Gantenerumab Medicine 07 December 2022 Extended indication Early Symptomatic Alzheimer's Disease Therapeutic value No estimate possible yet Total cost Registration phase No registration expected Product Active substance Gantenerumab Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Dementia Extended indication Early Symptomatic Alzheimer's Disease Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Roche Portfolio holder Roche Mechanism of action Unknown Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Amyloid beta-protein inhibitor. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date 2023 Expected Registration 2024 Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks De fabrikant heeft de studies voor dit geneesmiddel gestopt vanwege tegenvallende resultaten. Therapeutic value Current treatment options Op dit moment bestaan er alleen geneesmiddelen die de gevolgen van Alzheimer proberen te vertragen. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Het geneesmiddel leek initieel effectief. Er trad mogelijk vertraging op van de ziekte. In november 2022 werd echter bekend dat de fabrikant wegens tegenvallende resultaten de studies heeft gestaakt. Duration of treatment Frequency of administration 1 times every 4 weeks Dosage per administration 105 mg , 225 mg, tot1200 mg. References GRADUATE 1 (NCT03444870) en GRADUATE 2 (NCT03443973) Additional remarks Expected patient volume per year Patient volume < 21,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References http://www.levenmetalzheimer.nl/content/alzheimer/feiten-cijfers.asp, https://www.sfk.nl/publicaties/PW/2016/inzet-medicijnen-bij-dementie-loopt-terug 91); Expert opinie (2); Additional remarks In Nederland zijn 270.000 mensen dement. Hiervan hebben 160.000 tot 190.000 mensen de ziekte van Alzheimer (maximaal 70%). In totaal waren er 30.000 geneesmiddelen gebruikers, die medicijnen kregen tegen dementie (SFK), uitgaande van 70% zal het maximaal gaan om 21.000 patiënten (1). Afhankelijk van de therapeutische waarde kan dit aandeel patiënten oplopen (2). Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks