QuetiapineALKEM QUETIAPINE
Noted Mental healthAuthority RequiredNot applicable line
Maintenance therapy for treatment of acute mania and bipolar I disorder, and in the treatment of schizophrenia.
8
Submissions
5 resub
2010–18
On the record
$15k–75k
ICER range
2 sourced ICERs · 2010–2011
Not modelled
Cost basis
Decisions on record
- Meeting Mar 2018 Noted Schizophrenia, acute mania and bipolar I disorder no PSD
- Meeting Nov 2013 Not recommended Seroquel XR® AstraZeneca Pty Ltd Minor submission Bipolar disorder Treatment of depressive episodes associated with bipolar disorder Treatment of acute mania associated with bipolar disorder Schizophrenia Major Depressive Disorder Generalised anxiety disorder Authority required (Streamlined) listing no PSD
- Meeting Jul 2013 Not recommended Bipolar disorder Treatment of depressive episodes associated with bipolar disorder Schizophrenia Major Depressive Disorder Generalised anxiety disorder
- Meeting Nov 2011 Not recommended Anti-depressant no PSD
- Meeting Nov 2010 Recommended Anti-psychotic drug
- Meeting Nov 2010 Not recommended Treatment of acute mania associated with bipolar I disorder in combination with lithium or sodium valproate; Maintenance treatment of bipolar 1 disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes
Access path
- TGA registered · ALKEM QUETIAPINE
- Jul 2010Recommended · restricted
Evidence: RCT → Meta-analysis
- Jul 2010Recommended · restricted
Evidence: RCT → Meta-analysis
- Nov 2010Not recommended
inappropriate main comparator (olanzapine not TGA-registered or PBS-listed for this indication; lithium with…
- ↻ resubmittedNov 2010Recommended
Comparator changed: olanzapine → placebo
- 2011Not recommended
inadequate clinical evidence to support superiority over lithium comparator, open-label trial design, subjective…
- ↻ resubmittedJul 2013Recommended
Listing: Authority Required (STREAMLINED) → Authority Required
- Aug 2013Recommended · restricted
Evidence: RCT → Registry
- Jul 2018Recommended
Evidence: Registry → Other
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
5.1 The PBAC recommended that the current listing for the 25 mg strength quetiapine tablets be changed to allow for up to 5 repeats via an Authority Required prescription for maintenance therapy for treatment of acute mania, bipolar 1 disorder and in the treatment of schizophrenia.PSD · Jul 2018
5.2 The PBAC considered that this could be achieved by removing the note “No increase in the maximum number of repeats may be authorised” in the Administrative Advice and removal of “The treatment must be for dose titration purposes” from the clinical criteria.PSD · Jul 2018
Comparative effectiveness
The key results of the two trials (Study 144 and Tohen 2006) incorporated in the submission’s indirect comparison of quetiapine and olanzapine in time to recurrence of a mood event using interim intention to treat (ITT) population (patients for whom data was collected up to the interim stop date) and intention to treat (ITT) population (all randomised patients who received treatment) were as follows: Study 144 reported a significant advantage in time to …PSD · Jul 2010
The PBAC noted that there were three issues which reduced the comparability of the two trials used in the indirect comparison: 1. Structure of the trial. Both trials incorporated an open-label treatment stabilisation phase before the patients were randomised for the double-blind monotherapy maintenance treatment. Both trials saw a substantial number of withdrawals between enrolment and randomisation.PSD · Jul 2010
Cost-effectiveness
Not modelled — this is a minor administrative submission concerning repeats for an existing listing, not a new clinical or economic evaluation.
The PBAC considered that the submission’s claim that quetiapine XR augmentation is superior in terms of efficacy over lithium augmentation was inadequately supported by the evidence presented. In terms of safety, the PBAC observed the occurrence of specific adverse events was different between the two treatment arms. Given the differences in the adverse event profiles of the two drugs, the PBAC did not accept the submission’s claim that quetiapine XR augmentation was equivalent in terms of comparative safety to lithium augmentation. PBAC · 2011
ICER uncertain ×2ICER / price too highEconomic model disputed ×3Immature survival dataNo head-to-head trial ×2Indirect comparisonCost-effectiveness accepted
Decision context
PopulationPatients with schizophrenia, acute mania associated with bipolar I disorder, or bipolar I disorder requiring maintenance therapy at doses not adequately provided by other strengths of quetiapine (e.g. 37.5 mg or 52.5 mg).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2018 | Recommended | — | — | Other |
| Aug 2013 | Recommended · restricted | — | — | Registry |
| Jul 2013 | Recommended | lithium | — | RCT · MADRS |
| 2011 | Not recommended | lithium | $45k–75k | RCT · change in total Montgomery-Asberg Depression Rating Scale (MADRS) score from randomisation to study end |
| Nov 2010 | Not recommended | placebo | $15k–45k | RCT, Meta-analysis · change in the Montgomery-Asberg Depression Rating Scale (MADRS) score from baseline to week 8 |
| Nov 2010 | Recommended | risperidone | — | RCT | RCT (indirect comparison) · change in YMRS score from baseline to day 21, change in YMRS response |
| Jul 2010 | Recommended · restricted | olanzapine | — | RCT · time to recurrence of a mood event |
| Jul 2010 | Recommended · restricted | olanzapine | — | Meta-analysis · TTR |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| RUBY | Ph 3 | 688 | Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montg… | completed |
| ONYX | Ph 3 | 494 | To evaluate the efficacy of quetiapine fumarate sustained release | completed |
| PEARL | Ph 3 | 450 | To evaluate the efficacy of quetiapine SR in combination with an antidepressant versus an … | completed |