Durvalumab Medicine 03 December 2024 Extended indication monotherapy in endometrial cancer that is mismatch repair deficient (dMMR). Therapeutic value No estimate possible yet Total cost € 14,380,740.00 Registration phase Registered Product Active substance Durvalumab Domain Oncology Reason of inclusion Indication extension IND Main indication Oncology other Extended indication monotherapy in endometrial cancer that is mismatch repair deficient (dMMR). Current proprietary name Already available biosimilars / generics Proprietary name Imfinzi Manufacturer AstraZeneca Portfolio holder AstraZeneca Mechanism of action PD-1 / PD-L1 inhibitor Route of administration Intracavernous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks https://www.ema.europa.eu/en/medicines/human/variation/imfinzi-0 DUO-E studie Durvalumab in combinatie met olaparib heeft CHMP opinie voor de pMMR groep Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date November 2023 Expected Registration August 2024 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks CHMP opinie juli 2024 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 Additional remarks Expected patient volume per year Patient volume > 165 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Er waren in 2023 in totaal 2.199 patiënten met een endometriumcarcinoom (1). De verdeling van het aantal patiënten per FIGO stadium is 74,0% voor stadium I, 5,0% stadium II, 11,0% stadium III en 10,0% stadium IV (2). De kans op recidief is 6,5% (stadium I), 20% (stadium II), 37,5% (stadium III) en 66,7% (stadium IV) (3). 28,0% is dMMR. Dit betekent dat er ongeveer 165 patiënten in aanmerking komen. Expected cost per patient per year Cost € > 87,156.00 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 Additional remarks Potential total cost per year Total cost € 14,380,740.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks