SolifenacinAKM Solifenacin
Recommended UrologyRestrictedLater-line line
Detrusor overactivity in patients who cannot tolerate oral oxybutynin.
3
Submissions
2 resub
2007–10
On the record
$45k–105k
ICER range
1 sourced ICER · 2007
Cost-min
Cost basis
Decision on record
- Meeting Jul 2010 Recommended Overactive bladder and symptoms of urge urinary incontinence
Access path
- TGA registered · AKM Solifenacin
TGA label narrower than the PBS population
- Jul 2007Recommended
vs placebo for standard medical management
- Jul 2010Recommended · restricted
Comparator changed: placebo for standard medical management → transdermal oxybutynin
- Jul 2010Recommended · restricted
Comparator changed: placebo for standard medical management → transdermal oxybutynin
- PBS listing · Restricted
RecommendedDeferredNot recommended
Cost-effectiveness
Cost minimisation analysis; no ICER calculated by design.
The PBAC considered solifenacin tablets to be of non-inferior efficacy and safety to transdermal oxybutynin. PBAC · 2010
Cost-effectiveness accepted
Decision context
PopulationPatients with detrusor overactivity who cannot tolerate oral oxybutynin.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2010 | Recommended · restricted | transdermal oxybutynin | — | RCT, Single-arm · QoL, INCONTINENCE EPISODES, MICTURITIONS |
| Jul 2010 | Recommended · restricted | transdermal oxybutynin | — | RCT |
| Jul 2007 | Recommended | placebo for standard medical management | $45k–105k | RCT · QoL, micturitions per 24 hours, becoming continent, no urgency episodes, no nocturia episodes |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| VENUS | Ph 3 | 739 | Evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with urgency who hav… | completed |
| VIBRANT | Ph 4 | 768 | Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symp… | completed |
| SUNRISE | Ph 3 | 973 | Change from baseline in mean number of urgency episodes/24 hours at EOS -from the Patient … | completed |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients intolerant of oral oxybutynin, a specific treatment-failure subset of the broad TGA label.