Atezolizumab Medicine 09 January 2018 Extended indication Renal cell carcinoma (RCC), advanced, unresectable - first-line in combination with bevacizumab. Therapeutic value No judgement Total cost € 28,250,000.00 Registration phase Clinical trials 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 bevacizumab. 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 An engineered anti-PD-L1 antibody. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Indication extension ATMP Unknown Submission date April 2018 Expected Registration May 2019 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Sluis-product, financieel arrangement van toepassing. Therapeutic value Current treatment options Sunitinib Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Improved PFS versus sunitinib (IMmotion151). Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 1200 mg References NCT02420821; Scrip Additional remarks Expected patient volume per year Patient volume < 565 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: In 2016 waren er 565 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 (afhankelijk van het stadium 1% van de stadium I tumoren in een jaar en 8% van de stadium III tumoren in een jaar). Een deel hiervan zal in aanmerking komen voor een behandeling. 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 € 28,250,000.00 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 Gastric and TNBC worden later verwacht (2020). Other information Additional remarks