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Ipilimumab

Yervoy

Extended indication

Extension of indication to include in combination with nivolumab the treatment of adolescents (12 ye

Therapeutic value

No estimate possible yet
Registration phase

Positive CHMP opinion

Product

Active substance

Ipilimumab
Domain

Oncology
Reason of inclusion

Indication extension
Main indication

Skin cancer
Extended indication

Extension of indication to include in combination with nivolumab the treatment of adolescents (12 years of age and older) for advanced (unresectable or metastatic) melanoma.
Proprietary name

Yervoy
Manufacturer

BMS
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 (50mg): €3.268,50; Ipilimumab 5mg/ml, flacon 40ML (200mg): €1.3074. 
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.