Donanemab Medicine 07 December 2022 Extended indication Early Symptomatic Alzheimer's Disease Therapeutic value No estimate possible yet Total cost € 546,000,000.00 Registration phase Registration application pending 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 August 2023 Expected Registration September 2024 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Registratie wordt eind 2024 verwacht 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 NCT04437511 Sims JR, Zimmer JA, Evans CD, et al. Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial. JAMA. Published online July 17, 2023. doi:10.1001/jama.2023.13239 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 € 26,000.00 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 Eric L Ross. Cost-effectiveness of Aducanumab and Donanemab for Early Alzheimer Disease in the United States 2022. Additional remarks In een kosteneffectiviteitsanalyse worden de kosten in de Verenigde Staten beraamd op 28.000 per patiënt per jaar. De prijs in Nederland is nog niet bekend. Potential total cost per year Total cost € 546,000,000.00 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