Darolutamide Medicine 12 June 2018 Extended indication Nubeqa is indicated for the treatment of adult men with non-metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease. Therapeutic value No judgement Total cost € 1,750,000.00 Registration phase Registered Product Active substance Darolutamide Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Prostate cancer Extended indication Nubeqa is indicated for the treatment of adult men with non-metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease. Current proprietary name Already available biosimilars / generics Proprietary name Nubeqa Manufacturer Bayer Portfolio holder Mechanism of action Antiandrogen Route of administration Oral Therapeutical formulation Film-coated tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Androgreenreceptor blokker. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date March 2019 Expected Registration March 2020 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in januari 2020. Therapeutic value Current treatment options Enzalutamide en apalutamide zijn geregistreerd voor deze indicatie. Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Metastasevrije overleving was significant langer in vergelijking met placebo. De verwachting is dat de therapeutische waarde vergelijkbaar is met met enzalutamide en apalutamide. Duration of treatment Median 14.8 month / months Frequency of administration 2 times a day Dosage per administration 600mg References NCT02200614; Fizazi et al. N Engl J Med. 2019 Mar 28;380(13):1235-1246. Additional remarks Studieresultaten van de ARASENS studie verwacht in het vierde kwartaal van /2020. Expected patient volume per year Patient volume < 50 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References bron: NKR en Zinnige Zorg verbetersignalement: Zinnig gebruik van geneesmiddelen bij patiënten met castratie refractair prostaatcarcinoom Additional remarks Totaal aantal nieuwe prostaatkankerpatiënten per jaar is meer dan 12000. Patiënten geregistreerd in de NKR 2016 met cM0cNX, cM0cN0, cMcN1, cM1, pM1 betreft 8226 in totaal. Na starten van antihormonale therapie zal maximaal 20% van de patiënten binnen vijf jaar CRPC ontwikkelen (1645 patiënten). Op basis van de NKR data zien wij dat 1122 patiënten van de 8226 patiënten, hoog risico betreft (zo'n 13%). Echter gezien bijna alle patiënten met CRPC uitzaaiingen hebben is de verwachting dat de groep hoog risico CRPC patiënten zeer klein is. Expected cost per patient per year Cost € 30,000.00 - 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 Medicijnkosten.nl. Additional remarks Moet concurreren met enzolutamide en apalutamide dus de prijs zal vergelijkbaar zijn. Potential total cost per year Total cost € 1,750,000.00 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 castration sensitive cancer. References NCT02799602. Additional remarks Other information Additional remarks