Durvalumab Medicine 12 June 2018 Extended indication Neo-adjuvant durvalumab met chemotherapie en adjuvant durvalumab voor behandeling in patiënten met spier invasieve blaaskanker. Therapeutic value No estimate possible yet Total cost € 11,812,500.00 Registration phase Clinical trials Product Active substance Durvalumab Domain Oncology Reason of inclusion Indication extension IND Main indication Bladder cancer Extended indication Neo-adjuvant durvalumab met chemotherapie en adjuvant durvalumab voor behandeling in patiënten met spier invasieve blaaskanker. 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 No Submission date 2024 Expected Registration 2025 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Chemotherapie en immuuntherapie Therapeutic value No estimate possible yet 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 NCT03732677 Additional remarks Neo-adjuvant 4 cycli, adjuvant q4w 8 cycli. Expected patient volume per year Patient volume 150 - 200 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL 2021; Fabrikant; experts werkgroepen Additional remarks In 2021 waren er 459 diagnoses blaaskanker stadium 4. Fabrikant geeft aan dat het realistische patiëntvolume 412 patiënten bedraagt. De experts verwachten vergelijkbare patiëntvolumes zoals bij pembrolizumab met dezelfde indicatie, te weten 150 tot 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 fabrikant; G-standaard Additional remarks Dosis durvalumab is 1.500mg elke 4 weken. Prijs per toediening is dan (3x2.328)=€6.984. Voor 6 maanden is dit 26/4x€6.984=€45.396; Voor 52 weken is dit 52/4x€6.984=€90.792. 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. 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 Buiten de indicaties in de Horizonscan Geneesmiddelen voor meerdere indicaties in ontwikkeling: Biliary cancer; Cervical cancer; Fallopian tube cancer; Head and neck cancer; Liver cancer; Ovarian cancer; Peritoneal cancer; Renal cell carcinoma; Solid tumours. References adisinsight Additional remarks Fase 3 Other information Additional remarks