Rituximab Medicine 12 June 2019 Extended indication MabThera, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ≥2 to <18 years old) with severe, active GPA (Wegener’s) and MPA. Therapeutic value No judgement Total cost € 460,000.00 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 induction of remission in paediatric patients (aged ≥2 to <18 years old) with severe, active GPA (Wegener’s) and 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 February 2019 Expected Registration April 2020 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in januari 2020. Geregistreerd in april 2020. Therapeutic value Current treatment options Cyclofosfamide en prednison Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Mogelijk voordeel ten opzichte van alternatieven vanwege bijwerking op groeiontwikkeling van huidige behandelingen. 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 31 - 61 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 CBS bevolkingsstatistieken 2017 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. De populatie ≥2 tot <18 beslaat 18% van de totale bevolking. Bij een vergelijkbare verdeling van deze indicatie zou dit 31-61 patiënten betekenen. De werkgroep geeft aan enkele tientallen patiënten te verwachten. 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 € 460,000.00 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 Pamphigus vulgaris References EMA Additional remarks Other information Additional remarks