Durvalumab Medicine 03 December 2024 Extended indication Durvalumab in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with: - combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR). (DUO-E) Therapeutic value No estimate possible yet Total cost € 19,458,432.00 Registration phase Registered Product Active substance Durvalumab Domain Oncology Reason of inclusion Indication extension IND Main indication Oncology other Extended indication Durvalumab in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with: - combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR). (DUO-E) 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 Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Unknown Type of trajectory Unknown Particularity Unknown ATMP No Submission date 2024 Expected Registration August 2024 Orphan drug No Registration phase Registered Reimbursement Medicine sluice 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 Additional remarks NCT04269200 Expected patient volume per year Patient volume 149 - 155 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR (1); Advies - vergoed dostarlimab (Jemperli®) voor de behandeling van baarmoederkanker. Zorginstituut. 2024 (2). Additional remarks Jaarlijks worden ruim 2.000 nieuwe gevallen van endometriumcarcinoom gediagnosticeerd (1). Volgens de budget impactanalyse van de vergoeding van dostarlimab voor dezelfde indicatie als dit middel wordt een patiëntvolume van 149 tot 155 per jaar geschat (2). Expected cost per patient per year Cost € > 128,016.00 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 IMF Eerst 6 cycli 1.120mg Q3W (1*558.72 + 2*2.328,0 = €5.214), gevolgd door ongeveer 8 maanden 1.500 Q4W. 3*2.328,0 = 6.984. (31.284 + 55.872) 87.156 per patient LYN 41.95 per 150mg tablet, 300mg 2dd, €167,80 per dag voor 8 maanden land (alleen onderhoudsfase) = 167,80*30,44*8 = €40.860 / Totaal = €128.016 (87.156 + 40.860) Additional remarks Kosten van zowel durvalumab als olaparib (combinatiebehandeling) Potential total cost per year Total cost € 19,458,432.00 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