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Cannabis Extract Ycj-01

Medicine

Extended indication Cannabis extract ycj-01 monotherapy for treatment of refractory epilepsy secondary to Tuberous sclerosis complex in children, adolescents, adults and
Registration phase Clinical trials

Product

Active substance Cannabis Extract Ycj-01
Domain Neurological disorders
Reason of inclusion New medicine (specialité)
Main indication Epilepsy
Extended indication Cannabis extract ycj-01 monotherapy for treatment of refractory epilepsy secondary to Tuberous sclerosis complex in children, adolescents, adults and elderly
Manufacturer OILS4CURE
Portfolio holder OILS4CURE
Mechanism of action Cannabinoid
Budgetting framework Extramural (GVS)
Centre of expertise Kinderen: Sophia- of Wilhelmina Kinderziekenhuis. Volwassenen: UMCU of Erasmus MC

Registration

Submission date January 2027
Expected Registration February 2028
Registration phase Clinical trials

Therapeutic value

Current treatment options Anti-epileptica
References NCT07403266 (EstuEla2022)

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.
References (1) Vereniging Klinische Genetica Nederland, Tubereuze Sclerose Complex. (2) Chu-Shore, C., Major, P., Camposano, S., Muzykewicz, D., & Thiele, E. (2009). The natural history of epilepsy in tuberous sclerosis complex. Epilepsia, 51(7), 1236-1241.
Additional remarks Naar schatting zijn er in Nederland ongeveer 1.000 - 2.000 patiënten met TSC (1). Ongeveer 80%-90% hiervan vertoont epileptische aanvallen (800 -1800). Alleen patiënten met refractaire epilepsie zullen in aanmerking komen voor deze behandeling. "85.2% had a "history of seizureʼʼ en ʼʼOf epilepsy patients, 62,5% developed refractory epilepsyʼʼ (2). Dit komt neer op 85,2% van 800 -1800 is 682 -1534, waarvan 62,5% is een totaal van 426 - 959 patiënten.

Expected cost per patient per year

Additional remarks Er is nog niets bekend over de mogelijke prijs.

Potential total cost per year

Off label use

Indication extension

Other information