Blinatumomab Medicine 09 January 2018 Extended indication Extension of indication to include the treatment of Philadelphia chromosome positive CD19 positive B-cell precursor acute lymphoblastic leukaemia (ALL) in adult and paediatric patients with relapsed or refractory ALL and adult patients in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% Therapeutic value Possible added value Total cost € 340,000.00 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 treatment of Philadelphia chromosome positive CD19 positive B-cell precursor acute lymphoblastic leukaemia (ALL) in adult and paediatric patients with relapsed or refractory ALL and adult patients in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% 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 August 2019 Expected Registration November 2020 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Fabrikant verwacht registratie in november 2020. 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 9-28 μg References Fabrikant; Martinelli et al. ASH 2015; Abstract 679 and oral presentation. Volledige publicatie verwacht in 2017. Additional remarks Fabrikant: Behandelduur is maximaal 5 cycli (bij complete response in eerste 2 cycli). Cyclus: 4 weken continue infusie (cIV) daarna behandelingsvrij interval van 2 weken; Startdosering, (dag 1-7): 9 μg/dag; Vervolgdosering, (dag 8-28): 28 μg/dag; Cyclus 2 en daaropvolgende cycli, (dag 1-28): 28 μg/dag Expected patient volume per year Patient volume 3 - 5 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2015; Fabrikant Additional remarks NKR: 34 diagnoses B-ALL met specifieke cytogenetische afwijkingen. Fabrikant: Maximaal patiëntenvolume: ± 208 nieuw gediagnosticeerde patiënten op jaarbasis. Hiervan zijn ca. 16 patiënten Pre-cursor B-ALL en Philadelphia-positief, waarvan circa 30% een eerste recidief krijgt. Dit komt overeen met circa 5 patiënten per jaar. Hiervan komt waarschijnlijk 60% in aanmerking voor blinatumomab. Expected cost per patient per year Cost € 70,000.00 - 100,000.00 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 €2.750,67 per blinatumomab infpdr flacon 38,5 μg + solv 10 ml. Fabrikant (nov 2017): Behandelduur van 1 of 2 cycli (respectievelijk 28 behandeldagen + 14 medicatie-vrije dagen; 28 + 14 + 28 dagen); gebaseerd op gebruik in real world. Dosis: Startdosering (dag 1-7) 9 μg/dag. Vervolgdosering (dag 8 – 28) 28 μg/dag. Cyclus 2 en daaropvolgende cycli (dag 1 – 28) 28 μg/dag. Uitgaande van 1 behandeling per patiënt per jaar en een 50-50 verdeling van patiënten met 1 of 2 cycli. €70.000-€100.000 per patiënt per jaar. Potential total cost per year Total cost € 340,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions alle indicaties in de Horizonscan en nu ook een fase 3 studie gestart voor DLBCL. References clinicaltrials.gov Additional remarks Other information Additional remarks