Enzalutamide Medicine 12 June 2018 Extended indication Niet gemetastaseerde castratieresistente prostaatkanker (M0CRPC). Therapeutic value No judgement Total cost € 3,483,000.00 Registration phase Registration application pending Product Active substance Enzalutamide Domain Oncology and Hematology Reason of inclusion Main indication Prostate cancer Extended indication Niet gemetastaseerde castratieresistente prostaatkanker (M0CRPC). Current proprietary name Already available biosimilars / generics Proprietary name Xtandi Manufacturer Astellas Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Anti-androgeen, remmer van de androgeenreceptorsignalering. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Indication extension ATMP Unknown Submission date May 2018 Expected Registration November 2018 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options BSC 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 160 mg References NCT02003924 Additional remarks Data van de studie mogelijk beschikbaar in maart 2019. Expected patient volume per year Patient volume 85 - 238 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Fabrikant; CAPRI analyse; IKNL; mCRPC tracker Additional remarks In 2016 werden 7.133 diagnoses prostaatcarcinoom stadium 1-3 gesteld. 10% hiervan is hormoonresistent (n=713). Enzalutamide zal binnen deze indicatie moeten moeten concurreren met apalutamide en darolutamide dus wordt uitgegaan van 1/3 marktaandeel (n=238). Fabrikant geeft een inschatting van 85-135 patiënten. Expected cost per patient per year Cost € 3,000.00 - 40,000.00 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 Fabrikant; G-standaard; SmPC Additional remarks Minimale kosten indien patiënt slechts 1 verpakking van €3.080 euro per verpakking verbruikt omdat medicatie na 1 maand wordt gediscontinueerd. Potential total cost per year Total cost € 3,483,000.00 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 Metastatic Hormone-sensitive Prostate Cancer References NCT02677896 Additional remarks Other information Additional remarks