Olaparib Medicine 09 January 2018 Extended indication Extension of indication to include the use of Lynparza tablets as a montherapy for the treatment of adult patients with BRCA1/2-mutated HER2 negative metastatic breast cancer who have previously been treated with chemotherapy. These patients could have received chemotherapy in the neoadjuvant, adjuvant or metastatic setting. 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 Indication extension IND Main indication Breast cancer Extended indication Extension of indication to include the use of Lynparza tablets as a montherapy for the treatment of adult patients with BRCA1/2-mutated HER2 negative metastatic breast cancer who have previously been treated with chemotherapy. These patients could have received chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Current proprietary name Already available biosimilars / generics Proprietary name Lynparza Manufacturer 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 Unknown ATMP Unknown Submission date April 2018 Expected Registration February 2019 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