Glycopyrronium
Treatment of severe primary axillary hyperhidrosis (PAHH) in patients aged 18 years and older who have previously failed topical aluminium chloride or are intolerant to it.
Decisions on record
- Meeting Nov 2025 Recommended Severe primary axillary hyperhidrosis in patients aged 18 years and older
- Meeting Aug 2017 Recommended Indication not stated no PSD
Access path
- Nov 2025Recommended
vs Botulinum toxin type A purified neurotoxin complex (BTA)
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the General Schedule listing of glycopyrronium bromide cream (GPB) for the treatment of patients with severe primary axillary hyperhidrosis (PAHH). The PBAC was satisfied that GPB provides, for some patients, a significant improvement in efficacy over placebo (no treatment), but considered GPB to be less effective than botulinum toxin type A purified neurotoxin complex (BTA).PSD · Nov 2025
7.2 The PBAC acknowledged PAHH can be a burdensome condition for some patients, as the symptoms can lead to anxiety and social isolation, especially for adolescents. The PBAC also acknowledged that the only treatment option on the PBS for PAHH, BTA, can be costly, difficult to access (especially for regional and rural patients) and its administration is known to be painful for some patients.PSD · Nov 2025
6.42 The ESC considered the method used to determine the proposed price for GBP was inappropriate and could not be used as a reliable basis for establishing a cost-effective price relative to BTA. The ESC considered the clinical comparison to be unreliable for the purposes of establishing the magnitude of difference between GPB and BTA, but the evidence clearly indicated GPB is likely to be of inferior comparative effectiveness to BTA.PSD · Nov 2025
Furthermore, the ESC considered that an approach that does not consider the incremental benefits and costs of GPB and aluminium preparations does not represent a complete appraisal of GPB in the Australian context of PAHH.PSD · Nov 2025
6.36 The clinical claim in the submission, ‘treatment with GPB may not be non-inferior in terms of effectiveness compared with BTA’ was unclear. If the intended claim was that GPB is non-inferior to BTA, this claim was not adequately supported. There were substantial transitivity issues between the GPB and BTA trials that make a formal indirect treatment comparison of these products problematic.PSD · Nov 2025
6.37 The submission described GPB as superior in terms of efficacy compared to placebo.PSD · Nov 2025
Cost-effectiveness
No numeric ICER stated. Economic analysis was side-by-side cost per responder comparison (not incremental), and ESC considered the method inappropriate and not a reliable basis for cost-effectiveness.
The ESC considered the method used to determine the proposed price for GBP was inappropriate and could not be used as a reliable basis for establishing a cost-effective price relative to BTA. PSD · 2025
Decision context
PopulationAdults aged 18 years and older with severe primary axillary hyperhidrosis who have failed or are intolerant to topical aluminium chloride treatment.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2025 | Recommended | Botulinum toxin type A purified neurotoxin complex (BTA) | — | RCT |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients who failed or are intolerant to prior topical aluminium chloride treatment; TGA label has no such prior-therapy requirement.