Extended indication Adjuvant melanoma stage III - post-resection adjuvant therapy in high-risk patients.
Therapeutic value No judgement
Total cost 50,700,000.00

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 Financieel arrangement van toepassing op alle indicaties.

Registration

Registration route Centralised (EMA)
Expected Registration June 2018
Orphan drug No
Additional remarks Dit is een indicatie-uitbreiding.

Therapeutic value

Current treatment options Ipilimumab
Therapeutic value No judgement
Duration of treatment Not found
Frequency of administration 2 times a month
Dosage per administration 3 mg/kg
References Weber et al. N Engl J Med. 2017 Nov 9;377(19):1824-1835
Additional remarks Toedieningsfrequentie is 1 maal per 2 weken.

Expected patient volume per year

Patient volume

< 1,014

Market share is generally not included unless otherwise stated.

References NKR; Oncoline
Additional remarks NKR 2015: 1014 diagnoses stadium 2. Oncoline: Er wordt geadviseerd om patiënten met melanoom buiten onderzoeksverband geen systemisch adjuvante behandeling te geven.

Expected cost per patient per year

Cost 40,000.00 - 60,000.00
References Medicijnkosten.nl
Additional remarks 10 mg/ml flacon 10 ml kost €1.098,16. Maximum uitgaande van 12 maanden behandeling van een volwassene van 70 kg.

Potential total cost per year

Total cost

50,700,000.00

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.