Extended indication Advanced hepatocellular carcinoma (HCC) - first-line.
Therapeutic value No judgement
Total cost 7,900,000.00
Registration phase Clinical trials

Product

Active substance Nivolumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Liver cancer
Extended indication Advanced hepatocellular carcinoma (HCC) - first-line.
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)
Additional comments A fully human IgG4 monoclonal antibody targeting the programmed cell death-1 receptor (PD-1).

Registration

Registration route Centralised (EMA)
Submission date November 2019
Expected Registration August 2020
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options sorafenib, regorafenib
Therapeutic value No judgement
References NCT02576509
Additional comments Behandelduur onbekend.

Expected patient volume per year

Patient volume

< 158

Market share is generally not included unless otherwise stated.

References NKR
Additional comments Totaal aantal patiënten in 2016 met hepatocellulair carcinoom stadium 4 betreft 158.

Expected cost per patient per year

Cost 40,000.00 - 60,000.00
References G-standaard, januari 2019
Additional comments nivolumab 10 mg/ml flacon, 4 ml (40 mg): € 405,03; nivolumab 10 mg/ml flacon, 10 ml (100 mg): € 1.012,56; nivolumab 10 mg/ml flacon, 24 ml (240 mg): € 2.430,15; Z-index, 1 augustus 2018, excl. BTW. Gemiddeld aantal toedieningen nog niet bekend, prijs ingeschat in lijn met andere indicaties van nivolumab. Voor alle indicatie van nivolumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis (lopend tot eind 2019).

Potential total cost per year

Total cost

7,900,000.00

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Er lopen meerdere PhIII studies, o.a. Recurrent glioblastoma - second-line monotherapy, Advanced renal cell carcinoma - first-line in combination with ipilimumab.
References Clinicaltrials.gov; SPS.

Other information

There is currently no futher information available.