Leuco-methylthioninium Medicine 09 January 2018 Extended indication Dementia, behavioural variant frontotemporal. 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 Dementia, behavioural variant frontotemporal. 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 Expected Registration 2019 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Zou mogelijk een nieuwe 1e lijns behandeling kunnen worden. Expected patient volume per year Patient volume 900 - 3,600 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References http://www.levenmetalzheimer.nl/content/alzheimer/feiten-cijfers.asp, hersenstichting.nl, https://www.sfk.nl/publicaties/PW/2016/inzet-medicijnen-bij-dementie-loopt-terug Additional remarks In Nederland zijn 270.000 mensen dement. Gezien de indicatie "behavioural variant frontotemporal" betreft zal het gaan om 3%-12% van de mensen met dementie (hersenstichting.nl). Dit zijn omgerekend ongeveer 8.000 - 32.500 patiënten. Gezien maar 1/9de van de mensen met dementie geneesmiddelen gebruikt (SFK) is de verwachting dat er 900-3600 patiënten in aanmerking komen voor het middel gezien de indicatie. 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