ABBV-8E12 Medicine 10 December 2019 Extended indication Progressive Supranuclear Palsy (PSP) Therapeutic value No judgement Total cost Registration phase Withdrawn Product Active substance ABBV-8E12 Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Neurological disorders other Extended indication Progressive Supranuclear Palsy (PSP) Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Abbvie Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Gehumaniseerd recombinant antilichaam gericht tegen tau. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date Expected Registration Orphan drug Yes Registration phase Withdrawn Reimbursement Medicine sluice Additional remarks Programma door AbbVie gestaakt, product komt niet op de markt. Therapeutic value Current treatment options Geen, alleen symptoombestrijding. 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 NCT02985879 Additional remarks Expected patient volume per year Patient volume < 1,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Erfelijkheid.nl; Donker Kaat et al. Ned Tijdschr Geneeskd. 2004;148:519-23 Additional remarks Naar schatting krijgen 5-6 op de 100.000 mensen PSP. In Nederland zou dit dan gaan om ongeveer 1.000 mensen. Expected cost per patient per year Cost References Additional remarks Aangezien er geen huidige behandeling voor PSP voorhanden is zal er naar verwachting een hoge prijs gevraagd worden bij een bewezen therapeutische waarde. 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 Yes Indication extensions Alzheimer's disease (fase 2) References Clinicaltrials.gov Additional remarks Other information Additional remarks