Trastuzumab Medicine 09 January 2018 Extended indication Early and metastatic breast cancer and metastatic gastric cancer. Therapeutic value No judgement Total cost € 90,000,000.00 Registration phase Unknown Product Active substance Trastuzumab Domain Oncology and Hematology Reason of inclusion Main indication Breast cancer Extended indication Early and metastatic breast cancer and metastatic gastric cancer. Current proprietary name Already available biosimilars / generics Proprietary name Ontruzant Manufacturer Samsung Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Eerste biosimilar voor Trastuzumab die goedgekeurd is door de EMA. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration November 2017 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Geregistreerd in november 2017. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Average 1 year / years Frequency of administration 17 times a year Dosage per administration 600 mg References Additional remarks Toedieningsfrequentie is 1 maal per 3 weken. Behandelduur ingeschat op basis van huidige biological Herceptin. Expected patient volume per year Patient volume 2,000 - 4,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR, GIPdatabank Additional remarks Schatting op basis van NKR data: Ongeveer 1500 patiënten in 2015 met borstkanker in 1e lijn kregen trastuzumab. Aantal Her+ is circa 2000. Volgens de GIPdatabank waren er in 2016 4292 gebruikers van Herceptin, Ontruzant zal op termijn een marktaandeel van rond de 50% halen. Expected cost per patient per year Cost € 20,000.00 - 40,000.00 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 Herceptin €1.750,49 per injectieflacon van 120 mg/ml flacon van 5 ml. Potential total cost per year Total cost € 90,000,000.00 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