Trastuzumab emtansine Medicine 13 December 2018 Extended indication Kadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy. Therapeutic value No judgement yet Total cost € 33,500,000.00 Registration phase Registered Product Active substance Trastuzumab emtansine Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Breast cancer Extended indication Kadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy. Current proprietary name Already available biosimilars / generics Proprietary name Kadcyla Manufacturer Roche Portfolio holder Mechanism of action Antibody-drug conjugate 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 February 2019 Expected Registration December 2019 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in november 2019. In de sluis geplaatst per 23 december 2019. 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 < 500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2015 en 2016 Additional remarks Er zijn 1.958 HER2+ patiënten met mammacarcinoom (zo'n 12% van alle patiënten met mammacarcinoom), 50%-60% behandeld middels een systemische therapie, van deze ongeveer 1.000 patiënten komt dan een subgroep (personen met een ziekteresidu) in aanmerking voor deze behandeling. Inschatting: maximaal zo'n 50%, dit betreft dus zo'n 500 patiënten. Expected cost per patient per year Cost € 67,000.00 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 Fabrikant; Medicijnkosten.nl. Additional remarks Prijs voor 1 injectieflacon van 100 mg inclusief btw is €1.918,40, gebaseerd op lijstprijs € 1.760 (de genoemde prijs in kolom L is nog op basis van 6% btw). 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 per patiënt per jaar. In de sluis geplaatst om tot een financieel arrangement te komen. Potential total cost per year Total cost € 33,500,000.00 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