Atezolizumab Medicine 09 January 2018 Extended indication Gastric cancer Therapeutic value No judgement Total cost € 27,750,000.00 Registration phase Withdrawn Product Active substance Atezolizumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Stomach cancer Extended indication Gastric cancer Current proprietary name Already available biosimilars / generics Proprietary name Tecentriq Manufacturer Roche 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 An engineered anti-PD-L1 antibody Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration Orphan drug No Registration phase Withdrawn Reimbursement Medicine sluice Additional remarks Roche geeft aan dat deze indicatie-uitbreiding niet meer wordt verwacht. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Momenteel zijn fase II studies gaande. Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume < 555 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks In 2016 waren er gemiddeld 555 nieuwe patiënten met cardia of non-cardia maagadenocarcinoom stadium IV. 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. 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 € 27,750,000.00 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