PBAC's latest decision on Vortioxetine: Not recommended (2014). Considered for Major depressive disorder in adults who have received and not responded to an initial antidepressant medication, or who are intolerant of or have contraindications to other initial antidepressant therapy.
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
1
first 2014
Submissions
1
2014 → 2014
Eligible population
Adults aged 18 years or older with major depressive disorder who have not responded to or are intolerant of initial antidepressant medication.
Therapy area
Mental health
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
Other
Key trials
11492A, 13926A, 11984A, 12541A, 13267A, 304, 315
Comparator
weighted mean of SSRI use and other antidepressants
Economic model
Cost-minimisation
ICER note
No ICER stated in the document; economic model appears not to have been completed or accepted.
Why PBAC said no
Reasons cited in the latest PSD: uncertain clinical efficacy compared to active comparators (non-inferiority not demonstrated versus venlafaxine; inferiority versus duloxetine on MADRS and HAM-D measures), lack of demonstrated superiority over SSRI therapies, inappropriate comparator selection in cost-minimisation analysis, unclear trial inclusion criteria regarding treatment-naïve versus treatment-experienced status