Niraparib Medicine 10 December 2019 Extended indication mCRPC met DNA repair anomalies na 2-3 eerdere lijnen van behandeling waarvan 1 taxaan-bevattend regime en 1 androgeen-receptor (AR)-gerichte behandeling (abiraterone, enzalutamide of apalutamide). Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Niraparib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Prostate cancer Extended indication mCRPC met DNA repair anomalies na 2-3 eerdere lijnen van behandeling waarvan 1 taxaan-bevattend regime en 1 androgeen-receptor (AR)-gerichte behandeling (abiraterone, enzalutamide of apalutamide). Current proprietary name Already available biosimilars / generics Proprietary name Zejula Manufacturer Janssen Portfolio holder Mechanism of action PARP inhibitor Route of administration Oral Therapeutical formulation Capsule 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 November 2020 Expected Registration August 2021 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 1 times a day Dosage per administration 300 mg References NCT02854436 Additional remarks Expected patient volume per year Patient volume 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. 10-20% van de prostaatkankerpatiënten ontwikkelt CRCP (257-514). Gezien het gaat om patiënten met DNA repair anomalies zal een deel van deze patiënten niet in aanmerking komen. Daarbij gaat het om een 3e lijns therapie. Expected cost per patient per year Cost € 60,000.00 - 120,000.00 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 Additional remarks Een capsule van 100 mg kost €111,45. Het is momenteel niet bekend wat de behandelduur is maar bij behandeling van 6 maanden kost een behandeling ongeveer €60.000, bij een jaar €120.000. 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 Yes Indication extensions L1 Prostate cancer metastatic castration-resistant in combination with abiraterone acetate and Prednisone References Pipeline Janssen Additional remarks Other information Additional remarks