PBAC's latest decision on Midazolam: Recommended with restriction (2023). Considered for Generalised convulsive status epilepticus (GCSE) in patients aged over 6 months for initial and continuing treatment.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
2
first 2022
Submissions
2
2022 → 2023
Eligible population
Patients aged over 6 months with generalised convulsive status epilepticus (GCSE) who have been assessed to be at significant risk and have experienced at least one prolonged seizure (>five minutes duration) requiring emergency medical attention within the previous 5 years.
This is a Category 3 submission (resubmission for price/risk-sharing negotiations) following a November 2022 positive PBAC recommendation. No new economic evaluation or ICER calculation was presented in this submission; the focus was on revised financial estimates and risk-sharing arrangements.
Risk sharing
Risk-sharing arrangement in place — Risk Sharing Arrangement (RSA) recommended in November 2022 with 100% rebate above caps based on utilisation estimates; this November 2023 submission formalised negotiations and revised financial estimates and RSA terms.
Submission history
Nov 2022: Not recommended · Authority Required
Nov 2023: Recommended with restriction · Authority Required