Olaparib Medicine 09 January 2018 Extended indication Extension of indication for the maintenance treatment of gBRCAm metastatic pancreatic cancer in adults whose disease has not progressed on first line platinum based chemotherapy. Therapeutic value No judgement Total cost € 1,600,000.00 Registration phase Registration application pending Product Active substance Olaparib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Pancreatic cancer Extended indication Extension of indication for the maintenance treatment of gBRCAm metastatic pancreatic cancer 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 July 2019 Expected Registration May 2020 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Fabrikant verwacht registratie in Q2 2020. Therapeutic value Current treatment options Chemotherapie Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Median 7.4 Not found Frequency of administration 2 times a day Dosage per administration 300 mg References POLO trial: NCT02184195 Additional remarks Expected patient volume per year Patient volume 30 - 50 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Examining the Relationship Between BRCA and Pancreatic Cancer, curetoday.com Additional remarks NKR 2016: 1.432 diagnoses alvleesklierkanker stadium 4. 5% wordt geschat BRCA mutaties te hebben (72). Vrijwel iedereen wordt gemetastaseerd maar niet iedereen wordt behandeld, inschatting van de werkgroep: 30-50 patiënten per jaar Expected cost per patient per year Cost € 40,000.00 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 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 7,4 maanden is de totaalprijs €40,006,89 (7,4*30,4*4*€44,46). Potential total cost per year Total cost € 1,600,000.00 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 Advanced FIGO Stage IIIB - IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer References NCT02477644 Additional remarks Other information Additional remarks