Olaparib Medicine 09 January 2018 Extended indication Metastatic castration-resistant BRCAm prostate cancer patients who have received at least one new hormonal agent Therapeutic value No judgement Total cost € 4,000,000.00 Registration phase Clinical trials Product Active substance Olaparib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Prostate cancer Extended indication Metastatic castration-resistant BRCAm prostate cancer patients who have received at least one new hormonal agent 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 Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date 2020 Expected Registration October 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Fabrikant verwacht registratie in Q3/Q4 2020. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Median 7.4 month / months Frequency of administration 2 times a day Dosage per administration 300 mg References NCT02987543; fabrikant Additional remarks Expected patient volume per year Patient volume 100 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 prostaatkankerpatiënten ontwikkelt CRCP (15-30). Het gaat echter niet om een 1e lijns behandeling. Om die reden zal het aantal patiënten dat in aanmerking komt voor dit middel naar schatting eerder rond de 100 patiënten per jaar liggen. Expected cost per patient per year Cost € 40,000.00 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 G-standaard; fabrikant Additional remarks De lijstprijs van een tablet 150 mg is €44,46 per tablet. Bij een dosering van 300 mg tweemaal daags komt dit neer op €177,84 per dag. Bij behandeling van een volledig jaar is de totaalprijs €64.911,60 (365*4*€44,46). De mediane behandelduur is echter 7,4 maanden dus de kosten voor een behandeling zullen (€64.911,60/12)*7,4 = €40.029 bedragen. Potential total cost per year Total cost € 4,000,000.00 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