Extended indication Extension of indication for Keytruda to include in combination with chemotherapy, treatment of local
Therapeutic value No estimate possible yet
Total cost 6,750,000.00
Registration phase Registration application pending

Product

Active substance Pembrolizumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Breast cancer
Extended indication Extension of indication for Keytruda to include in combination with chemotherapy, treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express PD L1 with a CPS ≥ 10 and who have not received prior chemotherapy for metastatic disease.
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 December 2020
Expected Registration October 2021
Orphan drug Yes
Registration phase Registration application pending
Additional comments De fabrikant verwacht registratie in het laatste kwartaal van 2021.

Therapeutic value

Therapeutic value No estimate possible yet
Frequency of administration 1 times every 3 weeks
Dosage per administration 200 mg
References SmPC
Additional comments -bij mono therapie eenmaal in de 6 weken 400mg mogelijk; -tot maximaal 2 jaar behandeling.

Expected patient volume per year

Patient volume

70 - 80

Market share is generally not included unless otherwise stated.

References DGOG;
Additional comments Het aantal patiënten wordt door de Dutch Gynaecological Oncology Group (DGOG) geschat op maximaal 70-80 patiënten.

Expected cost per patient per year

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

Potential total cost per year

Total cost

6,750,000.00

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 Indicatieuitbreidingen worden weergegeven in de Horizonscan Geneesmiddelen (maagkanker, hoofd- en halskanker, huidkanker, Longkanker, Nierkanker, et cetera.)
References Fabrikant

Other information

There is currently no futher information available.