Incobotulinumtoxina
Recommended NeurologyAuthority RequiredSecond-line line 💬 consumer voice
Moderate to severe spasticity of the lower limb in adults following stroke, traumatic brain injury, or spinal cord injury.
2
Submissions
1 resub
2025–26
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Mar 2026 Recommended Moderate to severe spasticity of the lower limb in adults following an acute event
- Meeting Jul 2025 Recommended Moderate to severe spasticity of upper limb and dynamic equinus foot deformity in cerebral palsy aged 2+
- Meeting May 2025 Recommended Chronic sialorrhea due to neurological disorders no PSD
- Meeting Nov 2024 Deferred Chronic sialorrhea due to neurological disorders no PSD
- Meeting Nov 2024 Withdrawn Moderate to severe spasticity of the upper limb; dynamic equinus foot deformity in cerebral palsy aged 2-17 years no PSD
Access path
- Jul 2025Recommended · restricted
vs botulinum toxin type A (Botox)
- Mar 2026Recommended · restricted
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended the Authority required (STREAMLINED) listing of incobotulinumtoxinA (Xeomin®), on the basis that it should be available only under special arrangements under Section 100 (Botulinum Toxin Program), for the treatment of moderate to severe spasticity of the upper limb and dynamic equinus foot deformity in patients with cerebral palsy.PSD · Jul 2025
7.2 The PBAC considered that the nominated comparator of Botox was appropriate. The PBAC considered that Dysport was also an alternative therapy.PSD · Jul 2025
Economic analysis
6.34 The submission presented a cost-minimisation approach comparing Xeomin to Botox based on cross-trial comparisons.PSD · Jul 2025
6.35 Table 8 describes the key components and assumptions of the cost-minimisation approach. 20 OFFICIALPSD · Jul 2025
Clinical claim
• Xeomin is non-inferior to Botox for the treatment of dynamic equinus foot deformity due to spasticity in individuals with cerebral palsy aged ≥2 years. Source: Source: Table 1.1.1, pp 1-2 of the submission.PSD · Jul 2025
6.30 The submission described Xeomin as non-inferior in terms of comparative effectiveness and safety compared to Botox. The evaluation considered that the available evidence did not support this claim because of the lack of a direct and 19 OFFICIALPSD · Jul 2025
Consumer comments
6.1 The PBAC noted that no consumer comments were received for this item. The PBAC noted and welcomed the input from the Rehabilitation Medicine Society of Australia and New Zealand (RMSANZ) which was provided with the submission. The correspondence supported the listing of Xeomin on the PBS for adult and paediatric spasticity associated with cerebral palsy.PSD · Jul 2025
Cost-effectiveness
Cost-minimisation approach; no ICER calculated by design.
The submission presented a cost minimisation approach for the economic evaluation. PSD · 2026
Indirect comparison
Decision context
PopulationAdults aged 18 years or older with moderate to severe unilateral lower limb spasticity (MAS ≥2 or MAS ≥3, as clarified in clinical criteria) following stroke, traumatic brain injury, or spinal cord injury, with functional impairment affecting mobility, activities of daily living, or quality of life.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2026 | Recommended · restricted | botulinum toxin type A (Botox) | — | RCT · MAS |
| Jul 2025 | Recommended · restricted | botulinum toxin type A (Botox) | — | RCT · Other |
Consumer voice
No formal consumer comments were received. The Rehabilitation Medicine Society of Australia and New Zealand (RMSANZ) provided input supporting the listing of Xeomin on the PBS for adult and paediatric spasticity associated with cerebral palsy.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
treatment accessclinical support
Similar precedents
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