Veliparib Medicine 09 January 2018 Extended indication Breast cancer; HER2-negative metastatic or locally advanced unresectable BRCA-associated - first to third-line in combination with carboplatin and paclitaxel. Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Veliparib Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Breast cancer Extended indication Breast cancer; HER2-negative metastatic or locally advanced unresectable BRCA-associated - first to third-line in combination with carboplatin and paclitaxel. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Abbvie Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks PARP-remmer Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2019 Expected Registration 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Concurrentie van alle parp-remmers. 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 < 189 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks NKR 2015: 1.885 mammacarcinomen HER- stadia 3 en 4. 5-10% van borstkankers wordt veroorzakt door BRCA mutaties. Expected cost per patient per year Cost References Additional remarks 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