Olaparib Medicine 09 January 2018 Extended indication Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. Therapeutic value Possible added value Total cost € 1,602,240.00 Registration phase Registered and reimbursed Product Active substance Olaparib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Pancreatic cancer Extended indication Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. 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 July 2020 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in juni 2020. Registratie in juli 2020. Aanspraakstatus ZN JA Therapeutic value Current treatment options Chemotherapie Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Resultaten POLO trial in NEJM 2019 gepubliceerd; tonen effect op PFS, (nog) geen effect op OS voor zeer kleine groep patiënten; wel proof-of-principle studie. Positief CieBOM advies in sept 2020. Duration of treatment Median 7.4 month / months Frequency of administration 2 times a day Dosage per administration 300 mg References POLO trial: NCT02184195 https://www.nvmo.org/bom/onderhoudsbehandeling-met-olaparib-bij-gemetastaseerd-pancreascarcinoom/?meta 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 komt uiteindelijk in een gemetastaseerd stadium maar niet iedereen wordt behandeld, inschatting van de werkgroep: 30-50 patiënten per jaar. Het is de vraag of er een richtlijn zal komen betreffende het screenen op een BRCA mutatie. Expected cost per patient per year Cost € 40,056.00 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 fabrikant; z-index Additional remarks Prijs per maand is (4*€44,46*365,25)/12) = €5.413 * 7,4 = €40.056. Potential total cost per year Total cost € 1,602,240.00 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 - Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer (OlympiA) -Treatment in combination with abiraterone acetate in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC) who have not received prior chemotherapy or new hormonal agents (NHAs) mCRPC (first-line setting). (PROPEL) References adisinsight Additional remarks Fase 3 studies Other information Additional remarks