Clostridium Botulinum Type A Toxin-Haemagglutinin Complex
Recommended NeurologyRestrictedNot applicable line 💬 consumer voice
Treatment of moderate to severe focal spasticity of the upper limb in patients with cerebral palsy aged 2 years and older.
7
Submissions
4 resub
2007–20
On the record
$15k
ICER range
2 sourced ICERs · 2007
Cost-min
Cost basis
Decisions on record
- Meeting Jul 2011 Recommended Facial muscle spasm
- Meeting Mar 2009 Recommended Spasticity disorder no PSD
Access path
- Nov 2007Recommended · restricted
vs standard management (physiotherapy, orthoses ± oral…
- Nov 2007Recommended · restricted
- Nov 2007Recommended · restricted
- Nov 2018Not recommended
uncertain clinical effectiveness, high and uncertain incremental cost-effectiveness ratio based on flawed economic…
- Nov 2018Not recommended
uncertain clinical benefit, uncertain cost-effectiveness, high and uncertain financial impact, lack of evidence…
- ↻ resubmittedMar 2019Recommended · restricted
Comparator changed: placebo or best supportive care → placebo / standard of care
- Jul 2020Recommended · restricted
Comparator changed: placebo / standard of care → Botulinum toxin, type A purified…
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
The PBAC recommended the listing of clostridium botulinum toxin (Dysport®), 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 focal spasticity of the upper limb in patients with cerebral palsy.PSD · Jul 2020
The PBAC was satisfied that Dysport® was non inferior to botulinum toxin type A (Botox®) in terms of comparative efficacy and safety.PSD · Jul 2020
Economic analysis
The submission presented a cost-minimisation analysis based on the indirect comparison versus Botox®.PSD · Jul 2020
The submission indicated that the units used to express the potency of botulinum toxin preparations are not equivalent and therefore not interchangeable on a unit-to- unit basis; and a universal conversion factor between units of Botox® and units of Dysport® has not been determined. This was accurate.PSD · Jul 2020
Clinical claim
is as effective as Botox® at improving muscle tone and spasticity with a comparable safety profile. Source: Table 1-1, p16 of the submission.PSD · Jul 2020
The submission did not use superior, inferior or non-inferior wording as part of its clinical claim, and instead stated that for the treatment of moderate to severe upper limb spasticity in cerebral palsy patients, Dysport® is as effective as Botox® at reducing muscle tone and spasticity and it has a comparable safety profile.PSD · Jul 2020
Consumer comments
6.2 The PBAC noted that no consumer comments were received for this item. However, the PBAC noted that the consumer comments from the November 2018 submission were supportive of the listing, and outlined a range of benefits of treatment with Dysport® including improved mobility, improved quality of life, reduced pain and a reduced burden of care for carers and family.PSD · Jul 2019
Financial management – risk sharing
The submission stated that no risk-sharing arrangements (RSA) are proposed for this requested listing. There is a RSA for upper limb spasticity due to stroke or acute events. The sponsor did not provide discussion of why an RSA was not proposed. Given the uncertainty around the estimated financial implications of PBS listing for Dysport®, an RSA may be appropriate.PSD · Jul 2020
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated
The submission presented a cost-minimisation analysis based on the indirect comparison versus Botox®. PSD · 2020
ICER uncertainSurrogate endpoint ×2Indirect comparisonCost-effectiveness accepted
Decision context
PopulationChildren and adults aged 2 years and older with cerebral palsy and moderate to severe focal spasticity of the upper limb.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2020 | Recommended · restricted | Botulinum toxin, type A purified neurotoxin complex (Botox) | — | Indirect comparison · Spasticity as measured by Modified Ashworth Scale (MAS), Goal Attainment Scale (GAS), adverse events |
| Mar 2019 | Recommended · restricted | placebo / standard of care | — | RCT · MAS |
| Nov 2018 | Not recommended | standard of care (placebo) | — | RCT · MAS |
| Nov 2018 | Not recommended | placebo or best supportive care | — | RCT |
| Nov 2007 | Recommended · restricted | standard management (physiotherapy, orthoses ± oral anti-spasticity drugs) | $15k | RCT · MAS score change, GAS score, GAB score |
| Nov 2007 | Recommended · restricted | standard management (physiotherapy, orthoses ± oral anti-spasticity drugs) | — | RCT · AQoL |
| Nov 2007 | Recommended · restricted | standard management (physiotherapy, orthoses ± oral anti-spasticity drugs) | $15k | RCT · AQoL |
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Clostridium Botulinum Type A Toxin – Haemagglutinin Complex93%Botulinum Toxin Type A Purified Neurotoxin Complex87%Botulinum Toxin Type A85%Clostridium Botulinum Type A Toxin Haemagglutinin Complex85%Incobotulinumtoxin A75%Incobotulinumtoxina74%Baclofen63%Nabiximols61%