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

Registration application pending

Product

Active substance

Pembrolizumab

Domain

Oncology and Hematology

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

June 2022

Orphan drug

No

Registration phase

Registration application pending

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.