Ixekizumab Medicine 10 December 2019 Extended indication Taltz is indicated for the treatment of moderate to severe plaque psoriasis in children from the age of 6 years and with a body weight of at least 25 kg and adolescents who are candidates for systemic therapy. Therapeutic value No judgement Total cost € 1,411,800.00 Registration phase Registered and reimbursed Product Active substance Ixekizumab Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Skin diseases Extended indication Taltz is indicated for the treatment of moderate to severe plaque psoriasis in children from the age of 6 years and with a body weight of at least 25 kg and adolescents who are candidates for systemic therapy. Current proprietary name Already available biosimilars / generics Proprietary name Taltz Manufacturer Eli Lilly Portfolio holder Mechanism of action Immunosuppression Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks 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 June 2020 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in mei 2020. Therapeutic value Current treatment options Etanercept, adalimumab en ustekinumab. Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Ixekizumab is een belangrijke aanwinst voor de behandeling van psoriasis bij kinderen, aangezien het een ander werkingsmechanisme dan de huidige beschikbare biologicals heeft. Duration of treatment Frequency of administration Dosage per administration References NCT03073200 Additional remarks Expected patient volume per year Patient volume < 100 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Komt in principe beschikbaar voor alle patiënten met matige tot ernstige psoriasis, in Nederland zijn dat er circa 165.000. Middel zal zijn plek moeten veroveren ten opzichte van andere reeds aanwezige biologicals. Aangezien de indicatie voor patiënten van 6-18 jaar is gesteld is de verwachting dat er niet meer dan 100 patiënten voor in aanmerking komen. Expected cost per patient per year Cost € 14,118.00 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 G-standaard juni 2020 Additional remarks Apotheekinkoopprijs per verpakking van 80mg: €1.086. Behandelschema (op basis van SmPC en de pivotale registratiestudies): Dosering: 80mg (patiënten >50kg (grootste groep) Toedieningsfrequentie: De aanbevolen dosis is 80mg per subcutane injectie in week 0, gevolgd door 40mg (één injectie) in de weken 2, 4, 6, 8, 10, en 12, daarna een onderhoudsdosering van 40mg (één injectie) elke 4 weken. Startjaar: 16 injecties/ jaar= €17.376; Onderhoudsjaar = €1.086 x 13 = €14.118. De definitieve dosering is echter nog niet vastgesteld. Potential total cost per year Total cost € 1,411,800.00 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