INCOBOTULINUMTOXINA

The PBAC recommended the listing of incobotulinumtoxinA (Xeomin®) for the treatment of moderate to severe spasticity of the lower limb in adults following stroke, traumatic brain injury, or spinal cord injury. The PBAC noted that the submission did not provide any trials comparing Xeomin directly to Botox and instead, compared Xeomin to Botox using one trial comparing Botox to placebo and two trials comparing Xeomin to placebo. While the PBAC noted there were some uncertainties with the clinical evidence, it considered that overall, Xeomin was likely as effective as botulinum toxin type A (Botox®). The PBAC’s recommendation was on the basis that it should be available only under special arrangements under Section 100 (Botulinum Toxin Program) and its assessment that Xeomin® would be cost-effective if it cost no more than the least costly of either Botox or clostridium botulinum type A toxin-haemagglutinin complex (Dysport®). The PBAC advised the equi-effective doses to be Xeomin 1 U = Botox 1 U = Dysport 3.75 U.