Rituximab Medicine 10 June 2020 Extended indication Advanced stage paediatric B-cell Non-Hodgkin’s Lymphoma (B-NHL). Therapeutic value Possible added value Total cost Registration phase Registered and reimbursed Product Active substance Rituximab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Aggressive non-Hodgkin’s lymphoma Extended indication Advanced stage paediatric B-cell Non-Hodgkin’s Lymphoma (B-NHL). 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 antilichaam gericht tegen CD20. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date June 2019 Expected Registration March 2020 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve opinie januari 2020 Therapeutic value Current treatment options Het betreft een toevoeging aan de intensieve chemotherapie voor kinderen met Burkitt ALL/NHL of DLBCL, beide vormen van NHL bij kinderen. Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Er is een grote gerandomiseerde studie bij kinderen gedaan die de meerwaarde van de combi chemo-immunotherapie heeft aangetoond. Duration of treatment Average 6 day / days Frequency of administration 1 times a day Dosage per administration 375 mg/m² References NCT01516580 Additional remarks Rituximab 375mg/m² in vergelijk: 6 injections: two doses at 48h interval are given at D-2 and D1 of the 2 first courses (COPADM) and one dose at the beginning of the 2 following courses (CYM or CYVE). Expected patient volume per year Patient volume 20 - 30 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NHL commissie SKION in Nederland. Additional remarks In Nederland krijgen jaarlijks ongeveer 30 kinderen, tussen de 0-15 jaar oud, een non-Hodgkin lymfoom, waarbij het iets vaker voor komt bij jongens dan bij meisjes. Expected cost per patient per year Cost References medicijnkosten Additional remarks Rituximab concentraat voor oplossing voor infusie 10mg/ml flacon 50ML, €1.267,28 Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Momenteel wordt dit al toegepast als SOC na het afronden van de studie. Additional remarks Indication extension Indication extensions No Indication extensions References Adisinsight; Pipeline fabrikant. Additional remarks Other information Additional remarks