Cediranib Medicine 12 June 2018 Extended indication Recurrent Platinum-Resistant Ovarian Cancer (4L+) in combination with olaparib Therapeutic value No judgement Total cost € 5,002,500.00 Registration phase Clinical trials Product Active substance Cediranib Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Ovarian cancer Extended indication Recurrent Platinum-Resistant Ovarian Cancer (4L+) in combination with olaparib Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer AstraZeneca Portfolio holder Mechanism of action Angiogenesis inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks PARP inhibitor + VEGH inhibitor Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2020 Expected Registration 2021 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Indicatie-uitbreiding Therapeutic value Current treatment options Eribuline 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 400 mg / 30 mg References NCT02889900 Additional remarks Olaparib 2 maal per dag (2 maal 200 mg per dag), Cediranib 1 maal per dag (30 mg per dag). De behandelduur is nog niet bekend. Expected patient volume per year Patient volume < 87 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks In 2015 zijn 347 patiënten geregistreerd met ovariumcarcinoom stadium 4, hiervan heeft de helft waarschijnlijk een BRCA mutatie. Dat betekent maximaal 174 patiënten. Realistisch (gezien concurentie en 4L+ behandeling) zal maar een kwart hiervan voor het middel in aanmerking komen. Verwacht wordt echter dat de indicatie ongeacht BRCA mutatie gedefinieerd wordt, zoals het geval is bij niraparib. In dat geval zullen hier maximaal 87 patiënten voor in aanmerking komen. Expected cost per patient per year Cost € 50,000.00 - 65,000.00 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 olaparib 100mg tablet / 150 mg tablet ~ 44,46 euro). p.p.p.j. 365 dagen lang 400 mg, zo'n 50.000 -65.000 euro. Aanname is dat Cadiranib in eenzelfde soort range zal komen te liggen. Potential total cost per year Total cost € 5,002,500.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks