Durvalumab Medicine 08 December 2020 Extended indication Completely resected NSCLC Therapeutic value No judgement Total cost € 254,002,500.00 Registration phase Clinical trials Product Active substance Durvalumab Domain Oncology and Hematology 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 + CTLA-4 mAB Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date October 2021 Expected Registration July 2022 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks De fabrikant geeft aan indiening in oktober 2021 en registratie in juli 2022 te verwachten. Therapeutic value Current treatment options Geen (na operatie en eventueel chemotherapie) Therapeutic value No judgement 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 3,557 - 3,968 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 2016 waren er 1.699 stadium I, 830 stadium II en 2.056 stadium III patiënten met niet-kleincellig longcarcinoom. 30-50% van de patiënten met stadium IIIa en IIIb zal afvallen omdat het carcinoom niet resectabel blijkt. Dit betekent dat er maximaal 3.557 - 3.968 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 1.500 mg 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. Voor durvalumab geldt per 1 september 2019 tot en met 31 oktober 2023 een financieel arrangement voor oncologische indicaties. Potential total cost per year Total cost € 254,002,500.00 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