Extended indication Extension of indication to include the adjuvant treatment of adults and adolescents aged 12 years
Therapeutic value No estimate possible yet
Total cost 92,340,000.00
Registration phase Positive CHMP opinion

Product

Active substance Pembrolizumab
Domain Oncology
Reason of inclusion Indication extension
Main indication Skin cancer
Extended indication Extension of indication to include the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, Stage IIC or stage III melanoma and to include the treatment of adolescents aged 12 years and older with advanced melanoma for Keytruda
Proprietary name Keytruda
Manufacturer MSD
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Infusion fluid
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date August 2021
Expected Registration July 2022
Orphan drug No
Registration phase Positive CHMP opinion
Additional comments Positieve CHMP-opinie mei 2022

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation De Keynote 716 studie loopt nog door tot oktober 2022. Resultaten of informatie betreffende de plaatsbepaling zijn nog niet bekend.
Frequency of administration 1 times every 3 weeks
Dosage per administration 200 mg
References NCT03553836 (Keynote 716)
Additional comments Treatment up to 2 years.

Expected patient volume per year

Patient volume

< 1,026

Market share is generally not included unless otherwise stated.

References IKNL
Additional comments Incidentie IKNL: 1.026 patiënten, stadium 2, met melanoom van de huid in 2018.

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. Voor pembrolizumab is een financieel arrangement van toepassing tot 1 januari 2024. Aankomende indicatie uitbreidingen vallen onder deze overeenkomst, mits zij voldoen aan stand der wetenschap en praktijk.

Potential total cost per year

Total cost

92,340,000.00

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

There is currently nothing known about indication extensions.

Other information

Additional comments Voor pembrolizumab is een financieel arrangement van toepassing tot 1 januari 2024. Aankomende indicatie uitbreidingen vallen onder deze overeenkomst, mits zij voldoen aan stand der wetenschap en praktijk.