Durvalumab Medicine 12 June 2018 Extended indication Imfinzi in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as monotherapy adjuvant treatment after radical cystectomy, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC). Therapeutic value No estimate possible yet Total cost € 14,666,400.00 Registration phase Positive CHMP opinion Product Active substance Durvalumab Domain Oncology Reason of inclusion Indication extension IND Main indication Bladder cancer Extended indication Imfinzi in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as monotherapy adjuvant treatment after radical cystectomy, is indicated for the treatment of adults with resectable 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 November 2024 Expected Registration July 2025 Orphan drug Yes Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in mei 2025. 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 intraveneus driewekelijkse dosering (in combi met cis-gem) voor 4 cyclus gevolgd door adjuvant 1.500mg intraveneus vier-wekelijkse dosering voor 8 cyclus. Dus 4+8=12 cyclus (1 flacon durvalumab is 500ml dus per cycli 3 flacons = €6.984 12 cyclus 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