Relugolix Medicine 10 December 2019 Extended indication Advanced Prostate Cancer Therapeutic value No judgement Total cost Registration phase Registration application pending 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 Intermural (MSZ) Centre of expertise Additional remarks GNRH antagonist Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date April 2020 Expected Registration May 2021 Orphan drug No Registration phase Registration application pending 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 < 2,300 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks 2.302 diagnoses prostaatkanker stadium 4 in 2016. Deze gehele groep personen zou mogelijk in aanmerking kunnen komen. Afhankelijk van de prijs en therapeutische waarde zal een deel van deze patiënten het middel mogelijk gaan ontvangen. 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