Vortioxetine
Not recommended Mental healthAuthority RequiredSecond-line line
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.
1
Submissions
2014–14
On the record
—
ICER range
Not modelled
Cost basis
Decision on record
- Meeting Jul 2014 Not recommended Lundbeck Australia Pty Ltd New listing (Major submission) Major depressive disorders Authority required listing for treatment of major depression disorder in patients aged 18 years or older who have failed to respond to, or are intolerant/contraindicated to other antidepressant therapy On the basis
From the public summary
PBAC outcome
7.1 The PBAC rejected the submission on the basis that the clinical place of vortioxetine relative to SSRIs and SNRIs was unclear and that the claim of non-inferiority of vortioxetine compared to duloxetine was not adequately supported. Therefore, the cost-minimisation analysis against desvenlafaxine alone and the pre-PBAC response’s proposal to list vortioxetine on a cost-minimisation basis against a '''''''''''''''''''' SNRI class, were not accepted.PSD · Jul 2014
7.2 The PBAC noted the intent of the requested listing was to limit treatment to patients who had not responded to first line anti-depressant therapy but that interpreted literally, the requested listing would allow patients to receive vortioxetine after treatment with just one other anti-depressant therapy.PSD · Jul 2014
Economic analysis
6.28 The submission presented a cost-minimisation analysis comparing vortioxetine with desvenlafaxine. The cost minimisation analysis was based on '''''''''''''''''''''''' the ''''''''''''' of 10 mg vortioxetine and 100 mg desvenlafaxine.PSD · Jul 2014
6.29 By cost-minimising vortioxetine to desvenlafaxine alone, the submission suggested that the price of vortioxetine could be made more commercially viable than a price based on a cost-minimisation listing against venlafaxine or duloxetine which the submission had noted to have been affected by statutory price reductions through generic competition. The ESC considered that this was not reasonable.PSD · Jul 2014
Clinical claim
6.26 The submission described vortioxetine as non-inferior in terms of comparative effectiveness and similar if not more favourable in terms of comparative safety over the SNRI therapies.PSD · Jul 2014
6.27 The submission also described vortioxetine as superior in terms of comparative effectiveness against the SSRI therapies in some patients (the elderly) and non- inferior if not more favourable than SSRI therapies in terms of comparative safety.PSD · Jul 2014
Cost-effectiveness
No ICER stated in the document; economic model appears not to have been completed or accepted.
Decision context
PopulationAdults aged 18 years or older with major depressive disorder who have not responded to or are intolerant of initial antidepressant medication.
Why it was knocked back
- 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
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2014 | Not recommended | weighted mean of SSRI use and other antidepressants | — | RCT · Other |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to second-line use (after failed/intolerant initial antidepressant), while TGA label covers all adults with MDD.