PBAC's latest decision on Fenfluramine: Recommended with restriction (2024). Considered for Treatment of seizures associated with Dravet Syndrome in patients not adequately controlled despite treatment with at least 2 other antiepileptic drugs.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
1
first 2024
Submissions
1
2024 → 2024
Eligible population
Patients with Dravet Syndrome aged 2 years and older with generalised tonic-clonic seizures or generalised clonic seizures not adequately controlled with at least 2 other antiepileptic drugs.
Therapy area
Neurology
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
Convulsive and total seizure frequency
Comparator
cannabidiol
Economic model
CEA
ICER note
ICER value redacted/commercially sensitive; pricing details marked with $ placeholders in document