DCVAC Medicine 12 June 2019 Extended indication Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance DCVAC Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Prostate cancer Extended indication Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Sotio Portfolio holder Mechanism of action Immunostimulation Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Immunostimulants 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 Dosage per administration References NCT02111577 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; GIPdatabank Additional remarks 2.302 diagnoses prostaatkanker stadium 4 in 2015. 75% van deze patiënten ontwikkelt CRCP (n=1.727). In 2015 werden 1.648 patiënten voor deze indicatie behandeld met enzalutamide. Een deel van deze patienten zal in aanmerking komen voor deze behandeling. 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 Yes Indication extensions prostate cancer at various stages References https://www.sotio.com/pipeline/dcvac-product-candidates Additional remarks Other information Additional remarks