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Botulinum A toxin

Xeomin

Extended indication Chronic sialorrhoea in adults and children, associated with neurological conditions (Parkinson’s Dis
Therapeutic value No judgement

Product

Active substance Botulinum A toxin
Domain Neurological disorders
Main indication Neurological disorders other
Extended indication Chronic sialorrhoea in adults and children, associated with neurological conditions (Parkinson’s Disease (PD), stroke, traumatic brain injury (TBI), cerebral palsy (CP).
Proprietary name Xeomin
Manufacturer Merz
Route of administration Injection into the salivary glands
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Orphan drug No

Therapeutic value

Current treatment options Amitriptyline, Scopolamine, Atropine, Glycopyrronium.
Therapeutic value No judgement
Duration of treatment continuous
Frequency of administration 4 times a year
Dosage per administration Lage doseringen, tot 100 units per cyclus
References clinicaltrials.gov: NCT02270736, NCT01565395, NCT02091739, NCT01653132.
Additional remarks Toedieningsfrequentie: elke 12 weken. Botuline toxine A wordt voor deze indicatie nu al off label toegepast.

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost 600.00 - 900.00
References Medicijnkosten.nl
Additional remarks Huidige VVP 50 eenheden Xeomin circa 110 euro. Max 100 eenheden 4 *per jaar.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

Off label use Yes
Indications off label use In de praktijk zal het mogelijk off label worden gebruikt omdat een ziekenhuis doorgaans niet alle botuline preparaten op voorraad heeft.

Indication extension

Indication extension No

Other information

There is currently no futher information available.