Durvalumab Medicine 12 June 2019 Extended indication Squamous cell carcinoma of the head and neck, 1L PDL 1. Therapeutic value Possibly no place in the treatment regimen Total cost € 46,912,500.00 Registration phase No registration expected 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. 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 Anti PD-L1 Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks Voor durvalumab geldt per 1 september 2019 tot eind 2023 een financieel arrangement voor oncologische indicaties. De fabrikant geef aan dat er geen indiening meer verwacht wordt. De primaire eindpunten van de studie zijn niet gehaald. Therapeutic value Current treatment options Pembrolizumab / cetuximab in combinatie met chemo. Therapeutic value Possibly no place in the treatment regimen This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a month Dosage per administration 1500 mg References NCT02551159 Additional remarks 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 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 € 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 en in combinatie met tremelimumab. References Clinicaltrials.gov; Adisinsight Additional remarks Other information Additional remarks