Ipilimumab

Extended indication	Renal cell carcinoma, 1L. In combinatie met Nivolumab.
Therapeutic value	No judgement
Total cost	20,400,000.00

Product

Active substance	Ipilimumab
Domain	Oncology and Hematology
Main indication	Kidney cancer
Extended indication	Renal cell carcinoma, 1L. In combinatie met Nivolumab.
Proprietary name	Yervoy
Manufacturer	BMS
Route of administration	Intravenous
Therapeutical formulation	Intravenous drip
Budgetting framework	Intermural (MSZ)

Registration

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

Therapeutic value

Therapeutic value	No judgement
Duration of treatment	Median 12 week / weeks
Frequency of administration	2 times a month
Dosage per administration	1 mg/kg
References	Clinical trial NCT02231749; ESMO 2017 presentatie
Additional remarks	Behandelschema: 4 doseringen; 1 maal per 3 weken.

Expected patient volume per year

Patient volume	< 600 Market share is generally not included unless otherwise stated.
References	Expertopinie
Additional remarks	500-600 gemtastaseerde niercelcarcinomen.

Patient volume

< 600

Market share is generally not included unless otherwise stated.

References

Expertopinie

Additional remarks

500-600 gemtastaseerde niercelcarcinomen.

Expected cost per patient per year

Cost	< 34,000.00
References	Fabrikant
Additional remarks	Uitgaande van een gemiddeld gewicht van 70 kg zijn de behandelkosten per individuele patiënt €34.000 (bij 4 doseringen). De berekening is als volgt: voor een patiënt van 70 kg is 70x1 mg=70 mg ipilimumab nodig: 2x10 ml flacons (2x €4250) is €8.500 per gift. €8500x 4 doseringen= €34.000 Ipilimumab pppj. NB: berekening is alleen vooor Ipilimumab, Nivolumab komt hier nog bij.

Potential total cost per year

Total cost	20,400,000.00 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

20,400,000.00

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.