Durvalumab Medicine 03 June 2025 Extended indication Extension of indication for IMFINZI in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adults with BCG-naive, high-risk non-muscle-invasive bladder cancer (NMIBC). Therapeutic value No estimate possible yet Total cost € 101,250,000.00 Registration phase Registration application pending Product Active substance Durvalumab Domain Oncology Reason of inclusion Indication extension IND Main indication Bladder cancer Extended indication Extension of indication for IMFINZI in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adults with BCG-naive, high-risk non-muscle-invasive bladder cancer (NMIBC). Current proprietary name Already available biosimilars / generics Proprietary name Imfinzi Manufacturer AstraZeneca Portfolio holder AstraZeneca Mechanism of action Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date August 2025 Expected Registration August 2026 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Broadly excluded Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT03528694 (POTOMAC) Additional remarks Expected patient volume per year Patient volume 1,500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2021 (1); IKNL (2) Additional remarks Totaal aantal patiënten met invasief blaaskanker: 3.410 (1). De inschatting is dat hiervan ongeveer 1.500 patiënten gediagnosticeerd worden met hooggradig niet-spierinvasief blaascarcinoom (HG-NMIBC). Een deel hiervan krijgt BCG spoeling na een transurethrale resectie van de blaas. Nadere toelichting schatting 1.500 patiënten: In de afgelopen jaren kregen zo’n 700 patiënten met een in situ of T1 tumor een BCG-spoeling en zo'n 850 patiënten met een hooggradige tumor (2). De incidentie van blaaskanker lijkt wel toe te nemen. Dus mogelijk zullen aantallen in de toekomst hoger uitvallen. 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 De dosis durvalumab is 1.500mg elke vier weken tot ziekteprogressie. Prijs per toediening is dan 3x€1.850=€5.550. Voor zes maanden is dit 26/4x€5.550=€36.075. Voor 52 weken is dit 52/4x€5.550=€72.150. In de studie wordt durvalumab onderzocht als monotherapie en in combinatie met tremelimumab. A Deze kosten betreffen alleen durvalumab. Potential total cost per year Total cost € 101,250,000.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks