Enzalutamide Medicine 12 June 2018 Extended indication The treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT). Therapeutic value No estimate possible yet Total cost € 18,750,000.00 Registration phase Registered and reimbursed Product Active substance Enzalutamide Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Prostate cancer Extended indication The treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT). 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 April 2021 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in maart 2021. Therapeutic value Current treatment options BSC, docetaxel + prednison, abirateron + prednison. Therapeutic value No estimate possible yet 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 NKR en ARCHES Additional remarks Totaal aantal nieuwe prostaatkankerpatiënten per jaar is meer dan 12.000. Patiënten geregistreerd in de NKR 2016 met "cM0cNX, cM0cN0, cMcN1, cM1, pM1" betreft 8.226 in totaal. Echter, uitgaande van de ARCHES studie gaat het mogelijk slechts in 5% van de prostaat kankerpatiënten om gemetastaseerde hormoon gevoelige prostaatkanker (410). Aantal is afhankelijk van hoe vroeg patiënten zich melden. Uiteindelijke inschatting: maximaal 500 patiënten die reëel gezien in aanmerking zullen komen. Expected cost per patient per year Cost € 37,500.00 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 €37.500. Potential total cost per year Total cost € 18,750,000.00 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 nmHSPC References NCT02003924; NCT02319837. Additional remarks nmCRPC is reeds geregistreerd. Other information Additional remarks