Rucaparib Medicine 09 January 2018 Extended indication Ovarian cancer; BRCA-mutated or with BRCA-like mutation, platinum-sensitive, 2L of 3L. Therapeutic value No judgement Total cost € 7,860,000.00 Registration phase Unknown Product Active substance Rucaparib Domain Oncology and Hematology Reason of inclusion Main indication Ovarian cancer Extended indication Ovarian cancer; BRCA-mutated or with BRCA-like mutation, platinum-sensitive, 2L of 3L. Current proprietary name Already available biosimilars / generics Proprietary name Rubraca Manufacturer Clovis Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date December 2016 Expected Registration February 2018 Orphan drug Yes Registration phase Unknown Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Olaparib Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume 87 - 174 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR, CieBOM Additional remarks In 2016 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 2L,3L behandeling) zal maar de helft hiervan het middel ontvangen. Expected cost per patient per year Cost € < 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 Schatting o.b.v. olaparib (capsule van 50 mg €11,78) Potential total cost per year Total cost € 7,860,000.00 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 Ovarian cancer; advanced BRCA-mutated - maintenance therapy following response to third-line therapy (phIII); Pancreatic cancers (phII). References Additional remarks Other information Additional remarks