Botulinum A toxin Medicine 09 January 2018 Extended indication Chronic sialorrhoea in adults and children, associated with neurological conditions (Parkinson’s Disease (PD), stroke, traumatic brain injury (TBI), cerebral palsy (CP). Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Botulinum A toxin Domain Neurological disorders Reason of inclusion Indication extension IND 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). Current proprietary name Already available biosimilars / generics Proprietary name Xeomin Manufacturer Merz Portfolio holder Mechanism of action Unknown Route of administration Injection into the salivary glands Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Submission date Expected Registration June 2019 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Fabrikant verwacht goedkeuring in H1 2019. Therapeutic value Current treatment options amitriptyline, scopolamine, atropine, glycopyrronium Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment 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 Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost € 600.00 - 900.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References Medicijnkosten.nl Additional remarks Huidige VVP 50 eenheden Xeomin circa 110 euro. Max 100 eenheden 4 *per jaar. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Yes Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks