Relugolix Medicine 10 December 2019 Extended indication Advanced Prostate Cancer. Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Relugolix Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Prostate cancer Extended indication Advanced Prostate Cancer. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Myovant Portfolio holder Mechanism of action Receptor antagonist Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks GNRH antagonist. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date 2021 Expected Registration 2022 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Gosereline en leuproreline. 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 120 mg References NCT03085095. Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Een relatief grote groep personen zou mogelijk in aanmerking kunnen komen voor deze behandeling. Het is echter nog lastig om een goede inschatting van het aantal te patiënten dat realistisch gezien in aanmerking komt. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Uterine fibroids, endometriosis-related pain. References Clinicaltrials.gov. Additional remarks Other information Additional remarks