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Ipilimumab

Yervoy

Extended indication Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients wit
Therapeutic value No judgement
Total cost 15,844,000.00
Registration phase Positive CHMP opinion

Product

Active substance Ipilimumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Kidney cancer
Extended indication Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma.
Proprietary name Yervoy
Manufacturer BMS
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks CTLA-4 antilichaam

Registration

Registration route Centralised (EMA)
Submission date November 2017
Expected Registration January 2019
Orphan drug No
Registration phase Positive CHMP opinion
Additional remarks Negatieve CHMP-opinie juli 2018. Fabrikant heeft in september 2018 een herbeoordeling aangevraagd. Positieve CHMP-opinie november 2018.

Therapeutic value

Current treatment options TKIs; sunitinib, pazopanib en binnenkort cabozantinib en atezolizumab/bevacizumab.
Therapeutic value No judgement
Duration of treatment Median 12 week / weeks
Frequency of administration 1 times every 3 weeks
Dosage per administration 1 mg/kg
References NCT02231749; ESMO 2017 presentatie
Additional remarks Behandelschema: 4 doseringen; 1 maal per 3 weken.

Expected patient volume per year

Patient volume

367 - 565

Market share is generally not included unless otherwise stated.
References Fabrikant; NKR
Additional remarks In 2016 waren er 565 diagnoses niercarcinoom stadium 4. De inschatting is dat er tussen 367 en 565 mensen met dit middel behandeld kunnen gaan worden.

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

15,844,000.00

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

Off label use No

Indication extension

Indication extension Yes
Indication extensions Malignant melanoma - first-line adjuvant monotherapy
References SPS

Other information

There is currently no futher information available.