Ustekinumab Medicine 12 June 2018 Extended indication Pediatric Psoriasis 6-12 jr Therapeutic value Possible added value Total cost € 1,600,000.00 Registration phase Clinical trials Product Active substance Ustekinumab Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Skin diseases Extended indication Pediatric Psoriasis 6-12 jr Current proprietary name Already available biosimilars / generics Proprietary name Stelara Manufacturer Janssen Portfolio holder Mechanism of action Unknown Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks IL12/23 remmer Registration Registration route Unknown Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration July 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Ten opzichte van TNF remmers Duration of treatment Frequency of administration 5 times a year Dosage per administration 0,75 mg/kg References NCT02698475 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 De inschatting is dat er maximaal 100 patiënten zijn die voor deze indicatie van ustekinumab in aanmerking komen. Expected cost per patient per year Cost € 16,000.00 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 Medicijnkosten.nl Additional remarks 45 mg wegwerpspuit kost €3.235,84. Voor de behandeling van een patiënt van 50 kg betekent dit 5 spuiten per jaar en dus €16.179,20 Potential total cost per year Total cost € 1,600,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Lupus References Additional remarks Other information Additional remarks