Basimglurant Medicine 03 June 2025 Extended indication Basimglurant monotherapy for treatment of pain associated with primary Trigeminal neuralgia in adults and elderly with suboptimal response to their current anti-pain therapy. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Basimglurant Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Pain Extended indication Basimglurant monotherapy for treatment of pain associated with primary Trigeminal neuralgia in adults and elderly with suboptimal response to their current anti-pain therapy. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Noema Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date January 2026 Expected Registration February 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Trigeminusneuralgie wordt in eerste instantie medicamenteus behandeld. Neurontin en Tegretol zijn de eerste keuze preparaten. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a day Dosage per administration 1,5 mg tot 3,5 mg References NCT05217628 Additional remarks Expected patient volume per year Patient volume 180 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References 1: Nederlandse vereniging voor Neurologie; 2: Expert opinie; Additional remarks Trigeminusneuralgie (TN) is een invaliderend chronisch pijnsyndroom, gekenmerkt door spontane of uitgelokte aanvallen van een zeer hevige, schietende pijn in een zone van het gelaat. Met een incidentie van 4 à 5 per 100.000 per jaar is het de meest voorkomende neuralgie (1). De groep patiënten met een suboptimale respons na overige neuropathische pijnstillers zal in aanmerking komen. Uit een grove schatting volgt dat er dan waarschijnlijk 1 patiënt per 100.000 per jaar in aanmerking komt (2). 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