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Ocrelizumab

Ocrevus

Extended indication Multiple sclerosis, relapsing remitting (RRMS), PPMS.
Therapeutic value No judgement
Total cost 17,825,000.00

Product

Active substance Ocrelizumab
Domain Neurological disorders
Main indication Multiple sclerosis
Extended indication Multiple sclerosis, relapsing remitting (RRMS), PPMS.
Proprietary name Ocrevus
Manufacturer Roche
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Werkingsmechanisme: anti-CD20 monoklonaal antilichaam.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date June 2016
Expected Registration January 2018
Orphan drug No
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
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 continuous
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.
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
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

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.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.