Nivolumab

Extended indication	Extension of indication to include OPDIVO for the adjuvant treatment of adults and adolescents 12 years of age and older with stage IIB or IIC melanoma who have undergone complete resection.
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 OPDIVO for the adjuvant treatment of adults and adolescents 12 years of age and older with stage IIB or IIC melanoma who have undergone complete resection.
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	December 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
References	NCT04099251

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 de leeftijd van 12 tot 18 jaar. Op basis van een expertopinie wordt er verwacht dat er maximaal 5 patiënten in aanmerking zullen komen voor deze indicatie.

Patient volume

< 5

Market share is generally not included unless otherwise stated.

References

Expertopinie;

Additional remarks

Het betreft een indicatie-uitbreiding voor de leeftijd van 12 tot 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.

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.