Durvalumab Medicine 07 June 2022 Extended indication Unresectable locally advanced or metastatic urothelial cancer in combination with tremelimumab and chemotherapy Therapeutic value No estimate possible yet Total cost € 47,250,000.00 Registration phase Clinical trials Product Active substance Durvalumab Domain Oncology Reason of inclusion Indication extension IND Main indication Bladder cancer Extended indication Unresectable locally advanced or metastatic urothelial cancer in combination with tremelimumab and chemotherapy 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 Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Anti PD-L1 + anti CTLA-4 Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date December 2022 Expected Registration October 2023 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Voor durvalumab geldt tot eind 2023 een financieel arrangement voor oncologische indicaties. Fabrikant verwacht indiening in het vierde kwartaal van 2022 en registratie in het vierde kwartaal van 2023. Therapeutic value Current treatment options Chemotherapie. Positief cieBOM advies voor avelumab onderhoudsbehandeling na stabiele ziekte op chemotherapie. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er zijn nog geen resultaten van de NILE studie bekend. Duration of treatment Frequency of administration Dosage per administration Durvalumab 1500mg, tremelimumab 75mg (maximum of 4 doses) References NCT03682068 (NILE) Additional remarks Expected patient volume per year Patient volume < 700 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2018(1); Additional remarks Er zijn 700 patiënten met gemetastaseerde blaaskanker in Nederland (1). 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 Additional remarks De dosis durvalumab is 1.500mg elke 4 weken tot ziekteprogressie. Prijs per toediening is dan (3 x €2.328)=€6.984. Voor 6 maanden is dit 26/4 x €6.984 = €45.396; voor 52 weken is dit 52/4x €6.984 = €90.792. In de studie wordt durvalumab onderzocht als monotherapie en in combinatie met tremelimumab. Afhankelijk van de behandelduur zal de prijs per jaar tussen de €45.000-€90.000 bedragen uitgaande van 6 of 12 maanden behandeling. Deze kosten betreffen alleen durvalumab. Potential total cost per year Total cost € 47,250,000.00 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