Enzalutamide Medicine 12 June 2018 Extended indication Adult men with newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in combination with androgen depreviation therapy. Therapeutic value No judgement Total cost € 7,680,000.00 Registration phase Clinical trials Product Active substance Enzalutamide Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Prostate cancer Extended indication Adult men with newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in combination with androgen depreviation 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 Unknown Particularity Unknown ATMP Unknown Submission date June 2019 Expected Registration March 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks 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 Frequency of administration 1 times a day Dosage per administration 160 mg References NCT02677896 Additional remarks Studieresultaten verwacht in Q4/2020. Expected patient volume per year Patient volume < 192 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks 2.302 diagnoses prostaatkanker stadium 4 in 2016. Ongeveer 25% van deze groep patiënten is hormoongevoelig (n=575). Gezien de concurrentie binnen deze indicatie wordt uitgegaan van maximaal 1/3 marktaandeel (n=192). 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 Minimale kosten indien patiënt slechts 1 verpakking van €3.080 euro per verpakking verbruikt omdat medicatie na 1 maand wordt gediscontinueerd. Uitgaande van het verbruik van 1 verpakking per 28 dagen en een behandeling van >12 maanden komt dit dit neer op 13 verpakkingen voor een jaar en dus €40.040. Potential total cost per year Total cost € 7,680,000.00 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