Atezolizumab Medicine 09 January 2018 Extended indication Renal cell carcinoma (RCC), advanced, unresectable - first-line in combination with axitinib. Therapeutic value No judgement Total cost € 32,500,000.00 Registration phase Unknown Product Active substance Atezolizumab Domain Oncology and Hematology Reason of inclusion Main indication Kidney cancer Extended indication Renal cell carcinoma (RCC), advanced, unresectable - first-line in combination with axitinib. Current proprietary name Already available biosimilars / generics Proprietary name Tecentriq Manufacturer Roche Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration April 2019 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options 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 References Additional remarks Expected patient volume per year Patient volume < 650 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Ned Tijdschr Geneeskd. 2008;152:371-5 Additional remarks Ned Tijdschr Geneeskd.: Incidentie van gemetastaseerd niercelcarcinoom in 2007 lag op 650 patienten. Op basis van de NKR: Op jaarbasis verwacht je ongeveer 425-450 nieuwe patiënten met stadium IV niercelcarcinoom (dit is excl niet-carcinomen en niet PA bevestigde tumoren). Daarbij komen dan nog de patiënten die progressie vertonen na stadium I-III. Dat zal op jaarbasis ongeveer 1-8% zijn (afh van het stadium 1% van de stadium I tumoren in een jaar en 8% van de stadium III tumoren in een jaar). Expected cost per patient per year Cost € 40,000.00 - 60,000.00 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 Medicijnkosten.nl; drugs.com Additional remarks Verwacht in lijn met andere immunotherapieën. €1098,16 voor nivolumab 10mg per ml fl 10 ml; €3355,96 voor pembrolizumab 25 mg per ml fl 4ml. In de VS $9.000 dollar voor 1200 mg 20 ml. Potential total cost per year Total cost € 32,500,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Er lopen meerdere PhIII studies. References Additional remarks Other information Additional remarks