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 € 3,430,000.00 Registration phase Registration application pending 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 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 April 2018 Expected Registration December 2018 Orphan drug No Registration phase Registration application pending 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 Median 8 month / months Frequency of administration 2 times a day Dosage per administration 300 mg References Robson, M. et al. N. Engl. J. Med. 2017 377, 523–533. Additional remarks Mediane behandelduur is 8,2 maanden. Expected patient volume per year Patient volume 40 - 155 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Fabrikant: berekeningen op basis van Kankerzorginbeeld 2014, IKNL, OlympiAD publicatie. Additional remarks Expected cost per patient per year Cost € 35,000.00 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 Fabrikant Additional remarks €11,78 voor 50mg capsule. Potential total cost per year Total cost € 3,430,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks