Blinatumomab Medicine 08 December 2020 Extended indication Blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed Philadelphia chromosome negative CD19 positive B-precursor ALL as part of the consolidation therapy. Therapeutic value Possible added value Total cost Registration phase Registered and reimbursed Product Active substance Blinatumomab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication ALL Extended indication Blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed Philadelphia chromosome negative CD19 positive B-precursor ALL as part of the consolidation therapy. Current proprietary name Already available biosimilars / generics Proprietary name Blincyto Manufacturer Amgen Portfolio holder Mechanism of action Immunostimulation 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 Normal trajectory Particularity Unknown ATMP Unknown Submission date November 2020 Expected Registration June 2021 Orphan drug Yes Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in mei 2021. Therapeutic value Current treatment options Standaard consolidatie chemotherapie pediatrische ALL Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation De data uit de gerandomiseerde fase 3 studie is positief. De overall survival (OS) gemeten na 36 maanden was 81,1% voor patiënten behandeld met blinatumomab vergeleken met 55,8% voor patiënten behandeld met chemotherapie. Duration of treatment Frequency of administration Dosage per administration References Fabrikant; NCT02393859 Additional remarks informatie met betrekking tot effectiviteit, behandelduur, toedieningsfrequentie, dosering nog niet beschikbaar Expected patient volume per year Patient volume < 5 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Fabrikant; expert opinie uit Prinses Maxima Centrum Additional remarks Maximaal 5 patiënten Expected cost per patient per year Cost References Medicijnkosten.nl; Fabrikant Additional remarks €2.791 per blinatumomab infpdr flacon 38,5μg + solv 10ml. (inclusief BTW). Uiteindelijke kosten nog afhankelijk van dosering en aantal toedieningen. 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