Olaparib Medicine 09 January 2018 Extended indication Metastatic pancreatic cancer, gBRCA mutated - maintenance monotherapy in adults whose disease has not progressed on first line platinum based chemotherapy. Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Olaparib Domain Oncology and Hematology Reason of inclusion Main indication Pancreatic cancer Extended indication Metastatic pancreatic cancer, gBRCA mutated - maintenance monotherapy in adults whose disease has not progressed on 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 Therapeutic value Current treatment options Concurrentie van alle parp-remmers. 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 NCT02184195 Additional remarks Expected patient volume per year Patient volume 19 - 65 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Fabrikant; NKR; Examining the Relationship Between BRCA and Pancreatic Cancer, curetoday.com Additional remarks NKR 2015: 1301 diagnoses alvleesklierkanker stadium 4. 5% wordt geschat BRCA mutaties te hebben. Fabrikant geeft een realistisch patientvolume aan van 19. Expected cost per patient per year Cost References Medicijnkosten.nl Additional remarks €11,78 voor 50mg capsule. Potential total cost per year Total cost 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