Blinatumomab Medicine 09 January 2018 Extended indication Adults with minimal residual disease (MRD) positive B-cell precursor acute lymphoblastic leukaemia (ALL). Therapeutic value Possible added value Total cost € 2,625,000.00 Registration phase Unknown Product Active substance Blinatumomab Domain Oncology and Hematology Reason of inclusion Main indication Leukemia Extended indication Adults with minimal residual disease (MRD) positive B-cell precursor acute lymphoblastic leukaemia (ALL). Current proprietary name Already available biosimilars / generics Proprietary name Blincyto Manufacturer Amgen Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Unknown Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration June 2018 Orphan drug Yes Registration phase Unknown Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Diverse chemo-schema's Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration 15 μg/m2 References Gökbuget et al. ASH 2014; Abstract 379 and oral presentation. Volledige publicatie verwacht in 2017. Additional remarks Fabrikant: Behandelduur is max. 4 cycli indien response. Cyclus: 4 weken continue infusie (cIV) daarna behandelingsvrij interval van 2 weken. Expected patient volume per year Patient volume 20 - 30 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Fabrikant Additional remarks Incidentie is 0,12 per 100.000 mensen. Expected cost per patient per year Cost € 70,000.00 - 140,000.00 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; Fabrikant Additional remarks €2.912,21 per blinatumomab infpdr flacon 38,5 μg + solv 10 ml (uitgaande van 1,7m2). €55.331,99 per cyclus. Fabrikant (nov 2017): Behandelduur van 1-2 cycli (28 behandeldagen, 28 μg/dag). Uitgaande van 1 behandeling per patiënt jaar: €70.00-140.000 pppj. Potential total cost per year Total cost € 2,625,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks