Ozanimod Medicine 09 January 2018 Extended indication Adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features. Therapeutic value Possible equal value Total cost € 4,900,000.00 Registration phase Registered and reimbursed Product Active substance Ozanimod Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Multiple sclerosis Extended indication Adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features. 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 Extramural (GVS) Centre of expertise Additional remarks The treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date March 2019 Expected Registration May 2020 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in maart 2020. Dit geneesmiddel is deels vergoed. Therapeutic value Current treatment options Omdat het net als fingolimod een sfingosine 1-fosfaatreceptor modulator is en ook oraal wordt toegediend verwachten we eerst vergelijking met fingolimod en daarna met onder andere dimethylfumaraat en teriflunomide. Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Tussen de sfingosine-1-fosfaat receptoragonisten is veel concurrentie en weinig verschil in aangetoonde effectiviteit. Het verschil tussen deze geneesmiddelen ligt met name in de bijwerkingsprofielen. Duration of treatment Frequency of administration 1 times a day Dosage per administration 0,92 mg References RADIANCE: NCT02047734 SUNBEAM: NCT02294058 Additional remarks Expected patient volume per year Patient volume 200 - 500 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 1.000 inwoners. Nederland telt dus ongeveer 17.000 mensen met MS. RMS komt bij ongeveer 40% van alle mensen met MS voor (6.800 personen). Door de concurrentie aan middelen zal het verwachte marktaandeel op maximaal een paar honderd patiënten komen te liggen. Expected cost per patient per year Cost € 9,000.00 - 19,000.00 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 GIP-databank Additional remarks Prijs verwacht in lijn met directe concurrenten. Bij substitutie geen toename in kosten. Potential total cost per year Total cost € 4,900,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Colitis ulcerosa References Fabrikant Additional remarks Other information Additional remarks