Etrolizumab Medicine 12 June 2018 Extended indication Moderately to severely active Crohn's disease Therapeutic value No estimate possible yet Total cost € 6,000,000.00 Registration phase No registration expected Product Active substance Etrolizumab Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Bowel diseases Extended indication Moderately to severely active Crohn's disease Current proprietary name Already available biosimilars / generics Proprietary name Entyvio Manufacturer Roche Portfolio holder Mechanism of action Immunosuppression Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Gehumaniseerde monclonale antilichamen gericht tegen de beta7 integrin subunit van de heterodimeren alpha4beta7 (α4β7) en alphaEbeta7 (αEβ7). Scrip pipeline watch 3 november 2017: HICKORY trial: well tolerated, clinical improvement Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date Expected Registration Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks De fabrikant heeft de studies voor dit geneesmiddel gestopt vanwege tegenvallende resultaten. Therapeutic value Current treatment options Aminosalicylaten, corticosteroïden, immunosuppressiva, TNF-α-blokkers, Ustekinumab. Therapeutic value No estimate possible yet 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 NCT02394028 Additional remarks Toedieningsfrequentie is 1 maal per 4 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 in Nederland ruim 80.000 mensen met een chronische darmontsteking. Dit is ongeveer 1 op de 200 mensen. Hiervan heeft iets minder dan de helft de ziekte van Crohn. In 2017 werd vedolizumab voorgeschreven aan 1.658 patiënten met chronische darmontstekingen, hiervan hebben er ongeveer 800 Crohn. Uitgaande van 50% marktaandeel wordt geschat dat etrolizumab zal worden voorgeschreven aan 400 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 Additional remarks De fabrikant geeft aan dat de prijs in Nederland nog onbekend is. Op basis van het farmacotherapeutisch kompas zou een behandeling met de concurrent edolizumab ongeveer €20.000 per jaar kosten (9 infusies per jaar van 300mg). Volgens de GIP-databank is er in 2015 €9.317 per gebruiker vergoed. Potential total cost per year Total cost € 6,000,000.00 Total cost for sluice Additional remarks De fabrikant geeft aan dat de prijs in Nederland nog onbekend is. Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Ulcerative colitis References NCT02100696 Additional remarks Other information Additional remarks