Durvalumab Medicine 12 June 2018 Extended indication First line bladder cancer. Therapeutic value No judgement Total cost € 11,812,500.00 Registration phase Clinical trials Product Active substance Durvalumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Bladder cancer Extended indication First line bladder cancer. Current proprietary name Already available biosimilars / generics Proprietary name Imfinzi Manufacturer AstraZeneca Portfolio holder Mechanism of action PD-1 / PD-L1 inhibitor Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks PD-L1 remmer Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2020 Expected Registration 2021 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Durvalumab is opgenomen in de sluis voor oncologische indicaties. Therapeutic value Current treatment options Nivolumab Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times every 4 weeks Dosage per administration 1500 mg References NCT02516241 Additional remarks Toedingsfrequentie 1 maal per 4 weken. De behandelduur is nog niet bekend. Expected patient volume per year Patient volume 150 - 200 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Fabrikant; experts werkgroepen Additional remarks NKR 2016: 636 diagnoses blaaskanker stadium 4. Fabrikant geeft aan dat het realistische patiëntvolume 412 patiënten bedraagt. De experts verwachten vergelijkbare patiëntvolumes zoals bij Pembrolizumab met de zelfde indicatie, te weten 150 en 200 patiënten. Expected cost per patient per year Cost € 45,000.00 - 90,000.00 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 Dosis durvalumab is 1500 mg elke 4 weken. Prijs per toediening is dan (3*2328 EUR)6984 EUR. Voor 6 maanden is dit 26/4*6984 = 45.396 EUR; voor 52 weken is dit 52/4*6984 = 90.792 EUR De behandelduur is nog niet bekend. Afhankelijk van de behandelduur zal de prijs per jaar tussen de €45.000 en €90.000 bedragen uitgaande van 6 of 12 maanden behandeling. Durvalumab is opgenomen in de sluis voor oncologische indicaties tot er is gekomen tot een financieel arrangement. Potential total cost per year Total cost € 11,812,500.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Nog voor veel indicaties in ontwikkeling; monotherapie en in combinatie met tremelimumab. References Additional remarks Other information Additional remarks