PBAC's latest decision on Midazolam maleate: Recommended with restriction (2022). Considered for Treatment of generalised convulsive status epilepticus (GCSE) in patients with epilepsy aged over 6 months and at high risk of status epilepticus.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2022
Submissions
1
2022 → 2022
Eligible population
Patients aged over 6 months with diagnosed epilepsy and high risk of status epilepticus, who have experienced at least one prolonged seizure (>5 minutes duration) requiring emergency medical attention within the previous 5 years, and assessed to be at significant risk of status epilepticus.
Therapy area
Neurology
Line of therapy
First-line
Evidence base
Cost-minimisation
Primary endpoint
Seizure cessation
Pivotal trial size
51 patients
Key trials
Talukdar et al. (2009), Tonekaboni et al. (2012), SPL002
Comparator
midazolam hydrochloride solution for intravenous/intramuscular injection, administered buccally or intranasally
Economic model
Cost-minimisation
ICER note
Cost-consequences analysis conducted; no ICER calculated as the submission was based on cost comparison rather than cost-utility analysis.