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Nivolumab

Opdivo

Extended indication Adjuvant melanoma stage III - post-resection adjuvant therapy in high-risk patients.
Therapeutic value No judgement
Total cost 17,500,000.00
Registration phase Registration application pending

Product

Active substance Nivolumab
Domain Oncology and Hematology
Main indication Skin cancer
Extended indication Adjuvant melanoma stage III - post-resection adjuvant therapy in high-risk patients.
Proprietary name Opdivo
Manufacturer BMS
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks PD-1 remmer.

Registration

Registration route Centralised (EMA)
Particularity Indication extension
Submission date October 2017
Expected Registration September 2018
Orphan drug No
Registration phase Registration application pending
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 Ipilimumab
Therapeutic value No judgement
Duration of treatment Median 12 month / months
Frequency of administration 1 times every 2 weeks
Dosage per administration 3 mg/kg
References Weber et al. N Engl J Med. 2017 Nov 9;377(19):1824-1835
Additional remarks Maximaal 1 jaar behandelduur.

Expected patient volume per year

Patient volume

350

Market share is generally not included unless otherwise stated.
References NKR; Oncoline; Fabrikant
Additional remarks NKR 2015: 427 diagnoses melanoom stadium 3. Oncoline: momenteel wordt er niet geadviseerd om patiënten met melanoom buiten onderzoeksverband systemisch adjuvante behandeling te geven. Fabrikant geeft een realistisch patiëntenvolume aan van 350.

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. Maximum uitgaande van 12 maanden behandeling van een volwassene van 70 kg.

Potential total cost per year

Total cost

17,500,000.00

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 Diverse
References Fabrikant

Other information

There is currently no futher information available.