Secukinumab Medicine 10 June 2020 Extended indication Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy. Therapeutic value Possible equal value Total cost € 787,500.00 Registration phase Registered and reimbursed Product Active substance Secukinumab Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Skin diseases Extended indication Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy. Current proprietary name Already available biosimilars / generics Proprietary name Cosentyx Manufacturer Novartis Portfolio holder Mechanism of action Interleukin inhibitor Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Monklonaal antilichaam gericht tegen IL-17A. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date November 2019 Expected Registration August 2020 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie juni 2020. Therapeutic value Current treatment options Topicale middelen, lichttherapie en methotrexaat. Later in behandellijn een biological (etanercept, adalumumab of ustekinumab) Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Er wordt verwacht dat secukinumab de concurrentie aan zal gaan met de andere anti-IL17 remmers. Duration of treatment Frequency of administration 1 times every 4 weeks Dosage per administration Afhankelijk van gewicht 75 of 150 mg References NCT03668613 Additional remarks Verwachte loading dose bij start behandeling, conform SmPC. Expected patient volume per year Patient volume 100 - 200 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NHG-Standaard Psoriasis Additional remarks Bij jonge kinderen is de prevalentie laag (ongeveer 0,4 per 1.000 patiënten per jaar). In Nederland zijn er 1,5 miljoen kinderen in de leeftijd van 6 tot 12 jaar. Dit betekent naar schatting 600 kinderen met deze indicatie. Het huidige aantal kinderen op een biological zal mogelijk rond de 50 liggen. Er wordt verwacht dat dit aantal de komende jaren zal groeien naar 100-200. Hoe de verdeling van de markt over deze biologicals eruit zal zien is nog niet duidelijk. Een gedeelte van de patiënten zal mogelijk over stappen op deze behandeling. Expected cost per patient per year Cost € 3,500.00 - 7,000.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References Fabrikant Additional remarks Kosten per patient per jaar afhankelijk van gewicht. Potential total cost per year Total cost € 787,500.00 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