Ozanimod Medicine 08 June 2021 Extended indication Extension of indication to include the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. Therapeutic value No estimate possible yet Total cost Registration phase Positive CHMP opinion Product Active substance Ozanimod Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Bowel diseases Extended indication Extension of indication to include the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. Current proprietary name Already available biosimilars / generics Proprietary name Zeposia Manufacturer Celgene Portfolio holder Mechanism of action Immunosuppression Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Sphingosine 1 phosphate receptor modulator. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date October 2020 Expected Registration December 2021 Orphan drug Yes Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie ontvangen oktober 2021. Therapeutic value Current treatment options Vedolizumab, JAK-remmers, biologicals Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Nieuw werkingsmechanisme bij UC: functionele antagonist van de S1P1-receptor op lymfocyten, waardoor lymfocyten minder makkelijk migreren uit de lymfeklieren. Potentieel van meerwaarde voor UC-patiënten, die niet goed reageren of bijwerkingen hebben op andere geneesmiddelen daarnaast kan ook de orale toediening een voordeel zijn. Naar verwachting zal het ingezet worden na falen op 1e of 2e lijn biological en de concurrentie aangaan met vedolizumab. Duration of treatment Frequency of administration 1 times a day Dosage per administration 0,92 mg References NCT01647516 Additional remarks Expected patient volume per year Patient volume 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 ulcerative colitis. Er wordt verwacht dat er 200-300 patiënten in aanmerking zullen komen voor ozanimod. Expected cost per patient per year Cost € 16,461.00 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 Gemiddelde prijs per 28 stuks Zeposia, capsule 0,92mg €1.266,24. 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