Extended indication Extension of indication to include OPDIVO for the adjuvant treatment of adults and adolescents 12 ye
Therapeutic value No estimate possible yet
Registration phase Registered and reimbursed

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 Registered and reimbursed
Additional remarks Handelsvergunning per 31 mei 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.

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 indicaties 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.