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Nivolumab

Opdivo

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
Main indication Liver cancer
Extended indication Advanced hepatocellular carcinoma (HCC) - first-line.
Proprietary name Opdivo
Manufacturer BMS
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks A fully human IgG4 monoclonal antibody targeting the programmed cell death-1 receptor (PD-1).

Registration

Registration route Centralised (EMA)
Particularity Indication extension
Submission date 2018
Expected Registration November 2019
Orphan drug No
Registration phase Clinical trials
Additional remarks Nivolumab heeft in de sluis gezeten, de afspraken die gedurende die periode zijn gemaakt t.a.v. de vergoeding gelden ook voor deze indicatie-uitbreiding.

Therapeutic value

Current treatment options Sorafenib, Regorafenib
Therapeutic value No judgement
References NCT02576509

Expected patient volume per year

Patient volume

< 158

Market share is generally not included unless otherwise stated.
References NKR
Additional remarks 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
Additional remarks €1.036 voor 10 ml van 10 mg/ml en €414,30 voor 4 ml van 10 mg/ml.

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.