Enzalutamide Medicine 12 June 2018 Extended indication Adult men with metastatic hormone sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy. Therapeutic value No judgement Total cost € 20,000,000.00 Registration phase Registration application pending Product Active substance Enzalutamide Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Prostate cancer Extended indication Adult men with metastatic hormone sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy. Current proprietary name Already available biosimilars / generics Proprietary name Xtandi Manufacturer Astellas Portfolio holder Mechanism of action Antiandrogen 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 Unknown ATMP Unknown Submission date July 2019 Expected Registration February 2021 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Fabrikant verwacht registratie in november 2020. Therapeutic value Current treatment options BSC, docetaxel + prednison, abirateron + prednison. Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Median 12.8 month / months Frequency of administration 1 times a day Dosage per administration 160mg References NCT02677896; Armstrong AJ et al., 2019 J Clin Oncol. 2019 Nov 10;37(32):2974-2986. 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 prostaatkankerpatienten per jaar is meer dan 12000. Patienten 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). Echter, uitgaande van de ARCHES studie gaat het mogelijk slechts in 5% van de prostaatkankerpatienten om gemetastaseerde hormoon gevoelige prostaatkanker (410). Aantal is afhankelijk van hoe vroeg patienten zich melden. Uiteindelijke inschatting: max 500 patienten die reeel gezien in aanmerking zullen komen. Expected cost per patient per year Cost € 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 Uitgaande van het verbruik van 1 verpakking per 28 dagen en een behandeling van >12 maanden komt dit neer op 13 verpakkingen voor een jaar en dus €40.040. Potential total cost per year Total cost € 20,000,000.00 Total cost for sluice Additional remarks Off label use Off label use Yes Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Niet gemetastaseerde castratieresistente prostaatkanker (nmCRPC); nmHSPC. References NCT02003924; NCT02319837. Additional remarks Other information Additional remarks