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Nivolumab

Opdivo

Extended indication

Extension of indication to include in combination with cisplatin-based chemotherapy the first-line t

Therapeutic value

No estimate possible yet
Registration phase

Registration application pending

Product

Active substance

Nivolumab
Domain

Oncology
Reason of inclusion

Indication extension
Main indication

Bladder cancer
Extended indication

Extension of indication to include in combination with cisplatin-based chemotherapy the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
Proprietary name

Opdivo
Manufacturer

BMS
Mechanism of action

PD-1 / PD-L1 inhibitor
Route of administration

Intracavernous
Therapeutical formulation

Intravenous drip
Budgetting framework

Intermural (MSZ)

Registration

Registration route

Centralised (EMA)
Type of trajectory

Normal trajectory
Submission date

October 2023
Expected Registration

August 2024
Registration phase

Registration application pending

Therapeutic value

Therapeutic value

No estimate possible yet
References 
NCT03036098

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

References 
G-standaard
Additional remarks 
Nivolumab 10mg/ml flacon, 4 ml (40mg): €405,03; Nivolumab 10mg/ml flacon, 10ml (100mg): €1.012,56; Nivolumab 10mg/ml flacon, 24ml (240mg): €2.430,15; 
Z-index, 1 april 2021, exclusief btw. de prijs is ingeschat in lijn met andere indicaties. Voor alle indicaties van nivolumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis lopend tot 1 januari 2027. 
Ipilimumab 5mg/ml, flacon 10ml (50mg): €3.268,50; Ipilimumab 5mg/ml, flacon 40ml (200mg): €13.074 
Z-index, 1 april 2021, exclusief btw.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.