Nivolumab

Extended indication	Mesothelioom (in combinatie met ipilimumab).
Therapeutic value	No judgement
Total cost	28,350,000.00
Registration phase	Clinical trials

Product

Active substance	Nivolumab
Domain	Oncology and Hematology
Reason of inclusion	Indication extension
Main indication	Mesothelioma
Extended indication	Mesothelioom (in combinatie met ipilimumab).
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 remarks	PD-1 antilichaam.

Registration

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
Submission date	August 2020
Expected Registration	September 2021
Orphan drug	No
Registration phase	Clinical trials
Additional remarks	Fabrikant verwacht indiening in Q3 2020 en registratie in Q2/3 2021. Voor nivolumab is er een financieel arrangement afgesloten met het Ministerie van VWS (lopend tot eind 2020). Dit arrangement geldt ook voor alle toekomstige (geregistreerde) indicaties van nivolumab.

Therapeutic value

Current treatment options	Alle PD1 en PDL1 remmers worden verwacht voor deze indicatie (pembrolizumab, atezolizumab)
Therapeutic value	No judgement
Additional remarks	Behandelduur is onbekend

Expected patient volume per year

Patient volume	< 567 Market share is generally not included unless otherwise stated.
References	NKR 2016
Additional remarks	567 diagnoses pleuramesothelioom.

Patient volume

< 567

Market share is generally not included unless otherwise stated.

References

NKR 2016

Additional remarks

567 diagnoses pleuramesothelioom.

Expected cost per patient per year

Cost	40,000.00 - 60,000.00
References	G-standaard, januari 2019
Additional remarks	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, exclusief BTW. Gemiddeld aantal toedieningen is nog niet bekend, prijs ingeschat in lijn met andere indicaties. Voor alle indicatie van nivolumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis lopend tot eind 2020. (Het huidige Opdivo financiële arrangement is met 1 jaar verlengd (t/m 31 december 2020).

Potential total cost per year

Total cost	28,350,000.00 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.

Total cost

28,350,000.00

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	No
References	adisinsight
Additional remarks	Buiten de indicaties in de Horizonscan geen nieuwe indicatie-uitbreidingen bekend.

Other information

There is currently no futher information available.