Extended indication Tripple Negative Breast Cancer - Neoadjuvant and adjuvant.
Therapeutic value No judgement
Total cost 135,990,000.00
Registration phase Clinical trials

Product

Active substance Pembrolizumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Breast cancer
Extended indication Tripple Negative Breast Cancer - Neoadjuvant and adjuvant.
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 2021
Expected Registration February 2022
Orphan drug No
Registration phase Clinical trials
Additional comments De fabrikant verwacht registratie in het eerste kwartaal van 2022.

Therapeutic value

Therapeutic value No judgement
Frequency of administration 1 times every 3 weeks
Dosage per administration 200 mg
References NCT02819518
Additional comments Maximaal 1 jaar behandeling. NB: voor monotherapie ook 1 x 400 mg per 6 weken mogelijk.

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 < 90,000.00
References G-Standaard
Additional comments AIP per november 2017: €2.624,38 per injectieflacon 25MG/ML FL 4ML (oplossing). Uitgaande van een behandeling van 1 x per 3 weken 200 mg voor 12 maanden zou dat gaan om maximaal €90.000 per patiënt per jaar.

Potential total cost per year

Total cost

135,990,000.00

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, et cetera)
References Fabrikant

Other information

There is currently no futher information available.