Donanemab Medicine 07 December 2022 Extended indication Early Symptomatic Alzheimer's Disease Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Donanemab 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 Eli Lilly Portfolio holder Eli Lilly Mechanism of action Other Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise VUMC, UMCG, EMC en Maastricht UMC Additional remarks Humaan monoklonaal (IgG1) antilichaam gericht tegen geaggregeerd β-amyloid (N3pG). Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date 2023 Expected Registration 2024 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Er is op dit moment geen behandeling in de vroege fase van deze ziekte. Middelen zoals Galantamine, Rivastigmine, Donepezil, Memantine zijn symptomatische behandelingen, die in latere fasen van de ziekte worden ingezet. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times every 4 weeks Dosage per administration 1400mg References NCT03367403 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 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. 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 Unknown Indication extensions References Additional remarks Other information Additional remarks