Olaparib Medicine 12 June 2018 Extended indication BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy. Therapeutic value No judgement Total cost € 2,175,000.00 Registration phase Clinical trials Product Active substance Olaparib Domain Oncology and Hematology Reason of inclusion Main indication Ovarian cancer Extended indication BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy. Current proprietary name Already available biosimilars / generics Proprietary name Lynparza 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 Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Indication extension ATMP Unknown Submission date 2018 Expected Registration 2019 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks SOLO-1 trial. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 2 times a day Dosage per administration 300 mg References NCT01844986 Additional remarks Expected patient volume per year Patient volume < 87 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; CieBOM 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 concurrentie en 2L behandeling) maar de helft hiervan voor het middel in aanmerking komen. Expected cost per patient per year Cost € 20,000.00 - 30,000.00 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 50 mg kost €11,78. Prijs per patiënt per jaar gebaseerd op 300 mg per dag, 365 dagen lang (€25.798,20). Potential total cost per year Total cost € 2,175,000.00 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