Alicaforsen Medicine 09 January 2018 Extended indication Ulcerative colitis Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Alicaforsen Domain Chronic immune diseases Reason of inclusion Main indication Bowel diseases Extended indication Ulcerative colitis Current proprietary name Already available biosimilars / generics Proprietary name Oligo-TCS Manufacturer Atlantic Portfolio holder Mechanism of action Unknown Route of administration Rectal Therapeutical formulation Enema Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Indication extension ATMP Unknown Submission date Expected Registration Orphan drug No Registration phase Clinical trials 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 Dosage per administration References Van Deventer et al, Aliment Pharmacol Ther. 2006 May 15;23(10):1415-25; Miner et al, Aliment Pharmacol Ther. 2006 May 15;23(10):1427-34. Additional remarks Nog te vroeg om iets over te zeggen. Alleen fase 2 studie en open label studie beschikbaar bij CU. Gaat voorlopig nog niet op de markt komen. Expected patient volume per year Patient volume 150 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Crohn-colitis.nl Additional remarks Colitis ulcerosa komt steeds vaker voor, met name in de westerse landen. 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. Inschatting bij concurrerende medicatie (etrolizumab, ustekinumab) is 150 patiënten. Expected cost per patient per year Cost References Additional remarks Waarschijnlijk hoge kosten Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks