Pembrolizumab

Active substance Pembrolizumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Kidney cancer
Extended indication Advanced Renal Cell Carcinoma (1L) in combination with lenvatinib.

Product

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)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date 2020
Expected Registration October 2021
Orphan drug No
Registration phase Clinical trials
Additional comments Fabrikant verwacht indiening in 2020 en registratie in oktober 2021.

Therapeutic value

Therapeutic value No judgement
Duration of treatment Not found
Frequency of administration 1 times every 3 weeks
Dosage per administration 200mg
References SMPC Keytruda, NCT02811861
Additional comments Tot maximaal 2 jaar behandeling.

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost < 90,000.00
References G-standaard
Additional comments Voor alle indicatie van pembrolizumab geldt een financieel arrangement dat is voortgekomen uit de onderhandelingen in de sluis. AIP per november 2017: €2.624,38 per injectieflacon 25MG/ML FL 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

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Indicatieuitbreidingen worden weergegeven in de Horizonscan.
References Fabrikant.

Other information

There is currently no futher information available.