Apalutamide Medicine 12 June 2018 Extended indication Niet-gemetastaseerde castratie resistente prostaat carcinoom. Therapeutic value No judgement Total cost € 8,330,000.00 Registration phase Registration application pending Product Active substance Apalutamide Domain Oncology and Hematology Reason of inclusion Main indication Prostate cancer Extended indication Niet-gemetastaseerde castratie resistente prostaat carcinoom. 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 New medicine ATMP Unknown Submission date February 2018 Expected Registration April 2019 Orphan drug No Registration phase Registration application pending 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 Fabrikant; NCT01946204; Scrip; Smith et al. N Engl J Med. 2018 Apr 12;378(15):1408-1418. Additional remarks Improved metastasis-free survival in SPARTAN trial (feb 2018). Expected patient volume per year Patient volume < 238 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Kanker.nl Additional remarks In 2016 werden 7133 diagnoses prostaatcarcinoom stadium 1-3 gesteld. 10% hiervan is hormoonresistent (n=713). Apalutamide zal binnen deze indicatie moeten moeten concurreren met enzalutamide en darolutamide dus wordt uitgegaan van 1/3 marktaandeel (n=238). 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 dus de prijs zal vergelijkbaar zijn. Potential total cost per year Total cost € 8,330,000.00 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