Niraparib / abirateron Medicine 05 December 2023 Extended indication Niraparib in combination with abiraterone acetate and prednisone for treatment of patients with metastatic prostate cancer. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Niraparib / abirateron Domain Oncology Reason of inclusion Indication extension IND Main indication Prostate cancer Extended indication Niraparib in combination with abiraterone acetate and prednisone for treatment of patients with metastatic prostate cancer. Current proprietary name Already available biosimilars / generics Proprietary name Akeega 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 Unknown Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date 2025 Expected Registration 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks NCT03748641 Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Mediane rPFS in de BRCA1/2 subgroep was significant langer in de niraparib + AAP groep vergeleken met de placebo + AAP groep (16,6 versus 10,9 maanden; hazard ratio [HR], 0.53; 95% CI, 0.36 to 0.79; P = .001). Er wordt verwacht dat niraparib niet bij de gehele HHR populatie ingezet zal gaan worden, maar enkel bij patiënten met de BRCA1/2 mutatie. Duration of treatment Frequency of administration Dosage per administration References NCT03748641 Additional remarks Expected patient volume per year Patient volume < 220 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References (1) IKNL 2022; (2) https://iknl.nl/kankersoorten/prostaatkanker/registratie/incidentie Additional remarks In 2022 waren er 12.400 patiënten met prostaatkanker (1). 3.598 (2). Het betreft hier 2.197 patiënten die zich in stadium 4 bevonden. Daarvan heeft ongeveer 10% een BRCA1/2 mutatie. Expected cost per patient per year Cost References G-standaard Additional remarks Een capsule van 100mg kost €111,45 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