Enzalutamide Medicine 12 June 2018 Extended indication De behandeling van volwassen mannen met niet-gemetastaseerd hoogrisico-CRPC (castratieresistent prostaatcarcinoom). Therapeutic value No judgement Total cost € 2,120,000.00 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 De behandeling van volwassen mannen met niet-gemetastaseerd hoogrisico-CRPC (castratieresistent prostaatcarcinoom). 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 Unknown ATMP Unknown Submission date May 2018 Expected Registration November 2018 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie september 2018. Geregistreerd in oktober 2018. Therapeutic value Current treatment options BSC, apalutamide Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Median 18.4 month / months Frequency of administration 1 times a day Dosage per administration 160 mg References NCT02003924; Hussain et al. N Engl J Med 2018; 378:2465-2474 Additional remarks Expected patient volume per year Patient volume 53 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Kanker.nl; Fabrikant Additional remarks In 2016 werden 1.600 diagnoses prostaatcarcinoom stadium 3 gesteld. 10% hiervan is hormoonresistent (n=160). Enzalutamide zal binnen deze indicatie moeten moeten concurreren met apalutamide en darolutamide dus wordt uitgegaan van 1/3 marktaandeel (n=53). 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. De mediane behandelduur is 18,4 maanden. Uitgaande van het verbruik van 1 verpakking per 28 dagen komt dit uit op 20 verpakkingen en dus €61.600 per patiënt per behandeling. Voor een jaar behandeling komt dit neer op 13 verpakkingen en dus €40.040 Potential total cost per year Total cost € 2,120,000.00 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