Durvalumab Medicine 08 December 2020 Extended indication Completely resected NSCLC Therapeutic value No estimate possible yet Total cost € 277,830,000.00 Registration phase Clinical trials Product Active substance Durvalumab Domain Oncology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Completely resected NSCLC 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 mAb Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date 2023 Expected Registration 2024 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 2023 en registratie in 2024. Therapeutic value Current treatment options Geen (na operatie en eventueel chemotherapie) 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 1500 mg durvalumab References BR31 (NCT02273375) Additional remarks Expected patient volume per year Patient volume 3,871 - 4,361 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Therapeutic management options for stage III non-small cell lung cancer. SM Yoon. 2017. Additional remarks In 2018 waren er 1.724 patiënten in stadium 1, 921 patiënten in stadium II en 2.452 patiënten in stadium III met niet-kleincellig longcarcinoom. 30% tot 50% van de patiënten met stadium IIIa en IIIb zal afvallen omdat het carcinoom niet resectabel blijkt. Dit betekent dat er maximaal 3.871 tot 4.361 patiënten in aanmerking zullen komen. 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 Fabrikant Additional remarks De dosis durvalumab is 1.500mg elke 4 weken tot ziekteprogressie. Prijs per toediening is dan 3x€2.328=€6.984. Voor 6 maanden is dit 26/4x€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 en €90.000 bedragen uitgaande van 6 of 12 maanden behandeling. Deze kosten betreffen alleen durvalumab. Potential total cost per year Total cost € 277,830,000.00 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