Extended indication For the treatment of patients with previously treated unresectable locally advanced or metastatic co
Therapeutic value No judgement
Registration phase Withdrawn

Product

Active substance Atezolizumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
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.
Proprietary name Tecentriq
Manufacturer Roche
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks An engineered anti-PD-L1 antibody

Registration

Registration route Centralised (EMA)
Submission date August 2018
Expected Registration June 2019
Orphan drug No
Registration phase Withdrawn

Therapeutic value

Current treatment options Regorafenib
Therapeutic value No judgement
Frequency of administration 1 times every 3 weeks
Dosage per administration 1200 mg
References NCT02788279

Expected patient volume per year

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
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

There is currently nothing known about the possible total cost.

Off label use

Off label use No

Indication extension

Indication extension Yes
Indication extensions Gastric and TNBC
References Fabrikant
Additional remarks Deze indicatie-uitbreidingen worden later verwacht (2020).

Other information

There is currently no futher information available.