Obinutuzumab Medicine 06 June 2023 Extended indication Extension of indication to include the pre-treatment to reduce the risk of cytokine release syndrome (CRS) induced by glofitamab for Gazyvaro. Therapeutic value No estimate possible yet Total cost Registration phase No registration expected Product Active substance Obinutuzumab Domain Hematology Reason of inclusion Indication extension IND Main indication Other hematology Extended indication Extension of indication to include the pre-treatment to reduce the risk of cytokine release syndrome (CRS) induced by glofitamab for Gazyvaro. Current proprietary name Already available biosimilars / generics Proprietary name Gazyvaro Manufacturer Roche Portfolio holder Roche Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date December 2022 Expected Registration Orphan drug Unknown Registration phase No registration expected Reimbursement Medicine sluice Additional remarks Deze registratie is teruggetrokken. https://www.ema.europa.eu/en/medicines/human/variation/gazyvaro Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Obinituzumab zal preventief of bij symptomen gegeven kunnen worden zeven dagen voor de eerste gift glofitamab. De verwachting CRS 63% na glofitamab ondanks obinutuzumab, de verwachting is dat er dan alsnog CRS therapie gegeven moet worden. Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume 126 - 168 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Indien obinutuzumab bij alle glofitamab behandeling ingezet zal worden zou het patiëntvolume mogelijk tussen de 126 tot 168 patiënten liggen gebaseerd op de inschatting van glofitamab. Expected cost per patient per year Cost References medicijnkosten Additional remarks Prijs voor huidige indicatie is €3.957,86 per 1.000mg 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 Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks