Vedolizumab Medicine 07 December 2021 Extended indication Treatment of adult patients with pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with, lost response to, or were intolerant to antibiotic therapy. Therapeutic value No estimate possible yet Total cost € 2,298,700.00 Registration phase Registered and reimbursed Product Active substance Vedolizumab Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Bowel diseases Extended indication Treatment of adult patients with pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with, lost response to, or were intolerant to antibiotic therapy. Current proprietary name Already available biosimilars / generics Proprietary name Entyvio Manufacturer Takeda Portfolio holder Mechanism of action Immunosuppression Route of administration Intravenous Therapeutical formulation Powder for solution for infusion Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date June 2021 Expected Registration January 2022 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie ontvangen in december 2021. Therapeutic value Current treatment options anti-TNF. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Maximal 30 week / weeks Frequency of administration 1 times every 8 weeks Dosage per administration 300 mg References NCT02790138 (EARNEST) Additional remarks Toediening is op dag 1, in week 2 en week 6 en vervolgens 1 keer per 8 weken. In de studie werd maximaal 30 weken behandeld, maar trad klinische remissie vaak al op na 14 weken. Expected patient volume per year Patient volume 200 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expert opinie (1)(2); 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 ulceratieve colitis. Er wordt verwacht dat er 200 patiënten in aanmerking zullen komen voor deze behandeling (1). Er worden 100 pouchen per jaar gezet, waarvan 10% niet reageert. Daarom is er een incidentie van 10 patiënten per jaar ingeschat (2). Expected cost per patient per year Cost € 9,195.00 - 13,792.00 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 Additional remarks Entyvio, 300mg poeder voor oplossing voor infusie 300mg: €2.298,80. In de studie werden 4-6 injecties gegeven afhankelijk van wanneer klinische remissie optrad. Potential total cost per year Total cost € 2,298,700.00 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