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Donanemab

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
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
ATMP No
Submission date August 2023
Expected Registration September 2024
Orphan drug No
Registration phase Registration application pending
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
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

Expected patient volume per year

Patient volume

< 21,000

Market share is generally not included unless otherwise stated.
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
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

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.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.