Tetracosactide
Noted NeurologyRestrictedNot applicable line 💬 consumer voice
Treatment of hypsarrhythmia and/or infantile spasms, and acute exacerbations in patients suffering from multiple sclerosis.
2
Submissions
2 resub
2021–21
On the record
—
ICER range
Not modelled
Cost basis
Decisions on record
- Meeting May 2021 Noted Hypsarrhythmia and/or infantile spasms
- Meeting Mar 2021 Deferred Hypsarrhythmia and/or infantile spasms
Access path
- Mar 2021Deferred
- May 2021Deferred
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
6.1 The PBAC deferred the consideration of derestricting the listing of tetracosactide to an unrestricted benefit, pending further consultation with the ANZCNS.PSD · May 2021
6.2 The PBAC noted that the submission requested this restriction change to allow patients with MS to access PBS subsidised tetracosactide. The PBAC considered that the submission did not present sufficient evidence to support the clinical need in MS or the cost-effectiveness of tetracosactide as an unrestricted benefit.PSD · May 2021
Economic analysis
5.6 The submission used a cost plus analysis as the basis of the economic evaluation. The PBAC considered that this method is outdated and noted that it is not referenced in the current PBAC Guidelines.PSD · May 2021
5.7 The sponsor claimed that the cost of goods for an ampoule of Synacthen Depot is $''''''. The requested AEMP is $''''''' per ampoule.PSD · May 2021
Consumer comments
5.3 The minor submission did not provide any clinical evidence to support the requested restriction change or price increase.PSD · May 2021
5.5 The PBAC recalled receiving advice from the Australian and New Zealand Child Neurology Society (ANZCNS), which advised that there was a clinical need in the paediatric population for tetracosactide in the treatment of hypsarrhythmia, and/or infantile spasm. The PBAC considered that more current advice is required from the ANZCNS.PSD · May 2021
Cost-effectiveness
No ICER calculated. Cost plus analysis was used as the basis of economic evaluation, which the PBAC considered outdated and not referenced in current PBAC Guidelines. As a minor submission, economic analysis was not independently evaluated.
The PBAC considered that the submission did not present sufficient evidence to support the clinical need in MS or the cost-effectiveness of tetracosactide as an unrestricted benefit. PBAC · 2021
ICER / price too highEconomic model disputed ×2
Decision context
PopulationPatients with hypsarrhythmia and/or infantile spasms, and patients with multiple sclerosis requiring acute exacerbation treatment.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| May 2021 | Deferred | — | — | Cost-minimisation |
| Mar 2021 | Deferred | — | — | Cost-minimisation |
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both texts cover identical populations: hypsarrhythmia/infantile spasms and MS acute exacerbations, with no additional restrictions applied.