ClozapineAKM CLOZAPINE
Recommended Mental healthAuthority RequiredLater-line line
Schizophrenia in patients who are non-responsive to or intolerant of other neuroleptic agents (initial treatment), and continuing treatment in patients already stabilised on clozapine.
1
Submissions
2018–18
On the record
—
ICER range
Not modelled
Cost basis
Decisions on record
- Meeting Jul 2018 Recommended Schizophrenia
- Meeting Nov 2007 Recommended Schizophrenia no PSD
Access path
- TGA registered · AKM CLOZAPINE
TGA label narrower than the PBS population
- Jul 2018Recommended · restricted
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
5.1 The PBAC recommended the temporary Section 100 Highly Specialised Drugs Program (HSD) and Section 100 Community Access listings of clozapine (Versacloz®) on the Pharmaceutical Benefits Scheme (PBS) to address the current supply shortage of clozapine (Clopine Suspension®, 50 mg per mL clozapine suspension).PSD · Jul 2018
5.2 The PBAC considered that there is a clinical need for the supply of clozapine to be maintained on the PBS. The PBAC considered that the listing should remain during the validity of the Section 19A(1) approval by the TGA.PSD · Jul 2018
Cost-effectiveness
not-modelled — minor submission (supply shortage alternative); no economic evaluation conducted
Decision context
PopulationAdult patients with schizophrenia who are non-responsive to or intolerant of other neuroleptic agents (initial treatment phase), or patients already stabilised on clozapine for at least 18 weeks (continuing treatment phase).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2018 | Recommended · restricted | — | — | Other |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to treatment-resistant/intolerant patients or those stabilized ≥18 weeks; TGA label lacks these clinical criteria.