Apalutamide Medicine 12 June 2018 Extended indication Gemetastaseerde hormoon-gevoelige, hoog-volume prostaatcarcinoom. Therapeutic value No judgement Total cost € 8,448,000.00 Registration phase Clinical trials Product Active substance Apalutamide Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Prostate cancer Extended indication Gemetastaseerde hormoon-gevoelige, hoog-volume prostaatcarcinoom. 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 July 2019 Expected Registration May 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Fabrikant verwacht registratie in Q2 2020 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; NCT02489318 Additional remarks Expected patient volume per year Patient volume < 192 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Kanker.nl Additional remarks 2.302 diagnoses prostaatkanker stadium 4 in 2016. Ongeveer 25% van deze groep patiënten is hormoongevoelig (n=575). Gezien de concurrentie binnen deze indicatie wordt uitgegaan van maximaal 1/3 marktaandeel (n=192). 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 € 8,448,000.00 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 de horizonscan: Chemo-naieve gemetastaseerde castratie resistente prostaat carcinoom, in combinatie met abiraterone & niet-gemetastaseerde castratie resistente prostaat carcinoom. Other information Additional remarks