizures in patients not adequately controlled with benzodiazepine (usually clobazam) and valproate, under age 18 at initiation, treated by a neurologist (or paediatrician/GP under neurologist initiation).
Therapy area
Neurology
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
ORR
Pivotal trial size
65 patients
Key trials
STICLO-France, STICLO-Italy
Comparator
placebo plus valproate and clobazam
Economic model
CUA
ICER note
ICER value not stated in the public summary document; redacted or not published