Blinatumomab Medicine 08 December 2020 Extended indication Extension of indication to include the use of blinatumomab 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 consolidation therapy Therapeutic value No judgement Total cost Registration phase Registration application pending Product Active substance Blinatumomab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication ALL Extended indication Extension of indication to include the use of blinatumomab 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 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 September 2021 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Standaard consolidatie chemotherapie pediatrische ALL Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Resultaten worden gepresenteerd tijdens een congres later in 2020. Duration of treatment Frequency of administration Dosage per administration References Fabrikant 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 10 ml. (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