The PBAC has recommended the PBS listing for botulinum toxin type A (Botox) be extended to allow for the treatment of lower limb focal spasticity following an acute neurological event.

In addition to stroke, an acute neurological event could include traumatic brain injury, spinal cord injury, hypoxia or infection.

The PBS listing extension was supported by the Rehabilitation Medicine Society of Australia and New Zealand (RMSANZ), and the PBAC considered that, despite the lack of clinical trials in these populations, the request was reasonable and biologically plausible.

At the March 2019 meeting, the committee also recommended an extension of the current PBS listing for Clostridium botulinum type A toxin-haemagglutinin complex (Dysport) to include treatment of moderate to severe focal spasticity of the upper limb following a stroke. The extension would also cover the use of Dysport for treatment of spasticity following acute events other than stroke.

The PBAC said it was satisfied Dysport provided a modest improvement in efficacy compared with standard of care for some patients in spite of the treatment’s sponsor not presenting new clinical data in its resubmission.