Incobotulinumtoxin A
Treatment of chronic sialorrhea due to neurological disorders in adults (≥18 years) with Parkinson's disease, atypical parkinsonism, traumatic brain injury, or stroke; and in children and adolescents (2–17 years) with cerebral palsy, traumatic brain injury, or developmental disorders.
Decisions on record
- Meeting Nov 2019 Recommended Spasticity of the upper limb
- Meeting Jul 2014 Recommended 100 units injection, 1 x 100 units vial Xeomin® Merz Pharmaceuticals GmbH New listing (Major submission) Dystonia, blepharospasm post-stroke spasticity of the upper limb Section 100 (Botulinum Toxin Program) listing for treatment of: (i) cervical dystonia (spasmodic torticollis) in adults; (ii) ble
Access path
- Jul 2014Recommended · restricted
vs onabotulinumtoxin A (Botox®)
- Nov 2019Recommended · restricted
Comparator changed: onabotulinumtoxin A (Botox®) → Dysport®
- May 2025Recommended · restricted
Comparator changed: Dysport® → standard medical management or standard of care/placebo
- PBS listing · Authority Required
From the public summary
7.1 The PBAC deferred making a recommendation for the listing of incobotulinumtoxinA for the treatment of chronic sialorrhea due to neurological disorders. While the PBAC was of a mind to recommend incobotulinumtoxinA, the PBAC noted that an MSAC application for the administration of incobotulinumtoxinA for chronic sialorrhea was also required to ensure there would be access to the required MBS items.PSD · Nov 2024
7.2 The PBAC noted the input from health care professionals and Motor Neurone Disease (MND) Australia highlighting the clinical need for effective PBS-listed options for this population, noting that anticholinergics are associated with significant side effects and botulinum toxin injections are high cost.PSD · Nov 2024
6.77 The submission presented a stepped economic evaluation based on direct randomised trials (the SIAXI and SIPEXI trials) that compared incobotulinumtoxinA with SoC. Two models were presented:PSD · Nov 2024
• The adult population as included in the SIAXI trial – with chronic sialorrhea due to Parkinson's disease, atypical parkinsonism, stroke, or TBI.PSD · Nov 2024
• IncobotulinumtoxinA is superior to standard of care/placebo in reducing the severity and frequency of salivary flow in patients with chronic, troublesome sialorrhea due to neurological disorders, including Parkinson's disease, atypical parkinsonism, traumatic brain injury and stroke.PSD · Nov 2024
• IncobotulinumtoxinA is inferior to placebo in terms of safety. In children and adolescents aged 2−17 years:PSD · Nov 2024
6.2 The PBAC noted and welcomed the input from health care professionals (6) and 1 organisation via the Consumer Comments facility on the PBS website. The comments described the effectiveness of incobotulinumtoxinA in those with chronic sialorrhea in reducing salivary production.PSD · Nov 2024
6.3 The PBAC acknowledged the input from Motor Neurone Disease (MND) Australia expressing support for listing incobotulinumtoxinA on the PBS for those with chronic sialorrhea. MND Australia noted that sialorrhea is a life-altering and serious health issue and is often described by people living with MND as their most troubling and distressing symptom.PSD · Nov 2024
Cost-effectiveness
ICER not stated in the public text; economic evaluation was cost-effectiveness analysis but specific numeric ICER values are not disclosed in this PSD.
The submission requested that the effective price of Xeomin® retain the cost-minimisation therapeutic relativity with Dysport®. PSD · 2019
Decision context
PopulationAdults ≥18 years with chronic sialorrhea due to Parkinson's disease, atypical parkinsonism, traumatic brain injury, or following an acute event, with DSFS score ≥6; and children/adolescents aged 2–17 years with chronic sialorrhea due to cerebral palsy, traumatic brain injury, or developmental disorders, with mTDS score ≥6.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| May 2025 | Recommended · restricted | standard medical management or standard of care/placebo | — | RCT · Other |
| Nov 2019 | Recommended · restricted | Dysport® | — | RCT · AS-reduction |
| Jul 2014 | Recommended · restricted | onabotulinumtoxin A (Botox®) | — | RCT · Other |
Consumer voice
Healthcare professionals and Motor Neurone Disease Australia provided input supporting PBS listing of incobotulinumtoxinA for chronic sialorrhea, noting its effectiveness in improving quality of life despite manageable side effects, and highlighting the significant clinical need and cost barriers to treatment.
for some patients, sialorrhea can be a debilitating condition and that effective treatment and symptom control was associated with a significant improvement to the quality of life of patients. Consumer comments · PSD