Extended indication Breast cancer, metastatic, triple negative, 1L.
Therapeutic value No judgement
Total cost 5,000,000.00

Product

Active substance Pembrolizumab
Domain Oncology and Hematology
Main indication Breast cancer
Extended indication Breast cancer, metastatic, triple negative, 1L.
Proprietary name Keytruda
Manufacturer MSD
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Anti-PD-1

Registration

Registration route Centralised (EMA)
Particularity Indication extension
Expected Registration 2019
Orphan drug No
Additional remarks Pembrolizumab 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

Therapeutic value No judgement
Frequency of administration 1 times every 3 weeks
Dosage per administration 200 mg
References Fabrikant

Expected patient volume per year

Patient volume

< 100

Market share is generally not included unless otherwise stated.

References NKR
Additional remarks NKR 2015: 100 diagnoses mammacarcinoom HR-, HER-, stadium 4.

Expected cost per patient per year

Cost 40,000.00 - 60,000.00
References Medicijnkosten.nl, AIP fabrikant.
Additional remarks AIP per nov 2017: €2624,38 per injectieflacon 25MG/ML FL 4ML (oplossing). € 1312,19 per injectieflacon 50MG FL (poeder)

Potential total cost per year

Total cost

5,000,000.00

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.