Durvalumab Medicine 12 June 2018 Extended indication Extension of indication to include IMFINZI in combination with cisplatin-based chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy adjuvant treatment after radical cystectomy, for the treatment of adults with muscle invasive bladder cancer (MIBC) Therapeutic value No estimate possible yet Total cost € 14,666,400.00 Registration phase Clinical trials Product Active substance Durvalumab Domain Oncology Reason of inclusion Indication extension IND Main indication Bladder cancer Extended indication Extension of indication to include IMFINZI in combination with cisplatin-based chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy adjuvant treatment after radical cystectomy, for the treatment of adults with muscle invasive bladder cancer (MIBC) 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 Normal trajectory Particularity Unknown ATMP No Submission date 2025 Expected Registration 2026 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 (NIAGARA) 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 € 83,808.00 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 https://www.annalsofoncology.org/action/showPdf?pii=S0923-7534%2824%2903907-3 Additional remarks Dosering neo-adjuvant betreft 1.500mg IV Q3W (in combi met cis-gem) voor 4 cycles gevolgd door adjuvant 1.500mg IV Q4W voor 8 cycles dus 4+8=12 cycles (1 flacon durvalumab is 500ml dus per cycle 3 flacons = €6.984 12 cycles is dan €83.808 (op basis van apothekersinkoopprijs). Potential total cost per year Total cost € 14,666,400.00 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