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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.