Relugolix / estradiol / norethisterone acetaat Medicine 08 December 2020 Extended indication Extension of indication to include treatment of moderate to severe pain associated with endometriosis for Ryeqo in adult women of reproductive age with a history of previous medical or surgical treatment for their endometriosis Therapeutic value No estimate possible yet Total cost € 41,250,000.00 Registration phase Registration application pending Product Active substance Relugolix / estradiol / norethisterone acetaat Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Unknown Extended indication Extension of indication to include treatment of moderate to severe pain associated with endometriosis for Ryeqo in adult women of reproductive age with a history of previous medical or surgical treatment for their endometriosis Current proprietary name Already available biosimilars / generics Proprietary name Ryeqo Manufacturer Gedeon Portfolio holder Gedeon 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 Unknown Particularity Unknown ATMP Unknown Submission date October 2022 Expected Registration August 2023 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Hormonale therapie (GnRH agonisten) ter onderdrukking van ovulatie en oestrogeen: Leuproreline, Gosereline, Triptoreline. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Indien de effectiviteit voldoende is, kan het een aantrekkelijk alternatief voor de intramusculaire therapie zijn. Er is een vergelijkbaar product door Abbott in de Verenigde Staten en Canada op de markt gebracht: elagolix. Duration of treatment Frequency of administration 1 times a day Dosage per administration 40 mg References NCT03204318 (SPIRIT 1); NCT03654274 (SPIRIT EXTENSION) Additional remarks Expected patient volume per year Patient volume 35,000 - 75,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References CBS; Guidice et al. N Engl J Med 2010; 362:2389-2398. Additional remarks Er zijn ruim 3 miljoen vruchtbare vrouwen in Nederland (15 jaar-45 jaar). De prevalentie van endometriose in deze groep wordt geschat op 6%-10% wat leidt tot een patiëntvolume van 180.000-300.000. Hiervan hebben er 35.000 tot 75.000 ernstige klachten. Het geneesmiddel zal waarschijnlijk in eerste instantie alleen ingezet gaan worden bij mensen met medium-ernstige endometriose. 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 € 41,250,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks