Ustekinumab Medicine 12 June 2018 Extended indication Extension of Indication for Stelara to include treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies. Therapeutic value No judgement Total cost € 7,600,000.00 Registration phase Registration application pending Product Active substance Ustekinumab Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Bowel diseases Extended indication Extension of Indication for Stelara to include treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies. Current proprietary name Already available biosimilars / generics Proprietary name Stelara Manufacturer Janssen Portfolio holder Mechanism of action Interleukin inhibitor Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks IL12/23 remmer. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date January 2019 Expected Registration October 2019 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Mesalazines (oraal/ topicaal), glucocorticoiden en budesonides (oraal/ topicaal), thiopurines (oraal), tacrolimus (oraal), anti-TNF (sc, iv), vedolizumab (iv) Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times every 12 weeks Dosage per administration 90-130 mg References NCT02407236 Additional remarks 130 mg IV als inductie, daarna 90 mg SC als onderhoud elke 12 weken. Expected patient volume per year Patient volume 400 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Crohn-colitis.nl; GIPdatabank Additional remarks Er zijn momenteel ruim 80.000 mensen in Nederland met een chronische darmontsteking. Dit is ongeveer 1 op de 200 mensen. Hiervan heeft iets meer dan de helft colitis. Een vergelijkbare biological die gericht is tegen integrines is vedolizumab. In 2017 werd vedolizumab voorgeschreven aan 1.658 patiënten met chronische darmontstekingen, hiervan hebben er ongeveer 800 UC. Uitgaande van 50% marktaandeel wordt geschat dat ustekinumab zal worden voorgeschreven aan 400 patiënten per jaar. Expected cost per patient per year Cost € 19,000.00 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; fabrikant Additional remarks Huidige listprijs (+BTW) voor 1 spuit 90 mg is €3254,72. 30% krijgt om de 12 weken een 90 mg spuit, 70% om de 8 weken. Dat wil zeggen gemiddeld 5,85 dosissen op jaarbasis. Dus €19.040 per patiënt per jaar. Potential total cost per year Total cost € 7,600,000.00 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