Atezolizumab Medicine 12 June 2018 Extended indication For the treatment of patients with previously treated unresectable locally advanced or metastatic colorectal adenocarcinoma 3L in combination with cobimetinib. Therapeutic value No judgement Total cost Registration phase Withdrawn Product Active substance Atezolizumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Colon cancer Extended indication For the treatment of patients with previously treated unresectable locally advanced or metastatic colorectal adenocarcinoma 3L in combination with cobimetinib. 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 Unknown ATMP Unknown Submission date August 2018 Expected Registration June 2019 Orphan drug No Registration phase Withdrawn Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Regorafenib Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 1200 mg References NCT02788279 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks 2.632 diagnoses darmkanker stadium 4 in 2016. Gezien 3L behandeling ligt het patiëntvolume een stuk lager. Expected cost per patient per year Cost € 40,000.00 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 Additional remarks Flacon 1.200 mg kost €4.393,70. Uitgaande van 26 weken behandelduur (obv Cetuximab) zijn er 9 flacons nodig: €39.543,30. Voor alle indicaties van atezolizumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis (lopend tot en met 31 december 2019). Voor de indicatie blaaskanker zit atezolizumab nog in de sluis. Potential total cost per year Total cost 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 Gastric and TNBC References Fabrikant Additional remarks Deze indicatie-uitbreidingen worden later verwacht (2020). Other information Additional remarks