Leuco-methylthioninium Medicine 09 January 2018 Extended indication Alzheimer’s disease, mild-to-moderate. Therapeutic value No judgement Total cost 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. Current proprietary name Already available biosimilars / generics Proprietary name LMTX Manufacturer TauRx Portfolio holder Mechanism of action Other Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2020 Expected Registration 2021 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options donepezil, galantamine, rivastigmine. Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Leuco-methylthioninium zou een eerste disease modifying behandeling kunnen worden voor Alzheimer's. Echter, er zijn twijfels over de mogelijke effectiviteit. Duration of treatment Frequency of administration Dosage per administration 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) 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 (max 70%). In totaal waren er in totaal 30.000 geneesmiddelengebruikers, 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