Apalutamide Medicine 12 June 2018 Extended indication Niet-gemetastaseerde castratie resistente prostaat carcinoom (hoog risico). Therapeutic value No judgement Total cost € 2,332,000.00 Registration phase Registered and reimbursed Product Active substance Apalutamide Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Prostate cancer Extended indication Niet-gemetastaseerde castratie resistente prostaat carcinoom (hoog risico). Current proprietary name Already available biosimilars / generics Proprietary name Erleada Manufacturer Janssen Portfolio holder Mechanism of action Antiandrogen 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 Normal trajectory Particularity Unknown ATMP Unknown Submission date February 2018 Expected Registration January 2019 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie november 2018. Geregistreerd in januari 2019. 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 53 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Kanker.nl Additional remarks In 2016 werden 1.600 diagnoses prostaatcarcinoom stadium 3 gesteld. 10% hiervan is hormoonresistent (n=160). Apalutamide zal binnen deze indicatie moeten moeten concurreren met enzalutamide en darolutamide dus wordt uitgegaan van 1/3 marktaandeel (n=53). Expected cost per patient per year Cost € 44,000.00 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 Prestatie- en tariefbeschikking add-ongeneesmiddelen Additional remarks Erleada tablet filmomhuld 60mg, 112 stuks kost €3.357,20. Bij een behandelduur van een jaar 240 mg per dag komt dit totaal neer op €43.763,50 Potential total cost per year Total cost € 2,332,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions References clinicaltrials.gov Additional remarks geen fase III studies voor andere indicaties dan in de horizonscan. In horizonscan: Chemo-naieve gemetastaseerde castratie resistente prostaat carcinoom, in combinatie met abiraterone & gemetastaseerde hormoon-gevoelige, hoog-volume prostaat carcinoom. Other information Additional remarks