Ozanimod Medicine 09 January 2018 Extended indication Relapsing multiple sclerosis Therapeutic value No judgement Total cost € 10,200,000.00 Registration phase Clinical trials Product Active substance Ozanimod Domain Neurological disorders Reason of inclusion Main indication Multiple sclerosis Extended indication Relapsing multiple sclerosis Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Celgene Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Toedieningsvorm: naast een Capsule-vorm komt Ozanimod ook als vloeistof beschikbaar voor kinderen (bron EMA). Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity New medicine ATMP Unknown Submission date October 2018 Expected Registration August 2019 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a day Dosage per administration 0,5-1 mg References Additional remarks Expected patient volume per year Patient volume 400 - 800 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIP databank, hersenstichting, Nationaal MS fonds. Additional remarks Hersenstichting: In Nederland komt MS voor bij ongeveer 1 op de 1000 inwoners. Nederland telt dus ongeveer 17.000 mensen met MS. RMS komt bij ongeveer 40% van alle mensen met MS voor (6800 personen). Verwachting: minder patiënten dan Ocrevus. Inschatting reëel volume: 400-800. Expected cost per patient per year Cost € 12,000.00 - 22,000.00 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 Additional remarks Prijs in lijn met directe concurrenten. Bij substitutie geen toename in kosten. Potential total cost per year Total cost € 10,200,000.00 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