Durvalumab Medicine 12 June 2018 Extended indication Squamous cell carcinoma of the head and neck, 1L PDL 1 in combination with tremelimumab Therapeutic value No judgement Total cost € 46,912,500.00 Registration phase Clinical trials Product Active substance Durvalumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Head and neck cancer Extended indication Squamous cell carcinoma of the head and neck, 1L PDL 1 in combination with tremelimumab Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer AstraZeneca Portfolio holder Mechanism of action CTLA-4 antibody 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 Unknown Particularity Unknown ATMP Unknown Submission date November 2021 Expected Registration August 2022 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks De fabrikant verwacht indiening in Q4 2021 en registratie in Q3 2022. Therapeutic value Current treatment options pembrolizumab / cetuximab in combinatie met chemo Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Twee fase 2 studies (EAGLE en KESTREL) nog gaande (ESMO 2017). Nog geen publicatie. Duration of treatment Frequency of administration 1 times a month Dosage per administration 1500 mg durvalumab; 75mg tremelimumab References NCT02551159 Additional remarks Toedingsfrequentie 1 maal per 4 weken. Maximaal 4 doses tremelimumab. De behandelduur is nog niet bekend. Expected patient volume per year Patient volume < 695 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR, expertopinie Additional remarks Er zijn in totaal 2.855 met SCC van het hoofd-halsgebied. 375 hiervan hebben stadium III en 1.015 stadium IV. In totaal dus 1.390 met stadium III/IV. Ongeveer de helft zal in te slechte conditie zijn voor een behandeling (695). 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 G-standaard Additional remarks Voor tremelimumab is de dosering 75mg elke 4 weken (maximaal 4 keer). De prijs voor tremelimumab is nog niet bekend. 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 52/4 x €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 € 46,912,500.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Er lopen meerdere studies naar durvalumab als monotherapie en in combinatie met tremelimumab. References Additional remarks Other information Additional remarks