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Neurology

Botulinum toxin type a purified neurotoxin complex

Brand: BOTOX®

PBAC's latest decision on Botulinum toxin type a purified neurotoxin complex: Recommended with restriction (2019). Considered for Treatment of moderate to severe focal spasticity of the upper limb following an acute event (stroke, traumatic brain injury, spinal cord injury, infection, or hypoxia).

PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
8
first 2005
Submissions
8
2005 → 2019

Eligible population

Adults aged 18 years or older with moderate to severe spasticity of the upper limb (Modified Ashworth Scale rating of 3 or more) following an acute event, where standard management has failed or as an adjunct to physical therapy.

Therapy area
Neurology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
Spasticity reduction (Modified Ashworth Scale / Ashworth Scale score)
Pivotal trial size
216 patients
Key trials
Fietzek 2014, Grazko 1995, Richardson 2000, Simpson 2009, Snow 1990, Verplancke 2005
Comparator
Dysport®
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis conducted; no ICER calculated by design.
ICER (historical)
$15k/QALY–$45k/QALY across 5 submissions (2006–2012) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Risk sharing
Risk-sharing arrangement in place — Special Pricing Arrangements (SPA) requested to achieve parity with Dysport® approved ex-manufacturer effective prices (AEMP).

Submission history

Similar precedents

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