Extended indication Locally Advanced Head and Neck Squamous Cell Carcinoma With Chemoradiation.
Therapeutic value No estimate possible yet
Total cost 33,750,000.00
Registration phase Clinical trials

Product

Active substance Pembrolizumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Head and neck cancer
Extended indication Locally Advanced Head and Neck Squamous Cell Carcinoma With Chemoradiation.
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 2021
Expected Registration May 2023
Orphan drug No
Registration phase Clinical trials
Additional comments Fabrikant verwacht indiening in 2021 en registratie in het tweede kwartaal van 2023.

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation Op dit moment loopt de Keystone-421 studie nog.
Frequency of administration 1 times every 3 weeks
Dosage per administration 200mg
References SMPC KEYTRUDA; NCT03040999
Additional comments - tot maximaal 1 jaar behandeling.

Expected patient volume per year

Patient volume

< 375

Market share is generally not included unless otherwise stated.

References NKR, expertopinie
Additional comments Er zijn in totaal 2.855 met SCC van het hoofd-halsgebied. 375 hiervan hebben stadium III.

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, 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

33,750,000.00

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

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Indicatie uitbreidingen worden weergegeven in de Horizonscan Geneesmiddelen.
References Fabrikant

Other information

There is currently no futher information available.