Extended indication Triple Negative Breast Cancer - Neoadjuvant
Therapeutic value No judgement
Total cost 75,550,000.00
Registration phase Clinical trials

Product

Active substance Pembrolizumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Breast cancer
Extended indication Triple Negative Breast Cancer - Neoadjuvant
Proprietary name Keytruda
Manufacturer MSD
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments Anti-PD-1

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date 2019
Expected Registration 2020
Orphan drug No
Registration phase Clinical trials

Therapeutic value

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

Expected patient volume per year

Patient volume

< 1,511

Market share is generally not included unless otherwise stated.

References NKR
Additional comments NKR 2016: 1.511 diagnoses mammacarcinoom HR-, HER- waarbij een chirurgische ingreep is gedaan.

Expected cost per patient per year

Cost 40,000.00 - 60,000.00
References G-Standaard
Additional comments Voor alle indicatie van pembrolizumab geldt een financieel arrangement dat is voortgekomen uit de onderhandelingen in de sluis (lopend tot eind 2019). AIP per nov 2017: €2.624,38 per injectieflacon 25MG/ML FL 4ML (oplossing). Inschatting: in lijn met andere indicaties.

Potential total cost per year

Total cost

75,550,000.00

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
References Fabrikant

Indication extension

Indication extension Yes
Indication extensions Indicatie-uitbreidingen worden weergegeven in de Horizonscan (Maagkanker, Hoofd- en halskanker, huidkanker, Longkanker, Nierkanker, etc.)
References Fabrikant

Other information

There is currently no futher information available.