AsenapineSaphris
Recommended PsychiatryAuthority Required (STREAMLINED)
treatment of schizophrenia in adults
2
Submissions
2011–11
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Jul 2011 Recommended Anti-psychotic drug
- Meeting Jul 2011 Recommended Anti-psychotic drug
Access path
- TGA registered · Saphris
TGA label narrower than the PBS population
- Jul 2011Recommended · restricted
Comparator changed: quetiapine → risperidone
- Jul 2011Recommended · restricted
Comparator changed: quetiapine → risperidone
- PBS listing · Authority Required (STREAMLINED)
RecommendedDeferredNot recommended
From the public summary
Comparative effectiveness
The results of the head-to-head trials of asenapine and olanzapine showed no statistically significant differences in reductions in Positive and Negative Syndrome Scale (PANSS) total scores at 6 weeks, Negative Symptoms Assessment (NSA) total scores at 6 and 26 weeks, PANSS positive scores at 6 weeks, PANSS negative scores at 6 and 26 weeks, Calgary Depression Scale for Schizophrenia (CDSS) scores at 6 weeks and Clinical Global Impression – Severity of …PSD · Jul 2011
The PBAC noted that the differences in PANSS total score were small and did not meet the minimum clinically important difference (MCID) of 7 points, previously accepted by the PBAC. The differences in reductions in CDSS and CGI-S scores were small and unlikely to be clinically important.PSD · Jul 2011
Cost-effectiveness
Cost minimisation analysis performed; no ICER calculated
The PBAC recommended the listing of asenapine sublingual wafers as an Authority Required (STREAMLINED) listing for treatment of schizophrenia on a cost-minimisation basis with risperidone. The equi-effective doses are asenapine 8.3 mg daily and risperidone 5.3 mg daily. PBAC · 2011
Cost-effectiveness accepted ×2
Decision context
Populationadults with schizophrenia
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2011 | Recommended · restricted | quetiapine | — | RCT · OS | PFS | DFS | ORR | QoL | Surrogate |
| Jul 2011 | Recommended · restricted | risperidone | — | RCT · PANSS total score |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC recommendation covers only schizophrenia in adults; TGA label also includes bipolar I disorder manic/mixed episodes and relapse prevention.