PBAC's latest decision on Botulinum toxin type a: Recommended with restriction (2019). Considered for Moderate to severe spasticity of the lower limb following a stroke, or other acute neurological event (traumatic brain injury, spinal cord injury).
PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
9
first 2008
Submissions
9
2008 → 2019
Eligible population
Adults aged 18 years or older with moderate to severe lower limb spasticity (Modified Ashworth Scale rating ≥3) following stroke or other acute CNS injury (traumatic brain injury, spinal cord injury), for use as second-line therapy when standard management has failed or as adjunct to physical therapy.
Therapy area
Neurology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
ORR
Key trials
REFLEX
Comparator
standard of care / placebo
Economic model
CUA
ICER note
ICER redacted in Tables 1-4; Table 5 shows re-specified base case with effective price of $281.49/100 units resulting in ICER less than $15,000/QALY (exact value redacted).
ICER (historical)
$15k/QALY–$45k/QALY across 4 submissions (2008–2019) — 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) apply.
Submission history
Nov 2008: Recommended with restriction · Restricted — ICER $15k/QALY
Nov 2011: Not recommended — ICER $45k/QALY
Jul 2013: Recommended with restriction · Restricted — ICER $45k/QALY
Nov 2013: Recommended with restriction · Authority Required
Mar 2017: Recommended with restriction · Restricted
Mar 2018: Noted · Restricted
Jul 2018: Recommended with restriction · Restricted
Nov 2018: Recommended with restriction · Authority Required
Mar 2019: Recommended with restriction · Restricted — ICER $45k/QALY