Apalutamide Medicine 12 June 2018 Extended indication Chemo-naieve gemetastaseerde castratie resistente prostaat carcinoom, in combinatie met Abiraterone. Therapeutic value No judgement Total cost € 28,840,000.00 Registration phase Clinical trials Product Active substance Apalutamide Domain Oncology and Hematology Reason of inclusion Main indication Prostate cancer Extended indication Chemo-naieve gemetastaseerde castratie resistente prostaat carcinoom, in combinatie met Abiraterone. Current proprietary name Already available biosimilars / generics Proprietary name Erleada Manufacturer Janssen Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Androgeen receptor inhibitor. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Indication extension ATMP Unknown Submission date April 2019 Expected Registration February 2020 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 a day Dosage per administration 240 mg References NCT02257736 Additional remarks Expected patient volume per year Patient volume < 824 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. Apalutamide zal op termijn maximaal 50% marktaandeel bereiken (n=824). Expected cost per patient per year Cost € 30,000.00 - 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 Moet concurreren met enzolutamide en darolutamide dus de prijs zal vergelijkbaar zijn. Potential total cost per year Total cost € 28,840,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks