Ocrelizumab Medicine 09 January 2018 Extended indication Multiple sclerosis, relapsing remitting (RRMS), PPMS. Therapeutic value No judgement Total cost € 17,825,000.00 Registration phase Unknown Product Active substance Ocrelizumab Domain Neurological disorders Reason of inclusion Main indication Multiple sclerosis Extended indication Multiple sclerosis, relapsing remitting (RRMS), PPMS. Current proprietary name Already available biosimilars / generics Proprietary name Ocrevus Manufacturer Roche Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Werkingsmechanisme: anti-CD20 monoklonaal antilichaam. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date June 2016 Expected Registration January 2018 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie november 2017. In maart 2017 geregistreerd door de FDA. Therapeutic value Current treatment options Interferon β-1a, Interferon β-1b, Glatiramer acetate, Peginterferon β-1a, Daclizumab, Fingolimod, Teriflunomide, Dimethyl fumarate, Natalizumab, Alemtuzumab. Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation De genoemde huidige behandelopties hebben betrekking op RMMS en niet op de verwachte registratie voor PPMS. Voor PPMS wordt rituximab off label toegepast. Duration of treatment Frequency of administration 2 times a year Dosage per administration 600 mg References Hauser et al. N Engl J Med. 2017 Jan 19;376(3):221-234. doi: 10.1056/NEJMoa1601277. Additional remarks Toedieningsfrequentie: 1 maal per 24 weken. Expected patient volume per year Patient volume 550 - 1,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Max. patiëntaantal gebaseerd op voorgaande publicatie Horizonscan+ (december 2016). Fabrikant: van max. naar realistische patiëntaantal; gezien de beschikbaarheid van andere behandelopties voor deze patiënten. Expected cost per patient per year Cost € 23,000.00 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 Fiercepharma, Fabrikant Additional remarks Fiercepharma: $65.000 p.p.p.j. Fabrikant geeft aan dat de te verwachte prijs in Nederland waarschijnlijk minder gaat kosten dan €23000 p.p.p.j. Potential total cost per year Total cost € 17,825,000.00 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