Version 8

Leuco-methylthioninium

Medicine

Extended indication Alzheimer’s disease, mild-to-moderate.
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Leuco-methylthioninium
Domain Neurological disorders
Reason of inclusion New medicine (specialité)
Main indication Dementia
Extended indication Alzheimer’s disease, mild-to-moderate.
Proprietary name LMTX
Manufacturer TauRx
Mechanism of action Other
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Unknown
Particularity Unknown
ATMP Unknown
Submission date 2021
Expected Registration 2022
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options donepezil, galantamine, rivastigmine.
Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.
Substantiation Leuco-methylthioninium zou een eerste disease modifying behandeling kunnen worden voor Alzheimer patiënten. Echter, er zijn twijfels over de mogelijke effectiviteit.
References "The results of study TRx-237-015 suggested the hypothesis that LMTM might be effective only as monotherapy" (Wilcock et al. J Alzheimer's Disease 2018)

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

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information