Aducanumab Medicine 12 June 2019 Extended indication Mild Cognitive Impairment due to Alzheimer’s disease and mild Alzheimer’s disease Therapeutic value Possible added value Total cost Registration phase Registration application pending Product Active substance Aducanumab Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Dementia Extended indication Mild Cognitive Impairment due to Alzheimer’s disease and mild Alzheimer’s disease Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Biogen Portfolio holder Mechanism of action Other Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Humaan monoklonaal (IgG1) antilichaam gericht tegen geaggregeerd β-amyloid. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date November 2020 Expected Registration October 2021 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks PRIME status verkregen 26 mei 2016. Ontwikkeling stopgezet in april 2019. Biogen heeft na een her analyse van de studie uitkomsten het eerdere besluit om de verdere ontwikkeling van het middel stop te zetten teruggedraaid. Therapeutic value Current treatment options Galantamine, Rivastigmine, Donepezil, Memantine Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Eerste disease modifying geneesmiddel, nu is de behandeling met name gericht op symptoombestrijding. Duration of treatment Frequency of administration 1 times a month Dosage per administration References NCT02484547; NCT02477800 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Levenmetalzheimer.nl, SFK, GIP databank.; https://investors.biogen.com/news-releases/news-release-details/european-medicines-agency-accepts-biogens-aducanumab-marketing 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 in totaal 30.000 geneesmiddelengebruikers die medicijnen kregen tegen dementie (SFK / GIP databank). Het grootste deel hiervan betreft medicatie tegen Alzheimer. Kan alle 30.000 behandelde patiënten gaan vervangen en meer; afhankelijk van de therapeutische waarde kan dit aandeel patiënten oplopen . 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 Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks