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 € 402,500.00 Registration phase Clinical trials 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 Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Indication extension ATMP Unknown Submission date Expected Registration Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks 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 15 - 30 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: 2.568 gevallen van prostaatkanker, stadia 3 en 4. Ongeveer 6% van prostaattumoren heeft een mutatie in BRCA of ATM (154). 10-20% van de prostaatkankerpatienten ontwikkelt CRCP (15-30). Expected cost per patient per year Cost € 15,000.00 - 20,000.00 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 Medicijnkosten.nl; NCT02987543; GIPdatabank Additional remarks €11,78 voor een capsule van 50mg. Kosten geschat op basis van behandelschema in klinische studies en huidige vergoeding per gebruiker voor geregistreerde indicaties. Potential total cost per year Total cost € 402,500.00 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