Escitalopram
Major depressive disorders, generalised anxiety disorder, and social anxiety disorder. The submission requested listing of a new 20 mg/mL oral liquid strength as a Restricted benefit.
Decisions on record
- Meeting Jul 2014 Recommended Lexapro® Lundbeck Australia Pty Ltd New listing (Minor submission) Major depressive disorders Restricted benefit for major depressive disorders, generalised anxiety disorders and social anxiety disorder. The submission also requested delisting the existing listed 10 mg/mL strength.
- Meeting Nov 2008 Recommended Mood disorders no PSD
- Meeting Mar 2007 Not recommended Anti depressant
Access path
- Mar 2007Not recommended
uncertain cost-effectiveness, weak evidence for equivalence claim in SAD, short trial duration (12-24 weeks) with…
- Mar 2007Not recommended
uncertain cost-effectiveness, cost-minimisation comparison with paroxetine not sufficiently informative, lack of…
- ↻ resubmittedJul 2014Recommended
Evidence: RCT → Cost-minimisation
- PBS listing · Restricted
From the public summary
7.1 The PBAC recommended the listing of escitalopram 20mg/mL. The PBAC recommended that the restriction be consistent and refer to definitions in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) instead of DSM-IV.PSD · Jul 2014
The PBAC recommended the removal of the grandfather restrictions as suggested by the Secretariat.PSD · Jul 2014
6.8 The submission did not present a formal economic analysis.PSD · Jul 2014
For more detail on PBAC’s view, see section 7 “PBAC outcome”PSD · Jul 2014
Cost-effectiveness
No economic analysis was presented in this submission; this is a minor submission for a new strength formulation with no comparative effectiveness or economic evaluation.
However, as the cost-effectiveness of paroxetine is unknown in SAD or GAD, the comparison did not provide PBAC with a basis for a recommendation to list escitalopram because the cost-minimisation approach taken by the submission was not sufficiently informative. PBAC · 2007
Decision context
PopulationPatients with major depressive disorders, moderate to severe generalised anxiety disorder (GAD), or moderate to severe social anxiety disorder (SAD) as defined by DSM-V criteria who have not responded to non-pharmacological therapy and either have a GP Mental Health Care Plan or have been assessed by a psychiatrist.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2014 | Recommended | — | — | Cost-minimisation |
| Mar 2007 | Not recommended | paroxetine | — | RCT, Meta-analysis |
| Mar 2007 | Not recommended | paroxetine | — | RCT · LSAS |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients who failed non-pharmacological therapy and have GP Mental Health Care Plan or psychiatrist assessment.