Escitalopram OxalateAPO-ESCITALOPRAM
Extension of listing to include moderate to severe social anxiety disorder (social phobia; SAD) in patients who have not responded to non-pharmacological therapy.
Decisions on record
- Meeting Mar 2008 Recommended Antidepressant
- Meeting Mar 2008 Recommended Antidepressant
Access path
- TGA registered · APO-ESCITALOPRAM
TGA label narrower than the PBS population
- Mar 2008Recommended · restricted
Comparator changed: placebo, benzodiazepines (diazepam, oxazepam) → placebo
- Mar 2008Recommended · restricted
Comparator changed: placebo, benzodiazepines (diazepam, oxazepam) → placebo
- PBS listing · Restricted
Cost-effectiveness
PBAC noted the re-submission estimated the incremental cost per extra QALY gained to be less than $15,000; however, the PBAC acknowledged criticisms of the economic model and indicated the sensitivity analyses suggested a high probability the ICER would be acceptable rather than stating a precise figure.
The PBAC noted a number of uncertainties in the model, however, notwithstanding the issues the PBAC accepted that the use of this drug in severe GAD would yield a relatively low ICER and could be cost saving if the outcomes on costs i.e. medical visits are realised. PBAC · 2008
Decision context
PopulationAdults with moderate to severe social anxiety disorder (social phobia; SAD) as defined by DSM-IV criteria who have not responded to non-pharmacological therapy.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2008 | Recommended · restricted | placebo, benzodiazepines (diazepam, oxazepam) | $15k | RCT · HAM-A Total Score (Hamilton Anxiety Scale) |
| Mar 2008 | Recommended · restricted | placebo | $15k | RCT · Other |
Consumer voice
The PBAC noted a Consumer Report on the impact of social anxiety disorders and phobias on daily living.
The PBAC noted a Consumer Report on the impact of social anxiety disorders and phobias on daily living. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to moderate-to-severe SAD with prior non-pharmacological therapy failure; TGA label covers all SAD severity without treatment history requirement.