Relugolix Medicine 10 December 2019 Extended indication Advanced Prostate Cancer. Therapeutic value No estimate possible yet Total cost € 375,000.00 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 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 March 2021 Expected Registration April 2022 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks SPS UK: "Mar 21 · Considered a potential blockbuster drug for 2021 by analysts". Therapeutic value Current treatment options Gosereline en leuproreline. Therapeutic value No estimate possible yet 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 < 500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Bron: NKR en ARCHES Additional remarks Totaal aantal nieuwe prostaatkankerpantiënten per jaar is meer dan 12.000. Patiënten geregistreerd in de NKR 2016 met cM0cNX, cM0cN0, cMcN1, cM1, pM1 betreft 8226 in totaal. Maximaal 20% gaat het om gemetastaseerde hormoon gevoelige prostaatkanker (n = 1645). Uitgaande van de ARCHES studie gaat het mogelijk slechts in 5% van de prostaatkanker patiënten om gemetastaseerde hormoon gevoelige prostaatkanker (410). Aantal is afhankelijk van hoe vroeg patiënten zich melden. Uiteindelijke inschatting: max 500 patiënten die reëel gezien in aanmerking zullen komen. Expected cost per patient per year Cost € 500.00 - 1,000.00 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 medicijnkosten.nl; GIPdatabank Additional remarks Relugolix zal wat kosten betreft vergeleken moeten worden met de depot GnRH agonisten. Huidige behandelopties kosten tussen de €500-€1.000 per behandeling. Ter vergelijking kost Zoladex kost voor 6 spuiten €686,37. De gemiddelde vergoeding voor Zoladex in 2016 is €997,30. Kosten kunnen verder oplopen indien langer gebruik is toegestaan. Potential total cost per year Total cost € 375,000.00 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