Extended indication Renal cell carcinoma (RCC), advanced, unresectable - first-line in combination with axitinib.
Therapeutic value No judgement
Total cost 32,500,000.00

Product

Active substance Atezolizumab
Domain Oncology and Hematology
Main indication Kidney cancer
Extended indication Renal cell carcinoma (RCC), advanced, unresectable - first-line in combination with axitinib.
Proprietary name Tecentriq
Manufacturer Roche
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Expected Registration April 2019
Orphan drug No

Therapeutic value

Therapeutic value No judgement
Duration of treatment Not found

Expected patient volume per year

Patient volume

< 650

Market share is generally not included unless otherwise stated.

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
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

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.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Er lopen meerdere PhIII studies.

Other information

There is currently no futher information available.