PBAC's latest decision on Incobotulinumtoxin a: Recommended with restriction (2024). Considered for 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.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
—
ICER not stated
Submissions
3
first 2014
Submissions
3
2014 → 2024
Eligible population
Adults ≥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.
Therapy area
Neurology
Line of therapy
Third-line
Evidence base
RCT
Primary endpoint
Other
Key trials
SIAXI, SIPEXI
Comparator
standard medical management or standard of care/placebo
Economic model
CUA
ICER note
ICER not stated in the public text; economic evaluation was cost-effectiveness analysis but specific numeric ICER values are not disclosed in this PSD.
Submission history
Jul 2014: Recommended with restriction · Restricted
Nov 2019: Recommended with restriction · Authority Required
Nov 2024: Recommended with restriction · Authority Required