Atezolizumab

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Registration phase	Withdrawn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
Main indication	Stomach cancer
Extended indication	Gastric cancer
Proprietary name	Tecentriq
Manufacturer	Roche
Mechanism of action	PD-1 / PD-L1 inhibitor
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)
Orphan drug	No
Registration phase	Withdrawn
Additional remarks	Roche geeft aan dat deze indicatie-uitbreiding niet meer wordt verwacht.

Therapeutic value

Therapeutic value	No judgement
Substantiation	Momenteel zijn fase II studies gaande.

Expected patient volume per year

Patient volume	< 555 Market share is generally not included unless otherwise stated.
References	NKR
Additional remarks	In 2016 waren er gemiddeld 555 nieuwe patiënten met cardia of non-cardia maagadenocarcinoom stadium IV.

Patient volume

< 555

Market share is generally not included unless otherwise stated.

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
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 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.

Total cost

27,750,000.00

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.