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Mental health

Agomelatine

Brand: Valdoxan®

PBAC's latest decision on Agomelatine: Not recommended (2012). Considered for Major depressive disorders.

PBAC outcome
Not recommended
2012
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
3
first 2010
Submissions
3
2010 → 2012

Eligible population

adults with major depressive disorders

Therapy area
Mental health
Line of therapy
First-line
Evidence base
RCT, Single-arm
Primary endpoint
OS | PFS | DFS | ORR | QoL | Surrogate
Key trials
CL3-035, CL3-036, CL3-045, CL3-046, CL3-056, CL3-063
Comparator
SSRIs (fluoxetine, sertraline, escitalopram); venlafaxine
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis presented, not a traditional ICER with cost per QALY threshold
ICER (historical)
$15k/QALY–$30k/QALY in an earlier submission (2010) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.

Why PBAC said no

Reasons cited in the latest PSD: superior clinical effectiveness and safety over SSRIs had not been demonstrated, non-inferior efficacy and superior safety to venlafaxine had not been demonstrated, uncertain equi-effective doses, cost minimisation analysis not supported by clinical evidence, exclusion of liver function test costs from economic model inappropriate, highly uncertain utilisation estimates

Submission history

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