Olaparib / Cediranib Medicine 12 June 2018 Extended indication Recurrent Platinum-Resistant Ovarian Cancer (4L+) Therapeutic value No judgement Total cost € 2,200,000.00 Registration phase Clinical trials Product Active substance Olaparib / Cediranib Domain Oncology and Hematology Reason of inclusion Main indication Ovarian cancer Extended indication Recurrent Platinum-Resistant Ovarian Cancer (4L+) Current proprietary name Already available biosimilars / generics Proprietary name Lynparza / Cediranib Manufacturer AstraZeneca Portfolio holder Mechanism of action Unknown 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 Indication extension ATMP Unknown Submission date 2019 Expected Registration 2020 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) Expected patient volume per year Patient volume < 44 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References 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. Expected cost per patient per year Cost € 40,000.00 - 60,000.00 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 Tablet Olaparib 50 mg kost €11,78. Prijs per patiënt per jaar voor olaparib gebaseerd op 300 mg per dag, 365 dagen lang (€25.798,20). Aanname is dat Cadiranib eenzelfde bedrag zal kosten. Potential total cost per year Total cost € 2,200,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks