Talazoparib Medicine 12 June 2018 Extended indication Advanced breast cancer, BRCA mutation-positive - 2nd or 3rd-line. Therapeutic value No judgement Total cost € 13,455,000.00 Registration phase Registration application pending Product Active substance Talazoparib Domain Oncology and Hematology Reason of inclusion Main indication Breast cancer Extended indication Advanced breast cancer, BRCA mutation-positive - 2nd or 3rd-line. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Pfizer Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Poly(ADP-ribose) polymerase (PARP) inhibitor Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New medicine ATMP Unknown Submission date June 2018 Expected Registration May 2019 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Fase III studie (NCT01945775, EMBRACA : PFS extended). Therapeutic value Current treatment options Capecitabine, Eribulin, Gemcitabine or Vinorelbine 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 1 mg References NCT01945775 Additional remarks Expected patient volume per year Patient volume < 207 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR, clinicaltrials.gov, SPS Additional remarks Borstkanker stadium 3 en 4, excl. HER2+ (zie criteria studie clinicaltrials.gov) betreft 2068 (bron NKR), SPS geeft aan dat BRCA1 en BRCA2 bij 5-10% van alle borstkankers voorkomt. Bij het maximum zijn we uitgegaan van 10% wat zorgt voor een maximum volume van 207 patiënten. Zal moeten concurreren met andere PARP-remmers. Expected cost per patient per year Cost € 60,000.00 - 70,000.00 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 Medicijnkosten.nl Additional remarks Zal de concurrentie aan moeten gaan met meerdere andere PARP-remmers zoals olaparib, veliparib en rucaparib. Een behandeling van een jaar met olaparib kost tussen de €60.000 en €70.000. De verwachting is dat Talazoparib in dezelfde prijsrange zal vallen. Potential total cost per year Total cost € 13,455,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Squamous Cell Lung Carcinoma References clinicaltrials.gov Additional remarks Other information Additional remarks