Etrolizumab Medicine 12 June 2018 Extended indication Ulcerative colitis Therapeutic value No judgement Total cost € 2,250,000.00 Registration phase Clinical trials Product Active substance Etrolizumab Domain Chronic immune diseases Reason of inclusion Main indication Bowel diseases Extended indication Ulcerative colitis Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Roche Portfolio holder Mechanism of action Unknown Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Scrip pipeline watch 3 nov 2017: BERGAMOT trial: well tolerated, clinical improvement Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity New medicine ATMP Unknown Submission date 2020 Expected Registration 2021 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Aminosalicylaten, corticosteroïden, immunosuppressiva, TNF-α-blokkers, Vedolizumab, Ustekinumab. 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 4 weeks Dosage per administration 105 mg References NCT02100696 Additional remarks Toedieningsfrequentie is 1 maal per 4 weken 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; 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 2015 werd vedolizumab voorgeschreven aan 587 patiënten met chronische darmontstekingen, hiervan hebben er ongeveer 300 UC. Uitgaande van 50% marktaandeel wordt geschat dat Etrolizumab zal worden voorgeschreven aan 150 patiënten per jaar. Expected cost per patient per year Cost € 10,000.00 - 20,000.00 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; Farmacotherapeutisch Kompas; GIPdatabank Additional remarks Op basis van het FK zou een behandeling met de concurrent Vedolizumab ongeveer €20.000 per jaar kosten (9 infusies per jaar van 300 mg). Volgens de GIPdatabank is er in 2015 €9.317 per gebruiker vergoed. Potential total cost per year Total cost € 2,250,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Ziekte van Crohn References NCT02394028 Additional remarks Other information Additional remarks