Botulinum Toxin Type A Purified Neurotoxin Complex
Treatment of moderate to severe focal spasticity of the upper limb following an acute event (stroke, traumatic brain injury, spinal cord injury, infection, or hypoxia).
Decisions on record
The committee reached more than one outcome for this medicine at its most recent sitting — different indications were decided differently. The header reflects the least favourable of them; all are listed below.
- Meeting Jul 2012 Not recommended Prophylaxis of headaches in adults with chronic migraine (headache on at least 15 days per month of which at least 8 days are with migraine). Botulinum toxin type A purified neurotoxin complex is also TGA registered for the following indications: · Blepharospasm associated with dystonia, including b
- Meeting Jul 2012 Deferred Urinary incontinence
- Meeting Nov 2011 Not recommended Prevention of headaches in chronic migraine
- Meeting Mar 2010 Recommended Excessive sweating
- Meeting Nov 2009 Not recommended Hyperhidrosis (treats excessive sweating)
- Meeting Jul 2009 Not recommended Spasticity no PSD
- Meeting Mar 2009 Recommended Spasticity disorder no PSD
Access path
- Nov 2005Not recommended
Uncertainty with interpreting extent of clinically relevant benefits from spasticity outcomes (statistically…
- Nov 2005Not recommended
uncertainty with interpreting the extent of clinically relevant benefits arising from the spasticity outcomes…
- Jul 2006Not recommended
Uncertainty in extrapolation of response in terms of the Ashworth scale to a quality of life measure, high and…
- Jul 2008Not recommended
uncertain clinical benefit, considerable uncertainty in clinical outcomes from pivotal trial 702-8051, efficacy based…
- ↻ resubmittedJul 2008Recommended · restricted
Comparator changed: Placebo for standard medical management → placebo
- Mar 2010Recommended
Comparator changed: clostridium botulinum (Dysport®) → placebo
- 2012Recommended · restricted
Comparator changed: placebo → best supportive care
- Jul 2012Recommended
- Nov 2019Recommended · restricted
Comparator changed: best supportive care → Dysport®
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended an extension of the current Section 100 (Botulinum Toxin Program), Authority Required (STREAMLINED) listing for botulinum toxin (BOTOX®) for treatment of moderate to severe focal spasticity of the upper limb following a stroke, to also include spasticity following acute events other than stroke. The PBAC was satisfied that BOTOX® was non inferior to Dysport® in terms of comparative efficacy and safety.PSD · Nov 2019
6.2 The PBAC noted that the request to add additional acute aetiologies, including traumatic brain and spinal cord injuries, to the upper limb focal spasticity restriction was supported by the Rehabilitation Medicine Society of Australia and New Zealand (RMSANZ).PSD · Nov 2019
5.12 The minor submission presented a cost-minimisation analysis of BOTOX® compared with Dysport®.PSD · Nov 2019
5.13 The equi-effective doses were estimated in the minor submission as: BOTOX® 229U = Dysport® 989U; or BOTOX® 1U = Dysport® 4.3UPSD · Nov 2019
5.9 The clinical claim was that for patients with moderate to severe focal spasticity of the upper limb following an acute event, BOTOX® is non-inferior to Dysport® in terms of efficacy and safety.PSD · Nov 2019
5.10 The minor submission noted that the PBAC has previously considered that BOTOX was no worse in terms of effectiveness and had similar toxicity to Dysport in post-stroke upper limb spasticity (Section 9, BOTOX® PSD, July 2008).PSD · Nov 2019
5.2 The PBAC noted and welcomed the input from one individual for this item. The comment briefly described the difficulty of living with spasticity.PSD · Nov 2019
Cost-effectiveness
Cost-minimisation analysis conducted; no ICER calculated by design.
The minor submission presented a cost-minimisation analysis of BOTOX® compared with Dysport®. PSD · 2019
Decision context
PopulationAdults aged 18 years or older with moderate to severe spasticity of the upper limb (Modified Ashworth Scale rating of 3 or more) following an acute event, where standard management has failed or as an adjunct to physical therapy.
Risk sharingSpecial Pricing Arrangements (SPA) requested to achieve parity with Dysport® approved ex-manufacturer effective prices (AEMP).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2019 | Recommended · restricted | Dysport® | — | RCT · Spasticity reduction (Modified Ashworth Scale / Ashworth Scale score) |
| Jul 2012 | Recommended | best supportive care | $15k–45k | RCT · change in headache days per month |
| 2012 | Recommended · restricted | best supportive care | $15k–45k | RCT · ORR, QoL |
| Mar 2010 | Recommended | placebo | $15k–45k | RCT |
| Jul 2008 | Not recommended | placebo | $15k–45k | RCT |
| Jul 2008 | Recommended · restricted | clostridium botulinum (Dysport®) | — | RCT | Meta-analysis · Responder rate (Ashworth score change of greater than or equal to two) |
| Jul 2006 | Not recommended | Placebo for standard medical management | $15k–45k | RCT |
| Nov 2005 | Not recommended | placebo (standard medical management) | — | RCT · OS | PFS | DFS | ORR | QoL | Surrogate |
| Nov 2005 | Not recommended | placebo (standard medical management) | $1k–5k | RCT |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC requires urodynamic confirmation of NDO and specifies later-line positioning after anticholinergic failure; TGA label does not mandate urodynamic testing or treatment-line specification.