Blinatumomab Medicine 09 January 2018 Extended indication Relapsed / Refractory Ph+ Adult Acute Lymphoblastic Leukemia (ALL). 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 Main indication Leukemia Extended indication Relapsed / Refractory Ph+ Adult Acute Lymphoblastic Leukemia (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 Centralised (EMA) Type of trajectory Unknown Particularity Indication extension ATMP Unknown Submission date Expected Registration August 2018 Orphan drug Yes Registration phase Registration application pending 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 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 max. 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; Fabrikant Additional remarks NKR 2015: 34 diagnoses B-ALL met specifieke cytogenetische afwijkingen. Fabrikant: Maximaal patiëntenvolume: ± 208 newly diagnosed patients op jaarbasis. Hiervan zijn ca 16 patiënten Pre-cursor B-ALL en Philadelphia-positief, waarvan ca 30% een eerste recidief krijgt. Dit komt overeen met ca 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 €2.912,21 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 pppj. 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 Unknown Indication extensions References Additional remarks Other information Additional remarks