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 € 8,505,000.00 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 PARP inhibitor 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 July 2020 Expected Registration August 2021 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 veroorzaakt door BRCA mutaties. Expected cost per patient per year Cost € 30,000.00 - 60,000.00 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 Additional remarks Afhankelijk van de behandelduur vergelijkbaar met olaparib en rucaparib. Inschatting €30.000-€60.000. Potential total cost per year Total cost € 8,505,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References adisinsight Additional remarks Buiten de indicaties in de Horizonscan geen nieuwe indicatie-uitbreidingen. Other information Additional remarks