Olaparib Medicine 09 January 2018 Extended indication Lynparza is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy. Therapeutic value No judgement Total cost € 4,111,030.00 Registration phase Registered and reimbursed Product Active substance Olaparib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Breast cancer Extended indication Lynparza is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy. 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 PARP inhibitor Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date April 2018 Expected Registration April 2019 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie februari 2019. Geregistreerd in april 2019. 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 < 95 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Fabrikant; Kankerzorginbeeld 2014; IKNL; OlympiAD publicatie. Additional remarks De fabrikant geeft aan niet meer dan 95 patiënten te verwachten. De marktpenetratie zal laag zijn omdat er vele concurrerende producten beschikbaar zijn. Expected cost per patient per year Cost € 43,274.00 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 De lijstprijs van een tablet 150 mg is €44,46 per tablet. Bij 300 mg tweemaal daags komt dit neer op €177,84. Bij een behandelduur van 8 maanden is het totaal €43.274,40 (((365/12)*8)*4*€44,46). Potential total cost per year Total cost € 4,111,030.00 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