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 € 2,047,500.00 Registration phase Clinical trials Product Active substance Olaparib Domain Oncology and Hematology Reason of inclusion Indication extension IND 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 PARP inhibitor 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 2019 Expected Registration 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks POLO trial 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 POLO trial: NCT02184195 Additional remarks De behandelduur is nog niet bekend. 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 € 32,500.00 - 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 G-standaard / Medicijnkosten.nl Additional remarks De lijstprijs van een tablet 150 mg is €44,46 per tablet. Bij een dosering van 300 mg tweemaal daags komt dit neer op €177,84 per dag. Bij behandeling van een volledig jaar is de totaalprijs €64,911,60 (365*4*€44,46). Onbekend is echter wat de behandelduur is. Bij een behandelduur van 6-12 manden is de prijsrange €32.500-€65.000 Potential total cost per year Total cost € 2,047,500.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Advanced FIGO Stage IIIB - IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer References NCT02477644 Additional remarks Other information Additional remarks