Reason for request
Favourable opinion for reimbursement in the local symptomatic treatment of spasticity of the upper limbs in children two years of age or older.
What therapeutic improvement?
No clinical added value compared to BOTOX.
Role in the care pathway?
The conventional treatment of muscle hyperactivity of the upper limbs in children and adults includes rehabilitative therapy (passive stretching, posture and movement facilitation, fitting of orthotics), pharmacotherapy and surgical treatment (neurosurgery and/or orthopaedic surgery), in particular when fixed contractures have progressed and impede function.
Role of the medicinal product in the care pathway
The intramuscular injection of DYSPORT guided by electrical stimulation or ultrasound in combination with rehabilitative therapy methods is a therapeutic option in children and adolescents with focal spasticity of the upper limb when this impedes fine motricity, compromises rehabilitative treatments and hygiene care, causes pain or prevents the initiation of other therapies, such as the fitting of orthotics.
The clinical benefit of DYSPORT 300 and 500 SPEYWOOD UNITS powder for solution for injection is substantial in the local symptomatic treatment of spasticity of the upper limbs in children two years of age or older.
Clinical Added Value
|no clinical added value||
- demonstration of a dose effect of DYSPORT on reduction of muscle tone 6 weeks after intramuscular injection in patients aged 2 to 17 years with cerebral palsy, mostly treated by physiotherapy or occupational therapy;
- the absence of demonstration of efficacy in terms of functional improvement and quality of life in these patients, which are relevant endpoints;
- the risk of adverse effects related to spread of toxin distant from the site of administration and uncertainties concerning the degree of morphological and functional recovery of skeletal muscle in the longer term;
- the absence of a comparison with the medicinal product BOTOX;
the Committee considers that DYSPORT provides no clinical added value (CAV V) compared to BOTOX in the local symptomatic treatment of spasticity of the upper limbs in children two years of age or older.