Etrasimod Medicine 07 December 2022 Extended indication Treatment of patients 16 years of age and older 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 biological agent or a JAK inhibitor Therapeutic value No estimate possible yet Total cost € 3,600,000.00 Registration phase Registration application pending Product Active substance Etrasimod Domain Chronic immune diseases Reason of inclusion New medicine (specialité) Main indication Bowel diseases Extended indication Treatment of patients 16 years of age and older 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 biological agent or a JAK inhibitor Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Pfizer Portfolio holder Pfizer Mechanism of action Other Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Sphingosine 1 phosphate receptor modulator. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New therapeutical formulation ATMP No Submission date November 2022 Expected Registration February 2024 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Vedolizumab, JAK-remmers, biologicals en ozanimod. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Naar verwachting zal het ingezet worden na falen op 1e of 2e lijn biological. Ozanimod is een andere S1p-modulator die recent op de markt is gebracht voor deze indicatie. Op dit moment loopt de fase 3 studie nog. Duration of treatment Frequency of administration 1 times a day Dosage per administration 2mg References NCT03945188, fabrikant Additional remarks Expected patient volume per year Patient volume 200 - 250 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Maastricht umc(1); Crohn-colitis.nl(2); Expert opinie (3); Additional remarks Colitis ulcerosa komt steeds vaker voor, met name in de westerse landen. Er zijn momenteel ruim 90.000 mensen in Nederland met een chronische darmontsteking. Hiervan heeft iets meer dan de helft ulcerative colitis (2). In de praktijk zal het gebruik voor patiënten met ernstige ziekte niet heel groot zijn. Er wordt verwacht dat er 200-250 patiënten in aanmerking zullen komen voor etrasimod (3). De markt zal verdeeld worden met ozanimod. Expected cost per patient per year Cost € 16,000.00 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 Fabrikant; medicijnkosten.nl Additional remarks De prijs is nog niet vastgesteld. De prijsstelling zal niet vóór het 1ste kwartaal van 2024 beschikbaar zijn. Hierbij zal rekening worden gehouden met de prijzen van huidige beschikbare behandelopties. Ozanimod wordt ingeschat op €16.000 per patiënt per jaar. Potential total cost per year Total cost € 3,600,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks