Mirikizumab Medicine 04 June 2024 Extended indication Extension to include treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Mirikizumab Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Bowel diseases Extended indication Extension to include treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment Current proprietary name Already available biosimilars / generics Proprietary name Omvoh Manufacturer Eli Lilly Portfolio holder Mechanism of action Interleukin inhibitor Route of administration Subcutaneous Therapeutical formulation Injection 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 May 2024 Expected Registration March 2025 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Dit geneesmiddel is in de sluis geplaatst voor zover verstrekt in het kader van geneeskundige behandelingen. Therapeutic value Current treatment options IL-23 remmers risankizumab, ustekinumab, vedolizumab Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Op dit moment loopt er een fase 3 studie. Mirikizumab is een selectieve IL-23 remmer, die reeds geregistreerd is voor colitis ulcerosa. Dit middel zal gaan concurreren met IL-23 remmers risankizumab (reeds geregistreerd voor Crohn) en guselkumab (nog niet geregistreerd voor IBD) en IL12/23-remmer ustekinumab (reeds geregistreerd voor Crohn en colitis ulcerosa). Ustekinumab is daarbij snel beschikbaar als biosimilar en zal dan zeer waarschijnlijk veel goedkoper zijn. Duration of treatment Frequency of administration Dosage per administration References Additional remarks NCT03926130 Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References https://www.crohn-colitis.nl 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. Er wordt verwacht dat het patiëntvolume laag zal uitvallen door de concurrentie op deze indicatie. Expected cost per patient per year Cost References G-standaard november 2024 Additional remarks €1134,29 voor 15 ml concentraat voor oplossing voor infusie 20 mg/ml. 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 Unknown Indication extensions References Additional remarks Other information Additional remarks