Duloxetine HydrochlorideAPO-DULOXETINE
Recommended Mental healthRestricted
Treatment of major depressive disorder (MDD).
4
Submissions
2 resub
2007–08
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Mar 2008 Recommended Antidepressant
- Meeting Jul 2007 Not recommended Depression
Access path
- TGA registered · APO-DULOXETINE
TGA label equal than the PBS population
- Jul 2007Recommended
vs venlafaxine
- Jul 2007Recommended
- Mar 2008Recommended · restricted
- Mar 2008Recommended · restricted
- PBS listing · Restricted
RecommendedDeferredNot recommended
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated.
The PBAC recommended the listing of duloxetine on the PBS for major depressive disorders on a cost-minimisation basis compared with venlafaxine and that the equi-effective doses are duloxetine 60 mg and venlafaxine 150 mg, noting that the submission's lower proposed price for the 60 mg capsule is acceptable. PBAC · 2008
Cost-effectiveness accepted
Decision context
PopulationAdults with major depressive disorder.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2008 | Recommended · restricted | venlafaxine | — | RCT · Other |
| Mar 2008 | Recommended · restricted | venlafaxine | — | RCT · HAMD-17 |
| Jul 2007 | Recommended | venlafaxine | — | RCT · QoL |
| Jul 2007 | Recommended | venlafaxine | — | RCT · HAMD17 |
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both TGA label and PBAC recommendation cover treatment of MDD in adults with no additional population restrictions specified.