Trastuzumab emtansine Medicine 13 December 2018 Extended indication Adjuvante behandeling voor patienten met HER2+ vroege BC met ziekte residue Therapeutic value No judgement yet Total cost Registration phase Clinical trials Product Active substance Trastuzumab emtansine Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Breast cancer Extended indication Adjuvante behandeling voor patienten met HER2+ vroege BC met ziekte residue Current proprietary name Already available biosimilars / generics Proprietary name Kadcyla Manufacturer Roche Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks A humanized IgG1 monoclonal antibody covalently linked to mertansine (DM1), a microtubule inhibitor. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date November 2018 Expected Registration January 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Chemotherapie - trastuzumab - pertuzumab Therapeutic value No judgement yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Median 9.7 month / months Frequency of administration 1 times every 3 weeks Dosage per administration 3,6 mg/kg References Fabrikant Additional remarks Behandelduur is maximale adjuvante therapie, 14 toedieningen op basis van (www.clinicaltrials.org)" Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Nog niet bekend, afhankelijk van specifieke indicatie en studieresultaten Expected cost per patient per year Cost € 65,000.00 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 Additional remarks Trastuzumab emtansine poeder voor oplossing voor infusie 100mg fl. 1 injectieflacon € 1.865,60. Op basis van bovenstaand behandelschema, een behandelduur van 14 toedieningen en uitgaande van een persoon van ongeveer 70 kg liggen de verwachte kosten zo rond de €65.000,00 p.p.p.j.. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Fabrikant Additional remarks Indication extension Indication extensions No Indication extensions References Fabrikant Additional remarks Other information Additional remarks