OxybutyninAPOHIDE
Treatment of detrusor overactivity (overactive bladder) in patients unable to tolerate or swallow oral oxybutynin.
Decisions on record
- Meeting Nov 2023 Noted Detrusor overactivity (transdermal patch for patients unable to tolerate/swallow oral form)
- Meeting Nov 2010 Not recommended Urinary incontinence no PSD
- Meeting Mar 2009 Recommended Urinary incontinence
- Meeting Mar 2008 Not recommended Incontinence
Access path
- TGA registered · APOHIDE
TGA label narrower than the PBS population
- Mar 2008Not recommended
non-inferiority not demonstrated in Trial 017 (lower CI -17% vs specified -15%), efficacy results potentially…
- ↻ resubmittedNov 2008Recommended
ICER dropped $45,000 → $15,000 (-67%)
- Mar 2009Recommended · restricted
Listing: Restricted → Restricted Benefit
- Nov 2023Recommended · restricted
Evidence: RCT → Other
- PBS listing · Restricted
From the public summary
4.1 The PBAC advised that Oxytrol® (oxybutynin 3.9 mg transdermal patch) can be considered as an exempt item under subsection 84AH of the Act.PSD · Nov 2023
4.2 The PBAC noted that Oxytrol is the only listed brand of oxybutynin for patients for whom the oral formulation is unsuitable due to adverse events or inability to swallow; that there are no bioequivalent, biosimilar or ‘a’-flagged products listed for the same indication; and that there is at least one other listed brand of oxybutynin (Ditropan).PSD · Nov 2023
(ii) the relevant item is suitable for use by Patients requiring treatment for detrusor overactivity who are a particular subgroup of that unable to tolerate and/or swallow the oral formulation, and population because of either or both unable to afford alternate medicines that are not PBS listed.PSD · Nov 2023
3.5 The submission substantiated its request with clinical data that highlighted the prevalence of Urge Urinary Incontinence (UUI) and chronic conditions in various populations. The data did not demonstrate the clinical benefit provided by the patches over other available dose forms.PSD · Nov 2023
Cost-effectiveness
No economic evaluation performed; this was an exempt item status review under subsection 84AH of the Act, not a full economic submission.
The incremental cost per extra QALY gained of < $15,000 based on the revised price was considered acceptable by the PBAC. PBAC · 2009
Decision context
PopulationPatients with detrusor overactivity (overactive bladder) who are unable to tolerate or swallow oral oxybutynin formulations.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2023 | Recommended · restricted | — | — | Other |
| Mar 2009 | Recommended · restricted | placebo | $15k | RCT |
| Nov 2008 | Recommended | placebo | $15k | RCT · Surrogate |
| Mar 2008 | Not recommended | oral oxybutynin | $15k–45k | RCT · complete continence |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| MATRIX | Ph 4 | 2,878 | Change in health-related quality of life | completed |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients unable to tolerate or swallow oral oxybutynin, while TGA label includes all overactive bladder patients.