Rituximab Medicine 13 December 2018 Extended indication MabThera, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA). Therapeutic value No judgement Total cost € 2,550,000.00 Registration phase Registered and reimbursed Product Active substance Rituximab Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Cardiovascular diseases Extended indication MabThera, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA). Current proprietary name Already available biosimilars / generics Proprietary name MabThera Manufacturer Roche Portfolio holder Mechanism of action Immunosuppression Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Monoklonaal antlichaam gericht tegen CD20 Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date April 2018 Expected Registration January 2019 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie november 2018. Geregistreerd in januari 2019. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Ondanks IV behandeling wel een verrijking, gegeven de effectiviteit. Duration of treatment Frequency of administration 1 times every 4 months Dosage per administration 1 g References NCT01697267 Additional remarks Expected patient volume per year Patient volume 170 - 340 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Cartin-Ceba et al. Curr Rheumatol Rep. 2012 Dec;14(6):481-93 Additional remarks De incidentie van ANCA-associated vasculitis (granulomatose met polyangiitis (GPA), microscopische polyangiitis (MPA) en eosinophiele granulomatose met polyangiitis (EGPA)) wordt wereld wijd ingeschat op 10-20 gevallen per miljoen inwoners. Voor Nederland zou dit een aantal van 170-340 per jaar betekenen. Expected cost per patient per year Cost € 10,000.00 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 Medicijnkosten.nl Additional remarks Per jaar wordt er per patiënt 4 g rituximab gebruikt. Dit komt neer op een bedrag van €10.042,86 Potential total cost per year Total cost € 2,550,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Pemphigus vulgaris References EMA Additional remarks Other information Additional remarks