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DYSPORT 300 et 500 UNITES SPEYWOOD (toxine botulinique de type A) - Incontinence urinaire
Reason for request
Key points
Approval of reimbursement for the indication “treatment of urinary incontinence in adults with neurogenic detrusor overactivity due to spinal cord injury (trauma- related or not) or multiple sclerosis, who perform regular intermittent self-catheterisation” only in patients failing to respond or intolerant to anticholinergic medicinal products.
Disapproval of inclusion in the list of proprietary medicinal products approved for community use in other contexts (anticholinergic treatment-naive patients).
Therapeutic improvement?
No therapeutic improvement.
Clinical Benefit
| Substantial |
The Committee deems that the clinical added value of DYSPORT (botulinum toxin A) is significant for the indication “treatment of urinary incontinence in adults with neurogenic detrusor overactivity due to spinal cord injury (trauma-related or not) or multiple sclerosis, who perform regular intermittent self-catheterisation” only in patients failing to respond or intolerant to anticholinergic medicinal products. |
Clinical Added Value
| no clinical added value |
Considering the data available, the Committee deems that DYSPORT (botulinum toxin A) provides no clinical added value (CAV V) with respect to BOTOX (botulinum toxin A) for the treatment of urinary incontinence uncontrolled by anticholinergic treatment in adults with neurogenic detrusor overactivity due to spinal cord injury (trauma-related or not) or multiple sclerosis, who perform regular intermittent self-catheterisation. |
