Ocrelizumab Medicine 04 June 2026 Extended indication Pediatrische patiënten van tien jaar en ouder met relapsing remitting MS (RRMS) Therapeutic value Possible added value Total cost € 520,000.00 Registration phase Registration application pending Product Active substance Ocrelizumab Domain Neurological disorders Reason of inclusion Indication extension IND Main indication Multiple sclerosis Extended indication Pediatrische patiënten van tien jaar en ouder met relapsing remitting MS (RRMS) Current proprietary name Already available biosimilars / generics Proprietary name Ocrevus Manufacturer Roche Portfolio holder Roche Mechanism of action Immunosuppression Route of administration Intravenous Therapeutical formulation Injection / infusion Budgetting framework Intermural (MSZ) Centre of expertise Erasmus Medisch Centrum Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date November 2025 Expected Registration November 2026 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Fingolimod Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation De resultaten van de fase 3 Operatta studies zijn gepresenteerd op de ECTRIMS 2025.Hieruit is op te maken dat ocrelizumab een duidelijke meerwaarde vertoont ten opzichte van fingolimod. Duration of treatment Average 4 year / years Frequency of administration 1 times every 6 months Dosage per administration 600 mg References Additional remarks Expected patient volume per year Patient volume 20 - 30 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References 1: Expertopinie; Additional remarks De inschatting is dat het eerste jaar ongeveer 15 tot 25 kinderen zullen starten. De incidentie is 8 tot 10 patiënten per jaar (1). Expected cost per patient per year Cost € 20,800.00 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 De fabrikant geeft aan de bovenstaande kosten per patiënt per jaar te verwachten. Potential total cost per year Total cost € 520,000.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks