Olaparib Medicine 09 January 2018 Extended indication Metastatic breast cancer with gBRCA1/2 mutations - monotherapy in patients who have previously received treatment with anthracycline and taxane and are suitable for single-agent chemotherapy. Therapeutic value No judgement Total cost Registration phase Unknown Product Active substance Olaparib Domain Oncology and Hematology Reason of inclusion Main indication Breast cancer Extended indication Metastatic breast cancer with gBRCA1/2 mutations - monotherapy in patients who have previously received treatment with anthracycline and taxane and are suitable for single-agent 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 Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration 2019 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Dit is een indicatie-uitbreiding. 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 Dosage per administration References Additional remarks Expected patient volume per year Patient volume < 549 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks NKR 2015: 5486 diagnoses mammacarcinoom stadium 2. 5-10% van borstkankers wordt veroorzakt door BRCA mutaties. Expected cost per patient per year Cost References 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