GVS assessment oxybutynin intravesical solution (Vesolox®)
Zorginstituut Nederland has completed its assessment whether oxybutynin intravesical solution (Vesolox®) 1mg/ml is interchangeable with a product that is included in the Medicine Reimbursement System (GVS). Vesolox® is indicated for the suppression of detrusor overactivity due to spinal cord injury or myelomeningocele (spina bifida). The Zorginstituut recommends including Vesolox® 1mg/ml in List 1B of the Health Insurance Regulation.
Registered indication
Vesolox® is indicated for the suppression of detrusor overactivity due to spinal cord injury or myelomeningocele (spina bifida) in children aged 6 years and older, and adults who empty their bladder through clean intermittent catheterization, which is not adequately treated with oral anticholinergics.
Vesolox® is available as a 10 ml prefilled syringe containing 1 mg/ml of oxybutynin hydrochloride. In addition, the solution contains the following adjuvant with known effect: sodium 3.53 mg/ml.
Assessment of interchangeability
Vesolox® is not interchangeable with any other medicinal product that is included in the GVS.
Zorginstiuut's advice
On the basis of the considerations mentioned in the report, the Zorginstituut recommends to include oxybutynin intravesical solution (Vesolox®) 1mg/ml in List 1B of the Health Insurance Regulation.