Blinatumomab Medicine 09 January 2018 Extended indication Blincyto is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive B-precursor ALL 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 € 2,625,000.00 Registration phase Positive CHMP opinion Product Active substance Blinatumomab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Leukemia Extended indication Blincyto is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive B-precursor ALL 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 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 Normal trajectory Particularity Unknown ATMP Unknown Submission date Expected Registration January 2019 Orphan drug Yes Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Negatieve CHMP-opinie juli 2018. De fabrikant heeft een herbeoordeling aangevraagd in september 2018. Positieve CHMP-opinie november 2018. 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. Additional remarks 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 NKR: b-ALL in totaal 165 patiënten, hiervan hebben 40 patiënten b-ALL met cytogenetische afwijkingen. Inschatting fabrikant 20-30. 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: €70.000,00 - €140.000,00 p.p.p.j.. 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 Yes Indication extensions alle indicaties in de Horizonscan Geneesmiddelen en nu ook een fase III studie gestart voor DLBCL. References clinicaltrials.gov Additional remarks Other information Additional remarks