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Nivolumab

Opdivo

Extended indication Extension of indication to include adolescent patients aged 12 years and older in treatment of advan
Therapeutic value No estimate possible yet
Registration phase Positive CHMP opinion

Product

Active substance Nivolumab
Domain Oncology
Reason of inclusion Indication extension
Main indication Skin cancer
Extended indication Extension of indication to include adolescent patients aged 12 years and older in treatment of advanced (unresectable or metastatic) melanoma (nivolumab monotherapy), treatment of advanced (unresectable or metastatic) melanoma (nivolumab in combination with ipilimumab) and adjuvant treatment of melanoma (nivolumab monotherapy).
Proprietary name Opdivo
Manufacturer BMS
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date September 2022
Expected Registration June 2023
Orphan drug No
Registration phase Positive CHMP opinion
Additional remarks Positieve CHMP opinie ontvangen 26 april 2023

Therapeutic value

Therapeutic value No estimate possible yet

Expected patient volume per year

Patient volume

< 5

Market share is generally not included unless otherwise stated.
References Expertopinie;
Additional remarks Het betreft een indicatie-uitbreiding voor 12-18 jaar. Op basis van een expertopinie wordt er verwacht dat er maximaal 5 patiënten in aanmerking zullen komen voor deze indicatie.

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. Prijs is ingeschat in lijn met andere indicaties. Voor alle indicatie van nivolumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis lopend tot 1 januari 2024. Ipilimumab 5mg/ml, flacon 10ml (50 mg): €3.268,50; Ipilimumab 5mg/ml, flacon 40ml (200 mg): €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.