Incobotulinumtoxina

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 lower limb in adults following stroke, traumatic brain injury, or spinal cord injury.PSD · Mar 2026

7.2 The PBAC noted that a submission to the MSAC has been made to amend existing MBS item code 18360 to include incobotulinumtoxinA for the lower limb indication. The PBAC considered that changes to the PBS and MBS listing would have to be implemented on the same date.PSD · Mar 2026

6.44 The submission presented a cost minimisation approach for the economic evaluation.PSD · Mar 2026

The key components and assumptions used in the approach are shown in Table 8.PSD · Mar 2026

6.41 The submission described Xeomin as non-inferior in terms of effectiveness compared to Botox. The evaluation considered this claim was not adequately supported because of two randomised placebo-controlled trials submitted, the larger found no difference between Xeomin and placebo, and this trial was omitted from the indirect treatment comparison.PSD · Mar 2026

6.42 Whilst recognising the uncertainties associated with the comparison, the PBAC considered that overall, the claim of non-inferior comparative effectiveness was reasonable. The PBAC recalled it previously considered Xeomin and Botox would likely have similar effects as they are analogues of each other (paragraph 6.17, Xeomin PSD, July 2014 PBAC meeting).PSD · Mar 2026

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