Version 4

Nivolumab

Medicine

Extended indication Opdivo, in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Opdivo as monotherapy as adjuvant treatment, is indicate
Therapeutic value No estimate possible yet
Registration phase Registered

Product

Active substance Nivolumab
Domain Oncology
Reason of inclusion Indication extension IND
Main indication Lung cancer
Extended indication Opdivo, in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Opdivo as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1% (see section 5.1 for selection criteria).
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 January 2024
Expected Registration May 2025
Orphan drug No
Registration phase Registered
Medicine sluice Out of the sluice
Additional remarks Het financiële arrangement voor nivolumab, een geneesmiddel voor kankerbehandeling, is verlengd tot 1 januari 2027.

Therapeutic value

Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.
References NCT04025879 (Checkmate-77T).

Expected patient volume per year

Patient volume < 1,500

Market share is generally not included unless otherwise stated.
References Expertopinie
Additional remarks Volgens de studie AEGEAN (durvalumab) en andere perioperatieve studie, is de verwachting dat er 1.500 patiënten in aanmerking zullen komen.

Expected cost per patient per year

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. Voor nivolumab is er een financieel arrangement afgesloten met het Ministerie van VWS (lopend tot 1 januari 2027). Het verlengde financieel arrangement voor nivolumab heeft mede betrekking op alle (toekomstige) bewezen effectieve indicaties van nivolumab.

Potential total cost per year

Off label use

Indication extension

Other information