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Neurology

Clostridium botulinum type a toxin-haemagglutinin complex

Brand: Dysport

PBAC's latest decision on Clostridium botulinum type a toxin-haemagglutinin complex: Recommended with restriction (2020). Considered for Treatment of moderate to severe focal spasticity of the upper limb in patients with cerebral palsy aged 2 years and older.

PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
3
first 2007
Submissions
3
2007 → 2020

Eligible population

Children and adults aged 2 years and older with cerebral palsy and moderate to severe focal spasticity of the upper limb.

Therapy area
Neurology
Line of therapy
Not applicable
Evidence base
Indirect comparison
Primary endpoint
Spasticity as measured by Modified Ashworth Scale (MAS), Goal Attainment Scale (GAS), adverse events
Pivotal trial size
210 patients
Key trials
Study 153, Fehlings 2018, Fehlings 2000, Rameckers 2009/Speth 2005, Lowe 2006, Olesch 2010
Comparator
Botulinum toxin, type A purified neurotoxin complex (Botox)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated
ICER (historical)
$15k/QALY in an earlier submission (2007) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.

Submission history

Similar precedents

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