Tofacitinib Medicine 09 January 2018 Extended indication Ulcerative colitis Therapeutic value Possible added value Total cost € 243,000,000.00 Registration phase Unknown Product Active substance Tofacitinib Domain Chronic immune diseases Reason of inclusion Main indication Bowel diseases Extended indication Ulcerative colitis Current proprietary name Already available biosimilars / generics Proprietary name Xeljanz Manufacturer Pfizer Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Al op de markt voor andere indicaties, waaronder RA. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration June 2018 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Indicatie-uitbreiding Therapeutic value Current treatment options Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Allereerst zullen naar verwachting patiënten die niet reageren op (of intolerant zijn voor) bestaande anti-TNFs en vedolizumab worden omgezet naar dit middel. Maar positionering op termijn natuurlijk nog onduidelijk. Duration of treatment Frequency of administration 2 times a day Dosage per administration 5 mg References Sandborn et al. N Engl J Med. 2012 Aug 16;367(7):616-24. doi: 10.1056/NEJMoa1112168; Sandborn et al. N Engl J Med. 2017 May 4;376(18):1723-1736. doi: 10.1056/NEJMoa1606910. Additional remarks Onderhoudsbehandeling Expected patient volume per year Patient volume 500 - 40,000 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. Expected cost per patient per year Cost € 11,000.00 - 13,000.00 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 €16,34 per 5 mg tablet wat zou leiden tot €11.928,54 pppj Potential total cost per year Total cost € 243,000,000.00 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 Misschien indicatie-uitbreiding Crohn. Echter twee negatieve fase 2 studies bij ziekte van Crohn. References Panes et al Gut. 2017 Jun;66(6):1049-1059. doi: 10.1136/gutjnl-2016-312735; Sandborn et al, Clin Gastroenterol Hepatol. 2014 Sep;12(9):1485-93.e2. doi: 10.1016/j.cgh.2014.01.029 Additional remarks Other information Additional remarks