Apalutamide Medicine 12 June 2018 Extended indication gemetastaseerd hormoongevoelig prostaatcarcinoom in combinatie met androgeendeprivatie (ADT). Therapeutic value No judgement Total cost € 8,448,000.00 Registration phase Registration application pending Product Active substance Apalutamide Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Prostate cancer Extended indication gemetastaseerd hormoongevoelig prostaatcarcinoom in combinatie met androgeendeprivatie (ADT). 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 Registration application pending Reimbursement Medicine sluice Additional remarks Fabrikant verwacht registratie in Q2 2020 Therapeutic value Current treatment options Docetaxel, abiraterone, ADT, ADT + RT Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Median 20.5 Not found Frequency of administration 1 times a day Dosage per administration 240 mg References NCT02489318; Chi et al. N Engl J Med. 2019 Jul 4;381(1):13-24. 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. Per verpakking van 112 tabletten, €3.357,76. Bij een behandelduur van een jaar 240 mg per dag komt dit totaal neer op € 43.770,80 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. Other information Additional remarks