Trastuzumab duocarmazine Medicine 10 December 2019 Extended indication in 3e lijn gemetastaseerd borstkanker HER2+ Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Trastuzumab duocarmazine Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Breast cancer Extended indication in 3e lijn gemetastaseerd borstkanker HER2+ Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Synthon Portfolio holder Mechanism of action Receptor antagonist Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Fabrikant: Synthon. ERBB 2 receptor antagonists. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2020 Expected Registration 2021 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 6 mg/kg References NCT03262935 Additional remarks Expected patient volume per year Patient volume 100 - 120 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). Minder dan 200 patiënten betreft stadium 4 mammacarcinoom. Per additionele lijn mogelijk zo'n 20-25% van de patiënten minder (80-100 patiënten). Dit zou naar schatting uitkomen op zo'n 100-120 patiënten. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Clinicaltrials.gov, AdisInsight Additional remarks geen andere fase 3 studies op dit moment. Other information Additional remarks