MidazolamB. Braun Midazolam
Generalised convulsive status epilepticus (GCSE) in patients aged over 6 months for initial and continuing treatment.
Decisions on record
- Meeting Nov 2023 Recommended Generalised convulsive status epilepticus (ages 6 months+)
- Meeting Nov 2022 Recommended Generalised convulsive status epilepticus in patients aged over 6 months
- Meeting Jul 2022 Not recommended Epilepsy, generalised convulsive status epilepticus
Access path
- TGA registered · B. Braun Midazolam
TGA label narrower than the PBS population
- Nov 2022Recommended
vs midazolam hydrochloride ampoules (off-label use)
- Nov 2023Recommended · restricted
Comparator changed: midazolam hydrochloride ampoules (off-label use) → midazolam…
- PBS listing · Authority Required
From the public summary
5.1 The PBAC recommended the listing of midazolam oromucosal solution in pre-filled syringes (2.5 mg, 5 mg, 7.5 mg and 10 mg), for the treatment of generalised convulsive status epilepticus (GCSE) in patients aged over 6 months.PSD · Nov 2023
5.2 The PBAC reaffirmed that the proposed PBS listing of midazolam oromucosal solution provided in pre-filled syringes, that would be prescribed according to patient body weight, would provide clinically meaningful benefits over the currently used ampoules.PSD · Nov 2023
4.5 In July 2022, the PBAC considered that in comparison to midazolam ampoules, the benefits of the proposed presentation were likely clinically meaningful and important for carers, however the proposed price premium over midazolam hydrochloride (DPMQ of $ versus $40) was not justified.PSD · Nov 2022
4.6 The resubmission proposed a dispensed price of $ for 2 pre-filled syringes of midazolam oromucosal solution, which was % lower than the dispensed price proposed in July 2022 ($ for 2 pre-filled syringes).PSD · Nov 2022
4.4 In July 2022, the PBAC noted that the submission described midazolam oromucosal solution as non-inferior in terms of effectiveness and safety compared to buccal or intranasal midazolam hydrochloride. The PBAC considered it was reasonable to consider midazolam oromucosal solution comparable to midazolam parenteral solution given via the oromucosal route, although the TGA had not issued a bioequivalence statement.PSD · Nov 2022
4.2 The PBAC noted and welcomed the input from individuals (18), health care professionals (9) and organisations (7) via the Consumer Comments facility on the PBS website. The comments were generally consistent with those considered previously by the PBAC in November 2022 (1) and July 2022 (6), describing the benefits of timely and accurate treatment. Midazolam was described as an essential emergency medication.PSD · Nov 2023
4.3 The PBAC noted the advice received from Epilepsy ACT, The Epilepsy Centre (SA & NT), Epilepsy Australia, SCN2A Australia, Epilepsy Action Australia, Epilepsy Society of Australia and the National Paediatric Medicines Forum, supporting the proposed PBS listing. Three of the organisations had also provided comment in July 2022 (Epilepsy Action Australia, Epilepsy Australia, and National Paediatric Medicines Forum).PSD · Nov 2023
4.12 In November 2022 (paragraph 5.5), the PBAC considered that the cost-effectiveness of midazolam oromucosal solution would be acceptable at the price proposed in the resubmission with an appropriate Risk Sharing Arrangement.PSD · Nov 2023
Cost-effectiveness
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.
The PBAC noted the cost-effective price for midazolam oromucosal solution will depend on the revised population as defined by the restriction, and the maximum quantity and hence likely wastage, however considered that a price that is more than approximately twice the price of midazolam hydrochloride is unlikely to be cost-effective. PBAC · 2022
Decision context
PopulationPatients 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.
Risk sharingRisk 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
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2023 | Recommended · restricted | midazolam hydrochloride injection (off-label ampoules) | — | Registry · Not applicable |
| Nov 2022 | Recommended | midazolam hydrochloride ampoules (off-label use) | — | Cost-minimisation · Cost-minimisation |
Consumer voice
Consumer input from 18 individuals, 9 healthcare professionals, and 7 organisations described midazolam pre-filled syringes as an essential emergency medication that would improve access and ease of administration compared to ampoules, while raising concerns about affordability if not PBS-listed and emphasising the need for adequate training across multiple care settings.
Midazolam was described as an essential emergency medication. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients at significant risk with prior prolonged seizure (>5 minutes) requiring emergency care within 5 years.