Durvalumab Medicine 08 December 2020 Extended indication Lokaal gevorderd, niet-resectabel NSCLC (stadium III) Therapeutic value No estimate possible yet Total cost € 66,217,500.00 Registration phase No registration expected Product Active substance Durvalumab Domain Oncology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Lokaal gevorderd, niet-resectabel NSCLC (stadium III) 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 No Submission date 2024 Expected Registration 2025 Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Chemotherapie, chemoradiatie. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times every 4 weeks Dosage per administration 1500 mg durvalumab References PACIFIC-2 (NCT03519971) Additional remarks Expected patient volume per year Patient volume 735 - 1,226 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 2.452 stadium III patiënten met niet-kleincellig longcarcinoom. 30% tot 50% van de patiënten met stadium IIIa en IIIb zal in aanmerking komen omdat het carcinoom niet resectabel blijkt. Dit betekent dat er maximaal 735 tot 1.226 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 26/4 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 en €90.000 bedragen uitgaande van 6 of 12 maanden behandeling. Deze kosten betreffen alleen durvalumab. Potential total cost per year Total cost € 66,217,500.00 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