Olaparib Medicine 09 January 2018 Extended indication Prostate cancer - monotherapy for BRCA 1/2 or ATM gene-mutated metastatic castration resistant prostate cancer (mCRPC) in patients who have received a prior taxane-based chemotherapy and at least one newer hormonal agent (abiraterone or enzalutamide). Therapeutic value No judgement Total cost Registration phase Unknown Product Active substance Olaparib Domain Oncology and Hematology Reason of inclusion Main indication Prostate cancer Extended indication Prostate cancer - monotherapy for BRCA 1/2 or ATM gene-mutated metastatic castration resistant prostate cancer (mCRPC) in patients who have received a prior taxane-based chemotherapy and at least one newer hormonal agent (abiraterone or enzalutamide). 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 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Dit is een indicatie-uitbreiding. Therapeutic value Current treatment options 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 < 53 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Na et al. Eur Urol. 2017 May;71(5):740-747; Kirby et al. Int J Clin Pract. 2011 Nov;65(11):1180-92 Additional remarks NKR 2015: 4432 gevallen van prostaatkanker, stadia 3 en 4. Ongeveer 6% van prostaattumoren heeft een mutatie in BRCA of ATM. 10-20% van de prostaatkankerpatienten ontwikkeld CRCP. Expected cost per patient per year Cost References Medicijnkosten.nl Additional remarks €11,78 voor een capsule van 50mg. 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