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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.